Arena cuts workforce, shares fall. FDA sets PDUFA for Pain Therapeutics REMOXY. Thoratec slumps on weaker outlook Print E-mail
By BioMedReports.com Staff   
Thursday, 27 January 2011 19:26
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 27, 2011.

After the bell, shares of Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) took a hit after the company announced a reduction of its US workforce of approximately 25%, or 66 employees. The company aims to conserve cash and resources to be able to focus its effort on gaining FDA approval for its experimental diet drug, Lorcaserin. Arena anticipates the job cuts to be completed by March 28th and will take a $3.8 million charge, primarily in Q1 2011. The cuts will reduce annual cash outlay by about $13.5 million.

Arena is on track to resubmit its NDA for Lorcaserin by the end of 2011. The drug was rejected by the FDA in October 2010 mainly due to safety concerns.

In extended trading, shares slumped 18 cents or 9% to $1.82.

Also after the bell, DURECT Corporation (Nasdaq:DRRX) reported that the U.S. Food and Drug Administration has accepted the resubmission of the New Drug Application for REMOXY by King Pharmaceuticals, Inc. (NYSE:KG) and the PDUFA goal date is June 23, 2011. DURECT has licensed to Pain Therapeutics, Inc. (Nasdaq:PTIE) the right to develop and commercialize on a worldwide basis REMOXY.

REMOXY is an investigational drug that is a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. The FDA had previously asked for more evidence that the drug reduces abuse.

Thoratec Corporation (Nasdaq:THOR) fell in extended trading after the company reported lower than expected quarterly results as well as a weaker outlook for 2011. The company expects certain products, such as its Thoratic line and CentriMag and grafts to decline by 10% in sales over the year.

Gary F. Burbach, president and chief executive officer remains optomistic, stating "we have an active product pipeline that includes the continued evolution of the HeartMate II, the development of our next-generation pumps—HeartMate III, HeartMate X and PHP (Percutaneous Heart Pump)—and the introduction of cross-platform breakthrough technologies designed to enhance the HeartMate II, as well as future pump platforms. We believe these market-leading innovations will drive broader adoption of our offerings and enable us to serve an expanded patient population, while resulting in improved patient outcomes and quality of life, less invasive procedures and reduced cost of care."

Shares dropped after the bell, hitting a session low of $23.28, off about 11% from Thusday close of $26.13.

After the bell, Sanofi-aventis (NYSE: SNY) and its subsidiary, BiPar Sciences, today announced that a randomized Phase III trial evaluating iniparib in patients with metastatic triple-negative breast cancer (mTNBC) did not meet the pre-specified criteria for significance for co-primary endpoints of overall survival and progression-free survival.

In an earlier mid-stage study of women with metastatic triple-negative breast cancer, Iniparib had extended survival by an average of almost five months over chemotherapy alone. However, subjects in the 519-patient Phase III study who were undergoing their second or third treatment regimens for the disease did show an improvement in both overall survival and progression-free survival that was consistent with results from that earlier trial.

"While this trial did not meet its primary goal, we believe that the improvement in overall survival and progression-free survival in patients in the second and third- line setting are important findings," said Debasish Roychowdhury, head of Sanofi’s oncology unit.

Also Thursday:

Accuray Incorporated (Nasdaq:ARAY), a global leader in the field of radiosurgery, announced today financial results for the second quarter of fiscal year 2011, ended December 31, 2010.

CDEX (OTCBB: CEXI) a leading developer of chemical detection products, using patented technologies, for use in healthcare and security markets, announced today the initial shipment of its new Pocket ID2 Scanner to Lifeloc Technologies.

Cepheid (Nasdaq:CPHD) today reported revenue for the fourth quarter of 2010 of $58.7 million.

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced the publication of data affirming the safety and efficacy of Caldolor® (ibuprofen) Injection in treating post-operative pain in hospitalized patients.

Eli Lilly and Company (NYSE:LLY) today announced financial results for the fourth quarter and full year of 2010.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Matrix Laboratories Limited has signed an agreement with Tibotec Pharmaceuticals for a non-exclusive license to manufacture, market and distribute a generic version of the non-nucleoside reverse transcriptase inhibitor Rilpivirine Hydrochloride (TMC278), pending its regulatory approval for the treatment of treatment-naive HIV-1-infected adults.

NuGEN Technologies, Inc. and Caliper Life Sciences, Inc. (Nasdaq:CALP) today announced a co-marketing agreement for the development of automated methods for next generation sequencing sample preparation on Caliper's Sciclone® NGS Workstation.

Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) today announced that it will grant, on January 31, 2011, a stock option to John H. Johnson pursuant to the NASDAQ inducement grant exception as a component of Mr. Johnson's employment compensation.

Soligenix, Inc. (OTC Bulletin Board:SNGX), a late-stage biopharmaceutical company, today announced that it has entered into a definitive license agreement with the University of Colorado (CU) for novel technology for use in the development of subunit vaccines with long-term stability, including stability at elevated temperatures.

SMART Modular Technologies (WWH), Inc. (SMART) (NASDAQ: SMOD), a leading independent manufacturer of memory modules and solid state storage products, today announced that Barry Zwarenstein, Senior Vice President of Finance and Chief Financial Officer, will present at the following conference: Event: Stifel Nicolaus 2011 Technology, Communications and Internet Conference Date: Thursday, February 10th, 2011 Time: 2:05 - 2:35 PM Pacific Time Location: The Fairmont Hotel, San Francisco.

Warner Chilcott plc (Nasdaq:WCRX) today announced that it will issue its 2011 financial guidance prior to the market opening on Tuesday, February 15, 2011.

Waters Corporation (NYSE:WAT) today announced the release of NuGenesis® Scientific Data Management System 7.1 Service Release 7 (SR-7), structurally validated to support Microsoft's Windows 7, both Professional and Enterprise 32bit versions, and Waters new Empower™ 3 Chromatography Data System (CDS).

Weikang Bio-Technology Group Co., Inc. (OTC Bulletin Board:WKBT) ("Weikang" or the "Company"), a leading developer, manufacturer and marketer of Traditional Chinese Medicine (TCM), Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced that one of its products, Ranitidine Hydrochloride Capsule, has been added to the National Drug Reimbursement List ("NDRL") by China's Ministry of Human Resources and Social Security.

 

 




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