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Merck withdraws HIV vaccine, while activists seek fair price for Isentress

Phase II clinical trials of Merck's HIV vaccine were frozen on 21 September after failing to stimulate an immune response, while AIDS activists lobby the US company to keep Isentress' costs down

Phase II clinical trials of Merck's HIV vaccine, created using the same virus that causes the common cold, were frozen on 21 September.

The vaccine is essentially a cold virus modified to contain three proteins from HIV. Merck hoped that the vaccine would cause the patients' immune system to create antibodies against HIV, but this was not observed in trials. The vaccine joins VaxGen's HIV vaccine, which failed in 2003.

An independent data-monitoring board stopped all clinical trials associated with the vaccine after an interim analysis concluded that the vaccine failed to keep subjects from being infected with HIV, through behaviors that exposed them to the virus. The vaccine also failed to lower the amount of virus in the subjects after being infected, which was a secondary endpoint of the study.

Merck's vaccine was furthest along in clinical trials, but its failure opens up the door for other companies which have vaccines in early trials, including sanofi-aventis, Novartis and Wyeth.

The first company to launch a successful HIV vaccine would have an instant blockbuster to corner the market, as a vaccine is probably the most practical way to fight AIDS in developing countries.

Despite the failure, Merck still has two HIV drugs on the market, Crixivan (indinavir) and Stocrin/ Sustiva (efavirenz), which racked up combined sales of USD 75m in Q2 FY07.

An FDA advisory committee also unanimously recommended approval of its new HIV integrase inhibitor drug, Isentress (raltegravir). If it is approved (scheduled for mid-October 2007), sales of the first-in-class drug might be slow at the start, but should increase as more patients experience resistance to the currently available drugs.

Activists want fair price for Isentress
A coalition of AIDS activists is calling on Merck to set a 'fair and reasonable price' for their integrase inhibitor, Isentress.

The Fair Pricing Coalition has asked other activists, AIDS organisations and concerned individuals to sign a letter which urges Merck not to set too high a price for the novel treatment.

In the letter, activists question the escalating prices that other companies have set for drugs that have been approved in recent years. They point out that the price of the first protease inhibitors were many thousands of dollars less than those approved more recently, despite the fact that the cost of bringing newer drugs to market and manufacturing them has likely decreased.

Though the activists agree that Merck has made a significant investment in AIDS research and must be able to make a profit on Isentress, they argue that US government schemes like AIDS Drug Assistance Programmes (ADAP) will become even more overburdened, should the company set too high a price.

30th September 2008

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