BioBusinessBlog

While the FDA Advisory Committee voted 5-4 last December, against approval of Avastin in Metastatic Breast Cancer, one of the committee members may have changed his vote, leading to a 5-4 in favor of approval, according to a recent Conference Call of Roche. Roche is the parent company of Genentech (NASDAQ:DNA) and the marketer of Avastin in Europe. The European Regulatory Agency, EMEA, has expressed a favorable opinion. The FDA Approval decision is expected on February 23. If there is any doubt, the AVADO study, to be released by mid-2008, should demonstrate progression-free survival and convince the skeptics. Breast Cancer labeling is worth $ 1 billion in Avastin sales.

Genentech’s stock is trading at below $ 70 a share, assuming the worst scenario. The good news on February 23 as weel as other developments such as  adjuvant treatment of Colon Cancer with Avastin and Lupus and Multiple Sclerosis with Rituxan, should support a ride upwards for DNA.