|Roche’s Avastin Revoked for Use in Breast Cancer; Amgen To Supply Epogen To DaVita In New Seven-Year Pact|
|By Staff and Wire Reports|
|Friday, 18 November 2011 19:57|
U.S. regulators revoked approval of Roche AG’s (PINK:RHHBY) Avastin as a treatment for metastatic breast cancer, a move the drugmaker has said could put as much as 800 million Swiss francs ($873 million) in revenue at risk.
Avastin, with $6.2 billion in 2010 sales, didn’t extend patients’ lives and triggered serious side effects including high blood pressure and bleeding when used to attack the disease, said Commissioner Margaret Hamburg of the Food and Drug Administration in a statement today. The drug remains approved for colon, lung, kidney and brain cancer.
In June, Avastin failed to win backing at a first-of-its- kind advisory panel that was requested by Roche after the FDA first suggested approval be revoked. In that hearing, patients urged the advisers to continue access. The U.S. Centers for Medicare and Medicaid Services and the health insurer WellPoint Inc. said they would review today’s action.
“This was a difficult decision,” Hamburg said. “FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that drugs they take are both safe and effective for their intended use.”
The decision will lead insurers, including the government’s Medicare and Medicaid programs for the elderly and poor, to reconsider Avastin coverage policies, said Len Lichtenfeld, deputy chief medical officer at the American Cancer Society. Women who are already on the drug and benefitting from it shouldn’t be taken off, he said.
While Roche doesn’t plan to appeal the decision, it will continue a study seeking to identify breast cancer patients who would benefit most from Avastin, said Charlotte Arnold, a company spokeswoman, in an e-mail. The study will weigh whether higher levels of a protein in the blood known as VEGF-A might improve the results with Avastin.
Dialysis clinic operator DaVita (NYSE:DVA) signs a new, seven-year agreement to receive Amgen's (AMGN -0.5%) anti-anemia drug Epogen. In an SEC filing, Amgen discloses that the Epogen it supplies will meet at least 90% of DaVita's requirements for erythropoiesis stimulating agents in clinics in the U.S. and Puerto Rico.
Amgen USA Inc., a wholly owned subsidiary of Amgen Inc., entered into a seven-year Sourcing and Supply Agreement with DaVita Inc. pursuant to which Amgen USA will supply, and DaVita will purchase, EPOGEN (Epoetin alfa) in amounts necessary to meet no less than 90% of DaVita’s and its affiliates’ requirements for erythropoiesis stimulating agents used in providing dialysis services in the United States and Puerto Rico. The term of the Agreement commences January 1, 2012 and ends on December 31, 2018. The Agreement will replace the Dialysis Organization Agreement, effective January 1, 2011, between Amgen USA and DaVita that expires by its terms on December 31, 2011.
Amgen Inc. will continue to supply its anti-anemia drug Epogen to dialysis-clinic operator DaVita Inc. (DVA) under a new, seven-year agreement.
Amgen disclosed Friday in a regulatory filing with the Securities and Exchange Commission that the Epogen it supplies will meet at least 90% of DaVita's requirements for drugs known as erythropoiesis-stimulating agents, or ESAs, in clinics in the U.S. and Puerto Rico.
The agreement runs from Jan. 1, 2012 through Dec. 31, 2018, replacing a one-year pact that expires at the end of this year.
Amgen spokeswoman Christine Regan said financial terms weren't being disclosed. DaVita spokesman Skip Thurman confirmed the new agreement but declined to comment further.
Agilent Technologies Inc. (NYSE: A) today announced that Ron Nersesian has been appointed executive vice president and chief operating officer, effective immediately. Nersesian has been president of Agilent’s largest business, the Electronic Measurement Group (EMG), since 2009.
Baxter International Inc. (NYSE: BAX) announced today that it will present at the 23rd Annual Piper Jaffray Health Care Conference on Tuesday, November 29, 2011, at 12:00 p.m. (CT) or 1:00 p.m. (ET).
CEO Marc Grodman M.D. of Bio-Reference Laboratories, Inc. (BRLI) (NASDAQ – BRLI) was one of the key panelists at a November 17 bi-partisan policy forum in Washington, D.C.
Entest BioMedical Inc. (OTCQB: ENTB) (PINKSHEETS: ENTB) and RenovoCyte LLC today announced the treatment of the first canine patient of a 10 dog pilot study utilizing Canine Endometrial Regenerative Cells (CERC) licensed from Medistem Inc. (PINKSHEETS: MEDS) in the treatment of canine osteoarthritis.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the FDA Commissioner is revoking the approval of Avastin® (bevacizumab) for the treatment of mBC in the United States.
ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based therapies, today announced that John Yu, MD, Chairman of ImmunoCellular Therapeutics, will take part in the 16th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) to be held at the Hyatt Regency, Orange County, California from November 17-20, 2011.
Incyte Corporation (Nasdaq:INCY) announced today it will present at the 23rd Annual Piper Jaffray Health Care Conference on Tuesday, November 29, 2011 at 4:30 p.m. (ET) in New York.
Medical Marijuana Inc. (OTC: MJNA) is proud to announce the execution of an option to acquire 100% of PharmaSphere, LLC. PharmaSphere, a cutting edge biotechnology company which has a solution for the production of high value bio-compounds sourced from plants that can be used as active pharmaceutical ingredients.
SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification technologies to the healthcare industry, announced today that it has completed the previously-announced sale of its SurModics Pharmaceuticals assets to Evonik Industries AG (“Evonik”).