Below is a list of the companies that made news in the healthcare sector on Wednesday, June 30, 2010.
Dendreon Corp. (NASDAQ:DNDN) fell sharply in after-hours trading after the CMS (Center for Medicare & Medicaid Services) issued a report regarding coverage on cancer drug Provenge. The report on the CMS website said:
“We are opening this national coverage analysis to determine whether or not autologous cellular immunotherapy is reasonable and necessary under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act.”
Dendreon issued the following statement early this evening:
Dendreon Corporation announced that the Centers for Medicare and Medicaid Services (CMS) today initiated a National Coverage Analysis (NCA) of PROVENGE® (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies.
In CMS’s announcement of the NCA, CMS is requesting public comments on the effects of PROVENGE on health outcomes in patients with prostate cancer. It is not a change in Medicare coverage policy.
NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE. Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE.
Dendreon welcomes the opportunity to continue our discussions with CMS about how PROVENGE will be provided to Medicare beneficiaries, particularly given the survival benefit and safety profile of PROVENGE. We plan on continuing to work closely with CMS during this process to ensure patients with advanced prostate cancer have broad access to PROVENGE.
In the after-hours session, shares of Dendreon fell $5.64 to $26.69.
Exelixis, Inc. (NASDAQ:EXEL) after the market close today announced that Michael Morrissey, Ph.D., currently President of Research and Development at Exelixis, has been named by the Board of Directors to serve as President and Chief Executive Officer, effective July 15, 2010. He will replace George Scangos, Ph.D., who has resigned effective July 15, 2010 to become President and Chief Executive Officer of Biogen Idec, Inc. The company also announced that Dr. Morrissey will become a member of the Board of Directors of Exelixis. Dr. Scangos will continue to serve as a member of the Exelixis Board of Directors for the remainder of his current term.
Shares of Exelixis fell 29 cents to $3.18 in extended trading.
Santarus, Inc. (NASDAQ:SNTS) announced after the bell today “In connection with the anticipated launch of a competitor’s generic version of prescription ZEGERID Capsules, Santarus is ceasing promotion of ZEGERID prescription products effective immediately and is implementing a corporate restructuring, including a workforce reduction of approximately 37%, or approximately 120 employees, in its commercial organization and certain other operations. Santarus is also significantly reducing the number of contract sales representatives that it utilizes. Santarus expects to retain up to approximately 110 sales representatives, including a small number of contract sales representatives, to promote GLUMETZA® (metformin HCl extended release tablets), a product for the treatment of patients with type 2 diabetes”
“This is an extremely difficult decision for our company, but a necessary one in light of the anticipated launch of a generic version of ZEGERID,” said Gerald T. Proehl, president and chief executive officer. “I want to acknowledge the dedication and commitment of all of our employees, especially those whose positions have been eliminated, and sincerely thank them for their hard work and their contribution to the growth of Santarus.”
Celgene Corporation (NASDAQ:CELG) and Abraxis BioScience Inc. (NASDAQ:ABII) today jointly announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Abraxis BioScience. Under the terms of the merger agreement, each share of Abraxis BioScience common stock will be converted into the right to receive an upfront payment of $58.00 in cash and 0.2617 shares of Celgene common stock. The upfront payment values Abraxis BioScience at approximately $2.9 billion, net of cash. Each share will also receive one tradeable Contingent Value Right (CVR), which entitles its holder to receive payments for future regulatory milestones and commercial royalties. The transaction is expected to be modestly dilutive to non-GAAP earnings in 2011 and accretive in 2012 and beyond.
The acquisition of Abraxis BioScience accelerates Celgene’s strategy to become a global leader in oncology. The transaction adds ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) to the Company’s existing portfolio of leading cancer products. ABRAXANE was approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE was approved by the European Medicines Agency in January 2008 for a similar indication. Additionally, ABRAXANE® has received orphan drug designation for stage IIB-IV melanoma and pancreatic cancer.
“The acquisition of Abraxis BioScience is an exceptional strategic fit that will accelerate our strategy of becoming a global leader in oncology,” said Bob Hugin, Chief Executive Officer of Celgene Corporation. “We are excited by the opportunity to leverage our clinical, regulatory and commercial capabilities to provide metastatic breast cancer patients with an innovative treatment in ABRAXANE. We are also excited by the potential of ABRAXANE to treat additional solid tumor malignancies such as non-small cell lung and pancreatic cancer. Finally, the potential of nab®-based therapeutics developed by Abraxis coupled with Celgene’s innovative science offers the potential to deliver long-term value to patients, doctors and all of our stakeholders.”
“Our nab technology platform is changing the treatment paradigm for difficult-to-treat cancers,” said Patrick Soon-Shiong, M.D., Executive Chairman of Abraxis BioScience. “In Celgene we have found the ideal partner to further expand the reach of ABRAXANE and our other treatments, in order to improve the lives of patients worldwide.”
Shares of ABII gained more than 21% or $12.89, closing the day at 74.20
SuperGen, Inc. (NASDAQ:SUPG) shares dropped today after the company reported that its Phase III clinical trial of Dacogen for Injection in elderly patients with acute myeloid leukemia (AML) did not achieve statistically significant superiority over the control arm.
The company did say however that its partner, Eisai Inc. is planning to submit to the FDA a supplemental New Drug Application (sNDA) for Dacogen in the treatment of elderly patients with AML and poor- or intermediate-risk cytogenetics by March 31, 2011.
Shares of SuperGen fell 30 cents or nearly 13% to close the day at $2.02.
ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine™, manufactured at the Company’s intended commercial manufacturing site. The 9-month stability data are on track to support the submission of a New Drug Application (NDA) for Exelbine.
“These results are consistent with our expectations and what we anticipate from the 12-month data,” said Brian M. Culley, Chief Executive Officer of ADVENTRX. “Once the 12-month data is analyzed, we will prepare and submit the Exelbine NDA, which we expect will take place in the fourth quarter of this year.”
