Express Pharma (Vol.11, No.16) June 16-30, 2016

VOL. 11 NO. 16 PAGES 68

www.expresspharmaonline.com

Market ‘India market is very important to us’

Research SNEC30 was prepared with the use of the self nano emulsifying drug delivery system 16-30 JUNE 2016,` 40

CONTENTS Vol.11 No.16 JUNE 16-30, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap DESIGN

‘India market is very important to us’ John Conlon, Executive Vice President - Asia Pacific, IDA Ireland, in conversation with Viveka Roychowdhury, explains that while mergers between biopharma companies might lead to exits and facility shut downs, he is confident of finding takers for any Irish biopharma plants that might come up for sale | P8

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar

Marketing Team Rajesh Bhatkal Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

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PATIENTSAFE INDIA TO ADDRESS THE CHALLENGE OF DRUG COUNTERFEITING

MANAGEMENT

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NEW MERGER BETWEEN PFIZER AND ANACOR TO LEVERAGE OPPORTUNITIES IN ATOPIC DERMATITIS SPACE: GLOBALDATA

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PHARMA M&AS: VALUE CREATOR OR VALUE DESTROYER?

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MENINGOCOCCAL VACCINES MARKET SET TO APPROACH $1.8 BN BY 2025: GLOBALDATA

■ INTERVIEWS P23: ‘SNEC30 was prepared with the use of the self nano emulsifying drug delivery system’ Dr Saurabh Arora, Executive Director, Arbro Pharmaceuticals

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Ravindra Pawar - South Harit Mohanty - West & East

MARKET

P28: ‘Our courses are specially designed for Indian conditions’ Sheesh Gulati, Chairman, CCSI

P29: ‘India's share is hardly 10-12 per cent of the total (cleanroom consumables) market’ Sanjiv Marathe, Proprietor and CEO, Singapore India Trade Resources Company

P31: ‘Alfa Laval holds leading global market position within its fields of expertise

P LIFE

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KANCHANA TK APPOINTED NEW DIRECTOR GENERAL OF OPPI

NP Desai, Segment Manager PWW, Alfa Laval (India)

P33: ‘MedTrix is proud to partner with large global pharma companies’ Vimal Narayanan, Director, Medtrix Healthcare

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. The Indian Express (P) Ltd. All rights reserved throughout the world.

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EDITOR’S NOTE

Betting big on M&As

D

r Reddy's Laboratories' June 11 announcement that it had entered into an agreement with Teva and Allergan to buy eight Abbreviated New Drug Applications (ANDAs) for $350 million is the latest in a series of global buys by big Indian pharma companies.

DRL's peers like Sun Pharma, Lupin, and Cipla have been on an acquisition spree but they have been shopping very selectively. The collective wisdom seems to be that selective buys of brands and research leads are a much better bet than big buys, which might take longer and prove difficult to digest.

These Indian pharma companies are cashing in on opportunities provided by mergers between their global peers. For instance, DRL's latest deals cover products that need to be divested by Teva as it seeks to acquire Allergan’s generics business.

DRL's deal is subject to approval from the US Federal Trade Commission as well as Teva's buy of Allergan's generics portfolio going through.

This adds a layer of complexity to the deal but once it goes through, DRL is obviously looking at the end game: according to IMS Health, the combined sales of the branded versions of these eight ANDAs in the US is approximately $3.5 billion MAT for the most recent 12 months ending in April 2016.

Deal by deal, Indian pharma companies are deepening their forays into global markets as pricing pressures increase in the domestic market.

For instance, according to PharmaTrac's MAT for May, the fixed dose combination (FDC) related market continued its degrowth (by 14.6 per cent), while the non-FDCs market grew at 8.4 per cent.

The impact of the ban on FDCs is greater on Indian companies with their FDC portfolios showing a degrowth of 20.2 per cent whereas that of MNCs degrew by 0.9 per cent for May. Thus their focus on global markets will only increase but how will this impact prices of and access to medicines with India?

Similar concerns were raised after a slew of inbound M&As raised concerns that in response to the government opening the pharma sector for foreign direct investment (FDI), deals were skewed in favour of brownfield investments (more than 90 per cent, $989 million during April 2012April 2013 compared to $87.3 million for greenfield investments).

A report released in November last year titled, 'Impact of Merger & Acquisitions in Indian Pharma on Production, Access and Pricing of Drugs', analysed six major cases in which Indian pharma companies were acquired by MNCs, covering three years before and after the

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The collective wisdom seems to be that selective buys of brands and research leads are a much better bet than big buys, which might take longer and prove difficult to digest

acquisition. They were Ranbaxy’s acquisition by Daiichi Sankyo (its subsequent acquisition by Sun Pharma is out of the purview of this study), Fresenius Kabi’s acquisition of Dabur Pharma, Piramal Healthcare’s acquisition by Abbott, Matrix Laboratories’ acquisition by Mylan, acquisition of Orchid Chemicals’ generic injectable business by Hospira and acquisition of Shantha Biotechnics by Sanofi Pasteur.

The study was implemented by IPE Global, with support from the Knowledge Partnership Programme (KPP) supported by Government of UK’s Department for International Development (DFID). While the overall impact for the concerned companies was positive, the study highlighted some areas of negative social impact of these six M&As. For example, according to the IPE Global study, post M&A, rate of growth for these companies increased for tier 1-2 towns but a lower growth rate was seen in lower town class as compared to pre-acquisition period, possibly due to the industry view that lower tier markets are much more complex to penetrate and present less profitable opportunities in short term. Thus it recommends that policy makers should incentivise availability in these areas while pharma companies should participate in developing and sharing supporting infrastructure to ensure availability of medicines in rural areas is not impacted even after M&As. The study ends with a suggested policy roadmap to maximise the positive public health impact of such M&As in pharma sector, which includes measures such as promoting competition in molecules with high market share of one or two companies, molecule level price monitoring post-acquisition for a defined time period, harmonisation among national drug regulatory agencies in developing countries and incentivising exports to meet medicine access needs across the globe.

It is still too early to analyse the social impact of Indian pharma majors are increasing investments into global and mostly the US market. But if these forays allow them to grow big enough to lessen the pinch of pressures they face in the domestic market, will they plow back some profits into India? Will they increase R&D spend on molecules specific to India? For the short term, there may be some pain as the cover story in this issue points out (June 16-30, 2016 issue, M&As ka side effects, pages 12-16) but let’s hope that these big bets play out all the way.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘India market is very important to us’ The number of Indian companies investing in Ireland through IDA Ireland has doubled in the last three years, from 15 companies in 2013 to around 30 today but John Conlon, Executive Vice President - Asia Pacific, IDA Ireland would like to win more new investments from India.

In conversation with Viveka Roychowdhury, he explains that while mergers between biopharma companies might lead to exits and facility shut downs, he is confident of finding takers for any Irish biopharma plants that might come up for sale

With the referendum on Britain's exit around the corner, how would a Brexit impact Ireland?

Ireland's stated position on this issue is that it wouldn't be good for the UK to leave the Eurozone. It wouldn't be good for Europe for the UK to leave.

And it wouldn't be good for Ireland if the UK leaves the Eurozone. So we would be very supportive of the UK remaining in the EU. Ireland and the UK have a very close relationship, especially from a commercial point of view, as it is our biggest market. But that's a decision for the UK electorate to make.

In the context of Tata Steel deciding to exit the UK, how does Ireland handle such exits, in terms of ease of doing business?

Even as some companies might exit Ireland due to a change in business imperatives (an example being a small unit of Reliance Lifesciences which will close down over time due to an amalgamation with the company), I am confident of finding takers for any pharma manufacturing facility that might come up for sale.

Biotech facilities coming up for sale in Ireland are rare so finding buyers would not be a problem. There is also a rationalisation of API plants worldwide, thanks to the mergers between large companies. Such transactions would result in a consolidation as the companies seek to

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extract value by reducing cost and one way of doing that is to reduce the number of facilities. We've been very lucky in Ireland (on this front).

For example, as a result of Pfizer and Wyeth's amalgamation, and other acquisitions that Pfizer did, Pfizer sold their Dublin facility to Amgen. So that rationalisation brought another famous lifesciences company to Ireland.

Similarly, we already have a number of companies, both Indian and global, expressing an interest in Ranbaxy's facility in Ireland, which Sun Pharma is looking to offload (post the merger). Besides Ireland's track record in the lifesciences sector, we also offer business friendly labour and exit laws which allow smooth management changes.

What does Ireland offer investor companies?

The trend is for companies to use Ireland to develop new products and access the EU market. For example, one of the companies I met on my trip in April to India is a medical device company which wants to access the EU market. So, they would be looking to establish (an) R&D and European base in Ireland.

How does Ireland fare as a destination for FDI, specifically from global biopharma majors?

There are 1250 IDA assisted overseas companies that have set up in Ireland, across

About 30 Indian companies have a presence in Ireland across sectors, with Wockhardt and Ranbaxy among the larger pharma companies

sectors, employing around 190,000 people - an all time high presently. There are, however, more if you include non-IDA assisted companies.

Around 50,000 people are employed in the life sciences sector, split equally between pharma and medical devices.

Nine of the world’s top 10 pharma companies have a base in Ireland, with € one billion additional investments coming in the biopharma space in the last two to three years from the likes of Regeneron, Eli Lilly and, more recently, from Shire.

From an export point of view, our GDP (in 2015) is €214.6 billion, of which nearly € 90 billion is from exports.

IDA assisted companies contributed €124.5 billion to this GDP. Pharma and chemicals make up 27 per cent of exports out of Ireland, while medical devices make up six per cent. Pharma exports were €64.2 billion in 2015 while medical devices exports were €14.3 billion.

Ireland has around 75 pharma companies, both generic as well as innovator, with 33 US FDA approved pharma and biopharma plants. About 30 Indian companies have a presence in Ireland across sectors, with Wockhardt and Ranbaxy among the larger pharma companies.

What has been the growth in IDA Ireland's business, specifically from India, over the years?

70 per cent of the IDA Ireland business comes from the US, 20 per cent from Europe and the remaining 10 per cent from the Asia Pacific region.

Our goal is to grow this business but obviously this is a long term project, spanning 5-15 years. All our large investments come from companies that are already located in Ireland. Our goal is to get as many new Indian companies to invest in Ireland over time. And this takes time from the point of view that you have to find the right Indian company with the right fit. We are building the business year-on-year, so the Indian market would be very important to us.

In 2013, around 15 companies from India across sectors had invested in Ireland through IDA Ireland and today we have close to 30, with Wockhardt and Ranbaxy among the larger pharma companies, employing in excess of 3000 people. All of these companies are growing, which is proof that Ireland is a good location for Indian companies.

Ireland has both, big generic as well as research driven pharma companies, and thus reflects the global nature of this industry.

Ireland's track record of clinical and academic research excellence and its geographical location as a base in the EU region are two attractive features of the country for Indian companies. viveka.r@expressindia.com

MARKET PRE EVENT

PatientSafe India to address the challenge of drug counterfeiting The conference, to be held on June 28, 2016 at Courtyard Marriott, Mumbai, will deliberate on creative ways to raise awareness and devise strategies to curb the practice of drug counterfeiting DRUG COUNTERFEITING has emerged as a significant problem for all stakeholders in the pharmaceutical industry.

This menace causes serious health hazards to the patients while devaluing brand credibility and reducing the trust on the pharma industry.

As a part of a nationwide campaign against drug counterfeiting, PatientSafe India, a one-day conference on addressing the challenge of drug counterfeiting, is being organised at Mumbai. It is slated to be held on June 28, 2016 at Courtyard Marriott, Mumbai

International Airport, Mumbai. This conference will be facilitated by SynCore Consulting with active collaboration of all the industry associations, regulators, trade bodies and consumer groups such as OPPI, IDMA, IPA, IMA, PDA and AIOCD. The theme of the conference is to deliberate on the various aspects of drug counterfeiting and suggest creative ways to raise awareness and devise strategies to curb the practice of drug counterfeiting.

The initiative aims to ensure patient safety by ad-

The conference will be addressed by eminent speakers from different segments of the pharma ecosystem

dressing the challenge of drug counterfeiting through programmes such as trade meets, round tables and conferences. The initiative also intends to bring together the different stakeholders on a common platform to enable discussions, sharing of insights, best practices and strategies to tackle drug counterfeiting.

