Xeloda was previously approved for colon cancer, and Avastin was on the market for colorectal cancer. Xeloda was proved to be as effective as 5-flurouracil, but will reduce hospital time from five days every three weeks to one day every three weeks.
Dynavax (DVAX) said that Tolamba was unable to show efficacy against ragweed in a 738-patient Phase III trial because the incidence of the allergy was very low in the placebo. The trial was designed to break down results by region, and the Midwest did give evidence of efficacy. Because the results were disappointing, Dynavax will not continue following patients through the second and third years of the trial, as originally planned.
Dynavax used the same enrollment criteria for the latest test as it did in the Phase IIb trial, but now considers those criteria insufficient. Dyanavax said that suspending the trial will save the company about $25 million next year. It will concentrate on its efforts on a Phase III trial of Heplisave, a hepatitis B vaccine, and preclinical work on a flu vaccine.
Pfizer (PFE) won a preliminary injunction in Denmark against a generic version of Lipitor that is being marketed by Ranbaxy. Ranbaxy must withdraw its generic Lipitor from the market until the patent infringement trial is concluded.
Idenix Pharma (IDIX) received a recommendation in Europe for approval of Sebivo, a once-daily tablet for hepatitis B. A final decision on the drug should be handed down within 3 months. The drug is already available in the U.S. where it is known as Tyzeka. It is co-promoted with Novartis (NVS).
Pharmion (PHRM) and GPC Biotech (GPCB) are presenting data from a Phase III trial of satraplatin at the Prostate Cancer Symposium, currently underway in Orlando, Fla. In the trial, a combination of satraplatin and prednisone was found to reduce the risk of disease progression, when given to patients with hormone-refractory prostate cancer. Final overall survival data are not expected until later this year. A request for approval of satraplatin has been filed with the FDA, and a filing for European approval will be completed in Q2.
Peregrine Pharma (PPHM) said that its tumor necrosis therapy [TNT] technology was used in a cancer drug that is starting clinical trials in Europe. The technology targets the DNA released by dead and dying cells at the center of tumors. Peregrine said the licensee wishes to remain anonymous.
UCB (UCBJF.PK) said that a Phase III trial showed Cimzia was effective against rheumatoid arthritis. Cimzia is a PEGylated anti-tumor necrosis factor drug, and it was administered with methotrexate and compared with methotrexate by itself. The improvement was established at week 52 by both the change in baseline in modified Total Sharp Score and scans that examined structural damage to the joints.
Amgen (AMGN) had a nice gain mid-morning Friday following news that Roche would suspend trials of an anemia drug. Roche reported there was an imbalance of deaths among the four arms of the study, and that the deaths did not seem to be related to the drug. Amgen makes most of its profits from anemia drugs Epogen and Aranesp, so the news was initially taken as positive. But Aranesp has had its own safety called into question lately, and the Roche news, on reflection, lent credibility to the idea that the anemia drugs might be more dangerous than once thought. Amgen ended Friday down 51 cents at $66.23.
Biotech closed Friday’s session with a small loss, though it was almost flat on the week. The Centient Biotech 200™ dropped two points Friday to 4055, a slide of .04%, but was up 1 point for the entire week. The S&P 500 moved .36% lower and Nasdaq was off by .39%.
Disclosure: Centient Management holds a position in Genentech shares and does consulting work for Genentech.