2nd UPDATE: Roche Gets EU OK For Rheumatoid Arthritis Drug
January 21 2009 - 4:09AM
Dow Jones News
Roche Holding AG (ROG.VX) Wednesday said it received European
Union approval to sell its rheumatoid arthritis drug RoActemra,
underlining the Swiss drugmaker's strong position in a sector
suffering from lack of innovation and the loss on patents of big
money-earners.
Roche, based in Basel, said the biological drug, which takes a
new approach to treat the disease, will be sold in combination with
an older pill to patients who failed to respond to existing
therapies.
RoActemra, known as Actemra in the U.S., is Roche's most
important new drug launch this year.
In December, the company was dealt a big setback on Actemra,
when the U.S. Food and Drug Administration asked for a new animal
trial and other information, which will delay its launch by at
least 18 months.
Many analysts see Actemra reaching peak annual sales of around
$2 billion. A few see even higher results.
Actemra was developed by Japan's Chugai Pharmaceutical Co.
(4519.TO), which is controlled by Roche, and Roche owns the rights
to sell Actemra outside Japan.
There are already many treatments for rheumatoid arthritis,
including Rituxan/MabThera, which is sold by Roche and its U.S.
ally Genentech Inc. (DNA). But many of these drugs merely relieve
pain - in some cases with severe long-term side effects, including
osteoporosis and high blood pressure.
Actemra works by a different mechanism than older drugs. It is a
humanized monoclonal antibody - an antibody produced by a single
cell - and the first to inhibit the interleukin-6, or IL-6,
receptor. IL-6 is considered an important mediator of the acute
inflammatory response that underpins the rheumatoid arthritis
disease process.
At 0830 GMT, Roche shares were up CHF1.50, or 0.9%, at
CHF171.80, in a lower Swiss market and also outperforming the
broader European healthcaer sector. Roche shares have dropped 16%
over the past year, in line with the European drugs sector.
Roche, the world's seventh-largest pharmaceutical company by
sales, focuses on prescription drugs. Its most successful franchise
is cancer drugs, which made up nearly half of its total sales last
year.
Novartis AG (NVS) holds 33% of Roche shares.
Company Web Site: http://www.roche.com
-By Anita Greil, Dow Jones Newswires; +41 43 443 8044 ;
anita.greil@dowjones.com
Click here to go to Dow Jones NewsPlus, a web front
page of today's most important business and market news, analysis
and commentary. You can use this link on the day this article is
published and the following day.