I noted a number of news items over the past couple weeks that I thought are relevant to the business of global health and worth noting. Here is what caught my attention:
- “A serious flaw in the imagined future of oncology”
The imagined future of personalized cancer therapy hit a speed bump recently when a study by Gerlinger et al. (Gerlinger 2012) showed a high degree of genetic heterogeneity in samples taken from the kidney tumor and its metastases of the same patient- less than one-third of the genes with cancer-associated mutations showed up in all. As noted by authors of an editorial accompanying the report and articles at Bloomberg.com (Bloomberg) and the Wall Street Journal (WSJ), the implication is that beating cancer with drugs that target specific mutations will be harder and more expensive that originally thought, if not futile. Of course, more study is needed (and is underway), but I hope that the personalized medicine promoters sober up, the huge public and private investment in new cancer therapies is re-thought, and some small fraction of that effort is diverted into global diseases. As is well known, spending on cancer therapies dwarfs that for the neglected diseases. In 2010 about $3 billion was spent worldwide on r and d by companies and governments on neglected disease (G-Finder 2010 summary) while the spend on research by the NCI alone was $5 billion (NCI budget) and about 800 biotech companies had anti-cancer drugs in development (BIO statement).
- Biocon is dumped by Pfizer
As was reported last week, Pfizer, the world’s largest pharma company, and Biocon, India’s leading biotech, announced that their partnership to commercialize Biocon’s generic “biosimilar” insulins was over (FierceBiotech article). While Biocon’s share price took a hit (Moneycontrol.com), the long-term consequences for Biocon are minor, I think. Biocon got a $200 million upfront fee, has all rights returned, and will be free of a less-than-stellar agreement in which it borne the expenses for gaining approvals but Pfizer got exclusive rights in all but three countries, as I noted in my posting on the deal (“Deal of the Year 2011” 3/24/11). According to Reuters (Reuters article), Pfizer’s cold feet may have been due to its recognition that the biosimliar insulin market will be highly competitive (Lilly and Novo Nordisk are the major players), and that oral insulins, like those being developed by a handful of companies including Biocon, will bring more competition. So it is not the end of the world for Biocon, which remains well-positioned to deliver affordable rest-of-world products, and its founder, Ms. Mazumdar-Shaw, who, in her spare time, is trying to change the equation in global health care through the Biocon Foundation. The foundation, which was started in 2004 with a mission “to provide sustainable and affordable healthcare/educational services to under-served rural and urban communities in India” (Biocon Foundation) and recently launched a mobile oral cancer screening program.
- TREAT Act not treated nicely
The FDA is always under pressure from companies and disease-advocacy groups to speed up the approvals of new drugs (but without compromising safety), and the TREAT Act, introduced by Senator Nancy Hagen of North Carolina in February, is another push, aimed at accelerating drugs for the “rare” disorders (NORD summary). The principal mechanism proposed is that the FDA consider all data available on efficacy an applicant submits, e.g., Phase II trial results, interim data, and responses measured by biomarkers of disease progression. I’m for TREAT since it may encourage companies to develop new drugs for rare and orphan diseases including those that are rare in the US but afflict millions elsewhere (see my post, “Orphaned and Neglected” 2/16/12). But the bill’s progress was sidelined by opposition from both the major pharmas and the FDA (Businessweek article) despite support by biotech companies that saw it as a way to reduce their clinical trial costs and make them less reliant on finding a big pharma partner. The TREAT isn’t over yet. The author of the Businessweek article notes that Senator Hagan plans to submit a revised act later this year that may be rolled into FDA’s user fee renewal legislation making it harder to torpedo.
- New helmsman at Hilleman
Those of you with really good memories will remember my post in October 2009 about the founding of the Hilleman Laboratories in New Delhi, India (“Is There a Bottom Line Behind the Headline?” 10/13/09). The laboratory is a joint venture funded by the Welcome Trust, the British health philanthropy, and MSD, Merck and Co.’s Indian subsidiary, to advance vaccine development for diseases of the low-income countries (Hilleman Labs). In my post, I expressed concern that the experience of the top managers, modest funding ($130 million over seven years), and apparent non-involvement of Merck in product development were not aligned with the Lab’s stated mission of actually delivering effective, affordable, and “sustainable” (i.e., not totally grant-dependent) vaccines. So I was happy to learn that the Labs hired Davinder Gill as its new CEO in January because, not only is he a nice guy and former colleague at Wyeth, but he has lots of product development experience, most recently as a VP for biotherapeutics at Pfizer (Lab press release). Fulfilling the Labs’ mission requires his experience and that of others from the corporate sector, including, in my opinion, business development types who can “build partnerships that enable the widest possible access to these products” (Hilleman Operating Model).