Ghp March 2015

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ghp March 2015

www.ghp-magazine.com

global health & pharma

Plus

The latest deals from across the pharma and healthcare world

Healthcare Startups The new companies making their mark

Driving Innovation in Colonoscopy An exciting recent deal

Resolving Pharma IP Disputes

How drug companies can make sure their ideas stay their own


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ghp editor’s note

global health & pharma

this month’s features

inside this issue

Hello, and welcome to the inaugural issue of Global Health & Pharma.

04 News

Each month, we’ll be taking you behind the scenes of the worldwide healthcare and pharmaceutical industry, bringing you illuminating insights, opinion and interviews with the leading players.

10 Driving Innovation in

We’re kicking off our launch issue with a look at how, in an ever more competitive marketplace, pharma companies can best protect their intellectual property rights – and ensure that their valuable ideas stay their own (p.20).

The Five Essential Truths about US Prescription Drug Spending

Any discussion of prescription drug spending needs to consider the following facts, says the Pharmaceutical Research and Manufacturers of America. Page 8

Elsewhere, we hear how one company is revolutionising colonoscopy with a new product that promises to make the procedure safer, cheaper and more efficient (p.16). And, with venture capital flowing into healthcare startups, we take a look at some of the companies that should be on your radar (p.26). I hope you enjoy our launch issue, and we look forward to seeing you again next month. Mark Toon Editor

The latest news from across the global healthcare and pharmaceutical industries.

Colonoscopy

We hear how medical device company, invendo medical, closed a US$28m financing round led by new investor Xeraya Capital.

12 The Outlook

for Pharma

Peter Utterström, Senior Counsel at Hellström Advokatbyrå KB law firm, tells us how the pharmaceutical industry has fared so far this year, and what the future holds.

22 Healthcare Startups Resolving IP Disputes in the Pharma Industry

In today’s business environment, protecting your intellectual property rights is vitally important – and nowhere is this more the case than in the pharmaceuticals industry. Page 14

“The most progressive organisations are developing enhanced methods to deepen connections to patients.” Trina Gordon, President and CEO of Boyden World Corporation ghp March 2015 | 3

to Watch

Venture capital is flowing into healthcare startups. We pick out the ones to watch.

24 Deals

We bring you the biggest and brightest deals shaping the world of health and pharma.

Global Health & Pharma 39A Birmingham Road Blakedown Worcestershire DY10 3JW Tel: +44 (0) 1234 567 890 Email: info@ghp-magazine.com Web: www.ghp-magazine.com


news

Convenience, Cost Savings Bolster Patient Portals’ Adoption Rates in Africa Technology explosion facilitates the rollout of patient portal services, finds Frost & Sullivan Healthcare givers in Africa are gradually recognising the convenience and cost benefits of adopting patient portals that integrate financial and clinical data. This service not only improves anytime, easy, and secure access to patient data, but also reduces the cost of care and helps eliminate penalties such as readmissions. New analysis from Frost & Sullivan, Patient Portals in Africa, finds that while healthcare providers and payers in Africa clearly understand the value of patient portals, they do not perceive any urgent need to implement them. However, advantages such as patient engagement will encourage uptake in the future. As the patient portal market in Africa is nascent, it is marked by challenges relating to costs and data security. Among end users, insurance payers were the first to adopt similar eHealth technologies, which were mainly used to make patient records available to doctors. The installed base of these technologies has the potential to be upgraded to patient portals, once end users are made aware of its multiple benefits. “The ability of patient portals’ to optimise the operational and financial efficiency of healthcare providers and payers by leveraging time-saving technologies is a key purchasing factor,” said Frost & Sullivan Healthcare Research Analyst Saravanan Thangaraj. “Further, it can ease some of the tedious and monotonous administrative, as well as data-entry, tasks that consume hospital resources. Patient portals also eliminate the need for additional staff and postage by enabling patients to perform functions online.”

Currently, substitute technologies such as mobile applications (mHealth) and telemedicine have outstripped patient portals in popularity, but this situation may change in due course. Mobile applications may soon be overshadowed by applications that employ both mobile and web-based portals, as they enhance user engagement by allowing customers to choose the technology they wish to adopt. “The ubiquity of technology has stoked the use of online services and therefore, has fostered an environment that is ideal for the promotion of patient portals,” observed Thangaraj. Patient portals facilitate real-time health monitoring and patient engagement, which will ultimately lead to patient retention. They also make it possible to interact with patients who relocate, or patients living in rural areas who have difficulties visiting physicians and doctors. Apart from the obvious cost and convenience benefits, partnerships between payers and designated service providers to have a common patient portal will greatly enrich patient engagement and encourage its uptake.

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news

J.P. Morgan Joins UK Government to Create New Fund to Fight Dementia Fund to expand research on disease impacting 47 million people J.P. Morgan has been working with the UK government to develop a new multi-million pound fund to encourage investment into better treatments for dementia, a condition that affects an estimated 47 million people worldwide. The firm is providing financial advice to the government and support through its knowledge and experience of the healthcare industry to help identify private sector investment. The aim of the Dementia Discovery Fund is to create an innovative collaboration that will bring together the combined expertise and resources of J.P. Morgan, the UK government, national research organizations, and major pharmaceutical companies, including clients of the firm.

Fund’s supporters include GlaxoSmithKline, Johnson and Johnson, Biogen, Lilly, Pfizer, and Alzheimer’s Research UK.

“We believe J.P. Morgan has a responsibility to put our world-class financial advice and global network to work addressing major social and economic challenges. As a premier advisory firm for healthcare companies and leader in impact investing, advising the UK government on this Fund was a natural fit for J.P. Morgan,” said Daniel Pinto, CEO of J.P. Morgan EMEA. “With only three new dementia-treatment drugs approved in the past 15 years, it is clear that public-private partnership will be essential to accelerate funding and overcome this global health issue.”

JPMorgan Chase has a history of working on innovative funding structures like the Fund, which are critical to attracting new capital to the global health industry for new research and development. In 2013, JPMorgan Chase and the Bill & Melinda Gates Foundation structured a new $108 million investment fund to advance late-stage global health technologies, like vaccines, in low-income countries. The firm has also worked across a number of sectors to marshal impact funds including the African Agricultural Capital Fund, Novastar Ventures, and LeapFrog Investments, to pursue positive change for low-income and excluded populations.

The UK government has made it a priority to lead the global fight back against dementia, and committed to identifying new disease modifying treatments by 2025, which was a key commitment of the UK’s 2013 G8 summit. The Fund will finance pre-clinical research identified by renowned scientists as having good potential for clinical success.

“Alzheimer’s Research UK are delighted to be part of this unique and innovative initiative, a world first for dementia research,” said Dr. Matthew Norton, Head of Policy at Alzheimer’s Research UK. “The Fund will bring much needed new money into dementia research, but importantly also represents a new way of doing things. It will ensure some of the best minds in commercial drug discovery focus their efforts on dementia, widening the breadth of focus in the area and increasing our chances of success.”

The Fund is part of a broader effort supported by the World Dementia Council which works to improve regulatory pathways and data sharing across research organizations. The council formed following the 2013 G8 dementia summit and comprises of academics, practitioners and government representatives.