The conference is expected to see the presence of eminent speakers from different segments of the pharma ecosystem. Senior representatives from OPPI, AIOCD, IMA, IPA,

IDMA, FDA as well as various government agencies, Directors of Policies and Government affairs and senior management professionals from the industry will share their insights on tackling the challenge of drug counterfeiting.

Delegates from different segments of the pharma industry will also attend this event. Representatives from various drug packaging and labelling companies, drug regulatory agencies, security and risk management companies and formulation pharma manufacturers will also participate in the event.

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cover )

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THE MAIN FOCUS

Indian pharma companies have notched up some aggressive global buys recently but the sector's experience with cross border M&As has been mixed. Are they on the right track this time? And how will companies deal with the possible backlash from employees as they rightsize to maximise benefits from such deals?

BY VIVEKA ROYCHOWDHURY

T

he deal making path is certainly not smooth. The aborted PfizerAllergan merger, which was dubbed Phallergan, proves that even the biggest of big pharma is not immume to roadblocks. But aborted and failed deals are not going discourage corporates from planning, strategising, finalising and even fantasing about a dream deal that will jettison them ahead of their peers.

In fact, EY’s Firepower Index and Growth Gap Report 2016 predicted that focused acquisitions and divestitures will become paramount this year, specifying that deals targeting narrower therapeutic

battlegrounds, emerging and exciting scientific opportunities, geographic strongholds and strategic gaps will drive the M&A agenda. Even though the report was released before Phallergan was called off, the EY report’s predictions are in line with other industry analyses. As deals drive more deals, competitors are forced to respond but since few large companies have the financial wherewithal to pursue transformative acquisitions, targeted M&A and divestitures have and should continue to pick up the slack.

There are a number of signs that this is already happening.

After Pfizer and Allergan decided not to say ‘I do’, a

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It is key that one does their homework properly. The more challenges you can identify in advance, the easier and smoother the ride Manisha Shroff Associate Partner, Khaitan & Co

GlobalData report in early June commented that an upcoming merger agreement between Pfizer and Anacor, worth around $5.2 billion, would help both companies leverage their strengths in the atopic dermatitis space.

Pharma companies in India have had their fair share of successes and lemons. Far from being a dream of a deal, the Daiichi Sankyo-Ranbaxy saga will probably go down as a case study in the 'how not to do a deal' section. While the promoters of Ranbaxy got a good valuation when they sold out, Daichii Sankyo paid the price for insufficient due diligence.

Ranbaxy's peers seem keen not to make the same mistakes

when they acquire assets overseas. (See box: Fallen heroes)

In search of synergies In spite of the increasing levels of complexity due to tax regualtions and currency fluctuations, the search for synergies continues. Of late, the complexion of deals involving pharma players from India has been diametrically opposite to the mega Daiichi Sankyo-Ranbaxy and Sun Pharma-Ranbaxy buyout/mergers. The latter one seems to have spurred other big Indian pharma companies into an almost desperate race to close the gap in rankings and revenues. But are they going deeper with their due diligence? As acquirers, their

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cover ) recent buys seem more doable and deal complexity too has ratcheted to a new level but its still to early to tell for sure.

Consider for example, Lupin's acquisition of assets in the US (Gavis Pharmaceuticals, Novel Laboratories, VGS Holdings and one share of Novel Clinical Research) through bridge financing of $880 million from JP Morgan Chase Bank in July 2015.

Touted as one of the largest offshore acquisitions by a company from the Indian pharma sector, the deal reportedly created the fifth largest pipeline of ANDA filings with the US FDA, addressing a $63.8 billion market, with over 45 First-to-Files (FTFs).

The way Lupin derisked its financing was interesting but not completely novel.

Analysing the financials backing this deal, Anil Khanna, Partner, Tai Pi Advisors says, “Lupin took the debt in US market, in the foreign currency, gave corporate guarantee backed by the parent company, since US subsidiaries balance sheet wasn’t big enough to justify such a big loan. Much earlier, Wockhardt has also taken a similar route. This route enables the Indian company to take a low cost foreign currency loan and also avoid all the risks on account of currency movement or the change in business movement. These deals were valued at 16 times EBITDA multiple. Again some analysts felt it was a high price!” (For more analysis, read his article in this issue, Pharma M&As – value creator or a value destroyer?, pages 18-21) Other big pharma companies from India have forged deals similar to Lupin's, buying assets, either manufacturing facilities or research leads, in the US and other western markets. Sun Pharma continues to rationalise different parts of the merged entity. For

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The acquisition of Piramal by Abbott and Ranbaxy by Sun Pharma had culture and people issues.

Both Ranbaxy and Abbott had an ‘MNC way of working’, which made integration difficult.

Many Ranbaxy people chose to quit rather than opting to work with the merged entity

Due to the consolidation during the initial phase postmerger/ takeover, there are initially less roles available.

However, in the long run such corporate activity creates many vacancies due to the companies’ expansion plans

At a certain scale, some of the synergies and complementaritie s start breaking down. Sun Pharma got Ranbaxy at a good price, but can they derive better business value?

Mayank Chandra

Maneesh Chandra

Anil Khanna

Managing Partner, Antal International

Principal, ZS Associates

located outside of established industrial areas (as we have in India), higher categories of environmental due diligence may be called for,” Shroff pointed out. For companies looking at targets overseas, Shroff highlighted that “employment and pensions is another aspect which is tricky in several developed jurisdictions and something that Indian companies may not face in India.”

Thus as big Indian pharma companies look to grow their global footprint, they need to consider that big ticket deals would be more difficult to manage. For example, when Dr Reddy's Laboratories (DRL) bid for Germany's fourth largest generic firm, Betapharm in 2006, it was then the largest outbound deal by an Indian pharma company. But DRL's plans went haywire when the German government announced a switch to a tender-based process soon after the deal. Sun Pharma too faced a prolonged battle with hostile stakeholders in its attempts to

buy controlling stakes of Israeli Taro Pharma. Though it entered into an option agreement in 2007, it took three years to acquire a 69 per cent controlling stake in Taro Pharma.

Shroff agrees that “bigger deals tend to have several moving parts” like various operational matters, finance, tax and accounting workstreams, etc. which creates the possibility for slippage and creating wider crevices for deal process to fall through. Which is why she stresses that “it is key that one does their homework properly.

The more challenges you can identify in advance, the easier and smoother the ride.” She also advises that it is very important to ensure that all acquisition teams retain sight of the bigger picture and remain aligned on the direction of movement.

Partner,Tai Pi Advisors

instance, it has shut down or sold some of its global manufacturing plants (Ireland, Ohio, Philadelphia and Illoinois) in a bid to synergise operations.

Deeper due diligence So, is there a foolproof strategy to ensure deals do not go sour, especially when they are cross border transactions with higher levels of complexity?

Manisha Shroff, Associate Partner, Khaitan & Co., who advised Lupin on the Gavis Pharmaceuticals-Novel Laboratories- VGS Holdings- Novel Clinical Research transaction said that the deal process for such a deal is not very different from a pure domestic deal.

However, she does list a few action points. “Depending on the jurisdiction involved, it is advisable to focus on certain diligence work streams more than others. For instance, if the target involves plants for western jurisdictions, technical and GMP compliance diligence is very important,” she said.

“Additionally, for plants

From paper to practice Maneesh Chandra, Principal, ZS Associates, a consultancy involved with a variety of projects including sales force

optimisation, takes a slightly contrarian view when he says, “The track record of mergers in the global pharma industry, considering all the big M&As that happened in the 1990s, has been extremely mixed.

Especially when it comes to (achieving) complementarities in transactional mergers from a business perspective. In my opinion, some of the complementarities are good only on paper.”

The people factor If deal making as a trend is set to increase, it is sure to impact the pharma workforce. Mega mergers could see contraction in the number of job positions, as the merged entity strives to derive maximum synergies between workforces. A perceived dearth of positions could see the sector losing key talent to other sectors, especially in the sales and marketing functions.

For instance, the Sun Pharma-Ranbaxy merger created one of the largest sales forces in India but Sun Pharma’s moves to optimise this field force through transfers etc has met with stiff opposition from the Federation of Medical and Sales Representatives Association of India.

There are reports of medical representatives going on mass casual leave to protest these measures.

While deals are signed in boardrooms, they need to be executed across the rank and file of the company. And this is why Shroff stresses that communication between senior management and staff level is crucial and spells out that in order to retain employee morale, appropriate communication should be employed to give them context on why are they changing hands, and what lies in store for the future.

Would future mega mergers face a backlash and be opposed even before they get to the

(

drawing board? And would the perceived post-merger job uncertainty deter young talent from considering this sector or even cause an exodus of existing talent from the pharma sector to greener pastures?

As Khanna points out, “The acquisition of Piramal by Abbott and that of Ranbaxy by Sun Pharma had culture and people issues. Both Ranbaxy and Abbott had an ‘MNC way of working’, which made integration difficult. Likewise, many Ranbaxy people chose to quit rather than opting to work

THE MAIN FOCUS

If deal making as a trend is set to increase, it is sure to impact the pharma workforce. Mega mergers could see contraction in the number of job positions, as the merged entity strives to derive maximum synergies between workforces. with the merged entity.”

Recruiters, quite understandably, prefer to take the 'glass half full' approach.

Mayank Chandra, Managing Partner, Antal International,

agrees that across sectors, takeovers and mergers do have an effect on HR indicators like the appraisal system and the job markets. This is true for the pharma sector as well. “It is

usually observed that the appraisal process becomes stringent immediately post a takeover/merger process, simply because with numbers on its side the company doing the

takeover can afford to separate the wheat from the chaff rigorously. Naturally, the employees, especially those who are performing roles that can be overtaken easily by another in the same company and the underperformers start looking out, thus feeding the job market,” he reasons.

Similarly, during the initial post merger/takeover phase, he points out that initially there are less roles available due to consolidation. However, Chandra of Antal International stresses a positive long term

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cover ) view, because “in the long run such corporate activity creates many vacancies due to the companies’ expansion plans.”

He also refutes the charge that the pharma sector is losing talent. He has, in fact, observed that both candidates as well as companies, prefer to remain within the same sector due to the technical competencies and nature of the sector, especially in sales and marketing roles.

When synergies start breaking down History is proof that all deals do not have a happy ending.

“The track record of mergers in the global pharma industry, considering all the big M&As that happened in the 1990s, has been extremely mixed, says Chandra of ZS Associates, especially when it comes to (achieving) complementarities in transactional mergers from a business perspective. In his opinion, some of the complementarities are good only on paper.

Analysing the Sun PharmaRanbaxy merger further from a product portfolio point of view, his first point is that while Ranbaxy had a broad set of anti infectives, Sun Pharma has a broad set of cardiovascular and speciality products.

“With such a broad portfolio, where is the opportunity to offer this basket of products to the same set of physicians?

More sales people from the same company calling up the same set of doctors may not translate into synergies. At a certain scale, some of the synergies and complementarities start breaking down,” is his argument. Conceding that the Sun Pharma got Ranbaxy at a good price, he questions whether they can now derive better business value.

Secondly, he mentions how chance is an important factor in such deals. For instance, Ranbaxy's strong presence in the emerging markets (EMs) today does not make too much sense because all the EMs, except for India, are not doing that great. Any dependencies that the Indian companies had

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FALLEN HEROES

H

ailed as a milestone deal in 2008, the Daichii Sankyo-Ranbaxy merger was hailed as a badge of honour for the pharma industry in India and a win-win for both companies. The erstwhile promoters of Ranbaxy Laboratories, Malvinder and Shivinder Singh and their family, sold their entire stake of about 35 per cent in Ranbaxy for $2.4 billion to Daiichi Sankyo, allowing them to focus on their hospital business.

The main driver for the Japanese partner was access to the huge Indian market.

But today, the Daiichi SankyoRanbaxy deal will probably be remembered for all the wrong reasons.

The merged entity had to deal with repeated raps from the US FDA for serious non-compliance issues which finally resulted in a consent decree and a $500 million penalty. Five years after the deal, in November 2012, Daiichi Sankyo filed an arbitration case in Singapore, alleging that certain former shareholders of Ranbaxy 'concealed and misrepresented certain critical information concerning US Food and Drug Administration and Department of Justice investigations at the time of Daiichi Sankyo’s purchase of shares of Ranbaxy in 2008.'

