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Novartis readies Prexige for European launch

Published on 08/12/06 at 10:42am

Novartis will launch Prexige in its first European markets outside the UK next year following its EMEA approval for osteoarthritic pain.

Prexige is a Cox-II inhibitor and Novartis has had to work hard to overcome regulatory doubts about the drug class following the withdrawal of Merck's Vioxx in September 2004.

The company says Prexige has the largest-ever body of evidence of any anti-inflammatory agent, with pre-trial data from 34,000 patients.

Global head of development for Novartis Pharma James Shannon said: "Novartis has worked closely with the health authorities to ensure a full review of all Prexige efficacy and safety data, especially the cardiovascular data, to confirm the benefit for patients.

"We are delighted that Prexige will soon be available to patients in Europe, and we are committed to providing physicians with the information they need to appropriately prescribe and select patients for Prexige."

The EMEA and the US FDA have concluded that the benefit/risk ratio for selective COX-II inhibitors like Prexige remains positive when used in their target patient populations. But Novartis has agreed with the regulators that anti-inflammatory treatments should be used at the lowest possible dose for the shortest possible duration.

Prexige was first approved in the UK in December 2005 and has now completed the EU's Mutual Recognition Procedure, with European launches expected in 2007 and 2008.

The drug endured a two-year fight to reach the market after the withdrawal of Vioxx (rofecoxib) in 2004 and subsequent suspension of Pfizer's Bextra (valdecoxib) - prompting European regulators to review the safety of other drugs in the class.

Novartis agreed to delay the launch of Prexige until the completion of the review, which imposed new contra-indications and warnings on all Cox-IIs.

The fallout from the Vioxx withdrawal could have a substantial effect on the take-up of Prexige, which Novartis says will be targeted initially as a secondary care drug.

According to analysts Datamonitor, Prexige won't reach blockbuster status but will compete well against Pfizer's Celebrex (celecoxib) - the most commonly used osteoarthritis treatment - and Merck's Arcoxia (etoricoxib) in the five major EU markets.

Datamonitor does not expect osteoarthritis sales of Prexige in the seven major markets (UK, France, Germany, Italy, Spain, US and Japan) to exceed more than $500 million.

Elsewhere, Novartis plans to re-submit Prexige for US approval in 2007 and is hoping for Japanese approval of the treatment after 2010.

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