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Pharmaceuticals Newsletter - 06 May to 09 May, 2013

India Infoline News Service/ Mumbai 18:10 , May 09, 2013

Sun Pharma Advanced Research Company Ltd announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for Levetiracetam Extended-release Tablets, 1000mg and 1500mg, an anti-epileptic product.

Top Stories 

GlaxoSmithKline Pharma Q1 PAT at Rs. 1.69bn

GlaxoSmithKline Pharmaceuticals Ltd has posted a net profit of Rs. 1690.10mn for the quarter ended March 31, 2013 as compared to Rs. 1228.90mn for the quarter ended March 31, 2012.

Total Income has increased from Rs. 7031.90mn for the quarter ended March 31, 2012 to Rs. 7138.40mn for the quarter ended March 31, 2013.

Glenmark Pharmaceuticals Q4 cons rev up 25%

Glenmark Pharmaceuticals Limited (GPL), the research-led global integrated pharmaceutical company announced its full year results for the year ended March 31, 2013.

Both our Specialty and Generics businesses performed well in FY 12-13; taking our consolidated revenue very close to USD 1bn milestone”; said Glenn Saldanha, Chairman & Managing Director – Glenmark Pharmaceuticals. “The US, India and Russia businesses continued to maintain its high growth trajectory. We also made significant progress on the innovation R&D front with 5NCE and NBE molecules in clinical trials; including Crofelemer which recently received approval from the US-FDA for HIV associated diarrhea”, he added.

For the Fourth quarter ended Mar 31, 2013, Glenmark’s consolidated revenue was at Rs. 13354.85mn (USD 245.95mn) as against Rs. 10658.56mn (USD 209.63mn) an increase of 25.30 % in Rs. term over the previous corresponding quarter. Revenue from the generics business was atRs.5865.32mn (USD 108.04mn), as against Rs. 4685.03mn (USD 92.21mn), a growth of 25.19% in Rs. term over the previous corresponding quarter. The Specialty formulation business excluding out-licensing revenue was at Rs. 7412.94mn (USD 136.48mn) as against Rs. 5943.75mn (USD 116.98mn) for the corresponding previous quarter, recording a growth of 24.72 % in Rs. term over the previous corresponding quarter. Read more...

Ranbaxy Labs Q1 net profit at Rs. 701.47mn

Ranbaxy Laboratories Ltd has posted a net profit of Rs. 701.47mn for the quarter ended March 31, 2013 as compared to Rs. 8272.31mn for the quarter ended March 31, 2012.

Total Income has decreased from Rs. 19201.63mn for the quarter ended March 31, 2012 to Rs. 14339.62mn for the quarter ended March 31, 2013.

For the consolidated period for the Quarter ended March 31, 2013, the Group has posted a net profit after tax, Minority Interest and share of Profit / (Loss) of Associates of Rs. 1257.59mn for the quarter ended March 31, 2013 as compared to Rs. 12467.64mn for the quarter ended March 31, 2012.

Total Income has decreased from Rs. 38420.27mn for the quarter ended March 31, 2012 to Rs. 25629.69mn for the quarter ended March 31, 2013.

Infocus

How do stress hormones reduce number of new brain cells?

Research from King’s College London has revealed how stress hormones reduce the number of new brain cells – a process considered to be linked to depression. The researchers identified a key protein responsible for this process, and successfully used a drug compound to block the effect, offering a potential new avenue for drug discovery and treatment.
 
The study, published in Proceedings of the National Academy of Sciences (PNAS) was co-funded by the UK National Institute for Health Research Biomedical Research Centre (NIHR BRC) for Mental Health at the South London and Maudsley NHS Foundation Trust and King’s College London.
 
Depression is a common mental disorder worldwide, with more than 350mn people of all ages affected. The World Health Organisation estimates that by 2030, depression will be the leading cause of the global burden of disease. In India, a study in 2011 found that around 9 per cent of people reported having an extended period of depression within their lifetime and nearly 36 per cent had suffered from a major depressive episode (MDE). Read more...

'Pharma exports may witness 22% growth in 2013'

Mumbai, May India which exports around USD 10bn worth of pharmaceutical expects 22 percent growth in the current year, industry experts said. "India is the frontrunner in export of pharmaceuticals including formulations and active pharmaceutical ingredient (APIs) in the world. We expect 22% export growth in the current year," Sotax India managing director L Ramaswamy told reporters on the sidelines of a 'Disso India 2013' – a pharma convention opened here.

The country has exported US$10bn plus pharmaceuticals in 2012, which includes 90% share of formulations and 10% of APIs. More than 180 manufacturing plants are approved by US FDA in India, which is the highest number after US. India's share of the generic market is about to 35 percent. Hence the contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high, Ramaswamy said. The pharma industry needs new technology, innovation and needs to sort out various issues faced related to dissolution, he said. Read more...