The Japanese firm decided to cut its losses and sold out to Sun Pharma in April

on foreign markets, becomes more pronounced with the situation in the US. An ICRA report released in June foresees that moderating growth from the US market and macroeconomic concerns in EMs will be key challenges for the Indian pharma sector. Growth in revenues from the US will slow thanks to the relatively moderate proportion of large size drugs going off patent, increased competition, generic adoption reaching saturation

2014. The $4.2 billion merger/acquisition between Sun Pharma and Ranbaxy was completed in February 2015, and a month later Daiichi Sankyo sold out its remaining nine per cent stakes of Sun Pharma shares it had obtained during the acquisition. Thus ended its short-lived Indian presence.

On May 6 this year, three and a half years after filing the arbitration case in Singapore, the International Court of Arbitration of the International Chamber of Commerce awarded a judgement in favour of Daiichi Sankyo, asking the former promoters of Ranbaxy to pay damages of Rs 2,562.78 crores. Daiichi Sankyo would see this judgement as a vindication of its stand but Ranbaxy does not seem to be giving up without a fight. A statement from the Ranbaxy side indicated that it was exploring further legal options to challenge this decision.

Maneesh Chandra of ZS Associates agrees that given that Daichii Sankyo had already faced the brunt of the problems, the worst was probably behind them. But the Japanese company still decided to sell out.

Sun Pharma got Ranbaxy at a good price, so automatically at the point of purchase itself they were able to give a good deal to their shareholders in terms of value. But whether they can derive better business value, is still a big question.

levels, regulatiory overhang as well as a high base effect catching up with the sector. CAGR of revenue growth from the US during FY11-15 for ICRA's sample set was 33 per cent which dropped to 15 per cent in FY2016, and ICRA has indicated that this slide will continue.

A new sunrise Has the deal with Ranbaxy also resulted in Sun Pharma's own fall from grace? Chandra of

ZS Associates narrates how many of the senior executives and CFOs in other big Indian pharma companies used to be envious of Sun Pharma's high EBIDTA. For many CFOs, Sun Pharma's financials were the benchmark of a healthy balance sheet and they would give their eye teeth to emulate this role model. But today, they are no longer in awe as the merged entity's EBIDTA is nowhere near past levels. So, Sun Pharma has in a way

surrendered this 'sweet spot'.

Sun Pharma fans could argue back that this is a fallout of the changing dynamics of the business and in fact Sun Pharma's present strategy will once again prove to be the right one in years to come.

Right now, Sun Pharma is in the process of getting the basics right by organising themselves, putting together a structure and function in a holistic way but Chandra of ZS cautions that sometimes when these kind of mergers take place, they suck up so much time and attention of the senior management that they are not able to put time and effort into the new opportunities the merger offers.

According to him, there is an over invest of time into getting the two organisations to work together. To prove his points, he harks back to two examples of big global pharma mergers. Around 2001-2002, two UK-based companies, Glaxo Wellcome and SmithKline Beecham merged into GlaxoSmithKline (GSK). Another example of a merger of equals is Sweden's Astra and UK's Zeneca merger in 1999.

The Glaxo Wellcome-SmithKline Beecham merger took a very long time to consolidate as it was across two different locations. According to Chandra, 13-14 years down the line, staff within some of these companies are just beginning to feel like one team. Of course, given the pace of business today, no acquirer will today wait this long to derive benefits. While he agrees that Sun Pharma has been successful in its past deals, he points out that most of these transactions have been acquisitions of much smaller companies rather than the merger of equals that is now under way.

As Sun Pharma’s consolidation continues, the company is sure to remain in the news for some time, with competition tracking each move closely.

Let’s hope this merger finds its true place in the pharma M&A playbook. viveka.r@expressindia.com

MANAGEMENT REPORT

New merger between Pfizer and Anacor to leverage opportunities in atopic dermatitis space: GlobalData The severe atopic dermatitis market is set to be a difficult one for new entrants to penetrate

A

n upcoming merger agreement between Pfizer and Anacor, worth around $5.2 billion, could boost the marketing power of Anacor’s lead pipeline candidate, crisaborole, and pave the way for Pfizer to launch its own candidate, a topical form of Xeljanz, both for the treatment of mild-to-moderate atopic dermatitis, according to an analyst with research and consulting firm GlobalData.

As explored in GlobalData’s report on atopic dermatitis, with the expected launch in the second quarter of 2017 of Regeneron and Sanofi’s dupilumab, the severe atopic dermatitis market is set to be a difficult one for new entrants to penetrate. Crisaborole, however, will not face serious competition as it enters a dormant mild-to-moderate atopic dermatitis market.

Abhilok Garg, Analyst, GlobalData covering immunology states, “Prior to Pfizer’s interest in Anacor, GlobalData anticipated a US-only launch of crisaborole in 2017, with sales potential just shy of $200 million by 2024. However, Pfizer backing the launch of crisaborole across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, would substantially increase the available patient population for the drug, involving a further six million treatable patients by 2024.

Despite this, the drug will still face competition. In anticipation of crisaborole’s first-to-market advantage in the mild-to-moderate atopic dermatitis space, other companies targeting this portion of the market have taken steps to secure a position.

Medimetriks, for example, has licensed a pipeline candidate from Otsuka and collaborated with Knight Therapeutics in order to strengthen its marketing potential.

Continued on Page 22

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MANAGEMENT

Pharma M&As: value creator or value destroyer?

Anil Khanna, Partner, Tai Pi Advisors analyses the trend of rising M&As in the pharma industry and examines its causes and implications

WHAT IS it with M&As that they make the adrenalin skyrocket, or generate a strong urge to ‘go for the kill’? Perhaps a burning desire to be a leader or eliminate the competition, or is it just the ‘sex appeal’? What makes companies /people to focus on the ‘price’ of a particular acquisition, than what is its true ‘worth’?

While there is no conclusive view on their success, M&As continue unabated. It seems that the pharma industry is probably following the advice of Mario Joseph Gabelli – an investment advisor, financial analyst and Chairman of Gabelli Asset Management Company. He says, “How do you make money? Spinoffs, split-ups, liquidations, mergers and acquisitions”.

Before we go into the drivers of M&A in the pharma industry, let’s take a look at the M&A activity in 2015, both globally and in India.

The cumulative deal value doubled in 2015 largely due to the announced acquisition of Allergan by Pfizer. This mother-of-all deals worth $ 160 billion skewed the data significantly.

However, the unexpected significant tax regulatory changes introduced by Obama’s treasury administration have killed this deal for the moment. The deal was primarily based on the logic of escaping higher taxes in the US (a process called inversion).

However, the abrupt change in the rules made no sense at all, with the tax benefits evaporating completely. It left many people agitated due to the change of rules in the middle of the game. Wall Street experts are saying that it’s the

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Strategic imperatives 2: Market Share

Figure 1: 2015 overview

Source: Public information, internal analysis Figure 2: Increasing valuation of M&A deals In such cases, the benefits are optimum capacity utilisation of the acquired company, more dominant presence in the markets that they are present, and good quality at low-cost.

Strategic imperatives 3: Improve Product Portfolio

Source: IMAP, internal analysis

Strategic imperatives 1: Improve R&D Pipeline Here the rationale is to provide comprehensive solutions for a particular therapeutic area and that therapeutic segment is large enough to justify the price.

Strategic imperatives 4: Increase market access through consumer oriented brands

In these cases, the bigger company brings its capability to find the best R&D technology, fund it and handle regulatory issues, while the innovator company helps complement the product portfolio or assist in salvaging the sagging sales of some products failure of the leadership at the treasury department. In fact, it can possibly be called the ‘Vodafone moment’ of the US government, as the rules were

changed specifically to kill this deal!

However, with the exclusion of the Pfizer-Allergan deal, the number and value of

The focus is on marketing consumer products with a medical claim and leveraging their superior consumer marketing and branding prowess

MANAGEMENT deals between the US and Western Europe went down in 2015, and much less money was spent on targets located in Western Europe, as compared to 2014, largely due to a wave of ‘tax inversion’ deals in 2013 and 2014.

In the Indian market too, 2015 saw an increase in M&A activity, with value of deals reaching $3.7 billion. Of this, outbound deals contributed around $2 billion, largely due to generics consolidation in the US market. The biggest deal was acquisition of Gavis Pharma and Novel Labs by Lupin for $880 million. Here Lupin, took debt in the US market in the foreign currency, and gave corporate guarantee backed by the parent company, since the US subsidiary’s balance sheet wasn’t big enough to justify such a huge loan.

Much earlier, Wockhardt had also taken a similar route. This route enabled the Indian company to take a low cost foreign currency loan and also avoid all the risks on account of currency movement or the change in business movement. These deals were valued at 16 times EBITDA multiple. Again some analysts felt it was a high price!

The other notable deal in the Indian market was acquisition of InvaGen Pharma and Exelan Pharma by Cipla for $550 million, valued at 2.4 times in trailing twelve months (TTM) June 15 revenue. As in the case of Lupin, this all cash deal, would be largely funded by its own cash accruals.

Increasing valuation?

Another interesting point is that apart from a growing number of M&As in the pharma sector, the valuation of the acquisitions are also on the rise. Check Figure 2, which shows the pharma EBITDA multiples for the last 10 years, explains this point succinctly.

Who is to be blamed for this phenomenon? Company CEOs or the investment advisors?

As, Warren Buffet once said, “Wall Street is the only place that people ride to in a Rolls Royce to get advice from the people who take subway." Sure investment advisors stand to gain from higher valuations,

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and may shift from the subway to a limousine for themselves!

But it shows the desperateness of the pharma industry as well.

India also saw one wellknown case of over paying, and that was acquisition of Piramal domestic formulation business by Abbott at 9x rev-

enue of nearly Rs 2000 crores (excluding the OTC business) in 2010. Analysts were of the opinion that the price was too high, as among the 400 odd brands portfolio, there was a long tail of brands with revenue of less than Rs five crores, and 9x sales multiple

wasn’t justified for these tail brands. It was clearly felt that Abbott was desperate to do this deal to catapult to the No.1 position in the Indian domestic formulations market. But, it will take many years for Abbott to recover the investment it made.

What are the drivers of pharma M&As? There are typically four strategic imperatives for the pharma companies, leading to possible M&As. (Check Strategic imperatives on page 18 ) In fact, the portfolio deals, (as mentioned in Table 1 on page

MANAGEMENT 20), would be the flavour going forward for several years, and we may see more of such deals in future. Novartis clearly showed the industry a new way to deal making in 2014 through a three way swap between Novartis, GSK, and Eli Lilly. In one stroke it strengthened Novartis’ position in oncology, GSK’s in vaccines and created a JV in OTC, and relieved Novartis of its unwanted animal health business, which went to Eli Lilly.

The idea is to sell sub-critical businesses to other players who can manage it better and vice versa.

a failure rate of between 50 per cent and 85 per cent.

Similarly, slightly dated findings from Burrill & Co on the biotech industry highlighted the same point.

The study analysed that on December 31, 2000 the combined market capitalisation of 17 of the industry's most active acquirers was $1.57 trillion.

When the combined value of the acquisitions these companies completed during this time, $425 billion, is added, close to $1 trillion in value has been lost during the last decade.

So there is enough proof that large numbers of deals don’t create anticipated value.

Deals may go wrong in so many ways, ranging from

Table 1: Some of the key portfolio deals in 2015

Tax inversion – a major ‘financial’ deal driver It’s not something which is new. It has been in vogue since 1982. The first major inversion took place in 1982, when New Orleans construction firm McDermott shifted to Panama, switching its corporate headquarters to the Central American country and slashing the tax rate on its earnings.

Pharma companies have used this method very often, leading to strong protest (Check Figure 3, Figure 4). The US President, Barack Obama has called such companies ‘corporate deserters’ who are being ‘unpatriotic’ by seeking to reduce their contribution to the US coffers.

What’s next for Pfizer now?

Whatever options Pfizer may choose to make, one thing is for sure – it doesn’t have the option of standing still. It either grows or splits.

While Pfizer has announced that by the end of this year it will take a decision to split the business in two parts “innovative and established businesses”, experts do not believe it completely.

Already people are talking of acquisition options like Shire, GlaxoSmithKline and AstraZeneca. Incidentally, shares of all these companies gained value after the announcement of the collapse of Pfizer-Allergan deal.

