FDA Advisory Panel Backs Chelsea Therapeutics Northera; FDA Accepts Impax NDA Filing Print E-mail
By Staff and Wire Reports   
Thursday, 23 February 2012 19:36
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 23, 2012.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP)
announced the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 7-4 with 1 abstention and 1 non-vote to recommend approval of NORTHERA(TM) (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (also known as Neurogenic OH or NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

"Chelsea is committed to improving the lives of patients with Neurogenic OH," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "We believe our clinical data demonstrates the significant symptomatic benefit of Northera treatment across a broad range of Neurogenic OH symptoms. Since no other treatment has been proven to alleviate the symptoms of neurogenic OH or improve patients' ability to carry out activities of daily living, we continue to believe Northera could fill this unmet need for patients with Parkinson's disease, MSA, PAF and other neurologic diseases. We are pleased by today's panel vote and we look forward to continuing to work with the FDA in advance of the March 28, 2012 PDUFA action date."

While the FDA is not bound by the recommendations of its advisory committees, its guidance will be considered by the FDA in its review of the New Drug Application (NDA) that was submitted for Northera in September 2011. A Prescription Drug User Fee Act (PDUFA) action date for the Northera NDA has been scheduled for March 28, 2012.

Northera was previously granted Orphan Drug Designation, which is granted by the FDA to treatments for rare diseases/disorders.


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Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ:IPXL) announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for IPX066 for the treatment of idiopathic Parkinson's disease submitted to the Agency on December 21, 2011. IPX066 is a patented extended release capsule formulation of carbidopa-levodopa. The Prescription Drug User Fee Date for a decision by the FDA is October 21, 2012. IPX066 has been licensed to GlaxoSmithKline (NYSE:GSK) for countries outside the U.S. and Taiwan for development and marketing.

IPX066 has undergone extensive clinical development, including multiple studies in early and advanced PD in the U.S. and in Europe. The NDA included data from three controlled Phase III studies and two open label extensions of IPX066 in both early and advanced PD. IPX066 has been investigated in more than 1,000 subjects.



Also Thursday:




Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that the company plans to report financial results for the fourth quarter and fiscal year 2011 following the close of markets on Monday, March 5, 2012.

ArQule, Inc. (NASDAQ: ARQL)
today announced that it will report its financial results for the fiscal 2011 year-end and fourth quarter on Thursday, March 1, 2012 at 7:00 a.m. eastern time.

BIOLASE Technology, Inc. (NASDAQ: BLTI)
, the World's leading dental laser manufacturer and distributor, and Cefla Dental Group, a leading Italian dental equipment manufacturer, today announced that the companies have entered a definitive three-year agreement making BIOLASE a distributor of Cefla's NewTom Cone Beam 3D imaging products in the U.S. and Canada.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
today announced that Stephen M. Simes, BioSante’s president & CEO will present a corporate update at the Citi 2012 Global Health Care Conference to be held at The Waldorf=Astoria (February 27-29, 2012, New York, NY), on Monday, February 27, 2012 at 3:00 pm EST.

Bruker Corporation (NASDAQ: BRKR)
announced today that it will present at Citi’s 2012 Global Healthcare Conference on Wednesday, February 29, 2012, at 9:30 a.m. Eastern Time at the Waldorf Astoria Hotel. Frank Laukien, President and Chief Executive Officer, will present on behalf of the company.

Cannabis Science, Inc. (OTCBB:CBIS.OB)
a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products is monitoring the outstanding progress of the 3rd Self-Medicated Cannabis Patient with Clear Continued Improvement.

Celldex Therapeutics, Inc. (Nasdaq: CLDX)
today announced that it is offering shares of its common stock in an underwritten public offering.

Charles River Laboratories International, Inc. (NYSE: CRL)
announced today that it will present at four upcoming investor conferences.

Clovis Oncology, Inc. (Nasdaq: CLVS)
will announce its fourth quarter and year-end 2011 financial results on Thursday, March 8, 2012, before the open of the U.S. financial markets.

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) announced today that it will host a conference call to discuss fourth quarter and full year 2011 operating and financial results on Wednesday, February 29, 2012 at 9:00 a.m. Eastern time.

Exact Sciences Corp. (Nasdaq: EXAS) today announced its financial results for the quarter and year ended Dec. 31, 2011.

Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC) announced today that the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 12 to 2 in favor of approving the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of COPD.

Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced today the European Medicines Agency (EMA) has accepted the filing of the marketing authorization application (MAA) for once-daily oral teriflunomide for the treatment of relapsing forms of multiple sclerosis (MS).

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for IPX066 for the treatment of idiopathic Parkinson’s disease (PD) submitted to the Agency on December 21, 2011.

IntriCon Corporation (NASDAQ: IIN)
, a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, today announced financial results for its fourth quarter and year ended December 31, 2011.

MelaFind, developed by MELA Sciences, Inc. (NASDAQ: MELA), was shown to improve melanoma detection in a study of 179 dermatologists.

National Health Scan Inc. (PINKSHEETS:NHSN)
announces that the company will merge with Life Abled Inc.

Nuvilex, Inc. (OTCQB:NVLX)
, reports that its associate company, SG Austria, presented data about its proprietary encapsulation of living cell technology, in particular for the treatment of pancreatic cancer, at the Cell Line Development and Engineering Asia Event.

OPKO Health, Inc. (NYSE: OPK)
today announced that senior management will present at the Citi 2012 Global Health Care Conference on Monday, February 27, 2012 at 4:00 PM EST.

Oragenics, Inc. (OTCBB: ORNI)
announced the successful completion of an independently conducted, randomized, double-blind clinical trial on EvoraKids®.

Orthofix International N.V. (NASDAQ:OFIX)
(the Company) today announced its results for the fourth quarter and year ended December 31, 2011.

Remedent, Inc. (OTCBB: REMI)
, an international company specializing in research, development, and the manufacturing of oral care and cosmetic products, announced today that its management team will host its third quarter 2011 earnings conference call on Wednesday, February 29th, 2012.

Seattle Genetics, Inc. (Nasdaq: SGEN)
today announced that Chris Boerner, Ph.D. has been promoted to Senior Vice President, Commercial.

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 the date and time for its fourth quarter and fiscal year ended December 31, 2011 corporate update conference call.

TRIMEDYNE, INC. (OTCBB: TMED) today reported its financial results for the first quarter of its fiscal year.

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
today announced interim data from two treatment arms of the Phase 2 ZENITH study evaluating an interferon-free (all-oral) treatment regimen of the non-nucleoside polymerase inhibitor VX-222 in combination with INCIVEK ® (telaprevir) tablets and ribavirin in people with genotype 1a or 1b hepatitis C who were new to treatment.

WPCS International Incorporated (NASDAQ: WPCS), a leader in design-build engineering services for communications infrastructure, has announced that it has received approximately $9 million in new contracts.

Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle market, today reported financial results for its fourth quarter ended December 31, 2011 and provided financial guidance for 2012.

XenoPort, Inc. (Nasdaq: XNPT)
announced today that it will provide access via the World Wide Web to its presentation at the RBC Capital Markets' Healthcare Conference.



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