GlaxoSmithKline CEO Andrew Witty's proposal for companies to pool their patents to develop medicines for neglected tropical diseases is a somewhat unusual call for collaboration in the pharmaceutical industry, but not entirely without precedent.

In a Feb. 13 address to Harvard Medical School, Witty said GSK would put its relevant small molecule compounds or process patents for neglected tropical diseases into a pool that others could access to develop new products. A GSK spokesperson said the pool could also include information about studies that have failed so researchers would know what didn't work.

While companies are generally averse to sharing their intellectual property, they may be more willing to consider Witty's initiative since it is limited to medicines that generate relatively little revenue. And GSK has further limited the cost of its proposal by excluding products with potentially wider application beyond the less developed nations: vaccines and HIV/AIDS.

At the same time, the plan garners good will and demonstrates a receptiveness to some legislators' interest in this area, most recently made concrete in a new FDA program to provide priority review vouchers to companies that receive approval for a new molecule to treat neglected tropical diseases, such as tuberculosis, malaria, cholera, dengue fever and leishmaniasis (see ¹ Also see "Pfizer, Merck And Sanofi Show Interest In Priority Review Voucher Program" - Pink Sheet, 23 February, 2009.).

GSK has approximately 19 pharmaceutical R&D projects targeting diseases that are largely limited to the developing world, in addition to its vaccine projects. Its biologicals (vaccines) facility in Rixensart, Belgium is involved in the discovery and development of vaccines for malaria, TB and HIV.

Patent pools, in which patent owners agree to license their patents to one another or third parties, are common in other industries, such as manufacturing and electronics. Patent pools in these fields have been used to establish standards in television transmission, MPEG-2 compression technology and DVD formats.

Witty did not discuss his plan with other companies before announcing the patent pool and it's uncertain whether it will be widely embraced.

Lilly Shares A TB Drug Discovery Library

Lilly, for one, says it shares GSK's views on the issue. The Lilly TB Drug Discovery Initiative, a public-private partnership initiated in 2007, is already sharing its library of 500,000 compounds.

Other companies are pursuing different strategies to expand research on neglected diseases and improve access to drugs in poorer countries.

Paul Herrling, head of corporate research at Novartis, has developed a model to pool funds for research on neglected diseases of the developing world. He proposes that governments of developed and developing countries, charities and other entities contribute to a fund for R&D in neglected diseases.

Herrling describes how the fund would operate in the February issue of Nature Reviews Drug Discovery. He says the fund would nominate a team to evaluate projects that originate from academic institutions, public-private partnerships or pharmaceutical companies.

With regard to patenting, Herrling suggests that project originators would usually patent the molecules that they propose to the fund. And in return for the money they receive they would allocate an exclusive license for the neglected disease indication to the fund.

UNITAID Seeks To Pool HIV/AIDS Patents

While welcoming GSK's proposal, groups advocating greater access to medicines say it does not go far enough. Specifically, they want it to also include patent pools for HIV/AIDS research.

GSK's willingness to share its patents "is a very positive signal," said Ellen 't Hoen, UNITAID's senior advisor on intellectual property. UNITAID, a drug purchasing facility whose partners include the World Health Organization and the Clinton Foundation, seeks to increase access to treatments for HIV/AIDS, malaria and tuberculosis in low- income countries. But 't Hoen said GSK needs to go further and participate in the patent pool UNITAID is developing for HIV/AIDS research.

She said her group has had a number of informal conversations with companies, including GSK, and that they have all been receptive to UNITAID's initiative.

Tido von Schoen-Angerer, director of Médecins Sans Frontières' Campaign for Access to Essential Medicines, expressed concern that Witty's proposal might sideline UNITAID's proposal. He said an HIV/AIDS patent pool is necessary for development of new fixed-dose combinations as patents on individual drugs can block such research.

"At this point we do not see a need for patent pooling in HIV research," Sarah Alspach, GSK's director of U.S. media relations, said in an interview after Witty's announcement. "The purpose of the pool is to stimulate innovation in an area where there has not been innovation for 40 to 50 years."

Innovation Or Access?

Alspach said that with HIV the problem is not innovation as much as access to HIV medicines. To address this, she said GSK is providing antiretrovirals at not-for-profit prices in the developing world and has voluntary licenses with generic manufacturers to produce HIV medicines for these countries.

Witty also announced that GSK is going to reduce prices on all its medicines in the least developed countries so that they will be no higher than 25 percent of the cost in the developed world.

Von Schoen-Angerer said that even with the price reduction many people will still not be able to afford GSK's drugs and that generic competition is the only thing that drives prices down sufficiently. He noted that in 2001 GSK slashed the price of Combivir (lamivudine/zidovudine) from $6,200 to $730 per patient per year but entry of a generic brought the price down to $114.

Countries have sought to expand access to drugs by instituting compulsory licensing. In 2007, Thailand issued compulsory licenses for Merck's HIV drug Stocrin (efavirenz) and Abbott's Kaletra (lopinaivr/ritonavir). The Campaign for Access to Essential Medicines says as a result the price of Kaletra dropped from close to $3,000 to around $500 today.

GSK's price reduction is an "attempt to prevent further compulsory licensing," von Schoen-Angerer contended.

- Brenda Sandburg (b.sandburg@elsevier.com)

GSK Wades Into The Pooled Approach To Tropical Disease Research

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