Whatever strategic routes Pfizer may choose to take – split or acquire, one thing is for

20 EXPRESS PHARMA June 16-30, 2016

Figure 3: Number of deals involving ‘tax inversion’ during previous years

Source: IMAP

Figure 4: The tax saving is quite significant

Figure 5: Pharma companies pursue M&As with less senior people involvement

Figure 6: Pharma companies rely less on standardised process and guidelines

Source: Public information, internal analysis sure - future deals by Pfizer can’t be ruled out. Even if it decides to split, it will be looking at acquisition opportunities in the form of companies with innovative product pipelines. It’s simply the law of numbers – when you are this big, you have to keep demonstrating that you have the guts to keep doing new things and continue to

hold the pole position that you have now. So, expect the dealstreet to continue buzzing!

Do pharma M&As always work?

Despite these strong strategic imperatives and a wave of M&As, there are numerous cases where pharma M&As not working out as antici-

pated.

It is an accepted fact that more than 80 per cent of mergers do not increase shareholder returns and have

adhocism, to inadequate duediligence, to nature of the business (being a regulated sector, government policy changes can impact the

MANAGEMENT outcome of the deal),to clashing cultures, to distracted leadership and any other submerged issues.

For instance, Dr. Reddy’s Laboratory acquisition of Betapharm didn’t prove to be successful. The issue here wasn’t the price (though some analysts felt otherwise), or the funding. DRL had enough funds to finance the deal and then take part-debt. However, since acquisition, Betapharm revenue has been on a decline.

The problem, of course, had nothing to do with DRL. Within months of the

An analysis

by McKinsey highlighted two key points for pharma M&A failures – lack of involvement of senior people, and absence of standardised processes and guidelines acquisition, the German government changed its procurement policy, shifting to a tender-based system for a substantial number of drugs.

This reduced drug reference prices. So, what was aimed at securing access to the secondlargest generics market after the US turned into a liability.

Hence regulatory environment, not in the company’s control, can mar the deal as well.

Similarly, acquisition of Piramal by Abbott and that of Ranbaxy by Sun Pharma had cultural and people issues.

Both Ranbaxy and Abbott had the ‘MNC way of working’, which made integration difficult. Likewise, many Ranbaxy people chose to quit rather

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than opting to work with the merged entity.

Daiichi’s acquisition of Ranbaxy got tricky due to inadequate due-diligence. Daiichi simply didn’t go deep, and after the acquisition, plants and manufacturing related skeletons started to tumble out.

An analysis by McKinsey

highlighted two key points for pharma M&A failures – lack of involvement of senior people, and absence of standardised processes and guidelines (Check Figure 5 and Figure 6).

So it’s apparent that in their hurry to do M&As, pharma companies are probably not giving adequate attention to various aspects of

mergers and integration, be it sound strategies, focusing on the ‘price of the target’, rather than the ‘fair worth of the target’, or the lack of well laid processes and guidelines for post deal integration, or cultural issues. Hence, the success rate of pharma mergers, in terms of value creation, hasn’t been very good.

It would be interesting to close this article with an old statement by Donald Trump.

Though he has been in the news for making some very radical statements in his quest to become the US President, but he was probably spot-on when he said, “Sometimes your best investments are the ones you don't make”.

MANAGEMENT

Meningococcal vaccines market set to approach $1.8 bn by 2025: GlobalData The provision of a single vaccine that can protect the population against all prevalent serogroups is the most important opportunity for companies hoping to access a large market share, says analyst

THE MENINGOCOCCAL vaccines market is expected to grow from around $1.1 billion in 2015 to $1.8 billion by 2025 across the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan, and Brazil, representing a compound annual growth rate of 5.4 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that this substantial growth will mainly be driven by adjustments in national immunisation schedules, as governments implement more inclusive vaccination schedules to prevent invasive meningococcal disease. It will also be propelled by the anticipated launch of a first-in-class vaccine covering all serogroups currently prevalent in the 8MM by combining two different meningococcal vaccines, thereby decreasing the dosage burden involved in vaccinations.

Mirco Junker, GlobalData’s Analyst covering Infectious Diseases says, “Although the meningococcal vaccine market in the 8MM is highly ma-

ture, and the continuous decline in incidence rates of meningococcal disease across most of these countries will act as a barrier to launching new products, there will be several opportunities for a current or future player to distinguish itself from the competition.

“For example, the meningococcal vaccines market is characterised by a large diversity of vaccines, with each covering only a specific serogroup or a set of serogroups. However, the epidemiology of serogroup distribution varies by country and over time. Therefore, provid-

ing a single vaccine that can protect the population against all prevalent serogroups will represent the most important opportunity to access a larger market share during the forecast period, by reducing the number of vaccines required to prevent meningococcal disease.”

Traditionally, the meningococcal vaccine marketplace has been dominated by Big Pharma, with Sanofi, GlaxoSmithKline (GSK), Pfizer, and Novartis providing the majority of commercially available vaccines over the past decade.

In the last few years, the meningococcal vaccine market has experienced additional changes, after Novartis sold its meningococcal vaccine portfolio to GSK, and after the recent launch of GSK’s Bexsero and Pfizer’s Trumenba, the first two vaccines to offer protection against serogroup B. Junker concludes, “GlobalData expects that GSK will pass Sanofi as the main provider of meningococcal vaccines by the end of this forecast period. This growth in the company’s market share will be driven by Bexsero, which will hit sales of over $570 million in 2025, as well as their novel pentavalent vaccine, MenABCWY, which is expected to launch in the US and five European countries during the forecast period.”

EP News Bureau-Mumbai

New merger between Pfizer and Anacor...

Continued from Page 17 Crisaborole, however, leads the race to market, and has set itself apart from the competition with significant investment into proving its safety in paediatric patients, a largely underserved

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demographic.

Garg explains, “Pfizer now has the opportunity to build on the work of Anacor by utilising its existing relationships with paediatricians and primary care physicians, and its experience in markets outside of the US. In-

deed, this insight could serve to aid the company in its development of topical Xeljanz. Although further study into this drug is needed, its launch would result in Pfizer commanding a large portion of the mild-to-moderate atopic dermatitis patient

population. GlobalData expects crisaborole to encounter a drugtreated market size of 3.1 million mild-to-moderate atopic dermatitis patients by 2024 in the US. With the backing of Pfizer and potential entry into the rest of the 7MM, crisaborole could

gain access to a total of approximately eight million drugtreated mild-to-moderate patients by 2024, of which approximately 60 per cent would be paediatric or adolescent.”

EP News Bureau-Mumbai

RESEARCH I N T E R V I E W

SNEC30 was prepared with the use of the self nano emulsifying drug delivery system Arbro Pharmaceuticals recently launched SNEC30, a Curcumin formulation in 30 mg dose.

Dr Saurabh Arora, Executive Director, Arbro Pharmaceuticals explains more about the formulation's characteristics, its therapeutic advantages, the research that went into its creation and more, in an interaction with Lakshmipriya Nair Arbro Pharmaceuticals has recently launched SNEC30, a curcumin formulation. Tell us about its unique characteristics?

SNEC30 is a self-emulsifying system of curcuminoids with enhanced absorption. We have prepared this without adding any external functional products like piperine, lecithin etc. The ingredients are completely gluten-free and GMO-free.

Tell us about the research that went into its creation?

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RESEARCH The use of curcumin for medicinal purposes dates back to five millennia, to the Vedic times. It is also used in ayurvedic medicines. Despite its effectiveness against so many diseases, scientists have always been of the opinion that curcumin’s true potential has been limited by its poor bioavailability which is caused by its poor solubility and extensive pre-systemic metabolism. However, Arbro Pharmaceuticals partnered with Jamia Hamdard University to carry out research for developing a novel formulation which would be able to overcome curcumin’s poor bioavailability so that it could be used for its tremendous therapeutic potential. The development project was jointly funded by Arbro and the Department of Science and Technology Government of India under its Drug & Pharmaceutical Research Programme (DPRP) scheme.

Arbro Pharmaceuticals partnered with Jamia Hamdard University to carry out research for developing a novel formulation to overcome curcumin’s poor bioavailability and utilise its tremendous therapeutic potential various diseases like cancer, pain, inflammation, arthritis, ulcers, psoriasis, arteriosclerosis, diabetes and many more pro-inflammatory conditions.

How does this formulation overcome the problem of curcumin’s poor bioavailability?

In the new formulation we have used nano-technology.

We have been able to generate an industrially viable product to work as a curcumin-based, contemporary therapeutic agent for numerous indications.

What are the therapeutic benefits of the formulation?

Many studies have been carried out about curcumin.

The clinical research studies which have been carried out for the past 25 years have shown curcumin to be effective in the treatment of

Was a novel technology used to come up with this formulation?

Yes, the formulation was prepared with the use of the novel self nano emulsifying drug delivery system (SNEDDS). SNEC30 is the outcome of a joint development for which patents have been filed. The US patent has been granted.SNEC30 is a proprietary product with US patent (USPTO).

What are the other research areas that Arbro Pharma is currently involved in?

Currently, SNEC30 formulation is planned to be studied in a variety of conditions and these are under planning with the leading institutions. lakshmipriya.nair@expressindia.com

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services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

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24 EXPRESS PHARMA June 16-30, 2016

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RESEARCH UPDATE

FDApanel recommends approval of Novo Nordisk diabetes drug,iDegLira Clinical trials showed the drug helped patients control their blood sugar and did so with one injection rather than two A US advisory panel has recommended approval of a new diabetes drug made by Novo Nordisk A/S that combines two of its existing treatments in a fixed-dose combination. The panel voted 16-0 that the Food and Drug Administration (FDA) should approve the drug, iDegLira, for patients with type 2 diabetes.

IDegLira combines Novo Nordisk's diabetes drug Tresiba, also known as insulin degludec, with its GLP-1 agonist Victoza, or liraglutide. Clinical trials showed the drug helped patients control their blood sugar and did so with one injection rather than two.

Reportedly, the committee also intends to discuss a similar drug, iGlarLixi, made by Sanofi SA, which combines the company's experimental GLP-1 agonist lixisenatide with its insulin product Lantus.

The committee also intends to discuss a similar drug, iGlarLixi, made by Sanofi, which combines the company's experimental GLP-1 agonist lixisenatide with its insulin product Lantus The drugs, if approved, would be the first two products with different mechanisms of action in a single, fixed-ratio combination injection. The companies aim to show that treating diabetes earlier and more aggressively will stave off complications from diabetes such as heart disease and blindness.

FDA reviewers said the drug may look more effective in clinical trials than in practice because of the way the trials were

designed, adding that greater convenience could come at the price of reduced dosing flexibility. Panelists said the drug's benefits outweighed those concerns.

"I feel this does bring a new, useful treatment option," said Dr Robert Smith, a professor of medicine at Brown University and Chairman of the panel.

The panel struggled to precisely define which patients iDeGlira would be most useful for but agreed it would at least

be appropriate for patients who were previously taking either insulin or a GLP-1 drug.

There was less clarity about the drug's usefulness in patients who had not previously taken one of those drugs. Some panel members said they would be reluctant to start a patient on two new drugs at once. But certain patients in this group, such as those who were needle-shy, could benefit, they said.

Dr Todd Hobbs, US chief medical officer for Novo Nordisk, said the company was "extremely pleased" with the panel's recommendation. "This is an important milestone for healthcare providers and patients," he said.

Panel members recommended the agency ensure that the drug's label makes clear that the injection contains two drugs.

Source: Reuters

Amicus' Fabry disease drug gets European Commission approval AMICUS THERAPEUTICS has announced that European Commission has granted approval for the use of migalastat, its experimental treatment for Fabry disease, an inherited disease that creates pain and burning in the hands and feet.

The European Medicines Agency had recommended approving migalastat in April.

The Cranbury, New Jerseybased company is still seeking approval from the US regulators.

Fabry disease is caused by the build-up of fat-like substances, most notably in the kidneys, due to the deficiency or lack of an enzyme that metabolises these lipids.

The accumulation damages cells and can lead to kidney failure, heart attacks and strokes. It is currently treated with metoclopramide.

The US FDA last fall asked Amicus for more comprehensive analysis of its trial data and the company put off submitting a new marketing application for the treatment.

Source: Reuters

Tarantula venom could offer relief from irritable bowel syndrome A specific peptide in spider venom could be used to understand how people sense pain TARANTULA VENOM is being used to develop pain relief medications for people suffering from irritable bowel syndrome (IBS). Researchers from The University of Adelaide found that a specific peptide in spider venom could be used to understand how people sense pain.

