Also known as 415, the patent is the source of royalty revenue for Genentech, but MedImmune (MEDI) is contesting its legitimacy. MedImmune pays royalties to Genentech on Synagis, a drug for pediatric respiratory virus. A few months ago, the Supreme Court ruled that MedImmune could contest the patent, even though it was continuing to make the royalty payments.
The patent rejection was called an Office action, meaning that the issue is thrown into the courts, if Genentech wants to protect its rights. Genentech promised to fight the action through the entire appeals process, if necessary, and the patent remains in force until the appeals process is exhausted, which will take about two years. Genentech rose 80 cents to $87.74.
Theravance (THRX) reported the FDA accepted its filing for televancin as a treatment for complicated skin and skin structure infections [cSSSI] by Gram-positive infections. The FDA will review the filing under the 10-month review procedure. The acceptance triggers a $31 million payment from Astellas, Theravance’s partner on the drug. Theravance climbed $1.71 to $34.70, a gain of 5%.
Noven Pharma (NOVN-OLD) received a $25 million sales milestone from Shire (SHPGY) because Daytrana achieved more than $25 million in revenue during 2006. Daytrana, a transdermal patch for ADHD, is licensed world-wide to Shire. Additional $25 million milestones will be paid when annual revenues exceed $50 million and $75 million.
Genzyme (GENZ) will opt out of a partnership with Dyax (NASDAQ:DYAX) that was seeking to develop DX-88 for hereditary angioedema [HAE]. All the rights to the drug will now belong to Dyax. In addition, Dyax will receive $17 million in cash, while Genzyme will own 4.4 million shares of Dyax stock. Dyax will continue to develop DX-88 for HAE and cardiothoracic surgery. Dyax has completed a Phase III study of DX-88 and plans to release data from the trial in Q2. Genzyme was $1.17 lower at $64.58, and Dyax dropped 8 cents to $4.25.
Wyeth (WYE) lost a civil suit from a woman who alleged that Wyeth’s hormone replacement therapy caused her breast cancer. The jury awarded $3 million in damages to the woman and her husband. This was the third suit that Wyeth lost along similar lines. Wyeth fell 50 cents to $49.95.
Pharmacylcis (NASDAQ:PCYC) received a refuse to file letter from the FDA on its application for approval of Xcytrin Injection as a treatment for non-small cell lung cancer with brain metastases. The FDA said the filing was not complete because the clinical trials failed to show the drug caused an improvement over placebo. Pharmacylcis, while not committing to giving up on this indication, said that the drug is also in other trials. Pharmacylcis fell 37%, dropping $1.85 to $3.19.
Hana Biosciences (HNAB) said it may need to adjust the formulation of its anti-nausea drug Zensana, which is currently under review at the FDA. Small amounts of material are precipitating in the manufacturing process of the drug. As a result, the action data for Zensana, which is currently April 30, 2007, will be delayed. An oral spray, Zensana is seeking FDA approval as a treatment for nausea and vomiting caused by chemotherapy. Hana lost 20% of its value, sliding $1.25 to $4.99.
Biotech enjoyed a positive session. The Centient Biotech 200™ rose 17 points to 4085, an increase of .43%. The S&P 500 suffered a .14% loss, but Nasdaq was higher by .21%.
Disclosure: Centient management holds a position in Genentech shares and does consulting work for Genentech.