GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Tangentially relevant to GTC’s CD20 program…

Ofatumumab Works in CLL

[Ofatumumab is a Rituxan-like compound that also goes by the name, HuMax-CD20. It is being tested in RA (#msg-24683024) as well as cancer. GSK licensed Ofatumumab from Genmab is one of the largest biotech deal of all time (#msg-15652707).]

http://online.wsj.com/article/SB121752931200201673.html

›By JEANNE WHALEN
August 1, 2008

Marking a rare success in the European biotech sector, Danish firm Genmab AS said the most important drug in its pipeline has delivered strong results in a trial against a type of leukemia.

Genmab, which is developing the drug with GlaxoSmithKline PLC, said it aims to submit the drug, called ofatumumab, for U.S. and European regulatory approval by the end of this year.

In 2006, Glaxo agreed to pay as much as $2.1 billion for the rights to help develop and market the drug for a variety of potential uses. In addition to testing the drug for chronic lymphocytic leukemia, or CLL, Genmab and Glaxo are testing the drug against two additional types of blood cancer, rheumatoid arthritis and multiple sclerosis.

Glaxo is hoping that ofatumumab will boost its presence in the oncology business, which is growing at a faster rate than other disease areas. Ofatumumab is one of several cancer drugs Glaxo aims to launch in the coming years.

Big pharmaceutical companies have been moving to increase their investment in biotech in recent weeks. Thursday, Bristol-Myers Squibb Co. proposed acquiring the roughly 83% of ImClone Systems Inc. that it doesn't already own. And Roche Holding AG offered to buy full control of Genentech Inc. a few weeks ago. Genmab could be a target, analysts say. A Genmab spokeswoman declined to comment.

European biotech companies have delivered fewer drugs to the market than their counterparts in the U.S., in part because of a lack of funding. Venture capitalists, a big source of funding for American biotechs, have been less willing to risk money on the biotech sector in Europe.

Ofatumumab is a monoclonal antibody that is similar to Rituxan, a drug sold by Genentech and Roche.

Genmab said it was releasing preliminary data from a trial in patients with late-stage CLL. Genmab said the results were statistically significant and exceeded its expectations.

About half of 138 patients involved had previously not responded to two other medications -- Campath and the chemotherapy fludarabine. The other half didn't respond to fludarabine and were considered unsuitable for Campath because of their type of cancer.

All of the patients were given eight weekly infusions of ofatumumab and then four monthly infusions. After 24 weeks, 51% of patients in the group not responding to both older medicines experienced a strong response to ofatumumab, Genmab said. About 44% of patients in the other group responded well to ofatumumab. Genmab said patients generally tolerated the drug well, though some experienced fever, diarrhea, fatigue and other side effects.‹



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