To: Spekulatius who wrote (14362 ) 4/23/2002 11:05:15 AM From: keokalani'nui Respond to of 78507 Could keep the pressure on Merck. From forbes.com Paulo Costa, who heads the company's U.S. drug division, Novartis Pharmaceuticals, confirms that, for the near future, Novartis' growth will continue to rely largely on Diovan and Lotrel, two high blood pressure drugs that have been on the market for several years. But he points to one of the company's new drugs as a potential windfall: Prexige, an arthritis treatment previously known only by the code-name Cox-189. "For competitive reasons, we have not disclosed much about Prexige," Costa says. "Most of our competitive data will by released at the meeting of the American College of Rheumatology in October." Here's what is known: Prexige is a new drug in the same class as Celebrex and Vioxx, the blockbuster arthritis drugs developed by Pharmacia (nyse: PHA - news - people ) and Merck (nyse: MRK - news - people ). This drug class, known as the Cox-2 inhibitors, stops inflammation without causing the side effects in the stomach or intestine that can result from older drugs like aspirin and ibuprofen. However, growth of Vioxx and Celebrex may have been slowed by fears of cardiovascular concerns that were raised in the Journal of The American Medical Association (JAMA) in August 2001. The drug companies have argued that the concerns, raised by Dr. Eric Topol of the Cleveland Clinic and his colleagues, resulted from a misguided analysis of existing data, but the concerns have not fully lifted. Vioxx's label now indicates the drug may carry some cardiovascular risk. Novartis' response to the concerns that Cox-2 inhibitors might cause heart problems is to run extra clinical trials to try and prove that its drug does no cardiovascular damage. In addition to a study of 13,000 patients that will be used to convince the FDA to approve the drug, Novartis is conducting an 18,000-patient outcome study to try and demonstrate that its drug does not cause an increased risk, however rare, of heart attack. Right now, Costa says, the company does not know what the data from its clinical trials will show, but Novartis is very optimistic about Prexige based on earlier data. "We're going to have entrant data at the time of the launch, which will probably, at that point, only allow us to say that we haven't seen any indication of cardiovascular side effects," Costa says. "It is only nine months after launch that we will really know what the true profile of the drug is." Costa believes any new Cox-2 inhibitor could be competitive. The question Novartis' studies are asking is exactly how competitive this one will be.