Monthly Archives: April 2010

“It’s summertime here in India and same old rivalry has resurfaced- “”Coca Cola Vs Pepsi””! It’s been decades since these Cold drink giants are fighting over Indian beverage market share. Initially it was cold drink, but then the fight extended to other sections like energy drinks, healthy snacks, namkeens etc.

Trigger-

It started with Fanta’s Holi ad for Coke, where Genelia De Souza was seen in a retro look. The ad was fresh and sent a clear message.
Then
Just after this ad Coke’s another ad appeared on screens promoting Coca Cola and featuring Imran Khan…..
Followed by…..
Pepsi also started showing its new “”Ranbir Kapoor”” ad on TV, but with the same ‘Youngistan’ concept ….
But for now Coke wins this ad battle…………..
Similar is the scene with the rising competition – clinical development
versus generic/generic biologics….
The battles seems to be certainly in favor of generics because 3 major trails of 3 major global pharma have been withdrawn in 3 major growing therapeutic areas since the last week as all are aware (Pfizer –Last week, Astra and Roche today.) ”

“With Astellas Pharma and OSI Pharmaceuticals haggling over price, which biotech/biotechs could be next on the buyout menu? Mega-mergers might have been all the rage in 2009; however, with few targets left, the focus will shift to smaller acquisitions.
Some of the major Pharma-Biotech deals which have taken place since the month of December 2006 till date have been captured. The maximum numbers of deals have occurred in the year 2008 and a total of 23 major deals have taken place in the last 4 years. The year 2008 was the mega year for Pharma biotech acquisitions post which market has taken a completely different look and there has been substantial reduction in the number of acquisition targets as well.

”Improving cancer survival rates are real success stories that sometime get lost in the noise over our healthcare system. However, “”Targeted drugs are driving that survival in a major way.
Some cancer drugs like Sutent have proven effective for both stomach and kidney cancer and are likely to give benefits in both the cases as per the reports from the late phase clinical trials. Sutent (Pfizer Oncology product) has become one of the more expensive cancer drugs on the market at around $50,000. But even at that price, it’s become key to a treatment approach known as daisy-chaining, in which patients use one drug until it stops working, then move on to another. Some patients have survived as long as seven years this way.
Is paying for that survival sustainable? In Sutent’s case at least, even the U.K.’s cost watchdog thinks so; the National Institute for Health and Clinical Excellence finally OK’d the drug after Pfizer agreed to pay for the first cycle of treatment, which should weed out the patients who just won’t respond to the drug at all”

“It’s all about insights.

Information isn’t always power. Data is useless without context. Ultimately, it’s all about insights – what does this all mean to YOU given that your particular situation is unique? To process such a huge volume of information and give it contextual meaning requires a modicum of intelligence and some knowledge of the disease and therapeutic area in order to sort out the wheat from the chaff.
Insights analysis is a craft; making data sing is part art, part science. It also takes longer to be succinct and precise than it does to merely reproduce what is out there in copious quantities. Writing shorter, more impactful, reports based on data analysis takes more time too.”

“Eyeing strategic deals in India has been the major focus of the global pharma companies who are stepping their feet in India particularly Pfizer and Glaxo.
Pfizer has gone south in establishing licensing cum marketing deal for its 30-40 products in 2009. Further, Glaxo last year has had strategic stake investment in
Dr. Reddy laboratories.
This deal gave the UK drug giant exclusive access to the latter’s portfolio and future pipeline comprising more than 100 branded pharmaceuticals across areas such as diabetes, cancer and pain management, in emerging markets. In July 2008, the firm linked up with South Africa’s Aspen and its Indian joint venture partner Strides Arcolabs to sell branded generics in emerging markets.
The idea behind such strategies indicates that Glaxo is planning to take next “”giant”” leap in the Indian geography and the message line for the same is aim at creating shareholder value without using much cash.”

“While the behemoth health care reform bills have many positive attributes, patent reform will be critical to promote innovation, without which the health care industry will suffer. Some 26 years ago, The Hatch-Waxman Act attempted to reconcile the conflicting policies of increasing access to generic drugs while promoting innovation.
What has been the result of increased access to generic drugs? The Congressional Budget Office has reported that under the current system, increased competition has led to a 12% decrease in revenues for name-brand drugs. Despite this reduction in revenues, pharmaceutical companies have dramatically increased their investment in research and development.
The Hatch-Waxman Act allows for up to five years of patent protection after FDA approval, with a possible 14 year cap – critical for supporting innovation. Research and development of new drugs is expensive, with an estimate of $1.32 billion per drug in a 2008 study at Tufts University. Recouping this investment during a five year exclusivity period requires annual profits of at least $240 million for a single drug – often an unrealistic goal for some prescriptions, such as antibiotics. Even if this were possible, the company breaks even, neither losing nor gaining profits.”