“Dementia is a global threat and we have taken enormous steps in putting this condition on the international health agenda. But there is still much more we need to do to give people with dementia hope for the future,” said Jeremy Hunt, UK Secretary of State for Health. “That’s why I’m delighted that J.P. Morgan has worked with us to design this Fund to help turn innovative research into new drug development. It’s significant step in our fight against dementia.”

Appointments Dyadic International appoints Jack Kaye to board of directors

Dyadic International, Inc. has announced the appointment of Jack Kaye to the Board of Directors, effective April 1, 2015. Mr. Kaye will serve on the audit and compensation committees. With the addition of Mr. Kaye, there will be seven members on the Dyadic Board. Mr. Kaye is a seasoned financial executive with over forty years of diversified experience. He is currently the Chairman of the Audit Committee of Keryx Biopharmaceuticals, Inc. where he has served since 2006. He previously served on the board of directors of Tongli Pharmaceuticals (USA), Inc., a China-based pharmaceutical company and Balboa Biosciences, Inc., a privately held biotech company. Mr. Kaye began his career at Deloitte LLP, an international accounting, tax and consulting firm, in 1970, and was a partner in the firm from 1978 until May 2006. At Deloitte, he was responsible for serving a diverse client base of public and private, global and domestic, companies in a variety of industries. Mr. Kaye has extensive experience consulting with clients on accounting and reporting matters, private and public debt financings, SEC rules and regulations and corporate governance/ Sarbanes-Oxley issues. In addition, he served as Deloitte’s Tri-State liaison with the banking and finance community and assisted clients with numerous merger and acquisition transactions.

Splunk Appoints Amy Chang to Board of Directors

Neurotech Pharmaceuticals, Inc. has announced that Charles A Johnson, MD, has assumed the role of Chief Medical Officer. Dr. Johnson is an accomplished physician and pharmaceutical executive with over four decades of experience in clinical practice and the biotech sector. Dr. Johnson was most recently the Vice President of Global Medical Affairs at Vertex. Prior to this, he held leadership positions at Inspire Pharmaceuticals and APT Pharmaceuticals. Notably, during his 13 year tenure at Genentech, he was the Vice President and Head of the Immunology and Tissue Repair clinical group and had responsibility for the approvals of LUCENTIS® for wet age-related macular degeneration and RITUXAN® for rheumatoid arthritis. Prior to joining the pharmaceutical industry, Dr. Johnson spent 18 years practicing medicine. Dr. Johnson received his medical degree from the University of Cape Town in South Africa, attained Board Certification in Pediatrics at the Red Cross War Memorial Children’s Hospital and completed his Pediatric Pulmonology Fellowship at Washington University. Dr. Johnson has presented clinical data at numerous medical conferences and been published in several respected scientific journals. “We are extremely pleased to add such an experienced and high-caliber individual to our executive team,” commented Quinton Oswald, Chief Executive Officer of Neurotech. “Charlie’s unique combination of regulatory, medical, and drug development expertise in the ophthalmic space, particularly in posterior segment disease, will help to continue to position Neurotech and the NT-503 program for success as we commence our wet AMD Phase 2 trial.”

With the aim of diversifying investment into new exciting areas of research, the Fund intends to improve the likelihood of identifying treatments to slow the progression of the disease and improve the quality of life of dementia patients and their carers. The

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news

Better Pharma CMO and CIO Collaboration “Will Advance the Digital Revolution” Accenture survey shows 67% of the CMO respondents do not view IT as a strategic partner, compared to 50% of CMOs surveyed in all industries

Chief marketing officers and chief information officers in the pharmaceutical industry may be missing the opportunity to optimise the impact of digital technologies due to a lack of alignment on how they should respond, according to a new Accenture industry report, The Rising Opportunity for CMO and CIO Collaboration in the Pharmaceutical Industry, based on a global Accenture survey.

• Only 17 percent of pharmaceutical CMOs have spent funds to equip a mobile-enabled sales force, compared to 43 percent of pharmaceutical CIOs. • Just 13 percent of pharmaceutical CMOs said they have spent the most to invest in multichannel analytics, compared to 43 percent of pharmaceutical CIOs.

More than nine out of 10 large pharmaceutical company CIOs (91 percent) who participated in the Accenture Interactive 2014 CMO-CIO Alignment survey of senior marketing and IT executives believe that their companies are in need of greater marketing/IT alignment. By contrast, fewer than two out of three pharmaceutical CMOs (58 percent) agreed with that statement – a discrepancy of 33 percent. This difference in perspective is greater in the pharmaceutical industry than in all other industries surveyed by Accenture at the same time – where the average discrepancy was only 14 percent.

The survey also pointed to a lack of a common vision for technology and understanding between CIOs and CMOs in the pharmaceutical industry. For example, two-thirds (67 percent) of the CMO respondents do not view IT as a strategic partner, compared to 50 percent of CMOs surveyed in all industries. Additionally, while nearly 80 percent (77 percent) of pharmaceutical CIOs see the need for greater alignment with CMOs, just 44 percent of pharmaceutical CMOs feel that way.

Anne O’Riordan, senior managing director of Accenture’s Life Sciences industry group, said, “The reasons for the difference include traditional structures, cultures and sales representative-led commercial models. The industry faces a period of rapid change marked by digital advances, new expectations from health care professionals and patients, and a dominant outcomes-based reimbursement environment. This requires CMO-CIO collaboration to increase as patients and healthcare providers move more aggressively into the digital world.” CMOs and CIOs in the pharmaceutical industry have different views of integration and overall investment in the marketing function. According to the report, pharmaceutical CIOs view analytics as the top driver of integration (cited by 52 percent of respondents), but pharmaceutical CMOs rank analytics near the bottom (cited by just 13 percent). Priorities for technology spend were similarly divided:

CIOs and CMOs in the pharmaceutical industry also have differing attitudes on how to make alignment work between the two functions: Nearly four out of 10 pharmaceutical CIOs (38 percent) would favour co-locating IT and marketing staff, an option favoured by only 13 percent of pharmaceutical CMOs. At the same time, nearly four out of 10 pharmaceutical CMOs (38 percent) said they would support creating an IT lead within the marketing function, and a marketing lead within IT, a solution that only 19 percent of pharmaceutical CIOs favoured. “We suggest key steps to closing the gap between pharmaceutical CIOs and CMOs, including establishing a vision and set of common objectives for marketing IT that leverage the power of digital and unifying around the customer and patient experience,” added O’Riordan. “They should also integrate customer/ patient-focused skills throughout the company, and focus the IT agenda to empower marketing to exploit digital technologies.”

• A majority of pharmaceutical CMOs (54 percent) have spent the most in applying technology on customer experience, while just 14 percent of CIOs cited customer experience as a priority to further market impact and outcomes.

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news

Healthcare Sector Transformed by Innovation and Consumer Marketing Executives bring strong experience in change management, brand development and other areas important for mass marketing on a larger scale, finds new report

Appointments HighRoads Hires Mark Manning as SVP and Chief Revenue Officer HighRoads, the industry leader in plan management and benefits compliance, has announced that Mark Manning has joined the company as senior vice president and chief revenue officer. An accomplished health care executive, Manning will lead the strategic direction of sales as the company grows and expands its SaaS-based product and plan management solution. Manning has 30 years’ experience in the health care industry, demonstrating quantified business growth in the payer, pharmacy benefit manager (PBM), life science, self-insured employer and third-party administrator markets. Manning’s versatility includes leadership roles in general business management, product management, sales, marketing and consulting. “Mark excels at building relationships with both payers and employers because of his keen understanding of the significant challenges they face in an evolving regulatory environment,” said Michael Byers, CEO and president at HighRoads. “As we innovate and expand our product offerings, Mark will lead the evolution of our go-to-market team to grow revenue and profitability.”

