April 28, 2004
An interesting development in the fight against HIV
by Liza Sabater
Having worked as a writer for a pharmaceutical company, the FT.com : J & J gives away HIV drug rights story raises the sceptic in me. Why would this company give away the rights to a product? Is this a tax write-off? Is there more profit in getting the royalties? Is it a way to raise more money for the clinical trials? Tentatively I would answer to all with a yes.
One of the biggest hurdles pharmaceuticals have is the battery of clinical trials they have to perform before releasing a product to market. The fact that this product wouldn't be in the market before 2010 is probably a reason for J&J to farm it out to a non-prof that would probably get both the public and private funding needed for the trials. Not only that, once it becomes a publicly funded product, it might also get rushed through the FDA evaluation & approval process.
Then again, maybe, just maybe, there are people at pharmaceuticals that actually have a conscience. I am, after all, not yet a misanthrope of volterian proportions.
J & J gives away HIV drug rights
By Geoff Dyer in London
Published: March 28 2004 21:34 | Last Updated: March 28 2004 21:34Research into virus-killing gels that can prevent HIV infections in women will receive a large boost on Monday when Johnson & Johnson announces it has donated the rights on a potentially exciting new product to a non-profit group that specialises in the area.
J & J is to award a royalty-free licence for the product, which is based on a type of Aids drug, to the International Partnership for Microbicides (IPM), the non-profit group set up to help develop products that can prevent Aids infections.
Microbicides are vaginal medications such as gels and creams that can reduce the risk of HIV transmission during sex. Health officials believe that even a partially effective microbicide could prevent millions of infections among those women in the developing world who are unable to insist on the use of condoms.
Research into microbicides has been held back by lack of resources and the absence of interest from industry. However, in recent years the area has begun to attract attention because of the huge difficulties and delays faced by researchers developing Aids vaccines.
While early microbicide research focused on spermicides, scientists are now examining the use of the molecules used in Aids drugs that target specific mechanisms of HIV to see if they can block the virus before infection.
Tibotec, a subsidiary of J & J, initially developed the molecule, known as TMC120, as an Aids treatment. However, it has since adapted the molecule into a gel and conducted early-stage clinical trials for the microbicide.
Mark Mitchnick, director of research at IPM, said the group had high hopes for TMC120 because it was a highly potent compound, is relatively cheap to produce and is chemically stable. There was also little resistance to the compound, a problem with some Aids drugs. The fact that a large pharmaceuticals group had got involved in microbicide research was a validation of the science behind the products, he said.
Under the agreement, IPM will conduct further clinical trials to win regulatory approval, which could cost $50m-$100m (?41m-?82m, £27.5m-£55m). If a product does reach the market, Tibotec would have the rights to market it in developed countries, however it would have to pay a royalty to IPM.
Paul Stoffels, president of Tibotec, said: "There is a good chance it will work shortly after being applied, but the real development challenge is to have a product that will still work after a long period such as a week or even a month."
Writing in this week's issue of The Lancet, Robin Shattock of St George's Hospital Medical School in London said a microbicide could be available by 2010. But he added: "To be successful, such agents will have to be cheap, stable and easy to use."
Posted by Liza Sabater in Commerce, Health, Science
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