Two toxins from the tarantula species Heteroscodra maculata were found to specifically

26 EXPRESS PHARMA June 16-30, 2016

target Nav 1.1, a voltage-gated sodium channel in the nervous system to initiate the electrical impulses that signal pain.

Associate Professor Stuart Brierley said the study demonstrated that Nav 1.1 contributed to mechanical, but not thermal, pain signalling. “Using the highly specific peptide in the spider toxin we were able to work out how pain nerve fibres signal in a

healthy situation and also in chronic abdominal pain such as what you see in IBS,” he said.

“We found that the spider toxin was able to cause a lot more pain in the IBS state than what it was in the healthy state.

It’s important to note that because of the studies we should be able to develop treatments for IBS based pain – blockers for Nav 1.1 that only target the pe-

ripheral and don’t go to the central nervous system. Over a long period of time we were able to work out that one particular compound was in the venom that you could isolate, separate out and acted on this Nav 1.1 channel,” he added.

“It gave us a highly specific and highly selective tool to look at its role in pain,” he added.

The findings also pose poten-

tial implications for central nervous system diseases such as epilepsy.

The study was a collaboration between the University of Adelaide, Flinders University, South Australian Health and Medical Research Institute , the University of Queensland, The University of California, John Hopkins University and the Medical College of Wisconsin.

RESEARCH

Polaris Group reports phase III study results of ADI-PEG 20 plus best supportive care in advanced hepatocellular carcinoma The full study results were presented at ASCO's 2016 annual meeting in Chicago POLARIS GROUPâ&#x20AC;&#x2122;S phase III study of second line ADI-PEG 20 plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma (HCC) did not meet its primary endpoint of demonstrating overall survival (OS) benefits. Median OS was 7.8 months for ADI-PEG 20 vs. 7.4 months for placebo (p = 0.884, HR=1.022 [95 per cent CI: 0.847, 1.233]). However, analysis of study data revealed that patients with arginine depletion for seven weeks or longer had a median OS of 12.5 months, compared to 6.3 months (P < 0.0001) for patients with arginine depletion lasting less than seven weeks. It is believed that treating patients with ADI-PEG 20 depletes circulating arginine, thus starving cancer cells of arginine, which is an essential amino acid for these cancers.

This results in the starved cancer cells being unable to survive and grow while leaving the body's normal cells unharmed.

The statistically significant findings from the analysis of the study data appears to support this hypothesis. Additionally, sorafenib naive patients appear to have benefited more than those who failed prior sorafenib treatment, suggesting that ADIPEG 20 may be more efficacious in the first-line setting.

The study also showed ADIPEG 20 was well tolerated, with the most common side effects being fatigue and decrease of appetite. The full study results were presented at the American Society of Clinical Oncology's (ASCO) 2016 annual meeting in Chicago.

"We are encouraged to see the overall survival benefit demonstrated by ADI-PEG 20 in the patient population with prolonged arginine depletion, which supports the theory that arginine depletion can be a safe way to extend life for these very ill patients," said John Bomalaski, Executive Vice President, Medical Affairs at Polaris

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Pharma. "We have already identified new combination therapy strategies that can significantly

prolong arginine depletion and enable ADI-PEG 20 to synergise with current cancer treatments

as shown in early stage clinical studies. We are making plans to move these combination thera-

pies into late stage clinical development in the near future."

Source: Polaris Group

PHARMA ALLY I N T E R V I E W

'Our courses are specially designed for Indian conditions' The Contamination Control Society of India (CCSI) has started training programmes for production and supervision staff of cleanrooms. Sheesh Gulati, Chairman, CCSI, shares more details of the programme and its objectives, with Lakshmipriya Nair

Tell us about the training programmes conducted for the cleanroom production/supervision staff of pharma and biotech companies?

CCSI has one-day, two-day and four-day programmes.

The one-day events usually cover 'burning topics' of the day â&#x20AC;&#x201C; for example; currently there is a great interest in the new revised ISO 14644 cleanroom standards. We have already conducted training courses on this topic in Mumbai, Hyderabad and Bengaluru. The two-day intermediate course has theory and practical demos, with a written exam. The four-day advanced course will have both theory and practical exams. In addition, we regularly organise product presentations by cleanroom equipment suppliers.

What are the different aspects of the training programmes? What is the duration of these courses?

Depending on the duration of the programme, there will be theory and practicals, i.e. two and four day courses will not only have lectures but also hands-on demos of cleanroom monitoring and classification instruments like particle counters, photometers, smoke generators, air capture

28 EXPRESS PHARMA June 16-30, 2016

hoods etc. The four-day advanced course planned for next year will also have a practical exam.

How are these programmes designed? What is the fees/charges of each of these courses?

Our courses are specially designed for Indian conditions, and are priced at less than one-third what is charged in foreign countries. Being a not-for-profit organisation, the primary objective of CCSI is to impart knowledge at minimal cost, not make a profit. The intermediate course includes modules on airborne particle counting, HEPA filter testing, airflow and volume measurement, cleanroom protocol and gowning, etc.

What are the major objectives that you seek to achieve? How do you measure the impact of these programmes?

The objectives are to impart proper scientific and technical knowledge about the theory and practice of cleanroom certification and monitoring, HEPA filter testing, gowning, relevant international standards, procedures and instruments to personnel involved with the operation/certification /supervision/design/

construction of cleanrooms.

Impact is measured by performance in the exam, conducted at the end of the course. Long term impact will be fewer product rejections and fewer FDA warning letters.

Our courses are specially designed for Indian conditions, and are priced at less than one-third what is charged in foreign countries

When and where are these programmes conducted? How do companies opt for them?

These programmes are conducted at various cities all over the country, including Mumbai, Hyderabad, Bengaluru, Chennai, etc. We give extensive publicity to our courses via direct mailing, newsletters etc. We are also grateful to journals such as Express Pharma for providing us with a suitable platform.

Which companies have undergone your training programmes till date?

Almost every large pharma and biotech company has deputed its personnel including Cipla, Wockhardt, Aurobindo Pharma, Biocon, Dr Reddy's, Lupin, etc. Also large HVAC firms such as Voltas and Blue Star and big cleanroom contractors such as Fabtech have taken advantage of our programmes, besides consultants. We also encourage small cleanroom certifiers to attend and they

are doing so in increasing numbers.

Are these courses accredited by industry body?

We are very proud of the fact that our two-day Associate Level Course on Cleanroom Technology -Theory and Practice, has received accreditation from the International Confederation of Contamination Control Societies, Netherlands. In other words, the certificate given to successful participants of this course will now have international recognition. This two-day course will start from September in Mumbai and will later be conducted in Bengaluru, Chennai, Ahmedabad etc.

How do you plan to expand the reach and efficacy of your programmes in the future?

We will interact with cleanroom societies in other countries and plan to conduct some of our courses in other countries where such training programmes do not exist. CCSI is extremely fortunate to have on its faculty, highly educated and experienced persons with a depth of knowledge, perhaps unparalleled anywhere else in the world. lakshmipriya.nair@expressindia.com

I N T E R V I E W

'India's share is hardly 10-12 per cent of the total (cleanroom consumables) market' Cleanroom consumable products play a key role in pharma companies and the industry is growing rapidly. Sanjiv Marathe, Proprietor and CEO, Singapore India Trade Resources Company talks about the global trends in cleanroom consumable products, with Usha Sharma

How big is the global cleanroom consumables market? What percentage of the market share has been captured by the Indian suppliers? What is the growth percentage?

The global cleanroom consumables market is around $4 billion per annum, mainly being serviced by China, Malaysia, Korea and Singapore.

India's share is hardly 10-12 per cent of the total market.

What are the product segments under the consumables for cleanroom category? Which are the fastest growing segments?

Under the consumable cleanroom products category, the majority is non-woven products like face masks, bouffant caps and shoe covers which are low end items. They are the fastest growing segment worldwide in this category. Gloves, one of the other fastest growing segments, is being catered by China and Malaysia. India is a net importer. Today, we do not manufacture hi-tech consumables like washable sticky mats, disposable sticky mats and sticky rollers in India.

What are the regulatory guidelines for manufacture and use of

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PHARMA ALLY consumables for cleanrooms, globally and in India?

Regulatory guidelines involve conforming to the US FDA standards and CE certification for goods to be accepted in the US and Europe respectively. Even small countries like Reunion island, which is a French territory, insist on CE certification. Certification is key to the growth of the industry. Indian manufacturers are nowhere near this mark yet, but are waking up to export possibilities and shall soon have these in place.

In the recent past, global regulators have been more stringent and concerned about quality. Do you feel that this has led to increased demand for cleanroom consumables in India?

Indian manufacturers can

and washable/sterilisable.

Gloves, non-wovens and tailored garments from India shall see significant growth.

India can become a major player in modular cleanroom panels because of low cost of manufacturing and experience in meeting the US FDA regulations for the pharma industry locally supply to African countries like Nigeria and Togo where certification is not as stringent as in the West.

However, Indian manufacturers will have to quickly adopt global standards if they are to find a place in the sun.

Beside the pharma industry, which are the other industries where you foresee immense business opportunities for cleanroom consumables?

Besides pharma we see

growth for cleanroom consumable products in electronics, food, paint shops and aerospace.

What are the latest trends/demands in the cleanroom industry? Is there a demand for modular cleanroom systems and has that augmented sales and consumption of consumables products?

US continues to be the biggest market for consumables. It is being serviced by China mainly. The demand for

gloves is being catered to by Malaysia. India can become a major player in modular cleanroom panels because of low cost of manufacturing and experience in meeting the US FDA regulations for the pharma industry locally.

These can lead to export to the Middle East, Africa and also the US. Some Indian players like I Clean are already doing projects in the US with representatives and offices there. The demand trend will be mainly for garments, both disposable

Globally, which country is a major market for cleanroom consumables, why? Which companies do you consider as competitors and why?

I feel that China will continue to lead in products like sticky mats, sticky rollers and fabric because of the high capacity which has been already created.

What is the long term global outlook for the cleanroom consumables market?

As indicated, consumables will be one of the fastest growing segments, not only in the pharma industry but also in the others listed earlier.

Growth at 15-20 per cent in Asia is expected, in matured markets it would be at least 10 percent year on year. u.sharma@expressindia.com

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PHARMA ALLY I N T E R V I E W

Alfa Laval holds leading global market position within its fields of expertise Alfa Laval provides the complete spectrum of technologies and services that help process industries maximise reuse of water.

NP Desai, Segment Manager PWW, Alfa Laval (India), speaks on his company’s offerings and their advantages, with Sachin Jagdale

Describe the technologies Alfa Laval offers for the industrial waste water treatment?

Alfa Laval offers the following key technologies for industrial waste water treatment: Alfa Laval Membrane bioreactor (MBR) system, that combines secondary and tertiary wastewater treatment and delivers a superior effluent quality (effective filtration in sludge to 0.2 μm) suitable for reuse. It removes suspended solids down to <1 mg/l, BOD down to <5 mg/l and handles 5-40 liter/h/m2 filtration area.

The gravity driven, pump free and energy efficient design with compact membrane filtration modules (MFM) is based on our patented hollow sheet technology. Compared to other MBR solutions it offers improved safety, simplicity of operation, plus low operation and maintenance costs.

Alfa Laval Multi Effect Evaporators are ideal for concentration of effluent, waste reduction and product recovery plus water reuse. Based on the application requirements Alfa Laval has range of solutions for MEE including Falling film and Forced circulation Tubular Evaporators or Rising Film Plate type evaporators.

From the above range Alfa Laval

The core of Alfa Laval’s operations is based on three key technologies: heat transfer, separation and fluid handling

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PHARMA ALLY provides its customers the most effective way to enable excellent performance in most difficult and high fouling applications. Examples include anaerobic and salty chemicals effluent, reverse osmosis reject etc.

Reclaimed water is then recycled and reused in many ways: as industrial process water, for cleaning, cooling towers or ground water recharge.

Thermal sludge treatment: For pre-heating of wastewater sludge using Alfa Laval spiral heat exchangers and tube-in-tube heat exchangers prior to dewatering can also cut costs and provide an opportunity for heat recovery. Our thermal equipment can also be used for sludge digestion to produce biogas and for sludge hydrolysis and pasteurisation to meet even the most stringent environmental legislation and obtain class A or B sludge quality suitable for reuse as compost or fertiliser.

