Clot Wars contd. - J&J Will Unveil New Drug Results on Monday

By RON WINSLOW

Johnson & Johnson sat out the blockbuster heart-drug era when cholesterol-lowering statins and blood-pressure pills fueled years of double-digit earnings growth in the pharmaceutical industry.

Now, though, the company may be close to making a play in an emerging class of blood-thinning medicines that some analysts believe could become a $20 billion annual global market by the end of the decade.

On Monday, researchers will disclose the results of a clinical trial involving more than 14,000 patients that tested whether the drug rivaroxaban is at least as effective as the drug warfarin in preventing strokes in people who suffer from an irregular-heart-beat condition called atrial fibrillation.

The company plans to submit the drug for regulatory approval by the end of the year. The Food and Drug Administration earlier asked for more data for a different use, which the company is also planning to provide by the end of the year. If all goes well, the drug could be on the market in late 2011.

Like many other companies in the pharmaceutical industry, J&J is urgently seeking a big seller to reinvigorate its aging product portfolio.

The drug, which the New Brunswick, N.J., health-care giant is co-developing with Bayer AG of Germany, is among a new generation of anti-clotting medicines vying to replace warfarin, the effective but difficult-to-use workhorse pill that has been a major blood thinner for more than half a century.

Warfarin is effective in preventing clots, but it requires monthly blood tests to make sure anti-clotting effects are in the proper range. Certain foods, dozens of drugs and genetic differences all influence its clotting protection. The new agents avoid these problems, researchers say.

Years of frustration with warfarin and a growing population of patients with atrial fibrillation are fueling intense interest in warfarin replacements. Boehringer Ingelheim GmbH's drug dabigatran won U.S. Food and Drug Administration approval just last month.

At least three other compounds in development at major pharmaceutical companies are chasing rivaroxaban. In addition to stroke prevention, the anti-coagulants have been tested to treat a condition called deep vein thrombosis and to prevent blood clots after hip- and knee-replacement surgery.

If analyst predictions are realized, annual sales could eventually come close to the peak of the market for statins, which exceeded $20 billion before two big sellers lost patent protection in recent years.

"It feels we're on the threshold of something important in cardiovascular" medicine," said Martin Fitchet, J&J's global therapeutic area head, cardiovascular & metabolism.

Beyond rivaroxaban, J&J is testing a diabetes drug called canagliflozin in a 10,000 patient study with the hope of seeking regulatory approval by 2012.

Both drugs are being developed in the cardiovascular and metabolic therapeutic area of the company's recently revamped pharmaceutical research and development organization.

Until now, J&J's principal pharmaceutical products for heart disease were abciximab, which it acquired when it bought the biotech company Centocor in 1999, and nesiritide, approved for a condition called acute decompensating heart failure. That drug was developed by Scios Inc., which J&J acquired in 2003. Each of the drugs accounts for less than $500 million in annual revenue. In contrast, the company's device business has been a prominent player in heart disease for nearly two decades, notably with its line of stents used to prop open diseased coronary arteries.

The rivaroxaban study, called Rocket-AF, will be presented Monday at the annual scientific meeting of the American Heart Association.

Bayer has already disclosed that the study met its primary goal of demonstrating that rivaroxaban is essentially as effective as warfarin at preventing strokes among atrial fibrillation patients with a comparable risk of bleeding.

Doctors and investors will be intensely interested in the study's details—whether, for instance, rivaroxaban outperformed warfarin in preventing strokes and exactly what the risk of bleeding is. Such data could affect how the drug's performance stacks up against rivals, assuming it eventually wins marketing approval.

"The sweet spot of anticoagulation is where stroke reduction and bleeding risk is best balanced," said Peter M. DiBattiste, J&J's vice president of cardiology for pharmaceuticals.

Hints of liver toxicity will be another checkpoint. A few years ago, liver problems killed the prospects for an earlier warfarin-replacement drug called ximelagatran that was being developed by AstraZeneca PLC.

The J&J officials declined to disclose study results, citing the heart association's embargo policies.

The trial is one of two major J&J studies being highlighted at the association's meeting.

On Sunday, researchers will present findings from Ascend-HF, a 7,000-patient study intended to answer questions about the safety and efficacy of nesiritide. That drug is used to treat shortness of breath in patients brought to the hospital suffering from severe heart failure.

But in 2005, a researcher's analysis of pooled data on the drug suggested that patients had a higher risk of death or kidney damage from the drug. J&J disagreed, but it eventually decided to mount a large-scale study to answer the question. There are few proven remedies for such patients.

Write to Ron Winslow at ron.winslow@wsj.com

via online.wsj.com

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