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Glaxo AIDS Drugs to Be Tested In Topical Form, as Microbicide

Wall Street Journal - September 24, 2004
Marilyn Chase, marilyn.chase@wsj.com


A nonprofit AIDS agency is set to announce a new corporate partnership to beef up its portfolio of antiviral AIDS gels aimed at protecting vulnerable women in the developing world.

The International Partnership for Microbicides said it reached agreement with GlaxoSmithKline PLC to test several of Glaxo's proprietary AIDS drugs in a topical form that could be used as a gel shield against the deadly virus.

London-based Glaxo, whose top-selling AIDS products include the combination pills Combivir and Trizivir, also is pursuing experimental compounds called CCR5 blockers, or viral entry inhibitors. The company hasn't indicated how many or which products it will lend to the microbicide effort. Glaxo couldn't be reached to comment.

The Glaxo pact "is the first step in a long process of identifying products that might make good microbicides," said Zeda Rosenberg, chief executive of the International Partnership for Microbicides. Mark Mitchnick, director of research at the group, said GlaxoSmithKline was bringing to the table a distinct class of potential microbicides from those now in tests. "They're opening new prophylactic windows for us," he added.

DISCREET PROTECTION
Researchers have been working to develop topical microbicides that can kill the AIDS virus. It's expected that such creams or gels can offer economical, discreet protection for women, particularly in developing nations. Some products already in development:

Product Name Maker Stage of Testing
C31G Savvy Biosyn Inc. of Huntingdon Valley, Pa. now in efficacy tests
Carraguard Population Council of NYC now in efficacy tests
Cellulose sulfate Conrad, a nonprofit in Arlington, Va. will enter trials in late 2004 or 2005
PRO2000 Indevus Inc. of Lexington, Mass. will enter trials in late 2004 or 2005
BufferGel ReProtect Inc. of Baltimore will enter trials in late 2004 or 2005

IPM, based in Silver Spring, Md., aims to develop a portfolio of antiviral compounds that might be blended into a cream or gel-based cocktail to deliver multiple knockout blows to HIV as it enters the body. Earlier this year, IPM acquired rights to a similar product from the Tibotec Pharmaceuticals Ltd. unit of Johnson & Johnson.

With an AIDS vaccine at least a decade away, AIDS researchers believe that women in poor countries need a discreet alternative to latex condoms to protect them at times when condoms can't be used. Such antiviral products might be applied as gels or creams alone or with a diaphragm. Others might be put into sponges or continuous-release rings.

Microbicides, as this class of product is known, are considered a key part of the AIDS prevention toolkit. In places like sub-Saharan Africa, women represent 60% of new AIDS infections. Studies show even monogamous married women there are at high risk from husbands who have multiple partners but refuse to use condoms. Such women lack power to insist on safer sex practices. To date, AIDS has killed 22 million people and infected 40 million world-wide.

Computer modeling studies by the London School of Hygiene and Tropical Medicine suggest that an effective AIDS gel, if used by one-fifth of women in 73 low-income countries, could avert 2.5 million HIV infections in three years.

Dr. Rosenberg said the partnership now has two microbicide products in pivotal efficacy trials, and three more are expected to reach that stage in late 2004 or 2005. Microbicide products could be on the market in five to 10 years, she has said.

Under terms of the deal, which is structured as a material transfer agreement, GlaxoSmithKline will select and provide the compounds for testing at St. George's Medical School in London.

The pact was praised by Richard Klausner, executive director of global health at the Bill and Melinda Gates Foundation, which pledged $60 million to the microbicide partnership. Dr. Klausner said the deal with Glaxo was "precisely the kind of collaboration needed" to boost creative AIDS prevention initiatives.


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