For some types of industrial waste, e.g. pharma, pasteurisation of waste water sludge is a must. Spiral heat exchangers can also be used for final effluent cooling to recover heat and, if it is to be discharged into the sea, river or stream, to protect the biology of the water body.

Dewatering: To reduce the

amount of waste for disposal by up to 90 per cent. On-site dewatering of sludge is a fundamental part of all current wastewater treatment options to significantly reduce the sludge volume. This has a huge impact on costs for transportation, effluent disposal, storage and drying. It is also highly relevant for sludge to be used as digester feed for biogas production, thermal processes and composting. To meet every need, Alfa Laval offers a complete spectrum of robust, well-proven technologies that effectively separate off the liquid phases and achieve a high level of dry solids content.

For efficient dewatering of primary or biological sludge and separation of liquid and products from other waste streams you can choose ALDEC, ALDEC G2 and G3 range of decanters for centrifugal separation of very large volumes of sludge with very small footprint and low energy consumption.

Do pharma companies require special technologies for the waste water treatment?

Bringing a drug or vaccine to market requires cutting edge technologies. To succeed, pharma manufacturers demand efficient, hygienic equipment that delivers

continuous processes and sustainable performance. In this sector most of the industries are operating based on partial Zero Liquid Discharge (ZLD) system and partially treating effluents in the conventional way. In most of the cases, domestic effluent is treated separately or mixed with either low or high TDS effluents. Central Pollution Control Board, in its recent notification, has stressed upon water reuse and recycle by employing the ZLD concept. In some cases, ZLD can be achieved by adopting conventional primary, secondary and tertiary effluent treatment and polishing by filtration and using clean water back into process/or domestic use.

In the majority of cases, Reverse Osmosis, Micro Filtration and concentrating with Multiple Effect Evaporators (MEE) can be employed.

What is the average spend by the Indian pharma industry on waste water treatment technologies/solutions?

The Indian pharma market size is expected to grow to $100 billion by 2025, driven by increasing consumer spending, rapid urbanisation, and rising healthcare insurance among others. Need to reuse, recycle water

combined with stringent governing laws, investment in waste water treatment plants shall be significant.

Which are the useful resources from the main process that are usually found in waste water from the pharma plants? How do you retrieve them?

Alfa Laval has developed a wide range of waste recovery solutions based on our separation, filtration and thermal technologies. These include products that can be used for water recovery for reuse and waste heat recovery.

Which are the other industries that you cater to?

The core of Alfa Laval’s operations is based on three key technologies: heat transfer, separation and fluid handling.

All three have great significance for industrial companies and Alfa Laval holds leading global market position within its fields of technical expertise. Our customers are found in various process industries such as pharma, chemical, oil & gas, pulp and paper, waste water treatment, marine, power and food to mention a few.

How will you compare industrial waste water treatment plants in India with their overseas

counterparts?

Waste water from the pharma industry can be heavily laden with toxins, contaminants and organic nutrients which needs to be treated before disposal.

There is a great degree of awareness and willingness to comply with the norms and invest in waste water treatment plant. India is now one of the leading manufacturers of pharma and biopharma products in the world and we have kept pace with the international standards, even on waste water treatment. This can partly be attributed to our pollution control regulations also.

Who are your pharma clients? ?

Our esteemed clients include all leading/big players in the industry.

Any new technology in the pipeline?

Alfa Laval has acquired Ashbrook Simon Hartley, UK recently and thus now has added new product range comprising belt presses, Iso disc filtration, automatic filter presses and decanters for SBR to enhance its product portfolio and technologies for water and waste water treatment. These are very likely to be launched in India in the near future. sachin.jagdale@expressindia.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

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Email your contribution to: The Editor, Express Pharma, Business Publications Division,

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PHARMA ALLY I N T E R V I E W

â&#x20AC;&#x2DC;MedTrix is proud to partner with large global pharma companiesâ&#x20AC;&#x2122; MedTrix is working on developing a platform to improve healthcare and patient access. Vimal Narayanan, Director, Medtrix Healthcare shares more details about the platform and the company's key plans as well as strategies, in an interaction with Usha Sharma

What services are offered by MedTrix Healthcare? Tell us about your key initiatives?

MedTrix Healthcare is a provider of digital and medical communication solutions to top pharmaceutical companies having its headquarter in Bangalore. Acting as business catalysts, MedTrix enhances the medical and digital communication operations of pharma companies by forging and strengthening their relationships with key opinion leaders (KOLs), physicians, patients and other stakeholders. Some of our key initiatives include healthcare professional engagement through digital route, innovative platforms to reach out to doctors and educating them in their own terms, training of sales representatives in pharma, production of digital assets for pharma communications like apps, websites, videos, social media support etc. We also provide support to conceptualise, develop and launch new initiatives which would benefit the patients and healthcare providers along with securing a measured return on investment.

Tell us about your offerings for the global pharma sector? What are your plans for the Indian pharma market?

MedTrix has a widespread network of technical and medical professionals across the US, UK, APAC and the

Middle East. We have the trust of several of the top 20 pharma companies and some of the fastest growing pharma brands across the world. MedTrix is among the few companies globally, who are able to work in the strategic digital and medical communication space for their clients. For most of our clients, we are the first company from India or elsewhere to provide the kind of solutions that we offer. Among our clientele are some of the big pharma firms like Novartis, Bayer, Nestle, Eli Lilly, Pfizer, and Amgen to name a few.

We are in talks with Indian pharma companies and we plan to leverage on Digital India initiative to spur our growth in the domestic market.

What are the learnings from your global experience that would help to leverage the potential in the Indian market?

The sector, despite its competency, has been traditionally slower to ride the wave of change. The pharma sector is at its experimental phase as far as developing and deploying digital health solutions, which are aimed at reaching healthcare practitioners (HCPs) and patients to improve disease outcomes.

Though the pharma industry has been slow to adopt the technology, few global giants have been pioneers in bringing changes to this scenario. There is a sea change in the way digital technology is

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PHARMA ALLY redefining the nature of business. Digital has emerged as a buzzword today and the pharma sector has not been excluded from this evolution.

Hence, companies who have the expertise to fulfill the technical and scientific requirements for this natural progression would surely be leading navigators of the paradigm shifts occurring in Indiaâ&#x20AC;&#x2122;s pharma industry.

Globally as well as domestically, several pharma companies are investing substantially for adoption of digital solutions. What are the key trends in the industry? How well prepared are you to tap the market?

Ongoing trends show that both patients and healthcare professionals are increasingly moving online to manage health outcomes.

Simultaneously, pharma companies are establishing across-the-board virtual ecosystems on digital platforms, to create seamless interactions with all the stakeholders. While mobile phones have been the preferred medium across the globe, the total spend on digital marketing could start at one per cent and go up to even 30 per cent in some products depending on the product lifecycle and other promotional support.

The global pharma industry is at an inflection point, where it is pivoting from doing digital to being digital. The key aspect to this shift is the growing pressure on global pharma in terms of cost, ability to innovate, emergence of technology and the digital medium to reach their clients.

MedTrix is proud to partner with some of the large global pharma companies for their key initiatives in this direction. We bring together a unique matrix of science, technology and strategy in offering innovative, cost effective and impactful solutions that are designed and delivered to meet the commercial objectives of pharma and healthcare organisations. We have the expertise to fulfill the technical and scientific requirements for

34 EXPRESS PHARMA June 16-30, 2016

We are happy to announce that many of them have gone on to achieve substantial success metrics which has prompted our clients to provide us with larger engagements.

Tell us about the new technologies/services you have in the pipeline? When are they likely to hit the market?

India, with its firm lineage on IT, is all set to capitalise on this trend. MedTrix is working on developing a platform to improve healthcare and patient access for which the pilot would be implemented by early 2017.

Presently, how many people are working with the organisation and do you have plans to add more?

Currently, we have a team of 50 members from Bengaluru which includes programmers, graphic designers, developers, business managers and a team of medical content writers, who are certified medical doctors. We are planning to expand in multiple geographies by increasing our access into the top 20 pharma companies and doubling headcount within a year.

We are planning to expand in multiple geographies by increasing our access into the top 20 pharma companies and doubling headcount within a year this natural progression.

MedTrix has added a liberal dose of global pharma strategy, medical content and certified process to be among the top echelons of digital pharma communications. Unlike some of the western agencies, MedTrix offers an integrated understanding of a brand or therapy across several geographies since this is catered by one single team.

With an estimated investment on digital solutions

by global healthcare and pharma industry touching $6.9 billion in 2015, this space does look attractive and MedTrix has begun to offer a berth for India in this intellectually exciting space for others to follow. This means that global pharma and healthcare has to offer India a seat in the strategic planning table in the future.

Recently, MedTrix Healthcare announced its

plans to expand its presence in the US and EU. Can you elaborate on them?

We have announced our expansion in the US and EU in the light of some recent strategic agreements with our key clients in these markets.

Until recently, MedTrix had been engaging with some of our key clients in several projects in developed markets but most of them were in a pilot phase where our clients wanted to test our capabilities.

Tell us about the company's corporate plans.

In the long-term, we want to launch services panhealthcare segment, moving just beyond pharma. We will look for fund infusion to expand into tier-II and tier-III cities in India with our healthcare and patient access platform, which is at an early stage of development currently. Globally, we would like to be in the space of healthcare IT, with the ability to launch select products to improve patients outcomes, disease management, cost savings in healthcare management and better access to all across the healthcare management spectrum. These products would be used across the product life cycle starting from phase I clinical trials until later in the commercialisation stage. u.sharma@expressindia.com

PHARMA ALLY VENDOR NEWS

Datwyler to open its FirstLine production site in India The FirstLine facility will be integrated in the existing premise and will be fully operational in 2017 DATWYLER, A supplier of customised sealing solutions, has announced the construction of its manufacturing facility – FirstLine – at the Datwyler India site in Satara, Maharashtra. The FirstLine facility will be integrated in the existing premise, and will be fully operational in 2017. An additional area of 24,000 sq m is available for future growth. The complex rubber components produced at the FirstLine site belong to the Omniflex family of vial and syringe components, which prevent any interaction with the drugs due to their total fluoropolymer coating. These components are exclusively manufactured at the FirstLine sites.

The Omniflex coating process is a Datwyler proprietary process. Omniflex is an inert, flexible, fluorinated polymer coating for pharma rubber closures, which covers the entire product surface.

The chemical inertness of the fluorinated polymer coating provides a very high

Complex rubber components belonging to the Omniflex family of vial and syringe components that prevent interaction with drugs due to their total fluoropolymer coating are made at FirstLine sites

degree of compatibility with pharma or biotech products. Datwyler India will supply the products made in the FirstLine production facility in Satara to the company’s customers worldwide.

Rahul Dev, Vice President, Datwyler India said, “Datwyler’s latest investment in India through the commencement of the FirstLine facility in Satara is part of the company’s commitment to India and the Asian markets. Present in India since 2010, Datwyler is dedicated to guaranteeing the highest levels of quality and safety, and continues to make investments aimed at meeting global regulatory requirements. The plant currently employs 290 people. It will employ 350 people by the time the production starts in 2017.”

Dev further added, “India’s pharma and biotech markets are evolving rapidly and have been able to gain traction from global manufacturers, suppliers and customers. The country is also getting recognised as one of the global manufacturing destinations. Our new FirstLine facility in Satara makes a great business case for us as we look at catering to global markets. Datwyler is one of the leading producers of closure solutions for injectable and vial medicines. The company’s products are supplied to the world’s leading pharma and biotech companies to support their efforts towards save and effective drug delivery for a healthier world.”

The healthcare unit of the Datwyler Sealing Solutions division designs, develops and manufactures solutions for injectable packaging and drug delivery systems to facilitate customers to create a safer medical environment. In addition to the Omniflex series, vial stoppers of different sizes as well as plunger stoppers will be produced in this FirstLine facility.

EP News Bureau - Mumbai

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PHARMA ALLY

CPhI Pharm: Multisorb introduces sorbent technology and services for pharma companies Multisorb's Success through Efficiency programme helps companies quickly identify, select, and dispense the optimal sorbent solution MULTISORB TECHNOLOGIES will exhibit at CPhI Korea in Seoul, South Korea, August 23-25, 2016, and introduce how it can help companies stabilise their pharma or medical device packaging presentations with sorbent technology (desiccants and oxygen absorbers).

For over 50 years, Multisorb has provided end-to-end solutions to help pharma manufacturers around the world protect their products against moisture, oxygen, and volatiles through innovative and reliable solutions.