Innovation in treatments and business strategy, along with an increasing emphasis on consumer marketing, are shifting talent acquisition plans in the healthcare and life sciences sector, according to the quarterly Executive Monitor released today by Boyden Global Executive Search. “CEO turnover in the healthcare and life science industry remains high, as leadership will continue to face financial and regulatory challenges,” said Trina Gordon, President & CEO of Boyden World Corporation. “At the same time, the most progressive organisations are developing enhanced methods to improve operational effectiveness and deepen their connection to patients and customers, which has increased demand for executives who are effective in the new paradigm.” The report covers top line changes in the global healthcare and life sciences sector affecting talent strategy, including the prevailing need for prevalence of change management, increased use of big data, ageing populations posing challenges for both consumers and employers, and an expected increase of headcounts in many companies. “The healthcare industry has shifted and is putting great emphasis on talent acquisition from fast moving consumer goods companies such as Procter & Gamble, Unilever and Reckitt Benckiser,” explains Kerstin Roubin, Leader of Boyden’s Global Healthcare and Life Sciences Practice and Managing Partner, Boyden Austria. “These executives bring strong experience in change management, brand development and other areas important for mass marketing on a larger scale.”

The new report from Boyden also identifies the following trends affecting executive hiring in the sector: • Rising scrutiny of CEO and senior executive compensation, resulting in new evaluation metrics •

Focus on solution-oriented executives rather than product-oriented managers

Increased investment and patent applications

Expansion of generic drugs

Lack of adequate hospital infrastructure, especially in developing and emerging markets

Inversion or company relocation initiatives

“In the US, all of the life sciences sectors are experiencing a broad upswing after a tough first three years following the recession,” said Trevor Pritchard, Partner, Boyden San Francisco. “This growth, coupled with the renewed strength of the M&A and IPO markets, is resulting in aggressive investing and executive hiring in both larger companies and venture-backed concerns. We expect 2015 to deliver an even stronger growth curve than what we experienced over the last couple of years.” “With Indian pharma companies investing heavily in joint collaborative research for new drug discoveries, senior-level professionals with niche skills in the areas of drug discovery, regulatory affairs, quality systems/ compliance, clinical research and development and R&D program management are being sought after and well compensated,” explained Sushil Gulati, Head of Life Sciences Practice and Partner, Boyden India.

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“I’m thrilled to join HighRoads at a time when the market opportunity for a product and plan management solution continues to build,” said Manning. “The ACA has provided urgency for dynamic data management and HighRoads has the deep domain experience to help customers digitize their enterprise.”

Actavis Announces Michael R. Gallagher and Peter J. McDonnell to Join Board of Directors Actavis plc has announced that two former members of the Allergan Board of Directors Michael R. Gallagher, Lead Independent Director, and Peter J. McDonnell, M.D. - have been named to the Actavis Board of Directors. David E.I. Pyott, Chairman and Chief Executive Officer of Allergan, has elected not to join the combined company’s Board of Directors, but will continue to serve as Chairman of The Allergan Foundation, a U.S.-based, private charitable foundation committed to providing a lasting and positive impact in the communities in which Allergan, Inc. employees live and work. In addition to Mr. Gallagher and Dr. McDonnell, the Actavis Board includes Paul M. Bisaro Executive Chairman; Brenton L. Saunders, CEO and President; Catherine M. Klema, Nesli Basgoz, M.D., James H. Bloem, Christopher W. Bodine, Christopher J. Coughlin, Patrick J. O’Sullivan, Ronald R. Taylor, and Fred G. Weiss. On February 5, 2015, in preparation for the closing of the acquisition of Allergan, the Actavis Board of Directors voted to reduce the Actavis Board from 14 members to 12, and announced the voluntary resignation of Tamar D. Howson, John A. King, Jiri Michal and Andrew L. Turner, effective upon the close of the transaction.


r&d

The Five Essential Truths about US Prescription Drug Spending Any discussion of prescription drug spending needs to consider the following facts, says the Pharmaceutical Research and Manufacturers of America

Every day patients around the world are living healthier, more productive lives thanks to innovative medicines developed by biopharmaceutical companies. Retail prescription medicines have consistently accounted for just 10 percent of United States health care spending and federal actuaries project this share will remain stable through the next decade. At the same time, these medicines have helped to curb downstream health care system costs by reducing spending on expensive hospitalisations and long-term care. Any discussion of prescription drug spending needs to consider the following five facts: Government data shows that retail prescription medicines will continue to account for just 10 percent of US health care spending through the next decade. Contrary to recent rhetoric, prescription medicines are a small share of total health care spending and the most recent national health spending projections show that it is expected to grow at rates in line with overall health care spending through 2023. To put this in context, private insurers spent roughly as much on drugs as on administrative costs in 2013 and the US will spend $13.6tn on hospital care over the next decade, more than three times total spending on prescription medicines. 2014 was an unusual year, in which roughly 10 million of uninsured patients gained coverage, and a record number of new medicines were approved. Increases in health care costs were expected in 2014, given the expansion of insurance coverage under the Affordable Care Act. In addition, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved a record number of 41 new medicines, of which nearly 41 percent were first in class treatments, and more than 20 percent were personalised medicines. Among the new medicines are innovative cancer treatments with the potential to prolong and transform patients’ lives, therapies for hepatitis C with cure rates of more than 90 percent, and a record-setting 17 medicines to treat rare diseases. The Express Scripts drug trend report doesn’t tell the full story because it focuses on a small subset of medicines and excludes rebates from their calculations. While Express Scripts has claimed it will save the US $4bn annually as a result of its aggressive negotiations for hepatitis C medicines, they appear to exclude such savings in their public estimates of drug spending. This is surprising since public reports indicate that private payers are receiving discounts of up to 40 percent for hepatitis C medicines. In fact, published estimates of rebates paid by manufacturers put the total at $40bn per year. In addition, a recent actuarial analysis of pharmacy benefit manager drug trend reports show that trends for “specialty” medicines are frequently misleading, and often use inconsistent definitions and methods which can inflate and bias reported trends. Medicines can play a crucial role in controlling future health care costs. Many medicines shift the treatment paradigm toward prevention by allowing patients to avoid expensive hospital and long-term care. And every additional dollar spent on medicines for adherent patients with congestive heart failure, high blood pressure, diabetes and high cholesterol generated $3 to $10 in savings on emergency room visits and inpatient hospitalisations. Medicines help patients live longer, healthier lives. In many cases, research and medicines from the biopharmaceutical sector are the only chance for survival for patients and their families. Medicines have helped raise average US life expectancy from 47 years in 1900 to 78 years. Since its peak in 1991, the cancer death rate in the US has fallen 22 percent and 2 out of 3 patients diagnosed with cancer are living at least 5 years following diagnosis. And new hepatitis C therapies have cure rates above 90% and dramatically decrease the burden of the disease on the US health care system and the economy.

