InterMune gets EC approval. BioSante cancer vaccine shows survival increase. After the bell: Allos reaches SPA agreement with FDA Print E-mail
By Staff and Wire Reports   
Thursday, 03 March 2011 20:30
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 03, 2011.

After the bell, shares of Allos Therapeutics, Inc. (NASDAQ:ALTH) jumped higher after the company announced that it has reached agreement with the FDA under its Special Protocol Assessment (SPA) process for the design of the Company’s Phase 3 clinical trial of FOLOTYN (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL). The study will seek to enroll newly diagnosed patients with PTCL who have achieved a response following initial treatment with a CHOP-based therapy. The SPA provides FDA agreement that the study design and planned analysis of this Phase 3 trial adequately address the objectives necessary to support a regulatory submission.

In extended trading heavy volume pushed shares as high as $3.45, settling at $3.30, up 20 cents or 6.45%.

InterMune, Inc. (Nasdaq:ITMN) today announced that the European Commission (EC) has granted marketing authorization for Esbriet(pirfenidone). Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. More than 100,000 patients suffer from IPF in the 10 nations that comprise the most-populated European countries; approximately 87,000 patients in the five largest countries of Germany, France, Spain, Italy and the United Kingdom.

"InterMune is proud to bring the first IPF medicine, Esbriet, to patients in Europe," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "We are very pleased with our approved label for Esbriet and believe it will effectively support the access, pricing, reimbursement and marketing of Esbriet in Europe. The approval of Esbriet not only marks an historic moment in the treatment of IPF patients, but also an exciting new chapter for our company as we now transition to become an international commercial organization. Our seasoned leadership team in the EU is working very diligently to make Esbriet available to European patients as soon as possible, beginning with Germany in September of this year."

Shares gained $3.06 to $40.23, up 8%.

Shares of BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) moved higher today after the company announced results from a Phase II clinical study that show BioSante’s Pancreas Cancer Vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 percent. In addition, the vaccine demonstrated a 35 percent increase in one year survival, from 63 percent to 85 percent. A new multicenter clinical study is planned to begin this year. The results were published in the Annals of Surgery February issue, and involved 60 patients undergoing treatment at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore.

BioSante traded as high as $2.54 before pulling back and ending the day at $2.15, up 12 cents or 6%. More than 10 million shares traded hands.

BIOLASE Technology, Inc. (NASDAQ:BLTI), the World's leading dental laser manufacturer and distributor, today announced that the U.S. Patent and Trademark Office has issued BIOLASE a new patent covering the use of its laser technologies for treating various conditions of the eye, including presbyopia. The patent is related to applying dyes and colored lighting to make structures in the eye more visible for various eye procedures performed with the Company's patented laser technologies. Shares soared 19% Thursday.

Charles River Laboratories International, Inc. (NYSE:CRL) today announced that it has entered into a marketing and distribution agreement with Pfizer Inc. (NYSE:PFE), the world’s leading biopharmaceutical company, to supply a number of pre-competitive, transgenic research models developed by Pfizer across a broad range of therapeutic areas, including neuroscience, diabetes and cardiovascular disease to the global biomedical research community.

Depomed, Inc. (Nasdaq:DEPO) announced today that it has completed enrollment of Breeze 3, the company's pivotal Phase 3 clinical trial evaluating Serada (extended release gabapentin tablets) for the non-hormonal treatment of menopausal hot flashes.

"We are pleased to reach this important milestone in Serada's development. We continue to expect Breeze 3 will be successful based on our study design, and look forward to reporting results in the fourth quarter of this year," said Carl A. Pelzel, president and chief executive officer of Depomed.

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced the Company has identified a statistically significant survival benefit in a subgroup of Acute Myeloid Leukemia (AML) patients in its previous Phase III trial with Ceplene administered with low-dose interleukin-2 (IL-2). The identification of this subgroup is expected to influence the design of the protocol for a new Phase III trial to support resubmission of a New Drug Application NDA with the FDA. Ceplene is approved in the European Union and Israel for the remission maintenance and prevention of relapse in adult patients with AML in first remission.

OraSure Technologies, Inc. (Nasdaq:OSUR) and Roche announced today that the U.S. Food and Drug Administration FDA has granted the Companies 510(k) clearance on four homogeneous fully automated oral fluid drugs of abuse assays developed to be used exclusively as part of OraSure's Intercept Oral Fluid Drug Testing System. The cleared oral fluid assays include Phencyclidine (PCP), Cocaine, Opiates and Methamphetamine. The oral fluid assays use Roche's KIMS (kinetic interaction of micro-particles in solution) technology and were jointly developed under an agreement previously signed by the parties. These assays are designed to run on various clinical chemistry automated analyzers, which are intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests.

Also Thursday:

Amgen (Nasdaq:AMGN) will present at the Cowen and Company 31st Annual Healthcare Conference on Tuesday, March 8, 2011 at the Boston Marriott Copley Place, Boston, Mass., beginning at 8:45 a.m. Eastern Time.

Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS), a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C, today reported its program highlights and financial results for the fourth quarter and year ended December 31, 2010.

BioSpecifics Technologies Corp. (Nasdaq:BSTC)
, a biopharmaceutical company developing first in class collagenase-based products, today announced that BioSpecifics' President, Tom Wegman, will present at the upcoming Cowen and Company 31st Annual Health Care Conference on Monday, March 7, 2011, at 1:45pm ET at the Boston Marriott Copley Place in Boston, Massachusetts.