Domestic News

Sun Pharma gets USFDA response on Levetiracetam NDA

Sun Pharma Advanced Research Company Ltd announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for Levetiracetam Extended-release Tablets, 1000mg and 1500mg, an anti-epileptic product.

A Complete Response Letter is a communication from the FDA to companies that an NDA cannot be approved in its present form.
 
In the Complete Response Letter, the FDA specified that the clinical data submitted by SPARC establishes bioequivalence in the fasted state.

However, the FDA has raised certain queries on the Pharmacokinetic data in the fed state. SPARC is evaluating the contents of the letter and plans further discussions with the FDA.

Lupin FY13 net profit at Rs12604.3mn

Lupin Ltd has posted a net profit of Rs. 12604.30mn for the year ended March 31, 2013 as compared to Rs. 8043.70mn for the year ended March 31, 2012.

Total Income has increased from Rs. 53883.20mn for the year ended March 31, 2012 to Rs. 71458.20mn for the year ended March 31, 2013.

For the consolidated period, the group has posted a net profit after taxes, minority interest of Rs. 13141.60mn for the year ended March 31, 2013 as compared to Rs. 8676.50mn for the year ended March 31, 2012.

Total Income has increased from Rs. 70972.60mn for the year ended March 31, 2012 to Rs. 96691.50mn for the year ended March 31, 2013.

Commenting on the results, Dr. Kamal K. Sharma, Managing Director, Lupin Limited, said “We have had a great quarter and a remarkable year fuelled by strong business performance in the U.S. and India as well as improved operational efficiencies. We continue on our high growth journey." Read more...

Clinical drug trials on humans to be monitored by DGCI

In wake of increased criticism of the Health Ministry and regulatory body for their failure to monitor clinical trial of new drugs on human beings, Drug Controller General of India (DGCI), country’s top most medicine regulator in a bid to ensure compliance with the recently issued guidelines, plans to inspect the clinical trial sites periodically, said reports. Strict action would be taken against defaulters which includes suspension of the trials.

Expert teams led by senior drug inspectors would be formed in the zonal offices. These teams will visit the clinical trial sites at least once a year to ensure compliance.

The health ministry set up guidelines and an ethics committee to monitor registration of clinical trials after Supreme Court pressed the issue.

Around 80 people died in India due to clinical trials in India in the last seven years.

Jubilant Life Sciences Q4 income from ops up 18%

The Board of Directors of Jubilant Life Sciences Limited met to approve the financial results of the Company for Q4 & FY2013.
 
For the Quarter ended March 31, 2013

Income from Operations at Rs. 1,392 Crores, up 18% YoY

26% improvement in International markets at Rs. 1,077 Crores

14% volume backed growth across business segments

EBITDA at Rs. 244 Crores, lower by 2% YoY

EBITDA Margins at 17.5% for the quarter

EBITDA contribution from Pharma segment at 65%

Normalized Profit After Tax at Rs. 66 Crores

Normalized Earnings Per Share for Re. 1 FV equity share at Rs. 4.16

Reported PAT at Rs (31) Crores and EPS at Rs. (1.94). Read more...

International News

End of life care must be a priority: Dr Scott Wooder

Dr. Scott Wooder, a family physician from Stoney Creek, committed to leading an examination on how end of life care affects quality of care as he was sworn in as the 132nd President of the Ontario Medical Association. In the coming year, the OMA will play a lead role in developing a province wide strategy for end of life care in priority areas such as organ donation and palliative care. In addition he committed to putting a focus on raising awareness of end of life issues and to educate the public on the responsibilities that individuals can take in deciding their own end of life care plan.

Dr. Wooder has been practicing comprehensive family medicine in Hamilton for over 27 years. In addition to end of life care, Dr. Wooder will focus on other initiatives including:

Pressing the need for immediate action to tackle obesity, especially in children;

Continuing to push for adequate programs to treat alcohol abuse; and

The release of an advocacy platform with recommendations on strengthening the health care system. Read more…

GeBBS Healthcare appoints Milind Godbole as MD

Milind Godbole has been appointed Managing Director for GeBBS Healthcare Solutions, an industry leader in healthcare revenue cycle management outsourcing solutions.

Prior to joining the GeBBS team, Godbole served as President and COO of the Asia Pacific division of Aditya Birla Minacs where he was responsible for executing business strategy and directing the overall performance and growth of the organization in the Global IT, FAO and BPO business. Before that, he held the role of COO of Global Operations for MphasiS, a HP company.

“Over the years, GeBBS has grown to become a leading provider in the revenue cycle management industry,” remarked Vijay Singh, Chairman of GeBBS. “What started as a company of 100 people is a 2,400 plus strong team of likeminded individuals relentless in their pursuit of excellence. Milind Godbole joining our team will make the team absolutely unbeatable and unstoppable.” Read more…


 



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