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Biotech / Medical : HuMAB companies -- Ignore unavailable to you. Want to Upgrade?


To: Icebrg who wrote (932)7/29/2009 6:42:37 PM
From: A.J. Mullen  Respond to of 1022
 
UPDATE 1-Glaxo, Genmab drug meets goal in arthritis study
Wed Jul 29, 2009 5:18pm EDT Email | Print | Share| Reprints | Single Page[-] Text [+]
reuters.com
Market News

More Business & Investing News... * Ofatumumab achieves primary endpoint in Phase III study

* 20 percent plus reduction in swelling at 24 weeks

* No unexpected safety findings

(Adds details, background)

LONDON, July 29 (Reuters) - An experimental drug from GlaxoSmithKline (GSK.L) and Genmab (GEN.CO) has met its goal in a late-stage clinical trial for rheumatoid arthritis, the companies said on Wednesday.

Preliminary results from a Phase III study showed ofatumumab achieved its target of a 20 percent or greater improvement in the number of swollen and tender joints after 24 weeks.

In the study, which involved 260 patients, those given the drug had a 50 percent response rate, compared with 27 percent for patients given a placebo.

The new medicine, which is given intravenously, was tested on patients who had an inadequate response to the older but widely used drug methotrexate.

There were no unexpected safety findings. One death was reported in the study but was judged by the study investigator to be unrelated to ofatumumab.

Ofatumumab, or Arzerra, also is being developed to treat chronic lymphocytic leukemia (CLL) and was recommended for this indication by a U.S. expert advisory panel in May.

The U.S. Food and Drug Administration is expected to decide whether to accept the recommendation on using it to treat CLL by October 31.

While CLL, a common type of blood cancer in adults, would be the first market for the product, British-based Glaxo and Danish biotech group Genmab have high hopes for the product in other significant disease areas, such as arthritis.

Glaxo bought the global rights to ofatumumab in December 2006 in a deal worth up to $2.1 billion, a record sum for a biotech product agreement at the time. (Reporting by Ben Hirschler; editing by Carol Bishopric)

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