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| Veeda Clinical Research Corporate Blog on internal news, views, happenings in the group and discussion about the industry subjects. |
7/28/2010
The global pharmaceutical industry is facing a challenging battle to maintain its productivity in the face of an increasingly difficult research and development landscape.
Companies are starting to commit fewer resources to research activities in recent years, partly due to diminishing returns.
Between 2007 and 2009, the number of treatments whose clinical development was terminated during phase III testing was double the rate seen in 2004-06, while fewer than one in ten drugs reaching first toxicity dose now make it market.
Moreover, those treatments which are granted a commercial launch are contributing an increasingly small proportion of pharmaceutical industry revenues, with takings from drugs launched in the last five years making up less than seven per cent of total sales.
The consequence of this trend is that the pharmaceutical industries is becoming increasingly reliant on its most established and mature products; only 21 new molecular entries were launched on the global market in 2008, a 20-year low, while as of 2010 the top three drugs of an average company now provide 44 per cent of total sales.
This model is not likely to be sustainable, due to the fact that firms are now also facing increasing competition from the generics market, with Chinese and Indian companies producing alternative versions of existing best-selling treatments in cases where patents have expired.
7/26/2010At least 2% of all prescription drugs sold in the USA are without approval. There is a growing crackdown by the U.S. Food and Drug Administration on unapproved drugs being sold in the USA.
Recently, a federal judge denied a request by Cody Labs to block an FDA enforcement action requiring the company to halt production of a specific formulation of morphine sulfate, a powerful painkiller.
Though morphine has been used since the Civil War, the exact dosages and formulation for the orally administered version of the narcotic made by Cody Labs had never been formally approved by the FDA.
But the FDA has long allowed the sale of many such “unapproved” drugs that are generally considered safe and effective after decades of widespread use. The agency estimates that about 2 percent of all prescription drugs sold lack approval.
Over the last four years, however, the agency has been clamping down on unapproved versions of some drugs under a law that allows the first manufacturer that gains agency approval to continue production, while forcing unapproved versions off the market.
7/24/2010
The All Indian Origin Chemists and Distributors (AIOCD) Ltd, the distribution and retail company of the All India Organisation of Chemists and Druggists (AIOCD) which has forayed into sales of its own generic brands recently, is planning to set up an oncology division within next four months to launch and market generic cancer drugs in the market. After completing works to launch more than 100 generic brands in antibiotic, gastroenteritis, analgesics and multivitamin segments by the end of this month, the company has identified therapeutic segment of oncology as the next target area for its future expansion and operation. The new division is expected to be launched by the month of November this year. 7/21/2010
Moving to cost effective locations is an effort by almost all major pharma companies in the last 6-8 months particularly in the areas of drug manufacturing . One of the key locations today in manufacturing is the Asia Pacific region particularly the Indian geography. Companies like GSK and Pfizer have already moved their manufacturing capacities to India. One of the recent examples is Eisai, a leading Japanese pharma drug maker which has taken the bold step to manufacture Aricept Alzheimer's drug in India for exports to Japan, the United States and Europe as early as 2011. Eisai will start producing the drug at a newly constructed plant in the Indian state of Andhra Pradesh. Aricept accounts for about 40 percent of Eisai's total sales. Eisai is also expected to begin Indian production of the ulcer treatment Pariet, which will go off-patent in the United States in 2013. 7/19/2010
3 Drugs in CVS, 3 Drugs in CNS and 1 Drug in Cancer i.e. a total of 7 drugs rule the future of the generic drug market growth. All those companies which have filed Para IV filings in the recent past for these 7 drugs are likely to be gainers in the generic drug market in USA. 7/15/2010
Five years ago, Novartis was viewed as a lumbering giant in the pharmaceutical world--a behemoth that was running out of products and bereft of a bulging pipeline. The Swiss drug maker, which was known for its branded pharmaceutical products, made a fateful decision in February 2005: In a bid to create the world's largest generic drug-maker, it bought Germany's Hexal and Eon Labs, its U.S. division, for about $8.3 billion at the time.
Today, Novartis's bet appears to have paid off. The giant drug maker said second-quarter net profit jumped 19% to $2.46 billion (1.92 billion euros) compared with $2.04 billion in the same period a year ago. The company said sales in its pharmaceuticals business offset healthcare cost-cutting efforts by some European governments.
Contributing to the stronger profits was Novartis's generics business where sales grew 11% to $1.97 billion, outpacing the 8% sales rise in the company's core pharmaceuticals business. Though Sandoz's second-quarter sales beat consensus estimates by 1.4%, its core earnings before interest and taxes missed consensus forecasts by 3.3%, UBS said in a research note.
