Biotech Values

[corpstrat]

Arzerra - were trial design and results as murky as this piece makes them sound? Seems like FDA would be justified in overruling the panel on this one?

http://finance.yahoo.com/news/Glaxo-Genmab-cancer-drug-gets-apf-15383735.html/print


Glaxo, Genmab cancer drug gets FDA panel nod
GlaxoSmithKline, Genmab cancer treatment gets positive recommendation by FDA expert panel

* On Friday May 29, 2009, 12:27 pm EDT

NEW YORK (AP) -- GlaxoSmithKline PLC and its development partner Genmab came one step closer Friday to gaining approval on their cancer treatment Arzerra after an advisory panel recommended the Food and Drug Administration approve the therapy.

The panel recommended that the FDA approve the drug in a 10 to 3 vote. Arzerra is aimed at treating chronic lymphocytic leukemia, a type of blood cancer. Specifically, the company is asking the FDA to approve the drug as a treatment for patients who have either failed other treatments or who otherwise can't use standard therapies.

The panel's recommendation, which the FDA normally follows though it is not required to, came after a somewhat critical staff report from the agency on Wednesday. That report questioned some of the study data being used by the companies to gain accelerated approval.

The study itself did not compare Arzerra with other treatments. Also, it looked at patients who had been previously treated with the chemotherapy Fludara and with both Fludara and Campath, which is made by Genzyme Corp.

The staff report recommended an additional study on the drug to focus on a patients who had only received prior treatment with Fludara. The report said that portion of the data did not meet the FDA's regulatory standard.

Meanwhile, the report said it will focus on data from patients who had previously taken both Fludara and Campath.

Other concerns focused on whether there were sufficient diagnostics following treatment to determine the actual effect of the drug on tumors.

"FDA acknowledges that administration of ofatumumab (Arzerra) as a single agent yields antitumor activity in patients with CLL," the staff report said. But the report also said "the existence of anti-tumor activity alone does not satisfy the standards for accelerated approval."

Denmark-based Genmab and U.K.-based GlaxoSmithKline have been partners on Arzerra since 2006 in a deal worth up to $2.1 billion for Genmab.

U.S.-listed share of GlaxoSmithKline rose 8 cents to $33.57 in midday trading.