Onyx Shares Fall on Likely Delay in Myeloma Drug Approval; FDA OKs new Opana ER Version Print E-mail
By Staff and Wire Reports   
Monday, 12 December 2011 19:46
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 12, 2011. Shares of Onyx Pharmaceuticals Inc (NASDAQ:ONXX) fell as much as 7 percent on Monday, a day after the company said U.S. regulators will not conduct a fast-track review of its experimental myeloma drug, setting off fears of a delay in the drug's approval.

At least two brokerages said they now expect the approval of carfilzomib, designed to treat a bone-marrow cancer that afflicts about 50,000 Americans, to come later than expected.

Late on Sunday, the company said the FDA had given a July deadline for a decision on the drug's approval.  "We do not assume (carfilzomib) will reach the market next year as originally modeled," Canaccord Genuity analysts wrote in a note to clients.

BMO Capital Markets cut the price target on Onyx to $55 from $60 and noted that the FDA had raised issues related to the application being based on a single-arm study.  Shares of Onyx were trading down 6 percent at $38.31 on Monday morning on Nasdaq.

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Federal regulators approved a new, crush-resistant version of an Endo Pharmaceutical (NASDAQ:ENDP) pain treatment which comes with patent protection until 2023, sending shares sharply higher before the market opened Monday.

Endo partnered with German drugmaker Grunenthal to develop a new version of Opana ER, which is designed to make it more difficult to abuse the drug. Opana ER releases a painkiller over 12 hours, and extended-release drugs can often be abused if they are crushed, which defeats the purpose of a time-release chemical.  The new Opana ER version will go by the same name and come in the same dosage strengths, color and packaging as the older version. Endo, based in Chadds Ford, Pa., said Monday it was committed to a "seamless transition" next year to the new formulation.

Citi analyst John T. Boris said he that while he expected U.S. Food and Drug Administration approval of the new version, he raised his earnings estimates for Endo from 2012 through 2014.

He also said he assumes Endo will switch the entire Opana ER franchise to the tamper-resistant version in the first half of next year, before the old formulation's U.S. patent protection expires Jan. 1, 2013. Boris expects an "orderly commercial shift" to the new formulation to prevent a decline in prescriptions.

Opana ER generated $97.8 million in third-quarter sales.

Shares of Endo Pharmaceutical Holdings Inc. climbed neaerly 6 percent, or $1.99, to $36 Monday in premarket trading.



Also Monday:



Abbott (NYSE: ABT)
and Reata Pharmaceuticals today announced that they have entered into a worldwide collaboration to jointly develop and commercialize Reata's portfolio of second-generation oral antioxidant inflammation modulators (AIMs).

AdCare Health Systems, Inc. (NYSE Amex: ADK)
, a leading nursing home and assisted living company, appointed David Rubenstein to the new position of chief operating officer, effective December 19, 2011.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today reported encouraging preclinical data for its oral anticancer Akt inhibitor, perifosine, in Hodgkin Lymphoma.

Advanced Cell Technology, Inc. (OTCBB: ACTC)
, a leader in the field of regenerative medicine, announced today that the company has entered into settlement agreements (the "agreements") with 40 holders of certain warrants and debentures.

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN)
today announced the presentation of new data that underscore the severity of paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening blood disorder.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
today announced new clinical data for ferumoxytol (Feraheme®), the company’s treatment for iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).

Cannabis Science, Inc. (OTCBB:CBIS)
a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is very pleased to announce a second patient suffering skin cancer is self-administering cannabis extracts in collaboration with Cannabis Science.

eHealthInsurance (NASDAQ: EHTH)
, the leading online source of health insurance for individuals, families and small businesses, is pleased to announce that eHealthInsurance.com has been named the best website for health insurance quotes in the December 2011 "Best of Everything" issue from Kiplinger's Personal Finance magazine.

Emergent BioSolutions Inc. (NYSE: EBS)
announced today that a member of the company’s senior management team will provide a corporate overview presentation, which may include a discussion of recent business developments, preliminary 2011 financial results and financial guidance for full year 2012.

Geron Corporation (Nasdaq:GERN)
today announced the initiation of GRABM-B (GRN1005 Against Brain Metastases – Breast cancer), a Phase 2 clinical trial to evaluate GRN1005 in patients with brain metastases arising from breast cancer.

iCAD, Inc.(Nasdaq: ICAD)
, an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, today announced that it has entered into a global distribution agreement with Carestream Health.

ICON plc, (NASDAQ: ICLR; ISIN: IE0005711209)
, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has agreed, subject to closing conditions, to acquire BeijingWits Medical Consulting Ltd., a leading CRO in China.

InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV)
, a company focused on the development of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today congratulates Robert S. Langer, Sc.D., InVivo co-founder and member of the Company’s Scientific Advisory Board, for his selection as the recipient of the 2011 The Economistannual Innovation Award in Bioscience.

Kensey Nash Corporation (Nasdaq: KNSY)
today announced that it was recently informed by Spectranetics Corporation (Nasdaq: SPNC) that they reached a cumulative $20 million in end-user sales of the endovascular product lines purchased from Kensey Nash in May 2008.

Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) (PINKSHEETS: KBLB)
announced that the Company has taken delivery, from Sigma-Aldrich, of newly created zinc finger nuclease configurations.

MELA Sciences (NASDAQ: MELA)
today announced the appointment of several new directors to serve on its Board -- Robert Coradini, Mark Fabiani, John Goddard, James Noble, and David Stone.

MMRGlobal, Inc. (OTCBB: MMRF)
("MMR") (the "Company") today announced that on December 9, 2011 it signed a Settlement and Patent License Agreement (the "Agreement") with Surgery Center Management LLC ("SCM") to license certain of the Company's Health IT and Personal Health Record patents, including various patents covering uses of MMR's personal and professional Health IT products and services.

The board of directors of Pfizer Inc. (NYSE: PFE) today declared a 22-cent first-quarter 2012 dividend on the company’s common stock, payable March 6, 2012, to shareholders of record at the close of business on February 3, 2012.

Seattle Genetics, Inc. (Nasdaq: SGEN) today reported data demonstrating that prolonged treatment with ADCETRIS beyond 16 cycles of therapy was associated with clinically meaningful durations of response with a manageable safety profile.

Sigma-Aldrich Corporation (NASDAQ: SIAL) will be presenting at the following investor conference in January:  1.  30th Annual J.P. Morgan Healthcare Conference on Monday, January 9, at the Westin St. Francis Hotel, San Francisco, CA, presenting at 4:00 PM (Pacific).

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today results from several clinical trials further expanding the body of evidence supporting the safety and efficacy of ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use.

Wound Management Technologies, Inc., (OTCQB: WNDM | WNDM.PK) a leading innovator in advanced wound care solutions, today announced that Fort Smith, AR based Golden Living has added CellerateRX® to its formulary and is now on the list of preferred products approved for use within its healthcare network.

WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology, and medical-device research and development outsourcing company with operations in China and the United States, today announced the winners of its fifth Life Science and Chemistry Awards, held on December 12, 2011 at Diaoyutai State Guesthouse in Beijing.

Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502), today reported updated data from a pivotal trial of single-agent ADCETRIS in relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) at the 53rd American Society of Hematology (ASH) Annual Meeting and Exposition being held December 10-13, 2011 in San Diego, CA.

Pfizer Inc. (NYSE: PFE) today announced that its Board of Directors has elected current President and Chief Executive Officer, Ian Read, as Chairman of the Board and Chief Executive Officer, effective immediately. Mr. Read succeeds George Lorch as Chairman of the Board.



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