"For pharma companies, especially those exporting to regulated markets like the US,

EU, Canada and Australia, Multisorb offers unparalleled expertise in stabilising pharma products and meeting regulatory requirements. We leverage our technical expertise with proven sorbent technology to help companies speed their product launches and achieve market success," said Lax Khaitan, Commercial Director of Multisorb's Healthcare Packaging Group in Asia-Pacific.

An innovative and consultative approach Multisorb's Success through Efficiency programme helps companies quickly identify,

select, and dispense the optimal sorbent solution. The programme highlights include: ◗ Faster market access: The company's Quality by Design (QbD) simulations can eliminate costly ranging studies and help get the product to market 6-12 months faster. ◗ Sorbent options for all products: Multisorb offers a full range of desiccant and sorbent platforms to meet all packaging requirements. ◗ Lowest cost of ownership: The company's sorbent dispensing systems deliver an industry leading output efficiency of >99.997 per cent and the lowest total cost of

ownership.

Multisorb offers the experience you need

ately building key infrastructure and relationships in preparation for commercial launch,” said Nick Leschly, Chief bluebird. Our partnership with Lonza is one notable example of our progress on the manufacturing front, and we are pleased to benefit from their expertise and experience as we continue working to bring transformative therapies to patients in need.”

HOVIONE HAS announced the opening of its new sales and customer support office in Osaka, Japan.

The new office underlines the importance of Japan for Hovione’s business activities.

Japan is a strategic market for Hovione where the company is growing both its off patent API and its contract manufacturing businesses.

The new office will support customer relations and help in the development of new business within Japan.

“We are delighted to be opening our office in Osaka.

Hovione’s advanced technologies and focus on quality gives us an excellent fit with the Japanese market so we wanted to have a local presence offering the best possible support to our customers,” said Kristine Senft, Hovione’s Vice President of Marketing and Sales.

“We are fortunate to have Yasushi Usuda leading our office as he is a Japanese national with 20 years international business experience.

Usuda will ensure seamless communication with our customers and help us to develop our business even further,” said Dr Roger Viney, Senior Director of Off-Patent APIs. The new office is located at 20F Hankyu Grand Building 8-47 Kakuda-cho, Kita-ku Osaka 530-00178, Japan. The office offers a good accessibility and is centrally located in Osaka next to the main train station.

EP News Bureau - Mumbai

EP News Bureau - Mumbai

◗ Over 1,000 pharma presentations stabilised for market entry ◗ Full R&D, engineering, quality, and manufacturing support ◗ ISO 9001:2008 and BS EN ISO 14001:2004 registered facilities ◗ Type III Drug Master File (DMF) on file for all sorbent products ◗ Compliance with all US and EU regulatory requirements for pharmaceutical packaging EP News Bureau - Mumbai

Lonza and bluebird bio establish commercial manufacturing agreement The agreement provides for commercial production of bluebird bio’s Lenti-D and LentiGlobin drug products through dedicated production suites within Lonza’s facility LONZA HOUSTON and bluebird bio have entered into a strategic manufacturing agreement providing for the future commercial production of bluebird bio’s Lenti-D and LentiGlobin drug products.

This agreement follows a successful multi-year clinical manufacturing relationship and provides bluebird bio with a path to commercial supply including dedicated production suites within Lonza’s state-ofthe-art facility. This facility i

36 EXPRESS PHARMA June 16-30, 2016

s currently under construction, for the clinical and commercial supply of viral vectors and virally-modified cell therapy products.

Under this multi-year agreement, Lonza will complete the suite design, construction and validation along with process validation prior to anticipated commercial launch.

“This new strategic relationship with bluebird bio is an example of Lonza’s ability

to be a long-term commercial partner to the cell and viral therapy industry. Our global facilities, regulatory track record and security of supply offer customers like bluebird bio a reliable strategic manufacturing partner for the lifetime of their therapeutic drugs,” said Marc Funk, COO, Lonza’s Pharma & Biotech segment.

“As we advance our gene therapy programmes through clinical trials, we are deliber-

Hovione opens a sales and customer support office in Japan

PHARMA ALLY PRODUCTS

Mack Pharmatech launches stability chamber

MACK PHARMATECH has recently launched a stability chamber. The technical features are The chamber has PLC-based control system, 21 CFR Software, touch screen display, stand by refrigeration system, stand by humidity system, imported stand by Hygroflex sensor, GSM technology, Hooter system.

The technical specifications are as

follows: ◗Temperature range:20°C to 60°C ◗ Humidity range :40 per cent RH to 95 per cent RH ◗ Accuracy: ±0.2°C & ±2.0 per cent RH ◗ Uniformity: ±1.0°C & ±3.0 per cent RH ◗ Control system: PLC (Allen Bradly)

Test suitable for: ◗ 25°C & 60 per cent RH, ◗ 30°C & 65 per cent RH, ◗ 40°C & 75 per cent RH, ◗ 30°C & 75 per cent RH

To subscribe: bpd.subscription@expressindia.com

Contact Mack Pharmatech B-48, Malegaon MIDC, Sinnar, District-Nasik, Maharashtra 422 113 Harshal Ghoge Mobile : +91 93259 65656 Telefax : +91-02551230877 Website: www.mackpharmatech.com E-Mail : sales@mackpharmatech.com

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PHARMA ALLY

ALF 5000: New filling and closing machine for ampoules and injection bottles from Bosch BOSCH PACKAGING Technology, a leading supplier of process and packaging technology, presented the latest generation of the ALF series at Pharmatag 2016 in Crailsheim, Germany. In addition to many detail improvements, the new filling and closing machine offers an increased output of up to 600 ampoules per minute.

“Not only regarding its output, the new ALF 5000 is situated in the high-performance range,” Tobias Göttler, Product Manager at Bosch Packaging Technology, emphasises.

Optimised design, high process safety The improved pharmaceutical design of the new ALF 5000 is clearly visible: the machine table top is conceived without steps and interfering edges, providing a better sealing from the sterile area. Moreover, the

machine’s improved accessibility ensures easy and reliable cleaning. In addition to the common right-hand version, the ALF 5000 is now also available as left-hand version, which enables optimal adaption to existing production sites and workflows such as internal itineraries.

“During the development process, we put special emphasis on even higher process safety. For instance, the ampoule heads are removed sidewards during closing instead of from above,” says Göttler.” This avoids machine movements above the open ampoules, making the process safer and more reliable. For a particularly gentle processing, it is now possible to use a carrying rake transport system that slightly lifts the glass containers to prevent them from rubbing against the machine

ALF 5000 offers maximum flexibility. Whether four, six, eight, ten or twelve filling points – all established filling systems such as peristaltic pump or time-pressure-filling system can be used with the new machine

guide.

Maximum flexibility Whether four, six, eight, ten or twelve filling points – all established filling systems such as peristaltic pump or time-pressure-filling system can be used with the new machine. In its combi version, the ALF 5000

optionally processes injection bottles in addition to ampoules, which further increases production flexibility for drug manufacturers and contract packers, combined with easy changeovers. As an option, customers can also choose between a statistical or a 100 per cent in-process control, as well

High Speed Self Repairing Door by Gandhi Automations PRIME RESET is a unique high speed selfrepairing door with the latest technology that prevents downtime of the door system. In case the curtain is impacted accidentally it will cause the curtain to move out of the guides without damage. The movement of the door is designed in such a way it can be recovered with a simple opening and closing operation. Gandhi Automations manufactures doors of the highest quality that meet the issue for greater flexibility desired by clients. High

38 EXPRESS PHARMA June 16-30, 2016

speed self-repairing door in PVC is the most suitable solution in the field industries, it lowers the time of transition from one facility to another, avoiding any human error which can cause damage to the high speed door, and all this thanks to the innovative Anti Crash System. Gandhi Automations provides a world class product with great security.

The features of selfrepairing high speed doors offered by Gandhi Automations are:

◗ Flexible and Self-Repairing Door ◗ Functional, safe, quick and resistant ◗ Innovative anti-crash system ◗ Can be equipped with PVC vision windows ◗ Self-Lubricating maintenance free guide ◗ Smooth and silent opening and closing ◗ Protects traction unit, enables rapid wiring and safety photocell ◗ Flexible curtain in selfextinguishing material ◗ Self-resetting without intervention ◗ Quickly back to opera-

tion ◗ Control panel designed for an intensive continuous service Contact Gandhi Automations Pvt Ltd Chawda Commercial Centre, Link Road, Malad (West) Mumbai – 400064, India.

Off:+91 22 66720200 / 66720300 (200 lines) Fax:+91 22 66720201 Email: sales@geapl.co.in Website : http://geapl.co.in/ high-speed-self-repairing-doors.html

as different infeed and outfeed versions.

“We have used our expertise from more than 2,000 delivered filling and closing machines for ampoules and combined it with our successful technology from other machine series. The result is an especially flexible solution that can be tailored to specific customer requirements,” Göttler explains. Due to its compact design, the ALF 5000 is suited for wall mounting and integration into barrier systems without difficulty. Following Bosch’s pharma line competence approach, the new filling and closing machine can be combined with upstream and downstream equipment to form a complete line.

Contact Tobias Göttler Phone: +49 7951 402-619

PHARMA ALLY POST EVENT

Rockwell Automation conducts life science symposium in Mumbai Measures to meet the needs of increased regulation and quality while reducing manufacturing costs and risks in the life sciences industry were discussed Usha Sharma EP News Bureau - Mumbai ROCKWELL Automation recently organised a life science symposium in Mumbai on â&#x20AC;&#x2DC;Leveraging Technology to Ensure Quality and Complianceâ&#x20AC;&#x2122;. Key industry leaders discussed and recommended measures to meet the needs of increased regulation and quality while reducing manufacturing costs and reducing risk in the life sciences industry, at the symposium.

Gopal Nair, Director, International Society for Pharmaceutical Engineering India Affiliate presented data on the Indian pharma growth story and touched upon the opportunities and the challenges in the sector. He also spoke on leveraging technologies in

the life science sector. He expressed his concerns on pharma exports and mentioned that the growth rate for export of pharma products to the US from India is declining. He also highlighted that over the last three years, the proportion of warning letters received from the US FDA by Indian pharma companies have reduced.

He also stressed on the need for ensuring GMP and data integrity in the pharma industry and cited the Ranbaxy case as an example of how lack of data integrity cost the company its reputation in the global market. He also indicated that the future factories of the Indian pharma industry should be completely driven by automation.

Rishal Shah, Member, Indian Pharma Machinery Manufacturers

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June 16-30, 2016

PHARMA ALLY Association and Managing Director Jekson Vision briefed the delegates about the IPMMA and its initiatives to boost the Indian pharma machinery manufacturers in both the domestic as well as in the international markets.

Warford Reaney, Founding Partner and CEO, Aveta Lifesciences â&#x20AC;&#x201C; US â&#x20AC;&#x201C; Quality and Compliance Consultant informed that in the US anything related to healthcare is either a product or a medical device. He also shared a detailed note on the FDA quality metrics guidance which is in the draft stage.

He opined that automation is the need in the Indian pharma industry and the future looks good. Referring to a KPMG report, he indicated that by 2020, it is likely that there will be upward movement in organic growth by 8.6 per cent.

Dilip Sawhney, Managing Director-India Rockwell Automation spoke on the SMART manufacturing process. He emphasised that in order to realise SMART manufacturing, the manufacturers need to come together and establish the concept of 'Connected Enterprises'.

In this, the entire (manufacturing) chain have to collaborate and share their collected data for better delivery and smoother work processes.

Anil Kumar Kartha, Site Head- Patalganga Cipla talked about the top challenges faced by the pharma companies. He informed that the US FDA hopes that the future data integrity issues will do down in future. He cautioned his industry peers that unless the right validation processes are adopted there is no point on installing high tech software systems.

Dev Bakshi, Managing Director, Tapasya Engineering Works delivered a note on solutions to enable quality by design; machine builder's perspective. He also highlighted that innovation is not to make the product complicated or difficult but to design in such a manner that it simplifies the process with the help of technology. Rockwell Automation also organised technical sessions for the participants.