The Swiss drug maker's earnings helped lift pharmaceuticals stocks within Bloomberg's European 500 index, pharmaceuticals notched a 0.81% gain, making them the second-best performer in early trading. Among the biggest gainers in the drug sector were Elan and Novartis. 7/12/2010
Pharma MNCs Eye India for off-shoring CRO allied services
‘Allied services market in India is growing at 21% compared to 7.5% globally’
Not just for clinical trials, but India is also emerging as an attractive destination for allied services related to clinical research. According to a recent FICCI- Ernst & Young study, the Indian allied service market is growing at a compounded growth rate of 21 per cent as compared to 7.5 per cent globally.
The allied services outsourced market in India was estimated to be $106 million in 2008 and is growing at a rate of 21 per cent. These services comprise bio-statistics, data management, pharma co-vigilance and together they account for around 35 per cent of total global clinical research spend. The size is estimated to be around $22 billion globally. The global clinical research industry is currently pegged at $64 billion.
There are more than 40 companies in India which offer one or more allied services. According to Apurva Shah, group managing director, Veeda Clinical Research, "While outsourcing to India started for cost arbitrage in late 1990s, most western sponsors have now realised that Indian CROs can contribute a lot more. Indian CROs have graduated from just doing simple studies to doing more complex and challenging studies. We no longer just execute protocols but contribute in several ways to add value to the sponsor’s drug development". The likes of Pfizer, Eli Lilly, Astrazeneca, GlaxoSmithKline, Bayer get allied services work done here in India.
With the rise of clinical trial sites outside the US and Europe, and tightening of regulatory requirements that require thorough documentation and audit trials, India with its track record of managing IT-ITeS work has emerged as a favoured destination for outsourcing allied services work.
Columbus headquartered Veeda Oncology, a full service Oncology clinical research organisation (CRO) with facilities in North America, Europe and India, plans to conduct the bulk of the recent $8.4 million of new clinical research programs it has been awarded in the last one month in India itself.
Shah said, "India’s share of revenue has risen from 20 per cent in 2006 to 60 per cent in our present global revenue. We expect a steady growth to continue due to the attractiveness of India in terms of the value proposition. It’s the combination of quality, speed and cost. It’s the “can do” attitude and hard work that’s wining the work".
The cost of a data entry operator here is around $10-20 per hour, compared to $30-50 per hour in developed economies, says the report. Similarly, a bio-statistician and a medical writing professional charges around $30-70 per hour in India compared to $100-150 in western countries.
The world’s fifth largest clinical research organization (CRO) and Nasdaq listed Kendle that started operations at Mindspace, a special economic zone near Ahmedabad, plans to have a data center here that will serve as a back-end operation for data management, pharmacovigilence, bio-statistics, analytical work, medical writing and support of clinical research.
At first blush, it might seem like the wave of patent expirations could be enough to cut the entire health care sector off at the knees. But while the looming wave of expirations will affect the entire pharmaceutical chain — from drug makers to distributors to wholesalers and even some retail drug stores — the sector as a whole is actually being pulled down by a combination of issues including health care reform in the U.S. and pricing pressures in Europe. As those issues are resolved, the outlook for the sector could improve.
Meanwhile, as big pharmaceutical companies lose their patent protections, many are starting to adjust through consolidation and diversification.
It has been described as both a cliff and a wave, but whatever you call the unprecedented number of pharmaceutical drugs that will lose their patent protection in the next few years, it sets the stage for a host of investment opportunities — and potential pitfalls.
Between 2011 and 2013 more than $90 billion worth of annual pharmaceutical sales will lose their patent protection. Eli Lilly & Co. (LLY), for example, will lose Zyprexa next year. In 2012, Bristol-Myers Squibb Co. (BMY) will lose Plavix, Pfizer Inc. (PFE) will lose Lipitor and Merck & Co. Inc. (MRK) will lose Singular.
To be sure, drug patents expire all the time. But when large blocks of popular brand-name drugs move toward expiration all at once, it opens the doors for generic drug makers and causes investors to readjust their thinking about the whole pharmaceutical sector. 7/8/2010
- According to the World diabetes atlas and Japi, South East Asia (primarily India) has the highest diabetic patient population.
- India contributes to 64 % of the total impaired glucose population in SE Asia and to 48% of the total diabetes population in SE Asia.
- Prevalence indicators point towards rising prevalence of diabetes in urban India, especially Southern India.
- Prevalence Indicators point towards prevalence of IGT higher then diabetes higher in the age group below 40 years.
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