FDA Panel Will Review Zogenix's Zohydro on Dec. 7th; Catalyst Says CPP-109 Did Not Meet Primary Endpoint Print E-mail
By Staff and Wire Reports   
Thursday, 08 November 2012 19:36
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 8, 2012

Zogenix, Inc. (Nasdaq: ZGNX)
announced the U.S. FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) will review the Company's New Drug Application (NDA) for Zohydro™ ER (hydrocodone bitartrate extended-release capsules) on December 7, 2012. Zohydro ER is Zogenix's lead investigational product candidate for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Details of the meeting agenda will be available in the Federal Register.

The Prescription Drug User Fee Act (PDUFA) date for completion of the review by the FDA is March 1, 2013. If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products. Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications.


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Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX)
announced top-line results from its U.S. Phase II(b) clinical trial evaluating the use of CPP-109 (vigabatrin) to treat cocaine addiction. The data from the trial showed that CPP-109 did not meet the primary endpoint -- that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 8 and 9). The data also showed that the two key secondary endpoints, a significantly larger increase in cocaine negative urines and a significant decrease in the weekly fraction of use days in medication-treated subjects during weeks 3-9, also were not met. The clinical trial did not reveal any unexpected "serious" adverse events.

Catalyst expects the remaining protocol-specified analyses for other secondary and exploratory clinical endpoints and safety data to be completed during the first half of next year, after all the follow-up clinical data have been received to be able to fully unblind the trial data.



Also Thursday:



AdCare Health Systems, Inc. (NYSE MKT: ADK)
, a leading long-term care provider, will hold a conference call on Wednesday, November 14, 2012 at 8:30 a.m. Eastern time to discuss results for the third quarter ended September 30, 2012.

AeroGrow International, Inc. (OTCQB: AEROD)
("AeroGrow" or the "Company"), makers of the AeroGarden® line of indoor gardening products, announced the launch of its newest indoor garden system, the AeroGarden ULTRA, the next generation indoor garden system.

Antares Pharma, Inc. (NASDAQ: ATRS)
today announced that Paul K. Wotton, Ph.D., President and Chief Executive Officer, will present at the Jefferies 2012 Global Healthcare Conference on Thursday November 15, 2012 at 10:40 am (GMT) / 5:40 am (EST) in London.

Aradigm Corporation (OTC BB: ARDM.OB)
(the “Company”) today announced financial results for the third quarter and nine months ended September 30, 2012.

BioClinica®, Inc. (NASDAQ: BIOC)
, a leading global provider of clinical trial management solutions, today announced its financial results for the third quarter and nine months ended September 30, 2012.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
today announced financial results for the third quarter and nine months ended September 30, 2012.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, ranked 25th in the Orange County Business Journal's 2012 Fastest-Growing Public Companies list. Rankings are based on percentage revenue growth for the 12-month period ended June 30, 2012 as compared with the 12-month period ended June 30, 2010.

Columbia Laboratories, Inc. (Nasdaq: CBRX)
today reported financial results for the three- and nine-month periods ended September 30, 2012.

Cempra, Inc. (Nasdaq: CEMP)
, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today reported financial results for the third quarter ended Sept. 30, 2012.

CONMED Corporation (NASDAQ: CNMD)
, a medical technology company specializing in medical devices for surgical markets, announced today that the Company will participate in the Lazard Capital Markets 9th Annual Healthcare Conference on Tuesday, November 13, 2012 at 4:00 PM Eastern time, in New York City.

Daxor Corporation (NYSE MKT: DXR)
, an investment company with medical instrumentation and biotechnology operations, today announced the presentation of a study on Radioisotope Blood Volume Measurement in Hemodialysis Patients.

Durata Therapeutics (NASDAQ: DRTX)
today announced that Durata Chief Executive Officer Paul R. Edick will present an overview of the company at the Credit Suisse Healthcare Conference.

Energy crop company Ceres, Inc. (Nasdaq: CERE) today announced that the U.S. Agency for International Development, or USAID, has expanded its grant to the company to develop traits in rice for Asia.

GTx, Inc. (Nasdaq: GTXI)
today provided a Company update and reported financial results for the third quarter of 2012.

Mauna Kea Technologies (NYSE Euronext: MKEA)
, leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, today announced that Sacha Loiseau, PhD, Founder and CEO will present at the 9th Annual Lazard Healthcare Conference taking place on November 13-14 in New York City.

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for suvorexant, the company's investigational insomnia medicine, has been accepted for standard review by the U.S. Food and Drug Administration (FDA).

MMRGlobal, Inc. (OTCBB: MMRF)
(the "Company" or "MMR") today announced that an article appearing in the Election Day issue of the Pittsburgh Business Times reported on MMR's foundational health information technology patents and claims that these could force providers to purchase or license the Company's products, services or intellectual property to receive their share of stimulus monies under the American Recovery and Reinvestment Act.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
today announced third quarter 2012 financial results and highlighted key clinical development activities of its two product candidates, custirsen and OGX-427.

POZEN Inc. (NASDAQ: POZN)
, a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the third quarter ended September 30, 2012.

Repligen Corporation (NASDAQ: RGEN)
today reported financial results for its third quarter and year-to-date period ended September 30, 2012.

SafeCode Drug Technologies Corp. (OTCBB: SAFC)
, a developer of patent-pending voice recognition technology that reduces the risks of errors during the administration of prescription medications, the company is in negotiations with several manufacturers for the development of the company's first product prototype.

Senomyx, Inc. (NASDAQ: SNMX)
, a company using proprietary taste science technologies to discover novel flavor ingredients for the food, beverage, and ingredient supply industries, today provided a corporate update and reported financial results for the third quarter ended September 30, 2012.

Spectrum Pharmaceuticals (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that an overview of the Company's business strategy and commercial and development-stage programs will be given at the Credit Suisse 2012 Healthcare Conference being held at the Arizona Biltmore in Phoenix, Arizona.

Unilife Corporation (NASDAQ: UNIS; ASX: UNS)
today announced that its Precision-Therapy™ platform of bolus injection systems has been selected by a global pharmaceutical company to enter the next stage of collaboration as its preferred choice for long-duration subcutaneous drug delivery.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T)
(the "Company" or "Verisante"), a leader in cancer detection technology, today issued an operational update on the commercialization of Verisante's Aura™, the innovative skin cancer detection device.

Verenium Corporation (Nasdaq: VRNM)
, a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today reported operating highlights and financial results for the third quarter and nine months ended September 30, 2012.

XenoPort, Inc. (Nasdaq:XNPT)
announced today that it has reached an agreement with Glaxo Group Limited (GSK) to terminate their collaboration agreement concerning Horizant® (gabapentin enacarbil) Extended-Release Tablets, for which GSK held commercialization rights and certain development rights in the United States.

Zalicus Inc. (NASDAQ: ZLCS)
a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today reported financial results for the third quarter ended September 30, 2012.



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