The FluCAM regimen provided significantly higher overall and complete response rates. The overall response rate of patients on FluCAM was 84.8% compared to 67.9% on Fludara. The complete response rate was 30.4% on FluCAM versus 16.4% on Fludara. FluCAM was also found to have an acceptable safety profile compared to Fludara alone.
 
Genzyme also said that the trial’s independent data safety monitoring board recommended an early closure of the trial as it has achieved its primary endpoint. Final safety and efficacy data should be available in the second half of 2010.
 
The encouraging PFS results on the FluCAM regimen could help the combination treatment gain share in the CLL market, of which Fludara is considered to be the backbone. However, Fludara, which is marketed by Genzyme, faces competition from generic players like Teva Pharmaceuticals (TEVA) among others. Other therapies in the CLL market include Cephalon’s (CEPH) Treanda. 

Genzyme is looking to gain approval for the use of Campath in combination with Fludara in the United States, European Union, and other countries. Campath is currently approved in the United States as a single agent for the treatment of B-CLL, and in the E.U., where it is marketed as MabCampath, for the treatment of patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate.
 
Chronic lymphocytic leukemia is the most common type of leukemia in adults, accounting for approximately 25−30% of all forms of leukemia. The approval for combination use would be a major positive for Genzyme and would help boost Campath sales. We currently have an Underperform recommendation on Genzyme.

Genzyme Corp. (GENZ) said it acquired the worldwide rights of marketing leukemia treatment Campath and two other hematological-cancer drugs from its German partner Bayer for up to $650 million in royalties.

As part of the agreement, Genzyme will be responsible for developing Campath to treat multiple sclerosis (MS). However, Bayer will retain an option to co-promote the drug if it gets approval for MS and the right to commercialize Campath for use in organ transplantation.

After selling the rights of Campath, and blood cancer drugs Flurdara and Leukine to Genzyme, Bayer said it will focus on kidney and liver cancer drug Nexavar.

A Bayer spokesperson said the deal "significantly improves the profitability for two of our key franchises - oncology and MS". The company has generated about 220 million euros ($293.2 million) annually from the three drugs.

On the other hand, the deal will generate $185 million in sales for Genzyme's oncology segment in 2009 and up to $700 million over the next three years. The Cambridge, Massachusetts-based company also expects the transaction to add to its earnings per share.

Genzyme shares climbed more than 2% to $60.35 at noon on the NASDAQ.