Onyx Pharmaceuticals (ONXX):
This morning Onyx Pharmaceuticals said that they have sold the Japanese rights of carfilzomib and ONX192 to Ono Pharmaceuticals for a $59 million upfront payment and potential backend sales based payments related to the drugs that could total up to $280 million. » Read more: Daily Pharma Watch (Update in Progress)
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Recently investors in Immunogen and Epicept were caught off guard by the FDA’s Refusal to File their NDA’s for their cancer drugs T-DM1 for Breast Cancer and Ceplene for AML. Both drugs NDA’s were being filed with what I consider as proxy data for overall survival instead of actually having overall survival data available. Furthermore, in the case of ImmunoGen, Roche, their partner, had filed the drug as an accelerated approval of their product because the company said the drug shrank tumors in breast cancer patients. However, the FDA didn’t accept the » Read more: FDA Accelerated Approval, New Questions? ZIOPHARM, ONYX and Seattle
Dr. Pazdur Speaks out on Cancer Trials and Accelerated Approvals
So a lot of investors have been wondering what will happen to cancer drugs that are in the Accelerated approval process because of the recent fiasco surrounding Avastin. For those that don’t know the story, Avastin is a drug for breast cancer that has had significant setbacks. The drug was approved under the FDA’s coveted Accelerated Approval Process. » Read more: Dr. Pazdur Speaks out on Cancer Trials and Accelerated Approvals
Onyx Pharmaceuticals (ONXX):
This morning Onyx made some major announcements. The company said that one of their lead drugs in development, carfilzomib, showed strong results in a Phase IIb study in relapsed and refractory multiple myeloma patients. The company noted that 24% of patients achieved an overall response rate and had a median duration of response of 7.4 months with very few side effects. » Read more: Daily Pharma Watch
Keryx Biopharmaceuticals (KERX):
Keryx biopharmaceuticals said this morning that they have appointed Joseph Feczko to the company’s Board Of Directors. Mr. Feczko was the former Chief Medical Offer for Pfizer and was behind several of Pfizer massive successes. While at Pfizer he was involved with numerous efforts to push forward the drugs Viagra, Chantix and Celebrex. Mr. Feczko also worked their when Pfizer correctly stopped development of the torcetrapib cholesterol pill because of heart problems. The news is especially positive given that Mr. Feczko was directly responsible for key aspects of blockbuster drugs Chantix/Champix, Lyrica and Sutent. » Read more: Daily Pharma watch
Cell Therapeutics (CTIC):
Cell Therapeutics announced this morning that the Italian Medicines Agency has said that the manufacturing facilities in Italy are OK by their standards to make the drug Pixantrone if it ever gets approved in the E.U. The shares are up on the news, however, I believe that some investors may be misinterpreting this press release and inferring that if a manufacturing facility gets a clean bill of health for production that that must mean the drug agency will approve a drug. » Read more: Daily Pharma watch
Regeneron Pharmaceuticals (REGN):
Regeneron announced results from their Phase III study in gout patients this morning. The company said that their drug Arcalyst reduced Gout flares by up to 80% (p-0.0001) in patients when given an 80 mg dose in one Phase III study. The company also reported data from a gout pain study in 225 patients with Arcalyst that showed that the drug did not significantly reduce the intensity of gout pain. » Read more: Daily Pharma Watch
Alright Pharma Investors, time for the daily pharma watch.
Sunesis (SNSS):
This morning Sunesis provided some more guidance on the development of their lead product Voreloxin for patients with AML. The company said that they have received guidance from the EMA in regards to developing the drug in AML patients. The company further reiterated that the drug will enter Phase III trials in the second half of 2010. » Read more: Daily Pharma Watch
Alright Pharma investors, let’s run through some real promising data out of Keryx and Onyx on their two Multiple Myeloma Drugs. And remeber to sign up for the daily pharma watch and all the latest analysis articles out of GekkoWire.com.
A couple of months back Onyx decided to purchase a developmental cancer drug company Proteolix for $276 million dollars upfront. And hanging in the winds is another payment of up to $575 million to Proteolix if their lead drug Carfilzomib is successful. Here’s the thing, some viewed the deal as a » Read more: Keryx’s Perifosine and Onyx’s Carfilzomib: Two Promising Multiple Myeloma Treatments on the Horizon
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