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innovation

Driving Innovation in Colonoscopy In March 2014, medical device company invendo medical closed a US$28m financing round led by new investor Xeraya Capital. We spoke to dealmakers on both sides of the transaction

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invendo medical, manufacturer and distributor of a single-use and computer-assisted colonoscopy system, closed in March 2014 a US$28m financing round. Xeraya Capital, the Malaysia-based venture capital firm, was the lead investor, investing half of that sum via an affiliated company. Also, a German family office joined as a new investor and existing investors TVM Capital, Wellington Partner, 360° Capital. invendo’s founders also participated in the financing.

A colonoscope device is essentially a thin, flexible telescope. But as most colonoscopes are designed to be reused multiple times, there is a risk of bacterial infection, Hercegfi explains. Also, the inflexibility of most devices makes the procedure an uncomfortable one, and one which requires the patient to be put under sedation.

It’s a deal consistent with Xeraya’s stated objective: to “bring life sciences breakthroughs to humanity”. As venture capitalists, Xeraya naturally have a job to do, says Fares Zahir, CEO of Xeraya Capital. “We’re investors, and we look for opportunities where there is a potential to make a return. When we make a deal we try to have a picture of what the company can achieve over the following year.”

As the invendoscope SC20 device is single use, there is no hygiene issue. It is driven gently in and out of the colon with computer assistance, with all endoscopic functions controlled via a handheld device. Furthermore, the very flexible configuration of the invendoscope minimizes the forces applied to the colon wall and it is therefore mostly painless for the patient, who does not need to be sedated and can therefore return to work much sooner than if the procedure had been carried out using a traditional colonoscope.

But he also feels the deal will have positive implications for the medical technology industry, and also to the public. “invendo have the technology to raise the standard of colonoscopy,” he says.

Hercegfi feels it was invendo’s innovation in this field that convinced Xeraya to invest. “They liked the fact that invendo were trying to revive a sluggish market with a single-use product,” he says.

Xeraya has a strong background in life sciences, with a three-pronged vision: “to react quickly to opportunities, take a long-term view on investments, and ensure portfolio companies make a difference in the lives of Malaysians and people around the world.” Ethics are very important for Xeraya, says Zahir. “We’ve got our own set of values,” he says. “Working with others is very important to us.”

The deal presented the usual challenges, says Zahir, “although this was nowhere near as complicated as some.” Because invendo had already gone through the approval process, and now have approval to sell in the US, the deal was much easier to carry out, says Zahir.

With 20 years’ experience in the field of investments in public and private equities, Zahir was, before founding Xeraya Capital, with Khazanah Nasional, the Malaysian government’s strategic investment fund, and Xeraya Capital’s parent company. While there he headed the life sciences unit, formulating investment strategies and undertaking and monitoring the organization’s life sciences investments. Khazanah Nasional has substantial stakes in companies involved in various sectors, including healthcare. One of these companies, IHH Healthcare, is one of the largest private healthcare providers in the world, based on market capitalization, and operates nearly 5,000 hospital beds worldwide. “This is an advantage for us,” says Zahir. It’s also an advantage for the companies Xeraya invests in, he says. “We’re able to give innovative companies a great opportunity.” In addition, he says, they are providing opportunities for Malaysia and its workforce.

The smoothest deals usually benefit from an easy, natural relationship – and the Xeraya deal was no exception, says Hercegfi. “They got to know us over a period of time,” he says. This long standing relationship meant that there were no real challenges for invendo during the transaction. The company would visit Malaysia once or twice a year, to get to know the market, and in terms of due diligence they didn’t have to do very much, he says. As for how this deal will affect Xeraya Capital, Zahir says it gives the firm an opportunity to grow. “We’re relatively new,” he says – Xeraya was formed in 2012 – “and so it’s good to get things under our belt.” For invendo, the fresh funds will be used to build a marketing and service infrastructure in the US, to enhance production capacity for the device, and to support ongoing development projects that address optics and ease of use, among others, says Hercegfi.

There are around 40 million colonoscopy procedures in the US every year. The procedure involves a doctor or nurse using a device to look into the patient’s colon, in order to detect conditions including ulcerative colitis (which causes inflammation of the colon) Crohn’s disease (which also causes inflammation of the colon) diverticula (pouches which form in the lining of the colon), polyps of the colon and cancer of the colon (which is the second leading cause of cancer deaths). But, despite the vast number of procedures carried out each year, compliance remains insufficient. And until now, there has been little technology aimed at changing the ergonomics of colonoscopy, says Timo Hercegfi, chief executive & financial officer at invendo, which is based in New York, USA. and Kissing, near Munich, Germany.

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innovation

The Outlook for Pharma Peter Utterström, Senior Counsel at Hellström Advokatbyrå KB law firm, tells us how the pharmaceutical industry has fared so far this year, and what the future holds

How would you describe the current business environment in your region? Sweden has so far been fortunate in having a stronger financial situation than most countries in the western world and as a result the financial crisis has by and large passed without major effects. Unemployment is statistically high – approx. 7 % - which is low from an international point of view. The recent election to Parliament creates some concern as the populist won a stronger than expected position – 13% – which will make it difficult to rule the country; two balancing blocks and a populist majority is likely to create issues. It is being predicted that the pharmaceutical industry could be worth nearly US$1.6 trillion by 2020. Where in the industry will the largest and most rapid growth be seen and where will present the biggest opportunities for businesses looking to take advantage of this growth? Based on experience one comment is that the traditional pharma companies are likely to remain but with less influence and impact. Teaming up with focused specialist companies – startups as well as well established – and acquisitions of such companies are likely to be more frequent. Furthermore, the MedTech companies are likely to be very active as they are deemed to be lower risk (as compared to bio/pharma). What challenges (legal, operational, demand for medical services) face businesses looking to enter pharmaceuticals from another sector? The key problem is time – once you have found a molecule it will take at least 10+ years and more than US$1bn until you have a product which can go commercial. If you have one! Legally there are many regulatory hurdles to pass until there is a product to sell on the market and in addition there are a lot of IP-issues. Finally, in order to get to the market it is a necessity (in most cases) to qualify for state approval for subsidy, i.e. to show that the new product is more cost efficient than the one it is intended to replace. This may also be one of the reasons why investments are going to the substitute market and to MedTech. Finally, personalised medicine is something which is not in line with the regulatory rules – which creates issues as well. Tell us about the part your business has to play in the industry over the coming years. Where does your greatest expertise lie and how can this be leveraged, both for you your and your clients’ benefit? Law firms and lawyers can – in addition to the traditional role they have played – advocate the necessary changes to further the development. One area is the above-mentioned personalised medicine where the rules and the regulatory bodies must adapt to the technological development and how new products are likely to be brought to the market in the future.

