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Novartis Looks To Prexige, A New Arthritis Drug

Next For Novartis: An Arthritis Drug

Data Suggest New COX-2 Inhibitor, Offers Strong Efficacy

Prexige—Selective COX-2 Inhibitor

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Pharmaceuticals Novartis Looks To Prexige, A New Arthritis Drug Matthew Herper, 04.19.02, 12:10 PM ET NEW YORK - In the past two years, Novartis has executed one of the most impressive turnarounds in the drug industry. It has rammed nine new drugs through the U.S. Food and Drug Administration in that time, more than any other company. Among them was Gleevec, a treatment for chronic myelogenous leukemia that has been touted as a wonder drug and a harbinger of future breakthroughs derived through genetic research. But for all the breakthroughs, Novartis (nyse: NVS - news - people ) hasn't gotten many blockbusters. Drugs like Elidel, a non-steroidal treatment for eczema, and Zometa, a powerful treatment for the bone weakening that can occur in cancer, are great for patients but not yet powerful sellers. Gleevec brought in $109 million in the first quarter, again, not bad, but not massive either. Zelnorm, a potential blockbuster treatment for painful constipation known as irritable bowel syndrome, is caught up in delays at the FDA.       More on Novartis          Tear Sheet   Next For Novartis: An Arthritis Drug               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.

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Next For Novartis: An Arthritis Drug
Matthew Herper, 03.13.02, 5:00 PM ET

NEW YORK - Novartis is looking to enter the arthritis drug market with its own version of a widely successful class of painkiller. To make its entry, the company is conducting an audacious set of clinical trials that will directly compare its drug to the current market leaders. It will even look for worrisome side effects, hoping to definitively prove that its product has a safety advantage.

This is an all-or-nothing strategy. If it works, the new drug, still known by the code name Cox-189, could capture a big chunk of the market for a class of drugs called Cox-2 inhibitors, which is pushing sales of $6 billion annually. If the strategy fails for Novartis (nyse: NVS - news - people ), the drug would provide an alternative to doctors and patients but would do little for the bottom line.

"It makes me think that either they're very confident in the compound, or that they think that their opportunity is so slim as a late, me-too compound that it is worth taking a swing for the fences," says Carl Seiden, a pharmaceuticals analyst at J.P. Morgan, who does not cover Novartis but does cover its competition.

Right now, Pharmacia (nyse: PHA - news - people ) and Merck (nyse: MRK - news - people ) rule the arthritis market with Celebrex and Vioxx, which reduce inflammation without causing side effects like ulcers in the stomach or intestine. These drugs, along with a new Pharmacia drug, Bextra, are the only members of the Cox-2 class that are on the market. They stop inflammation by blocking an enzyme called Cox-2 without also hitting a related enzyme called Cox-1. Older drugs such as ibuprofen cause stomach problems in part because they inhibit both enzymes.

Growth of the Cox-2 class was fast and furious until an August 2001 study in the Journal of the American Medical Association (JAMA). Dr. Eric Topol of the Cleveland Clinic and his colleagues reanalyzed data from pivotal clinical trials conducted by the drug companies and found that both Vioxx and Celebrex might have cardiac side effects. Their reading of the data was by no means conclusive--the way the doctors combined data from several different clinical trials may have been misleading, but it hurt sales.

Enter Novartis' Cox-189. Right now the company is conducting massive clinical trials on the drug. More than 13,000 patients have been enrolled in one study to test the drug's safety and efficacy for an application with the Food and Drug Administration. Another 18,000 patients are signing up to do wider testing. Eventually, Novartis could use data from 31,000 patients to back up its marketing claims.

"The questions raised in the JAMA article have never really been settled," says Catherine J. Arnold, an analyst at Sanford C. Bernstein. "Having that robust data set will provide a competitive advantage."

Novartis is taking the bold move of actually comparing its drug to Celebrex and Vioxx. Such head-to-head studies are rare, because there is the risk that the new drug won't work as well as the old one--torpedoing sales. The drugmaker is also conducting a long-term outcomes study to see if any heart- or kidney-related side effects turn up in patients using Cox-189, hoping to forestall any of the safety concerns that have hurt Celebrex and Vioxx.

Merck is also conducting such an outcomes trial for Vioxx and its follow-up drug, Arcoxia. Bernstein's Arnold expects that Novartis' outcomes data may not be available until 2006, two years after Merck's results are expected.

Still, it's worth keeping an eye on Cox-189. Lately, Novartis has been batting them out of the park. It leads the pharmaceutical industry in new drug approvals for the past two years, with four brand-new drug molecules approved in 2001 and five approved in 2000.

There have been snags, though. Approval for Zelnorm, a treatment for painful constipation known as irritable bowel syndrome, was delayed on safety concerns. Xolair, an asthma drug developed with Genentech (nyse: DNA - news - people ), has been slow to go before regulators.

But other drugs have been breakthroughs. Cancer drug Gleevec gives chronic myelogenous leukemia patients a 24-month survival rate of 92%. Zometa, a treatment for bone erosion during cancer, may be so powerful that it might also work as a once-a-year injection for osteoporosis. (Data on both drugs come from studies appearing in a recent issue of the New England Journal of Medicine.)

So far, Novartis hasn't made much noise about Cox-189. That may change later this year as the company unveils new data. "I think the stock market hasn't fully appreciated Cox-189," says Bernstein's Arnold, "but I think in the second half, once the kimono opens up on it, there will be some excitement."
 

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Prexige—Selective COX-2 Inhibitor

In November 2002 Novartis filed an NDA for its cyclooxygenase-2 (COX-2) selective inhibitor, Prexige (lumiracoxib) as a treatment for arthritis and pain. Worldwide clinical studies with Prexige involved more than 13,000 subjects diagnosed with osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenorrhea. In addition to the effective treatment of the symptoms associated with arthritis, Prexige has been shown to have a superior tolerability and safety profile to non-steroidal anti-inflammatory drugs (NSAIDs). Prexige does not appear to induce the gastrointestinal side effects that are seen in patients using NSAIDs. This was evaluated in the phase III TARGET study (Therapeutic Arthritis Research & Gastrointestinal Event Trial), the largest arthritis clinical trial worldwide, which was initiated in May 2002.

In an earlier clinical trial involving 1042 subjects with osteoarthritis, the safety and tolerability of Prexige was compared to ibuprofen and celecoxib, over a 3-month period. The results showed that use of Prexige at 200mg and 400mg once a day resulted in a significantly lower gastroduodenal ulcer rate than ibuprofen given 800mg three times a day (p<0.01). In the ibuprofen group, 15.7% of the patients experienced ulcers compared to 4.3% and 4% in the Prexige groups (200mg and 400mg, respectively), which was comparable to the celecoxib group (3.2%) in 1011 patients.

In other studies, subjects taking Prexige demonstrated little or no erosion in the gastrointestinal tract, compared to gastric erosions seen in a significant number of subjects taking naproxen.

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