1-15 Sept ember 2012 I Vol 1 I No 5 I `100
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In Conversation With 17
Special Focus 18
Interface 21
Automation Trends 22
Shyam S Bhartia CMD, Jubilant Life Sciences Ltd
Funding in biotechnology A wavering graph
Anuradha Acharya Founder & CEO, Ocimum Biosolutions
Plant automation Reducing cost in ensuring regulatory compliance
Pharma industry pegged to grow to $ 60 billion by end of 12th Plan UR Associates recently released its report on pharma sector. According to the report, overall pharma industry was pegged at ` 1000 billion with the domestic pharma industry at over ` 600 billion in 2009-10. The Indian pharma industry accounts for 20 per cent of the global generics industry. During the 11th Plan, the domestic market grew at 14 per cent CAGR and exports grew at 19 per cent CAGR with anti-infective, anti-asthmatic and anti-hypertensive being the major therapeutic categories.
Universal flu vaccine in reach, says NIH THE first universal flu vaccine for all ages is in reach, thanks to a DNA vaccine prime, according to the US National Institute of Health (NIH). The quest for an influenza vaccine that can protect against all strains of the virus has been difficult. However, using a prime-boost vaccine regimen in mice paves the way for delivery; the team found that the correct antibodies could be produced even with preexisting immunity to flu.
Bilcare to sell global clinical supplies biz for ` 340 crore BILCARE Ltd recently stated that it will sell its global clinical supplies business in the US and UK for $ 61 million (around ` 340 crore) to Ireland-based United Drug Plc. The two parties have signed a definitive agreement for the sale. The agreement will allow Bilcare GCS Asia to leverage United Drug’s deep capabilities and resources in US and Europe.
FDA approves Lucentis to treat diabetic macular edema THE US FDA approved Lucentis for the treatment of diabetic macular oedema, a sight-threatening eye disease that occurs in people with diabetes. The drug’s safety and effectiveness were established in two clinical studies involving 759 patients who were treated and followed for three years. Lucentis is marketed by Genentech.
AstraZeneca MD resigns ANANDH Balasundaram has resigned as MD and member of the Board of AstraZeneca Pharma, India. The company said that he would be relived with effect from August 31. The company has, as an interim measure, appointed Jonathan Hunt as COO and President, for a period of four months commencing September 1.
Post quarterly results: Challenges expected in the future THE financial results of pharma companies for the quarter ending in June 2012 have been mixed bag. Despite registering immense growth, several challenges stay lined up for the future. The general trend observed in this quarter is the significant rise in the sales but a decline in the profits. The reasons stated by companies for these thin margins are Forex losses and delays in product launches. Aurobindo Pharma’s net sales increased but suffered a net loss due to increase in manufacturing costs and Forex losses. Despite tremendous increase in sales the companies have recorded comparatively lesser profit. Ranbaxy Laboratories reported a ` 586 crore loss due to foreign exchanges despite sales in the US. The government projected the growth of the pharma industry to be around 18 per cent by 2016-2017. Industry gurus predict several challenges that pharma companies are likely to face in future, unpredictable government policies being prima facie. The uncertainty about the implementation of the National Pharmaceutical Policy 2006 that was proposed to control the price of 348 essential drugs is expected to meddle with the plans of many pharma companies. Post the quarterly results, the predicted growth appears a challenge with changes expected in the government policies. Dr Ajay Kumar Sharma, Associate Director - Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle
Dr Sharma
Dr Dangi
East, said, “The projected domestic growth rate of 21 per cent seems to be unrealistic on revenues. With National Pharmaceutical Pricing Authority (NPPA) contemplating the idea of reducing prices and bringing almost 70 per cent of the industry under price control this figure looks highly unlikely.” The government also plans to bring all patented drugs under a reference pricing model and this is also expected to have a major impact on the industry. Dr Ajit Dangi, President and CEO, Danssen Consulting, explained, “Research-based MNCs have also hit the pause button on introducing new patented drugs in India due to recent development of granting compulsory licensing for patented drugs to Indian generic manufacturers based on ambiguous criteria of ‘affordability’ and ‘patent not worked in India’.”
For example, Nexavar of Bayer and now Sprycell of BMS. The compulsory licensing of the drug Nexavar from Bayer to being its price down by 97 per cent and has led to a debate between innovation and affordability. Novartis has also filed a case to maintain the exclusivity rights of its cancer drug Glivec. Uncertain government policies are likely to have a great effect on the investment in this sector. Dr Dangi explains, “Slowing down of economic reforms and downgrading of Indian economy by major international rating agencies as well as ambiguity of FDI in pharma sector has also made investment climate uncertain not only for MNCs but also for Indian companies looking for JVs, collaborations etc. It is estimated that over ` 3,000 crore Continued on page 8
Anthem to expand its facility in Bengaluru ANTHEM Biosciences, a Bengaluru-based Discovery Research Alliance Partner (DRAP) company dedicated to supporting research efforts in the discovery of new compounds by pharmaceutical, biotechnology, speciality chemicals, agriculture chemicals and material science companies, is in the process of expanding its existing facility at Bommasandra, Bengaluru. The facility is expected to be functional in the next three months. The main function of this facility will
be to provide early stage pre-clinical drugs testing along with production of small scale proteins and enzymes and large scale chemical synthesis. Sharing details on the same, Ajay Bharadwaj, CEO, Anthem BioSciences, said, “We are expanding our facility by adding another 200,000 square feet of new labs, which would include a GMP animal facility, fermentation pilot facility and also new labs. In addition to this, we are also adding more chemistry synthesis labs.
Sharma
We would also be increasing our manufacturing capacity by tripling the existing capacity.” To set up this facility Anthem has invested ` 25
crore. It would also be increasing its manpower with an aim to undertake more projects in future. “We started with 200 people and today we have 400 people working with us. In future as the project nears completion, we would be adding another 100 people,” informed Bharadwaj. Anthem would also be investing ` 100 crore in setting up another facility in Kanakpura, Bengaluru with the motive to provide large scale chemical synthesis and fermentation to its clients. - Jasleen Kaur Batra