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marketing

Resolving IP Disputes in the Pharma Industry In today’s business environment, protecting your intellectual property rights is vitally important – and nowhere is this more the case than in the pharmaceuticals industry. We spoke to legal practitioners around the world to find out how pharma companies can ensure that their ideas stay their own

Papula Nevinpat was founded in 1975 and now has an 80-strong team in Finland of whom 30 are IP attorneys. It has offices in Finland, Russia, some of the former Soviet states and Munich with a total staff of 150 and around 50 professionals. Director Mr Folke Johansson and Mrs Erja Partio, both European Patent Attorneys, talk to ghp about IP litigation in Finland. Finnish IP law underwent an important change in 1995 when the country joined the WTO. Until that point IP protection in the pharmaceutical industry was only available for the method of manufacture of a pharmaceutical and not the product itself. As these patents and their Supplementary Protection Certificates can be in force for 20 + max 5 years, the majority of pharmaceutical IP disputes in Finland still revolve around manufacturing methods. Still the majority of the pharmaceutical patent litigations go about whether the manufacturing method is an equivalent to the patented method – the burden of proof lies with defendants to prove it’s not within the patent scope. “Pharmaceutical products must have market authorisation issued by the Finnish Medicine Agency Fimea or European Comission/the European Medicine Agency EMEA,” explains Mrs Partio. “Patent holders monitor applications for market authorisation to recognize potential infringing products – and the burden of proof is on the defendant to prove that a different method which is workable in industrial scale has actually been used, which may involve revealing trade secrets to the court.” As part of the Finnish government’s IP strategy, Finland’s new IP court opened in September 2013. As yet, no pharmaceutical cases have been decided by it, so it is unclear whether there will be any differences in approach. However, Mr Johansson points out that it will be important for companies to invest in litigation. “Previously IP cases were heard in the district court with appeals to the court of appeal and then the high court, although permission was rarely granted,” he says. “The new IP court only allows for appeal to the high court and it may be equally rare, so it will be important to get it right first time.”

The Traple Konarski Podrecki Law Office and Partners is one of the leading law firms on the Polish market in its areas of practice Pharmaceutical patent litigations are the most difficult among the patent infringement cases. This is partly because they are strongly influenced by public interest in securing the access to low cost generic drugs as soon as possible and partly due to the complicated subject matter of this kind of patents. It is the principle that when a patent proprietor sues for infringement the generic manufacturer this challenges the validity of the patent. In pharmaceutical disputes the scope of protection of the patent is, of course, the key problem and the application of doctrine of equivalence makes the outcome difficult to predict.

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marketing

Resolving IP disputes in the Pharma Industry...

The approach to the evaluation of claims could be different even among European countries. The invalidation procedure can last three or more years, so the pharmaceutical companies take substantial financial risks. Therefore it is necessary not only to determine the appropriate level of costs in relation to the patent validity claim and the costs of main proceeding, but also to take into consideration possible damages due to the defendant in case of a negative outcome of the case. Of course, this calculation depends on the procedural situation i.e. if the plaintiff obtains preliminary relief against the alleged infringer. In Poland the invalidation procedure takes place before the PO and the infringement dispute is resolved in a civil court. According to the Polish Supreme Court, there is no reason to suspend the proceeding on infringement until the PO has ruled on validity. Therefore it is possible that the case in court ends before the decision on validity is taken, and then it is necessary to determine the risk connected with enforcement of the court verdict. The amicable settlements in pharmaceutical disputes are subject to close scrutiny of antitrust authorities which can rule that the agreement was unlawful; for example, reverse payment settlement and commitment not to sell generic version until x months before the expiry of the patent term would be challenged.

Partner at Phillips Ormonde Fitzpatrick Lawyers (POF), Mr Chris Schlicht considers the most common causes of IP conflict in Australia. POF is an Australian specialist IP law firm, practicing in all areas of IP. It has experience in patent litigation where the IP right has been based on complex technology, and all of its patent litigation lawyers are qualified as patent attorneys. Its lawyers have a diverse range of technical backgrounds including pharmaceuticals, chemistry and biotechnology. With offices in Melbourne, Sydney and Adelaide, the POF group incorporates a patent and trade mark attorney firm and a research and investigation company, to provide a comprehensive range of intellectual property services. “IP infringement conflicts most often arise where one party has not conducted an intellectual property clearance search before releasing a new product or service in Australia. Conflicts have arisen where a party has not recognised that more than one type of intellectual property right can exist for a particular good or service,” Mr Schlicht explains. Customs and border protection services in Australia and New Zealand offer a cost-effective strategy to monitor and enforce IP rights and POF work with these agencies, lodging notices with them so that customs can seize suspected counterfeit goods entering the country. Mr Schlicht explains: “Investigations monitoring markets are very helpful and research investigation company, IP Organisers, is a registered investigation agency. POF is the only Australian IP firm with a licensed in-house investigator, ensuring we are able to obtain reliable evidence, if court action is necessary.” Before launching new products POF recommend carrying out investigations into IP rights and determine the likelihood of an infringement. If an allegation does occur, attending pre-trial mediation can be a cost effective way of resolving the dispute before escalation into court proceedings. April 2013 saw changes to IP legislation coming into effect through the intellectual property laws amendment bill 2013, with its implementation expected sometime this year. Mr Schlicht ended saying: “Progress and development can be seen, with greater alignment of Australian IP law with overseas IP laws, particularly Europe and the US.” Mikhaiyuk, Sorokolat and Partners is a one of the leading IP law firms on the territory of the former Soviet Union, operating in; Ukraine, Russia, Kazakhstan, Lithuania, Armenia, Azerbaijan, Belarus, Estonia, Georgia, Kyrgyzstan, Latvia, Moldova, Tajikistan, Turkmenistan, and Uzbekistan. Causes of IP conflicts in Ukraine are rooted in infringements or disputes with the PTO. The infringement cases are caused by allegedly unlawful usage of

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marketing

Resolving IP disputes in the Pharma Industry...

the IP objects. The cancellation cases are mostly caused by the disagreement of the claimant, with the granting decision of the PTO in respect of the IP object. Companies may use monitoring and investigation services, however the custom recordal of the IP objects is becoming more popular, and since 2012 Ukraine legislation does not contain restrictions as to the recordal of patented objects in the custom register. Recordal of the patents for inventions and utility models in the custom register is mainly used by pharmaceutical and agricultural companies. Several cases considered by the Ukrainian courts after introduction of amendments to the legislation demonstrate the general effectiveness of the custom recordal of the patented objects. For the most part, companies use out-of-court procedures for dispute settlement, with such procedures often demonstrating effectiveness as most of the infringers are not intended to be involved in cost and time consuming court disputes. The IP law in Ukraine consists of a group of special laws regulating the certain types of IP objects. Besides these laws, the IP area is regulated by civil and commercial codes, which establish the general framework of IP regulation in Ukraine. The changes to IP regulation, which are due to take place in 2014 are minor. Over time Ukrainian IP legislation is progressing towards alignment with EU legislation; a trend set to persist in the future.