40 EXPRESS PHARMA June 16-30, 2016

ADVERTORIAL

Potential of the Linear Ion trap Mass Spectrometer Dr Manoj Pillai, Director,Application Support, SCIEX, India and Raghunath MV, Market Development Manager, SCIEX, India elaborate on the potential of QTRAP system for Impurity Profiling/Genotoxic Quantitation LIQUID CHROMATOGRAPHY combined with atmospheric pressure ionization (API) tandem mass spectrometry (LC/MS/MS) is particularly suitable for the analysis of pharma compounds. Triple quadrupole systems have been widely used for quantitation due to their specificity, selectivity and high duty cycle in MRM mode. In addition to the MRM scan, triple quadrupole instruments can also perform selective scan functions like constant neutral loss and precursor ion scan which are useful for establishing structural relationship. At the same time the full scan sensitivity of the ion trap based mass spectrometers make it better suitable for qualitative analysis compared to the quadrupole based mass analyzers. Hybrid instruments like QTRAPTM provide the capability and specificity of triple quadrupole scan functions and sensitivity of a ion trap operational modes present unique opportunities for the use in both quantitative and qualitative analysis.

Hybrid Triple Quadrupole Linear Ion Trap (QTRAP®) Systems provide a novel workflow for the screening and identification of a multitude of targeted analytes by combining selective MRM detection with a highly sensitive MS/MS scan using Q3 as Linear Ion Trap. In Information Dependent Acquisition (IDA) experiments, the detection of an MRM signal above a specified threshold automatically triggers an Enhanced Product Ion (EPI) scan.

These EPI spectra are as sensitive and selective as MRM signals and contain the complete molecular fingerprint because of precursor ion selection in Q1, product ion generation in the collision cell (Q2), and ion accumulation in the LIT (Q3).

The rich product ion spectra are the

QTRAP Systems provide a novel workflow for screening and identification of a multitude of targeted analytes result of the generation of fragment ions in the collision cell. These spectra can be searched against existing mass spectra libraries. The information saved into a full scan MS/MS spectrum allows identification with a higher degree of confidence minimizing the risk of potential false positive and negative detection. In addition, the improved cycle time for all confirmatory MRM transitions can be used to increase the dwell time of all other MRM transitions to improve S/N, resulting in better reproducibility and accuracy. Alternatively, additional compounds can be screened in the MRM survey scan.

The additional capabilities of the QTRAP system based on the IDA workflow are given below:

Triple quadrupole scan functionality ◗ MRM & dynamic range for quantitation ◗ Neutral loss scanning for structural relationship between patent and impurities ◗ Precursor ion scanning for structural

To subscribe: bpd.subscription@expressindia.com

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June 16-30, 2016

ADVERTORIAL Need for Impurity Profiling/Quantitation Need

Required MS Scan Type

Best Mass Analyser

Identification of Significant impurities

Full Scan MS – Sensitivity is important

TRAP based

Determination of the origin of the impurities

Establishing the structural relationship 1. Product ion scan ( MS/MS) 2. Precursor ion scan 3. Neutral Loss scan

Triple Quad

Isotopic pattern determination

Enhanced resolution scan

Trap based

Identification of potential degradation products

Full Scan MS – Sensitivity is Important Isotopic pattern of the compound

Trap based

Understanding degradation pathway

Establishing the structural relationship 1. Product ion scan ( MS/MS) 2. Precursor ion scan 3. Neutral Loss scan

Triple Quad

Quantitation of impurities

Multiple Reaction Monitoring – Selectivity and sensitivity in ppb level

Triple Quad

relationship between patent and impurities ◗ Normal quadrupole style MS/MS fragmentation pattern

QTRAP Scan Functinality ◗ Superior full scan sensitivity in EMS, MS/MS and MS/ MS/MS scan ◗ High resolution scanning (For isotopic pattren determination) ◗ Enhanced multiply charged scanning (Peptide analysis) ◗ MRM3 quantitation ◗ MRM and dynamic range for qunatitation ◗ Neutral loss scanning for structural relationship between patent and impurities ◗ precursor ion scanning for structural relationship be-

tween patent and impurities ◗ IDA triggered on-the-fly combination of classic QqQ and QTRAP specific scan modes enabling unique & powerful new LCMSMS workflows

Role of Quadrupole Based Mass Analyzer in Impurity Profiling/Genotoxic Quantitation ◗ Best for low level Quantitation (Use MRM selective scan) ◗ Neutral loss and Precursor Ion scan – Best to find the structurally similar compound in impurity Profiling ◗ Low Full Scan sensitivity ◗ No accurate isotopic pattern determination ◗ Product Ion Spectra (Unit resolution)

◗ Both quantitative and qualitative analysis cannot be possible on typical Triple Quad based system. ◗ No MS/MS/MS for interpretation of Impurities ◗ Resulting in no confirmation of any impurities or degradation products

Benefits of QTRAP Based Mass Analyzer in Impurity Prolfing/Genotoxic Quantitation ◗ Best Full Scan Sensitivity (Trap Mode) ◗ Best product Ion Scan (Trap Mode) ◗ MS/MS/MS (Trap Mode) ◗ All the QqQ scan function will remain same, hence best for Quantitation (Quadrupole

Traditional QqQ vs QTRAP (IDA-DBS) Based Impurity Profiling

42 EXPRESS PHARMA June 16-30, 2016

Mode) ◗ Tools like Information Dependent Analysis (IDA) enables user to improve their throughput by generating MS and MSMS data in a single LC run, thus high throughput. ◗ Can perform high sensitivity quantitative experiments in combination with high sensitivity qualitative scans in one experiment, which is ideally suited to investigations of both expected and unexpected impurities.

Workflow based experiments in QTRAPTM for Impurity Profiling ◗ Information dependant workflow (IDA) ◆ IDA helps in the on the fly

acquisition of the Full scan spectra (EMS), the isotopic pattern of the masses (ER), the fragmentation pattern (EPI) and can also do the MS/MS/MS. This will be an ideal tool for unknown sample analysis as this can collect the detailed data from a single LC MS run. ◆ Further IDA workflows can use the combination of scan functions that is pertaining to the triple quad and the trap thus improving the power of both qualitative and quantitative analysis. This is unique to the hybrid QTRAP instrument. ◆ The combination of scan functions from the triple quad and trap makes the identification workflow very selective and specific too. ◆ IDA workflows can be used for general unknown screening, impurity profiling and metabolite identification, and for any simultaneous quantitative and qualitative work.

Real time algorithm for Impurity profiling with QTRAP ◗ Dynamic background substraction (DBS) ◗ Collision energy Spread (CES) Dynamic Background substration (DBS): This is noval automated MS/MS techniques for impurities analysis. Real time dynamic background substraction (DBS) is useful triggering tool for MS/MS in IDA experiments, on peaks of interest not on the background ion.

The concept of DBS is to subtract the previous scan from the current one, before applying any other IDA selection criteria. This can eliminate the need for a second injection in order to acquire MS/MS. This will be use full tool for characterizing the impurities present at very low level in API samples.

Collision energy Spread (CES): This real time algorithm uses three different collision energy to fragments the ion of interest. This reduce the optimisation step for enhanced product ion spectra and MS/MS/MS. This algorithm avoids reinjection of samples to get the best and rich production spectra.

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PACKAGING PRODUCTS FOR HEALTH CARE

RUBBER STOPPERS

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EXPRESS PHARMA Available for takeover

PHARMA COMPANY MARKETING FORMULATIONS WITH OWN FIELD FORCE A Mumbai based profitable & systems oriented pharma co. marketing formulations ethically (T.O. 3.15cr) with 42 MRs + Mgrs, 17 niche very high margin brands is available for takeover with brands & field force. No liabilities. Quick/ transparent deal. Big opportunity to enter recession proof, high growth / high returns Pharma field. Scalable to All India operations in a phased way quickly.

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email: info@ptelectronics.in June 16-30, 2016 53

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EXPRESS PHARMA LABORATORY EQUIPMENTS Walk-in chamber

Cyclomixer Mini Rotary Shakers

Ultra Low Frezeer

Double Door Refrigerator

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Refrigerated Centrifuge Laboratory Centrifuge

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OSMOMETER 3250

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EXPRESS PHARMA Group Companies:

KILITCH HEALTHCARE LLP

NBZ

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Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957

Factory: NBZ Pharma Ltd. R-905, T.T.C. Indl. Area, M.I.D.C, Rabale, Navi Mumbai - 400 701.

Tel. : 022 2769 9174, 6516 2146 Mr. Krishnakant Yajurvedi : +91 7710040409

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PHARMA LIFE APPOINTMENT

Kanchana TK appointed new Director General of OPPI Most recently, she was with Bristol Myers Squibb, where she was Lead - Public Affairs for Middle East, Africa and India

T

he Organisation of Pharmaceutical Producers of India (OPPI), which represents the research-based pharmaceutical companies, has appointed Kanchana TK as its new Director General, with effect June 01, 2016. Kanchana takes over from Ranjana Smetacek, who has decided to

relocate to the US. Kanchana brings almost two decades of professional experience across a range of healthcare-related businesses. Most recently, she was with Bristol Myers Squibb, where she was Lead - Public Affairs for Middle East, Africa and India.

Dr Shailesh Ayyangar, Pres-

ident, OPPI said, “I would like to thank Ranjana for her professionalism and leadership over the last three years at the OPPI and I am delighted to welcome Kanchana as her successor.

With her sound experience in two highly-regulated sectors, insurance and pharma, Kanchana brings a new strategic

perspective to India’s evolving healthcare policy ecosystem.”

Speaking on her appointment, Kanchana TK said, “As Director General of OPPI, I look forward to the opportunity to contribute towards the growth of our industry and strengthen OPPI’s key role in finding ways to ensure quality healthcare is

accessible to all. In my role, I will continue to drive advocacy programmes and work towards bringing diverse stakeholders together on issues related to Intellectual Property, Access to healthcare and Ethics in pharma marketing.”

EP News Bureau - Mumbai

Lupin appoints Yugesh Goutam INITIATIVE Rusan Healthcare as President – Global HR Goutam has a track record of developing and sustaining scalable leading edge HR systems/practices for large scale businesses across the globe LUPIN HAS announced the appointment of Yugesh Goutam as President – Global Human Resources (HR). Goutam will lead the HR function for Lupin globally and will be based at the company’s corporate headquarters in Mumbai, India. Goutam takes over from Divakar Kaza who has opted to retire after a transition period to pursue other interests.

Goutam comes to Lupin from the JSW Group where he was Group President – Human Resources with responsibility for the HR function across all their businesses. Reportedly, he has over 29 years of diverse experience across sectors and geographies. Prior to JSW he worked with RPG Life Sciences, Beckton Dickenson, Pfizer and Reliance Industries.

64 EXPRESS PHARMA June 16-30, 2016

Goutam has a track record of developing and sustaining scalable leading edge HR systems/practices for large scale businesses across the globe. He has completed his Post Graduate Diploma in Personnel Management and Industrial Relations from CBM, Chandigarh. He has also done a Human Resources

executive program from the University of Michigan, US in 1998.

Commenting on the appointment, Nilesh Gupta, Managing Director, Lupin said, “We are very happy to have Yugesh join Lupin at a time where we are not only building on our leadership in key markets but also expanding our geographical presence, as we continue on our transformational journey to emerge as a specialty pharma and complex generics major globally. We are already recognised as one of the best companies to work for in Asia and are confident that Yugesh will continue to build on our HR processes and systems, adding depth to deliver a world-class people driven organisation.”

EP News Bureau - Mumbai

supports BESTemployees to quit tobacco Provides free treatment for tobacco cessationto 100 BEST staff ON THE eve of World No Tobacco Day, Rusan Healthcare with an aim to promote ‘Tobacco free BEST’ provided medical guidance and assistance to BEST conductors and drivers to help them quit tobacco and lead a healthy life.

Rusan Healthcare conducted a special camp for BEST staff to assess their level of tobacco addiction, educate them about health hazards of tobacco consumption and the importance of leading a healthy life by giving up tobacco. Thence, Rusan Healthcare has taken this initiative to provide three months Nicotine Replacement Therapy to 100 BEST employees to keep them

away from the harmful effects of tobacco consumption.

Rusan Healthcare’s medical team conducted tobacco cessation camps across 26 depots in the city and provided counselling to support them in quitting tobacco. Basis the intensity levels of addiction, around 100 conductors and drivers will be provided complete three month tobacco cessation therapy using 2baconil transdermal patch. This is a nicotine replacement therapy that provides a measured dose of harmless nicotine that reduces the withdrawal symptoms experienced by a patient.

EP News Bureau - Mumbai

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