Novartis AG asked European Union regulators to approve the Prexige pain pill that was pulled off the market four years ago, as the company seeks to revive a drug that once had the potential for $1 billion in annual sales.
The medicine, renamed Joicela, has been submitted to the EU regulators for approval, according to the Basel, Switzerland-based company’s 2010 annual report. Joicela sales were halted in 2007 after reports it caused liver damage.
Approval of Joicela would help Novartis replace revenue it will lose as its best-selling products start to face competition from generic medicines. The drug belongs to the same group of treatments as Merck & Co.’s Vioxx, which was pulled from the market in 2004 after research linked it to heart attacks and strokes.
“Zombie products are never very much fun,” Andrew Weiss, an analyst with Bank Vontobel AG, said in an interview. “It looks like Novartis is trying to launch anything they can get their hands on. They must be really nervous about the patent situation.” He recommends buying Novartis shares.
Eric Althoff, a spokesman for Novartis, didn’t respond to requests for comment. Sabine Haubenreisser, a spokeswoman for the European Medicines Agency in London, declined to comment.
The EU filing is Novartis’s second run at re-introducing the drug. The company planned to re-submit the treatment to U.S. regulators in 2009 along with a genetic test to detect patients prone to liver damage, Novartis said at the time.
Novartis declined to comment on the drug’s status with the Food and Drug Administration. Erica Jefferson, a spokeswoman for the FDA, declined to comment.
The FDA said in September 2007 it couldn’t approve Prexige for patients suffering from osteoarthritis because studies showed too high a rate of liver damage. European regulators halted sales of the drug months later. Novartis once estimated Prexige’s peak sales as likely to top $1 billion annually.
Joicela, if approved in Europe, would be given only to patients who the test shows aren’t prone to liver damage, according to Novartis’s annual report.
Novartis’s best-selling drug, the hypertension treatment Diovan, began to lose patent protection in Europe in February. The drug had 2010 revenue of $6.1 billion. Gleevec, a leukemia drug that brought in $4.3 billion, may face generic competition starting in 2015.
The oral multiple sclerosis pill Gilenya, approved in the U.S. last year, gained European backing this year and may generate as much as $5.3 billion a year for Novartis by 2016, according to Fabian Wenner, a UBS AG analyst.
Joicela, Vioxx and Pfizer Inc.’s Celebrex are drugs known as Cox-2 inhibitors. The medicines were intended to cause less stomach irritation than older treatments such as ibuprofen and aspirin.
The Novartis drug caused fewer stomach ulcers in arthritis patients than ibuprofen or naproxen, sold by Bayer AG as Aleve, in a 2004 clinical study published in the medical journal The Lancet. In the same trial, Prexige led to elevated liver enzymes in four times as many patients as naproxen.