* 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 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
The trial tested patients who had failed to respond
adequately to methotrexate, a standard treatment. Patients
received ocrelizumab and methotrexate or methotrexate and a
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
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
(Additional reporting by Toni Clarke and Sven Egenter; Editing
by Dan Lalor, Rupert Winchester and Gerald E. McCormick)