Archive: Food for Thought

Food for Thought: Lessons from a Start-up Nation

“Start-up Nation” by Dan Senor and Saul Singer addresses the trillion-dollar question: How is it that a country of a mere 7.1 million people has per capita venture capital investments 2.5 times greater than in the US (more than 30 times greater than in Europe), the highest density of high tech start-ups in the world (1 for every 1,844 inhabitant) and more companies listed at NASDAQ than all companies from the entire European continent?

The book is about Israel, and while much can be attributed to the extraordinary history of the country and its hostile environment, other factors such as a culture of leadership, risk management and  “can do” attitude are at least equally important . “When an Israeli entrepreneur has a business idea,” the authors state, “he will start it that week.”

The book points out that while clusters of excellence with tight proximity to great universities, large corporations and start-ups (as well as to suppliers, an engineering talent pool and venture capital) are important, this is not enough. In Israel, a typical high tech start-up receives about 10 times more seed funding than in Europe although the turnover rate of start-ups is much shorter and faster, even compared to US standards. In addition, as compared to Korea, Singapore, China and even to the EU and US, the country has a culture of constantly challenging authorities and wide-held beliefs and of team orientation and networking.

And while macro-economic factors can only be altered slowly, cultural attitudes can be changed more easily on a coporate and personal level, and this is why the book makes an inspiring reading.

Food for Thought: Finally, a Test for Alzheimer’s?

If the story by a small, Philadelphia-based company called Avid Radiopharmaceuticals communicated earlier this month holds up, there will be a reliable diagnostic test for Alzheimer’s disease available in a few years.

Such a test not only would change diagnosis but also help develop novel Alzheimer treatments as it would enable clinical researchers to check whether a drug candidate is making a difference in terms of plaque formation or reduction. At present, the only definite diagnosis of Alzheimer is by brain autopsy.

The company presented interim data  of a Phase III study of patients with a life expectancy of less than 6 months, in which the results of  a brain scan using florbetapir, a novel radiolabeled compound that specifically and sensitively binds β-amyloid, were compared to the autopsy results obtained after the patients’ death. The data were presented at the 2010 Annual Society of Nuclear Medicine (SNM) meeting in Salt Lake City. According to the abstract, the florbetapir PET brain images  are highly correlated with autopsy-confirmed β-amyloid deposition in the brain.

According to the New York Times, the company will present final data of 35 patients during next month’s ICAD, the Alzheimer’s Association International Conference on Alzheimer’s Disease 2010 in Honolulu, Hawaii.

Food for Thought: The Future of Biosimilars

On June 8, the Society of Investment Professionals in Germany (DVFA) and its Life Science Committee hosted its annual conference which this time focused on biosimilars. The event covered key scientific topics, regulatory pathways and commercial issues of the market.

While experts agreed that the US will soon follow the EU in establishing a regulatory pathway for filing and approval of biosimilars – with a few originator companies still taking rearguard actions – it is not yet evident whether biosimilars will conquer the markets simply because of lower prices. In many EU countries, there will be no automatic substitution as with small molecule generics so that doctors need to be convinced to prescribe a particular “branded” biosimilar.

However, while the regulatory pathway is based on comparability, this claim cannot be made for marketing as Adem Koyuncu, Partner of Mayer Brown LLP explained. He said, it will constitute a case for litigation to claim that safety and side effect profiles of a biosimilar are the same as those of the originator product as these features have not been demonstrated to the same extend during the approval procedure. So the question for marketing is to educate practitioners and patients on biosimilars as an “alternative”, not as “substitute”. In fact, as Frank Pieters of Teva Pharmaceuticals said, it may be advisable, depending on the product and the environment, to develop hybrid marketing models, mixing “generic” and “branded” approaches.

Gertraud Unterrainer of ProBioGen explained the intricacies of developing cells lines for the production of biosimilars: the goal is to aim for the closest possible match to the originator product, not for a product that might be regarded as superior, e.g. in respect to the amount of impurities. She also stressed that activity assays are not a substitute for assessing the clinical impact of differences.

With all these details being tricky, both Falk Ehmann of the European Medicines Agency (EMEA) and Christopher Klein of Sandoz International do not expect imminent fierce competition from the many Asian and Indian companies developing biosimilars. “They can market their products in Europe,” Ehmann said, “however, they have to meet all our standards and requirements to get approval.”

Last but not least, Manfred Ruediger of LSP Life Science Partners said that as a VC, he is still refraining from investing in biosimilar companies as he still is not convinced on the investment multiples that can be reached with biosimilars within ten years time.

A link to the presentations will be available shortly here.

Food for Thought: Simply Obscene

In a recent article (“Simply Obscene”) the influential German news magazine “Der Spiegel” (20/2010, May 17, 2010) stated the pharma industry was using “with the unscrupulousness of a stock jobber” a loophole in Germany’s highly regulated health care system to charge extremely high prices for basically useless cancer medications. In particular, the article featured Yondelis by Pharma Mar, Nexavar by Bayer, Hycamtin and Tyverb by GlaxoSmithKline, Erbitux by Merck KGaA, Sutent by Pfizer, Iressa by AstraZeneca, Avastin, Xeloda, Mab-Thera and Herceptin by Roche and Alimta by Lilly as examples for cancer drugs providing only marginal survival benefits at enormous costs and stated this was “lawful looting of the health care system”.  The only exception according to the authors of the article was Novartis’ Gleevec.

This week, the Competence Network Malignant Lymphomas published an open “letter to the editor”  (only available in German) stating that in the case of lymphoma therapy the authors of the article had done “obviously sloppy work”: “Therapy costs of lymphocyte-specific antibody Rituximab [MabThera] amount to €24,000, not €134,000 per year. Several independent studies have demonstrated that overall survival in both follicular and diffuse large B cell lymphoma is prolonged on average by several years (!), in fact without substantial side effects.” Der Spiegel had stated extension of survival in these two indications was “not proven”.

The letter also said that administrative costs for studies to optimize therapies had increased by a a factor of 10 in the last couple of years due to legal requirements.

The article of Spiegel magazine is available online in German, however without the tables featuring treatment costs and extension of survival for the drugs mentioned.

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