Swiss drugmaker Novartis AG (NVS) Tuesday said it will start selling its painkiller Prexige in the European Union next year, marking the return of a drug that many analysts had considered dead.
Prexige belongs to the same class of drugs as Vioxx, which maker Merck & Co. (MRK) in 2004 withdrew from the market after a study showed it increased the risk in some patients of heart attacks and strokes.
This type of drug, known as Cox-2 inhibitors, was developed to be gentler on the stomach than traditional pain relievers, such as ibuprofen and naproxen. These conventional pain medications belong to a class of drugs called nonsteroidal anti-inflammatory drugs, or NSAIDs.
After the Vioxx debacle, Novartis suspended the filing process for Prexige in Europe.
Since then, initial approval for Prexige - also known as Lumiracoxib - was granted in the U.K., where it has been available since December 2005. With all 26 member agreeing to issue national approval, Prexige can now go on sale in the E.U. for the treatment of ostheoarthritis, a leading cause of chronic pain.
The Basel-based company plans to refile Prexige for U.S. approval next year, meaning it could go on sale there in 2008 at the earliest.
Novartis underlined that Prexige was both effective and safe, but many analysts remain skeptical about the drug's potential.
"Although Prexige appears to have a better safety profile than Vioxx, general practitioners will remain cautious, and probably continue to prescribe NSAIDs, even though this class of drugs has its own safety issues," said Paul Diggle, analyst at Nomura Code Securities in London, who has a buy rating on Novartis.
NSAIDS are available in cheap generic versions - another reason why physicians will in most cases prefer to prescribe these older drugs, Diggle said.
For its part, Novartis highlighted the safety issues associated with these traditional pain relievers.
"Many patients can't tolerate the gastrointestinal side effects associated with NSAID pain treatments," said Dr. Gerd Burmester, Professor of Medicine at the Humboldt University in Berlin, and an investigator on one of the Novartis-sponsored studies on Prexige.
"Lumiracoxib has been extensively studied for both efficacy and safety, and has the potential to provide a valuable new treatment option for physicians."
Until two years ago, Novartis had bet on Prexige to become a blockbuster product with annual sales of $1 billion or more. Then Merck pulled Vioxx from the market, and the whole class of drugs to which it belonged came under scrutiny.
Most analysts remain cautious on Prexige's potential, despite the drug's strong showing in human testing.
"The whole class has been tainted," said Navid Malik, analyst in London at brokerage Collins Stewart, who has a hold rating on the stock.
"I don't think it will become a big product, and the FDA will proably be taking a very cautios view, and may grant it market permission only with a restricted label."
The news had little impact on Novartis shares, because the approval had been expected for the fourth quarter.
At 0940 GMT, Novartis shares were down CHF0.40, or 0.5%, at CHF76.40, while the broader Swiss market was also lower.
Company Web Site: http://www.novartis.com
No comments:
Post a Comment