Head of the science group of LexOrbis, Mr Rajeev Kumar considers how effectively IP disputes are resolved in India. Mr Kumar has over 10 years’ experience, acquiring a proficiency in patent prosecution across the board. He regularly advises national and international clients on filling and prosecution strategies in India, with prolific experience in handling opposition cases and writing legal opinions for invalidity and non-infringement. In the past decade, the Indian pharmaceuticals market has seen a steady increase in growth. The future expected growth of a promising market in India for the pharmaceutical and health care industry has been catching the eyes of major players in this industry. When many players enter a market, disputes are bound to arise. How effectively the disputes are resolved and reliefs are granted to the right holders governs the investment by the players in such market. In the Indian pharmaceutical market, the generic market is very dominant, and especially the branded generics. In view of this dominance of branded generics, the major causes of disputes are related to use of similar trademarks for similar categories of drugs/medicines, and copying the promising molecules by the generic manufacturers. Mr Kumar said: “The jurisprudence related to trademark has developed significantly in India, however with respect to patent rights, we are still evolving, but with some significant developments already. In this article, we are looking at the trend in effectively enforcing the IP rights with the help of a few case laws.” In the trademark related cases, LexOrbis has seen that the courts have been taking position to avoid deceptively similar marks being used, especially in the pharmaceutical sector. One of the landmark judgements which, has since been cited in many other cases, is the judgement by Hon’ble Supreme Court of India in Cadila Healthcare Limited versus Cadila Pharmaceuticals Limited. In this case, the appellant had brand name ‘Falcigo’ for its drug Artesunate; for the treatment of cerebral malaria. The defendant launched its product ‘Falcitab’ containing Mefloquine Hydrochloride; also used for the treatment of malaria. The trial court held the marks to be dis-similar, with this position upheld by the high court. The supreme court, although decided not to interfere with the

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marketing

Resolving IP disputes in the Pharma Industry...

orders, framing certain factors to be considered for similar nature of marks, which has become the guiding principle for trademark infringement cases. With these guiding principles, the supreme court remitted the matter back to the trial court to decide the suit in view of the above principles. In a recent case of Himalaya Drug Company versus S.B.L. Limited 2013 (53) PTC 1 (Del.), the issue came related to the brand ‘Liv.52’ of the plaintiff against ‘LIV-T’ of the defendant. The plaintiff is the registered proprietor of trademark Liv.52; a medicinal preparation for the treatment of liver disorder being marketed. LIV-T is also for a preparation for treatment of liver related disorder. The trial court did not find the marks to be deceptively similar, based on the differences being highlighted on a one to one comparison in appearance and phonetic similarity. The Trial Court also considered the word ‘LIV’ to be a generic word, as this word is derived from the word ‘Liver’ which is a human organ. The plaintiff appealed against the trial court’s judgment. The appellate court reversed the trial court’s judgment and ruled that in absence of any cancellation petition filed by the defendant, and the maintenance of the trademark ‘Liv.52’, the plea of ‘LIV’ being a generic word was not available. And the plaintiff was granted injunction against the defendant’s LIV-T. We see a trend that the courts have been considering the overall appearance of a trademark, and the actual confusion, which can be caused to the actual user while deciding the deceptive similarity. Especially in the pharmaceutical sector, even a remote possibility of similarity may be dangerous. Mr Kumar explains: “An error can be made by chemists or pharmacists when reading hand written prescriptions and dispensing medicines. Hence, the IP owners are advised to maintain their trademarks and keep a watch on the similar trademarks being launched in the market, or being advertised in the trademark journal to safeguard their interests.” The Indian Courts have been quite quick in granting interim injunctions on a prima facie case. There are instances wherein an ex-parte ad interim injunction has been granted on the very first day. This trend of granting quick interim relief has also been observed in the patent related cases. One of the recent cases is related to the drug ‘Sitagliptin’, used for the treatment of Type-2 diabetes. A patent for the drug ‘Sitagliptin’ is owned by Merck & Co. (Indian Patent No. 209816). The company’s MSD unit is marketing the drug under its two brands ‘Januvia’ (Sitagliptin) and ‘Janumet’ (Sitagliptin plus Metformin). Merck also owns separate patent for the monohydrate phosphate salt of Sitagliptin in many countries, but did not pursue the application for this salt in India. Merck could effectively stop Aprica Pharmaceuticals from launching its generic versions of Januvia and Janumet by seeking ex-parte ad interim injunction. Although Merck could not stop Glenmark, one of the generic manufactures, who took a position that it is launching its product with the phosphate salt of Sitagliptin, and the application for said salt is no more maintained by Merck. However, the same Delhi high court, granted ex-parte ad interim injunctions to Merck against other generic players; Vetri Vadivelan, NMC Biopharm Pvt. Ltd and Shilpex Pharmysis. In the pharmaceutical sector in India, the patent owners have to be cautious about the patents covering their innovative drugs and especially the variants of the drug. In the Sitagliptin case, Glenmark could strengthen its position by highlighting the position of a separate patent application being sought for the phosphate salt of Sitagliptin by Merck, worldwide and also in India. As Merck could not convincingly plead against this position, it failed to obtain in interim relief against Glenmark. The IP owners have to relook at their strategy in obtaining and maintaining their trademarks and patents with a clear strategy to cover their products under such intellectual properties. Also, as the world is shrinking, the conduct of the IP owners in other countries is being closely considered in India.

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healthcare

Healthcare Startups to Watch Venture capital is flowing into healthcare startups. We take a look at some of the companies that should be on your radar

AdhereTech

Founded: 2011, USA They say: AdhereTech smart wireless pill bottles are currently being used by patients in pharmaceutical and research engagements. These bottles collect and send all adherence data in real-time. The system automatically analyses this information and populates the data on our secure dashboard. If doses are missed, patients can receive customizable alerts and interventions - using automated phone calls, text messages, and more. More info: www.adherehealth.com

RespondWell

Founded: 2013, USA They say: RespondWell is a digital health company empowering physical therapists and physicians to engage patients anywhere through gamified tele-rehabilitation. As the developers of the world’s first fitness game, RespondWell saw the opportunity to marry the art of reward and game theory with the science of physical therapy to create a ground-breaking delivery system that moves physical therapy into the next chapter of patient care. With over $29 billion spent annually on physical therapy, RespondWell’s aim of providing quality care at a lower cost finds its well-timed place in today’s expanding pay for performance environment. Our mission is to be the top provider of high quality, computer vision based solutions in healthcare that produce better outcomes and reduce the cost of care for both injury prevention (prehab) and restoration of health (physical therapy). More info: www.respondwell.com

Zesty

Founded: 2012, UK They say: Using Zesty, it’s easy to find a Dentist, Private GP, Physiotherapist, Osteopath, Chiropractor or Podiatrist. Simply pick a service, tell us where you are and we’ll show you great health professionals in your area. Real people, just like you, have left valuable feedback from their experiences with health providers all over London.

Choose your healthcare provider, day and appointment time and book online right now. You can book an appointment anytime — never be on hold for Healthcare again! More info: www.zesty.co.uk

Put simply: no clinical trials, no new drugs or treatments; so, whether you have a condition or not, clinical trials affect you.

babylon

At TrialReach, we make patients getting in touch with researchers (and vice versa) simple, clear and quick — so that new drugs and life changing treatments can reach the people who need them faster. More info: www.trialreach.com

They say: Being ill is difficult enough, getting healthcare shouldn’t be.

