UPDATE 3-Roche arthritis drug effective in late-stage study

Fri Dec 11, 2009 11:46am EST

* Ocrelizumab meets primary end-point in Phase III study

* Potential billion-dollar seller partnered with Biogen

* 20 mln people suffer from rheumatoid arthritis globally (Adds economic breakdown, details; updates share price)

By Sam Cage

ZURICH, Dec 11 (Reuters) - Swiss drugmaker Roche Holding AG (ROG.VX) said on Friday that a late-stage trial of its experimental rheumatoid arthritis drug showed it significantly reduced the signs and symptoms of the painful joint disease.

The drug, ocrelizumab, was developed by Roche's Genentech unit and Biogen Idec Inc (BIIB.O) of Cambridge, Massachusetts. It is similar to their drug Rituxan, which is approved to treat cancer and rheumatoid arthritis.

Rheumatoid arthritis is an autoimmune disease characterized by inflammation that leads to stiff, swollen and painful joints It affects some 20 million people, according to the National Rheumatoid Arthritis Society.

The Phase III trial of ocrelizumab -- the first of four needed to win regulatory approval -- succeeded in meeting its main goal, which was to significantly reduce symptoms in patients with seropositive RA, or those who tested positive for the presence of certain antibodies.

About 80 percent of RA patients are seropositive, Roche said.

The trial tested patients who had failed to respond adequately to methotrexate, a standard treatment. Patients received ocrelizumab and methotrexate or methotrexate and a placebo.

Martin Voegtli, an analyst at Kepler Capital Markets, said he expects the drug to reach the market in 2012 and eventually generate revenue of more than $1 billion.

Roche's shares were off 0.2 percent at 168.50 Swiss francs. Biogen's shares rose 0.2 percent to $48.35 in late morning trading on Nasdaq.

Roche and Biogen currently split the profit on Rituxan, with 60 percent going to Roche and 40 percent to Biogen in the United States. Outside the U.S. Biogen gets a low double-digit royalty.

On approval of the new generation product, Biogen would receive 30 percent of the profit for both Rituxan and ocrelizumab. Biogen would receive a mid-double-digit royalty outside the United States.

While the drug was efficacious, it also was also associated with a higher number of serious infections -- something Karl-Heinz Koch, an analyst at Helvea, said could come as a disappointment, even though it is not uncommon for RA drugs to be associated with a higher rate of infection.

A fuller safety analysis, and more detailed efficacy data, will be presented at upcoming scientific meetings.

The study showed that the drug in combination with methotrexate alleviated symptoms of the disease both at week 24 and week 48 more than in patients treated with methotrexate alone. (Additional reporting by Toni Clarke and Sven Egenter; Editing by Dan Lalor, Rupert Winchester and Gerald E. McCormick)

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