“Forecast –
By 2012, analysts project that more than 65 percent of all FDA-regulated trials will take place outside the United States. This is reflected in the Indian biotechnology market, which is expected to grow at a compounded annual growth rate of 30 percent, and the Indian CRO market, which is expected to see growth of 49 percent annually.
Basis- According to Clinical trials Gov, Currently greater than 50, 000 clinical trials have been registered in North America where the US accounts for around 46,000 of the same. If the above forecast holds true then presuming that all trials are FDA regulated and industry sponsored and outsourced to India, then the market for clinical trials in India would take a market look as follows:

This would mean among emerging markets, India would gave the highest share…..  ”

“AMAZING FINDINGS-
In a major survey conducted by a top MNC conducted with more than 1,300 women living in 13 countries in five continents. Countries were selected to represent a global mix of locations, economies, and levels of cancer treatment. The countries included Belgium, France, Poland and Spain from Europe; the United Kingdom; Australia; Egypt; Canada, the United States and Mexico from North America; and Argentina, Brazil, and Venezuela from South America.
The women were predominantly recruited by physicians and support group, representing approximately 100 women per country. They were polled by telephone and face-to-face interviews, although mailed questionnaires were also used in Belgium and the United States. The majority of women were over 50 years old, and most of them had a positive outlook on life.
While the availability of participating in clinical trials differs from country to country, less than one fourth of the women (308) said they were told about or ever asked to participate in a clinical trial. In total, 240 women did. More than 75%of this group said that they reason they did participate in a clinical trial was that their primary care doctor told them about it. (The survey did not ask the remaining 1.016 survey participants if they would have participated in a clinical trial if they had been aware of one.)
Clinical trial participation varied greatly by country, with Venezuela having the lowest percentage (1%) and Canada and Mexico having the highest (both 35%). In Europe and the UK, Belgian women had the highest level of participation (27%), followed by Poland (21%), Spain (19%), United Kingdom (13%), and France (7%). Women in Australia and the United States were most proactive about looking for information relating to clinical trials.
The women who participated in clinical trials had very positive attitudes about them. They said that they valued the support of their personal physician the most, followed by contact and information provided by the medical staff conducting the clinical trial.
With respect to medical information about metastatic breast cancer, half of the women throughout the world did not think that enough information was available or addressed their needs. Medical therapists ranked the lowest with respect to being a good source of information. The majority relied on written information. ”

“Industry estimates suggest, that by 2015, when the Indian pharmaceutical market would be worth $20 billion, about 15% of total drugs would be patented molecules.
In September 2009, a patent application for AIDS drug darunavir was rejected as it did not meet patentability criteria laid down in the Indian Patent Act. Had the patent been granted, no generic version of the drug could have been introduced and, with the innovator drug by Johnson &Johnson yet to hit Indian shores, patients would have had to suffer. But one patent rejection is not the end of the story for J&J… Darunavir still has six other patent applications for various forms floating in patent offices across India. Similarly, the diabetes drug, rosiglitazone,which has for some time been in the eye of a controversy over its heart risks, has
four patent applications in India. Companies have been filing applications for patenting different forms of the same drug, including the salt, polymorph form, analogue form, crystalline form, solid dosage form, combination of the drug with other drugs, etc. This enables them to cover a broader scope of protection
to commercially and therapeutically significant forms of the same compound, and also for extending the term of protection, also referred to as ever greening.
Moreover, multiple patents burden the patent offices, which have been crying hoarse about manpower shortage. There are four patent offices in India (at Delhi, Mumbai, Kolkata, Chennai) with about 150 officers. Amit Sengupta, general secretary of All India Peoples Science Network, said, “”multiple applications would toughen the work of the patent offices and there could be chances of applications getting wrongly granted.”” ”

”With the latest on Global Pharma late stage drug candidates failing in the late stage in key therapies like Alzheimer’s disease and cancer in particular, the inevitable question arises on the future of clinical development.
The stakes on the drug candidates in the late stage are very high and if the products of Big Pharma majors continue to fail consistently since the last 6 months of 2009 and continuously in the beginning of 2010, the trends forecasting the future of drug development are definitely pointing “”generic”.
Big Pharma majors like Sanofi and Pfizer late stage drugs having unfavorable clinical trial endpoints in the final stages are definitely not going to invite a positive investor sentiment.
Another question which is likely to strike an impact is- what will happen to those companies which are directly and indirectly dependent on the Global Pharma pipeline, i.e. outsourcing providers, trial sites, SMO’s and CRO sites involved in the late stage trials. The business sentiment is likely to have a crash down effect because of such drug failures. ”