Butterfly Network

Founded: 2013, UK

Founded: 2011, USA For many of us getting access to healthcare can be inconvenient or costly. But for some, the problem is more serious: almost 50% of the global population has little access to quality healthcare. Yet irrespective of where we live, most of us have a mobile phone in our pocket. Our mobiles are getting smarter every year: mobile phones today are a thousand times more capable than they were only 10 years ago and they will be at least a thousand times more powerful in the next ten years. Can you imagine the possibilities? At babylon, we are combining the latest technology with the knowledge and experience of the best doctors to make healthcare simpler, better, and more accessible and affordable for people everywhere. Our goal is to help people around the globe live happier, healthier lives. We have started with United Kingdom, have already moved to cover the entire population of Jersey in partnership with Jersey’s government and clinicians, will be launching in a new European country next month, and will soon start providing services to the whole population of an East African nation. And hopefully, that’s just the start. More info: www.babylonhealth.com

TrialReach

Founded: 2010, USA They say: Here’s the problem: despite huge advances in medical science, millions of people still lack effective treatments to either cure or help manage their conditions. Often, their only hope is that researchers will find new and better treatments. This can only be done through clinical trials. However, the people doing the research struggle to find the people to take part in it.

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They say: Transforming Diagnostic and Therapeutic Imaging with Devices, Deep Learning, and the Cloud. Butterfly Network operates at the intersection of engineering and medicine by bringing together worldclass talent in computer science, physics, mechanical engineering, electrical engineering and medicine. The company is privately held and well-funded by a group of extraordinarily successful entrepreneurs. We are in the enviable position of being able to focus 100% of our efforts on product and intellectual property development rather than fundraising. Butterfly Network has created an entirely new approach to observe and heal the human body and coupled it with deep learning and the cloud to enable insights that will profoundly impact society. We seek the talent of truly gifted, self-starting and driven individuals to help advance this mission. More info: www.butterflynetinc.com

Big Health

Founded: 2010, USA Billions of people worldwide are suffering from problems for which we have proven behavioral solutions. Yet most can’t access anything other than pills. That’s where we come in. We use tracked data to create highly personalized behavioral medicine programs, all delivered via web and mobile to the highest standards of clinical evidence. More info: www.bighealth.com


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deals

Who’s Buying Who in Health & Pharma Welcome to our pick of the transactions causing a stir across the worlds of healthcare and pharmaceuticals

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deals

Janssen Acquires XO1 Limited Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has announced that it has acquired XO1 Limited, a privately held asset-centric virtual biopharmaceutical company founded to develop the anti-thrombin antibody ichorcumab. Financial terms of the transaction have not been disclosed. Ichorcumab is a recombinant human antibody developed to mimic the activity of a human antibody which appears to produce an anticoagulated state without predisposition to bleeding. “Ichorcumab provides an excellent complement to the Janssen cardiovascular portfolio,” said Peter DiBattiste, M.D., Global Development Head, Cardiovascular, Janssen Research & Development, LLC. “Given Janssen’s leadership in the fields of anticoagulation and biologics, we are well positioned to explore the potential of this next generation anticoagulant.”

The opportunity was identified and facilitated through Johnson & Johnson Innovation, London. “This acquisition illustrates how our global innovation strategy enables a local, hands-on approach that supports the regional life science ecosystems, provides Janssen a window on the most exciting science around the world and provides access to potentially breakthrough products in areas of strategic interest,” said Patrick Verheyen, Head, Johnson & Johnson Innovation, London. Ichorcumab was initially developed by Cambridge University Hospitals and Cambridge University with support from Cambridge Enterprise, the University’s commercialization arm. The technology was licensed by Cambridge Enterprise to XO1 Limited in order to take its development towards the clinic. XO1 Limited was established by Index Ventures as an asset centric company, a model advanced by Index, via a fund launched in 2012 in which Johnson & Johnson Innovation – JJDC, Inc. is an investor.

Valeant to Acquire Salix Pharmaceuticals for $158.00 per Share in Cash

Kite Pharma, Inc. acquires T-Cell Factory B.V. Kite Pharma, Inc., a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products based on CAR and TCR gene therapy platforms for the treatment of cancer, has announced that it has further strengthened its TCR product platform and established a European presence through the acquisition of T-Cell Factory B.V. (TCF™), a privately held Dutch company, which has been renamed Kite Pharma EU. Founded by preeminent scientists, including Professor Dr. Ton N. M. Schumacher, Ph.D., of the Netherlands Cancer Institute (NKI) and Professor Dr. Dirk H. Busch, M.D., of the Technische Universität München (TUM), TCF has the ability to discover and develop tumor-specific TCRs for broad application in cancer treatment based on its proprietary TCR-GENErator™ platform. Professor Schumacher will assume the role of Chief Scientific Officer of Kite Pharma EU, and maintain his position as Deputy Director of the NKI. Through this

acquisition, Kite Pharma has obtained license agreements with IBA GmbH, Sanquin Blood Supply Foundation, and the NKI that include rights to certain new intellectual property in the TCR space developed by Professor Schumacher at the NKI. In addition, the acquisition provides access to European clinical manufacturing facilities, launching a base for Kite to build its global presence and initiate clinical programs in the EU. The acquisition of TCF follows the announcement earlier this month of Kite’s expanded Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop new TCR candidates, including against tumor neo-antigens, truly tumor-specific antigens generated as tumors accumulate genetic mutations. TCRs broaden the approach to cancer treatment by allowing targeting of tumor antigens found inside cancer cells, as well as surface antigens.

Valeant Pharmaceuticals International, Inc. and Salix Pharmaceuticals, Ltd. announced that they have entered into a definitive agreement under which Valeant will acquire all of the outstanding common stock of Salix for $158.00 per share in cash, or a total enterprise value of approximately $14.5bn. The transaction was approved by the Boards of Directors of both companies. Salix Pharmaceuticals is a widely recognized gastrointestinal market leader with a portfolio of 22 total products, including well-known prescription brands Xifaxan, Uceris, Relistor, and Apriso, as well as a strong near- term pipeline of innovative, new assets.

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5 avenue Marchand Abidjan Ivory Coast Phone: +225 20 30 60 50 Fax: +225 20 21 12 59 eyci@ci.ey.com

www.ey.com/FA

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deals

Chiasma Completes $70M Series E Chiasma, Inc., a US privately-held biopharma company developing octreotide capsules, its lead product for the orphan condition acromegaly, has announced the closing of a $70m Series E financing round. Participants in the financing included new investors Rock Springs Capital and Sofinnova Ventures, and an undisclosed blue chip public investment fund, as well as existing investors MPM Capital, F2 Capital, 7 Med Health Ventures, Abingworth and ARCH Venture Partners. Chiasma intends to use the new capital to build its sales and marketing capabilities and prepare for the US commercial launch of its lead product, octreotide capsules for adults with acromegaly, a rare endocrine disease. The company intends to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for octreotide capsules in the second quarter of 2015 and, if the NDA is approved, to launch the product in the US soon thereafter. If approved,

octreotide capsules would be the first and only oral somatostatin analogue, providing another option to patients currently receiving painful injections. Chiasma will also conduct additional clinical studies for octreotide capsules to support approval in the European Union and advance new product candidates based on its proprietary Transient Permeability Enhancer (TPE) technology into preclinical development. ‘The commitment from both new and existing investors provide us with the resources to advance our regulatory efforts, prepare for a successful launch of octreotide capsules, test oral octreotide capsules for additional indications and further invest in earlier-stage TPE programs that can fuel our growth over the long term,’ stated Roni Mamluk, Ph.D., chief executive officer of Chiasma. ‘With this financing in place, we are well positioned to advance a portfolio of oral drugs that address unmet needs in orphan indications.’

