Biotech Values

[DewDiligence]

Genmab Announces Preliminary Top-Line Results for Arzerra in Front-Line CLL

[Arzerra (a/k/a/ ofatumumab) is a “second generation” knockoff of Rituxan that is being tested in both cancer and autoimmune diseases. It has a BLA pending in second-line CLL, supported by a 10-3 vote from the FDA advisory panel (#msg-38239069); the PDUFA date in this indication is Oct 31. The PR below is about an open-label (no control arm) phase-2 trial in first-line CLL, which is a larger market.

Arzerra also has a successful phase-3 trial under its belt in second-line RA (#msg-40022740). It would seem to be shaping up to be a big-selling drug, justifying the colossal amount of money GSK committed to it in 2006 (#msg-15652707).

Second-generation CD20 compounds comprise a crowded class (#msg-32767969), but there is a lot of money to be made here. BMY stands to make a small royalty on Arzerra by way of its MEDX acquisition.

CC by Genmab tomorrow at 9am ET.]

http://finance.yahoo.com/news/Genmab-Announces-Preliminary-pz-1241247939.html?x=0&.v=1

›Tuesday August 11, 2009, 3:57 pm EDT

COPENHAGEN, Denmark, Aug. 11, 2009 (GLOBE NEWSWIRE) -- Summary: Genmab announced top-line results from the Phase II study of Arzerra in front line CLL.

Genmab A/S (Copenhagen:GEN) announced today top-line results from the Phase II study of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to treat chroniclymphocytic leukemia (CLL) in previously untreated patients.

A total of 61 patients were treated in the study. Treatment response was assessed using the 1996 National Cancer Institute Guidelines. The complete remission rate was 32% in patients who received 500 mg of ofatumumab (n=31) and 50% in patients who received 1000 mg of ofatumumab (n=30). The overall response rate was 77% in the 500 mg treatment group and 73% in the 1000 mg treatment group.

There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse event reported was neutropenia at 48%. Other common adverse events (greater that 15 percent) were nausea, leukopenia, rash, vomiting, pyrexia, headache and thrombocytopenia. The number of patients, who experienced adverse events, including serious adverse events,was similar between the two dose groups. One death was reported and was judged by the investigator as unrelated to ofatumumab.

"We are pleased to see the positive results of this first study investigating ofatumumab for the treatment of front line CLL," said Lisa N. Drakeman, Ph.D.,Chief Executive Officer of Genmab. "We look forward to presenting the full data at a future medical meeting."

About the study

Patients in this open label study were randomized into two treatment groups.Each patient was to receive one infusion of 300 mg of ofatumumab in combination with FC followed by 5 monthly infusions of either 500 or 1000 mg of ofatumumab in combination with FC. Disease status was measured every 4 weeks until week 24and every 3 months thereafter until disease progression or 24 months. Treatment response was assessed according to the 1996 National Cancer Institute Working Group guidelines by an Independent endpoints Review Committee. Patients not having progressed on their disease at 24 months will be followed for disease progression at 6 month intervals until 60 months.

The objective of the study was to determine the efficacy of ofatumumab in combination with FC in previously untreated CLL patients. The primary end point was complete remission rate from start of treatment until 3 months after last infusion.

About ofatumumab

Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by otherCD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients.

Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.

Conference Call

Genmab will hold a conference call to discuss the ofatumumab results August 12, 2009, at

3:00 pm CEST
2:00 pm BST
9:00 am EDT

The conference call will be held in English.

The dial in numbers are as follows:

[phone] (in the US) and provide conference ID number 4140340
[phone] (outside the US) and provide conference ID number 4140340

To listen to a live webcast of the call please visit www.genmab.com.

About Genmab A/S

Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.Genmab's world class discovery, development and manufacturing teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit www.genmab.com.‹