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FDA approves maraviroc for treatment-experienced HIV patients

The FDA has approved Pfizer's novel-acting, CCR5 co-receptor HIV drug, Celsentri (maraviroc) in the US

The FDA has approved Pfizer's novel-acting, CCR5 co-receptor HIV drug, Celsentri (maraviroc) in the US for use in treatment-experienced patients from a specific population.

Celsentri's novel mode of action prevents the HIV virus manufactured by infected cells from entering uninfected cells by blocking the CCR5 co-receptor entry route on the cell wall.

The Antiviral Drugs Advisory Committee says that Celsentri will offer patients resistant or intolerant to the current inventory of HIV drugs an alternative treatment option. The FDA has, however, asked Pfizer to conduct further studies to investigate liver toxicity and other side effects, as well as the treatment's efficacy in patient populations hitherto untested, specifically females and non-caucasians.

The earning potential of Celsentri may not be initially that great for Pfizer, as patients will have to submit to a diagnostic test to verify they have the HIV virus type which can be treated with the drug. Pfizer says that maraviroc will be used for treatment-experienced patients, but its label could eventually be expanded for the treatment-naive.

In 2005, the market for HIV was worth USD 7.1bn, will undergo significant changes over the next several years. A Datamonitor report published on 11 April revealed that the value of the HIV market could grow to USD 10.6bn by 2015.

Celsentri will make a significant contribution to the predicted growth in the HIV market, but Merck & Co's integrase inhibitor, Isentress (raltegravir), and Tibotec's non-nucleoside reverse transcriptase inhibitors, TMC125 and TMC278, will also add value. Gilead and Bristol-Myers Squibb's (BMS) Atripla (efavirenz/ tenofovir/ emtricitabine) has already been launched in the US and should reach the EU market in 2007.

Datamonitor adds that Celsentri and Isentress should capture market share from Roche's injectable fusion-inhibitor, Fuzeon, which currently dominates late-stage salvage therapy in cross-resistance patients, as Celsentri and Isentress can be taken orally. Fuzeon will probably be restricted for use in patients who have exhausted all other treatment options.

Datamonitor's report projects Celsentri sales to reach USD 350m in 2015, while Isentress should make USD 400m. Atripla, which is experiencing rapid uptake, could bring in sales for Gilead and BMS of USD 1.7bn by 2015.

Tibotec's TMC125 is set to reach market in 2008 followed by TMC278 in 2009. TMC125 may be limited to late-stage use, but TMC278 has been touted for use in early-line therapy and may have a greater impact on the market, according to the report. TMC125 sales could reach USD 200m by 2015, while TMC278 is expected to exceed USD 500m by the same year.

25th April 2007

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