Orgenesis Acquires Cell Therapy Manufacturer MaSTherCell

Leonard Green to sell Scitor for $790m

Orgenesis Inc., a leader in the emerging fields of cellular therapy and re-generative medicine for the treatment of Type 1 Diabetes, has announced the Company’s plan to increase its global presence and capabilities by acquiring MaSTherCell, an emerging pioneer in the industrialisation of cell-based therapeutics, based in Gosselies, Belgium.

Science Applications International Corp. (NYSE: SAIC) today announced that it has entered into a definitive agreement to acquire intelligence community market leader Scitor Corp. for $790 million in an all cash transaction from private equity firm Leonard Green & Partners. The SAIC Board of Directors has approved the transaction, which is expected to close in May 2015 and is subject to customary closing conditions.

Orgenesis entered into a share exchange agreement with MaSTherCell SA and Cell Therapy Holding SA (collectively “MaSTherCell”) and each of the shareholders of the MaSTherCell, which provides for the acquisition by the Company of all of the issued and outstanding shares of MaSTherCell in exchange for the issuance of $24,593,000 in value of shares of common stock in the capital of the Company. “The acquisition of MaSTherCell creates incremental value for both companies in business-critical ways. First, it allows us to accelerate the

transition of our lead product, Autologous Insulin Producing Cells (AIPCs) being developed as a therapeutic for Type 1 Diabetes, from pre-clinical testing into clinical trials. Second, the acquisition will also allow us to diversify our business model and future product offering,” said Vered Caplan, chairperson and CEO of Orgenesis. “We are creating a vertically integrated company that will deliver more end-user value and generate a stronger financial position for our overall business. Both businesses will remain operationally independent, but will become strategically aligned in ways that maximise technical, financial and management synergies. As a result of the acquisition, Orgenesis benefits from deeper involvement in the manufacturing process and resulting cost of goods efficiencies, while MaSTherCell benefits by expanding its international presence and by gaining access to public markets and financing for further technology-based investment.”

“The acquisition of Scitor unites two great companies with premier workforces making a profound difference for customers,” said SAIC CEO Tony Moraco. “Scitor is a recognized market leader with long-standing customer and industry relationships within the intelligence community and is aligned with SAIC’s market expansion strategy. Operating as one company represents an opportunity to create shareholder value by gaining access to new customers and leveraging capabilities from both companies to increase revenues and earnings.”

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Scitor President Timothy Dills said, “The blending of Scitor and SAIC is the logical next step in Scitor’s evolution as we continue to support the increasing needs of our intelligence community and Department of Defense customers. This deal is a rare opportunity to unite two successful companies with shared core values, world-class employees, unbridled entrepreneurial spirit, dedication to customer mission, and complementary talent in the broadest and deepest technical capabilities. ” “I look forward to the opportunities that SAIC will provide in offering increased scale and services to our customers, as well as increased opportunities for our employees,” Dills added.


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deals

Epic Health Services acquires Clarity Service Group Epic Health Services Inc., a portfolio company of Webster Capital and a Dallas-based provider of paediatric skilled nursing, therapy and autism services, has announced that it has acquired Clarity Service Group, a provider of applied behaviour analysis, special education, behavioural consulting and therapeutic staffing services based in Trevose, Pennsylvania. The acquisition, Epic’s first in the autism space, marks a substantial commitment by the company to further develop its autism services division. Clarity currently provides care to about 320 kids in homes, schools and communities throughout Pennsylvania, Maryland, Delaware, New Jersey and Virginia.

exciting new service line that provides services greatly advantageous to many of the patients we serve.” Using evidence-based practices and applied behaviour analysis, Clarity has made it its mission to provide children with the skills necessary to maximise their potential. “At Clarity, we believe all things are possible for the children and adolescents that we serve,” said Kathleen Bailey Stengel, CEO and Board Certified Behaviour Analyst of Clarity. “We are excited to be able to partner with Epic as their reputation for high quality service and belief in implementation of evidence-based practices dovetails with Clarity’s’ mission.”

“As experts in autism treatment, Clarity was a perfect fit for us,” said Epic President and CEO Chris Roussos. “This acquisition allows us to extend our presence in the area of behaviour analysis and continue to grow this

Aura Biosciences Closes $21m Series B Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has secured a $21m Series B round of funding. The financing was led by Advent Life Sciences, with participation from new investors, Chiesi Ventures, Ysios Capital, and Alexandria Venture Investments. Existing investors, including LI-COR Biosciences and Henri Termeer, former Chief Executive Officer of Genzyme, also participated in the financing. The financing will be used to advance Aura’s unique and novel therapies into clinical trials for the treatment of rare cancers of the eye, and to further develop for additional cancer indications its first-in-class technology that was discovered and developed in partnership with Dr. John Schiller at the National Cancer Institute (NCI). “Our investors share our vision and our conviction that our technology will uniquely enable the development of breakthrough therapies for orphan cancers that have no effective treat-

Daktari Closes Funding Round for $15.5M Daktari Diagnostics, which is commercializing a diagnostic platform to meet the need for accuracy, speed, and simplicity at the point of care, has closed a $15.5 million Series D round. Daktari Diagnostics, which is commercializing a diagnostic platform to meet the need for accuracy, speed, and simplicity at the point of care, has closed a $15.5 million Series D round of funding from new and existing investors, led by Eastern Capital Limited and the Merck Global Health Innovation Fund. Existing investors Norwich Ventures and Partners Innovation Fund also participated in the investment round. Ferghana Partners (Boston, New York, London) assisted Daktari in raising the financing and served as its placement agent and financial advisor. Daktari’s instruments are designed for use in any environment, from pharmacies and physicians’ offices to remote health facilities worldwide.

The first application to launch on the company’s diagnostic platform, Daktari CD4, completed clinical validation studies in January 2015, and will be commercialized globally this year. Daktari Virology will add molecular tests for HCV and HIV in a non-PCR format. This investment marks the culmination of a 5-year development program for Daktari’s platform, built on innovative electrochemical and microfluidic technologies. ‘We are excited to take the next steps toward becoming a global leader in the emerging field of point-of-care diagnostics,’ said Bill Rodriguez, M.D., Founder and CEO of Daktari. ‘Our near-term goal is to create a menu of tests for major infectious diseases, all of which can run on the Daktari platform in 15 to 30 minutes. We appreciate the continued support from our investors and our global partners as we expand our menu, and expand our global reach.’

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ments,” said Elisabet de los Pinos, founder and CEO of Aura Biosciences. “Our lead product is focused on treating ocular cancers that are life-threatening, yet for which patients have no targeted or FDA-approved therapies available. We are dedicated to bringing to this patient population first-in-class therapies that can both eliminate the tumour and preserve vision.” Aura Biosciences’ platform is based on viral nanoparticles, a new class of drugs that harness the potential of a unique cell targeting for the treatment of cancer. The technology was discovered and developed in partnership with Dr. John Schiller’s lab at the National Cancer Institute (NCI). Dr. Schiller is the recipient of the National Medal of Technology and Innovation by President Obama, the nation’s highest honour for technological achievement.



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