A Quiet Week at Lake Woebegone

While the politically-motivated impasse in Washington has been closing in on precipitating a financial meltdown of the US and, in turn, world economy, it’s been a quiet week for the business of global health.  In my business development work, I rearranged the deck chairs by adding three pro bono clients and dropping one, but have spent most of my time on one compensated project, cycling about the local ex-urbs, and attending to house maintenance jobs.  So, instead of a thoughtful analysis of news, here are follow-ups to three earlier postings.

Last summer I attended the BIO Ventures for Global Health Partnering for Global Health Forum and wrote about the progress of the Clinton Foundation’s Health Access Initiative’s (CHAI) Drug Access Team (DAT) which at the time was headed by Inder Singh, and specifically on the DAT’s “Innovator Access to Medicines Strategy.”   In my posting of 6/3/10, I boiled down this strategy to a few key practices that run contrary to the “conventional wisdom” in big pharma product marketing.  In addition to the usual selling in a few lucrative markets, companies should license nonexclusively to low-cost, high-quality generic manufacturers who are likely to enter most potential markets (i.e., increase access and revenue), allow licensees to invent “new” drugs through new formulations and combinations  to increase revenue opportunities, register broadly to create robust private markets for your licensees, and partner with (sell to) the leading public sector purveyors to ensure appropriate adoption and use at an affordable and fair price (mutual value).  So when I learned that Inder was a panelist on “New Product Introduction” at the 2011 Partnering Forum, I reviewed the web cast (PGH web cast) to see what progress had been made, e.g., what has been the response of biotech/pharma companies to whom the DAT had pitched this strategy.  Alas, Inder gave no update but made several points that were new to me:

  • he is now Executive Vice President of Access Programs;
  • CHAI has 600 employees;
  • DAT’s mantra is “affordable yet sustainable pricing;”
  •  the “sweet spot” for negotiating developing world access to new medicines is 12 months prior to 6 months post product launch;
  • one role for intermediaries like the DAT and others is to neutralize conflict of interest, either on the part of the drug companies who may be accused of negotiating deals that maximize profit rather than access and governments who may be accused of being influenced by pay offs and kick backs;
  • South Africa has a model and sophisticated drug procurement division; and
  • the best companies for low-cost, quality drug production and manufacturing innovation are in India.

Speaking of drug access, last year I posted on the less important role of patents and the more important role of licensing in improving access to drugs, specifically commenting on UNITAID’s push for drug companies to “donate” key drug patents to their “Medicines Patent Pool” (my posting of 8/5/10) and in contrast the success of Gilead’s licensing program for first-line HIV drugs (my posting of 8/12/10).  UNITAID, as one may remember, is the WHO-backed and airline-ticket-tax-funded “International Drug Purchase Facility” established in 2006 with the intent of accelerating the access to drug and diagnostics for HIV, tuberculosis (TB), and malaria in high-disease burden countries (WHO press release).  Although the intent was for UNITAID to act as an intermediary between the product inventors/producers and the pubic procurers (similar to the CHAI DAT), the group has made its most progress in funding a wide variety of projects, like evaluating ways o minimize maternal HIV transmission, and buying and supplying TB drugs (UNITAID 2011 fact sheet).  Hence, I was happy to see the group’s recent announcement that Gilead was the first company to sign on to the UNITAID pool (FierceBiotech article).  Happy for Gilead because the agreement with UNITAID is a rational extension of Gliead’s long-standing strategy of licensing generic manufacturers for developing world markets, happy for UNITAID because it gives them credibility as an drug market intermediary, and happy for the procuring agencies since the agreement includes Gilead’s second-line drugs (and one in development) and hence there should be lots of competition among the generic companies to come up with low-cost manufacturing (and low-price products) and new combinations.  Of course, UNITAID will need to market to, sublicense, and support any technology transfer to the generic companies, as well as line up and fund buyers, and I look forward to learning how it will do so (from the press release:  UNITAID “will publish the licenses on its website, welcoming feedback and suggested improvements from all stakeholders.”)Finally, I note that it was reported in June that the new monovalent meningitis vaccine, MenAfriVac, had demonstrated a superior antibody response to that of an older vaccine, Glaxo’s quadrivalent Mencevax (96% vs. 64% response rate, Bloomberg article).  This is good news.  First, it means that the 20 million people in sub-Saharan Africa who have received the vaccine to date and the additional 45 million people who will be inoculated this year will be well-protected against the most prevalent African infection due to Neisseria meningitides, subgroup A.   Second, as I posited in my posting of 12/6/10, the results may encourage the MenAfriVac producer, the for-profit Serum Institute of India, to apply the conjugation technology it licensed (invented by scientists at the US FDA) and used to make MenAfriVac to developing a low-cost, multivalent vaccine which would really be useful globally.


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