Caliper Life Sciences, Inc. (Nasdaq:CALP) today announced that its licensee Wako Pure Chemical Industries, through its Wako Diagnostics division, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its uTASWako® i30 Immunoanalyzer and AFP-L3 and DCP Assays, which are used to assess liver cancer risk in patients with chronic liver disease.

Chembio Diagnostics, Inc. (OTCQB: CEMI) (PINKSHEETS: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, reported record revenues and earnings for the year ended December 31, 2010.

China Biologic Products, Inc. (Nasdaq:CBPO), one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, today announced that effective February 27, 2011, its Board of Directors has appointed Dr. Bing Li and Professor Wenfang Liu to serve on the Company's board of directors.

China Pharma Holdings, Inc. (NYSE Amex:CPHI) , a fully-integrated specialty pharmaceuticals company in China, today announced financial results for the year ended December 31, 2010.

CONMED Corporation (NASDAQ: CNMD) announced today that its Annual Meeting of Shareholders will be held at the Company's corporate offices, 525 French Road, Utica, NY 13502 on Thursday, May 19, 2011 at 3:30 P.M. Eastern Time.

Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX), manufacturer and distributor of the MedFlash®, the nation's premier Personal Health and Wellness Management System (ePHM) for maintaining personal health records (PHR), announced today that Atrium Travel Club is offering MedFlash to its many members.

Cornerstone Therapeutics Inc. (NASDAQ: CRTX) today reported full year and fourth quarter 2010 results.

Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Cowen and Company 31st Annual Health Care Conference in Boston on Tuesday, March 8, 2011 at 9:30 am EST (6:30 am PST) at the Boston Marriott Copley Place.

Endo Pharmaceuticals (Nasdaq:ENDP)
announced today the appointment of David B. Nash, M.D., M.B.A., to the company's board of directors. Dr. Nash is the Founding Dean of the Jefferson School of Population Health at Thomas Jefferson University in Philadelphia.

Entest BioMedical Inc. (OTCQB: ENTB) announced today that on Wednesday (March 2, 2011), it successfully completed the implantation of its ImenVax™ immuno-therapeutic cancer vaccine in the first canine cancer patient as part of the ImenVax™ Canine Safety Study.

ExamWorks Group, Inc. (NYSE: EXAM) a leading provider of independent medical examinations (IMEs), peer reviews, bill reviews and related services, today reported financial results for the fourth quarter of 2010.

GenVec, Inc. (Nasdaq:GNVC) announced that it will release financial results for the fourth quarter and year ended December 31, 2010 on Thursday, March 10, 2011 after market close.

Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced highlights from the inaugural International Colon Capsule Expert Meeting, which took place in Tarquinia, Italy, on February 17th and 18th, 2011.

Healthzone Limited (ASX: HZL; OTCQX: HLTZY) announced that it has entered into a services agreement with The Trout Group LLC ("the Trout Group"), a leading New York-based investor relations and strategic advisory firm.

Huifeng Bio-Pharmaceutical Technology, Inc. (OTCQB: HFGB), a leading developer and producer of plant extracts and biochemical raw materials used in pharmaceuticals, nutraceuticals and food production, announced today that the Company will present at the upcoming 2011 Rodman & Renshaw Annual China Investment Conference in Shanghai being held March 6th through March 8th, 2011, at Le Royal Meridien Shanghai Hotel in China.

Insulet Corporation (NASDAQ: PODD) the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the Cowen and Company 31st Annual Health Care Conference at The Boston Marriott Copley Place Hotel.Management is scheduled to present an overview of the Company on Wednesday, March 9, 2011 at 8:00 a.m. E.T.

Oncolytics Biotech Inc. (TSX: ONC) (NASDAQ:ONCY), will present a corporate overview of the Company at the 31st Annual Cowen and Company Healthcare Conference on Tuesday, March 8th, 2011 at 8:45 a.m. ET.

Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced it expects to report fourth quarter and full year 2010 financial results after the NASDAQ Global Market closes on Thursday, March 10, 2011.

Palatin Technologies, Inc. (NYSE Amex:PTN) today announced that the U.S. Food and Drug Administration (FDA) has cleared Palatin's request to begin a Phase 2A proof-of-concept human trial under an Investigational New Drug (IND) application using a subcutaneously administered formulation of PL-3994, an NPR-A agonist compound, in development for treatment of acute exacerbations of asthma.

PROTEONOMIX, INC. (OTCBB:PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that it has formed a new subsidiary called THOR BioPharma, Inc., a Nevada Corporation.

Simulated Environment Concepts (PINKSHEETS:SMEV), the manufacturer and developer of medical, aesthetic, weight loss, wellness, and slimming equipment, announced today that it plans to seek a 3rd U.S. patent to protect new technologies supporting the weight loss, cellulite reduction and cell regeneration attributes the SpaCapsule exhibits.

SpectraScience, Inc. (OTCQB: SCIE), a Minnesota corporation today provided an explanation of the Company's common stock quotation on the OTCQB.

Sinovac Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China, announced today it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China's State Food and Drug Administration (SFDA) on March 3, 2011.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that it has been included in MDB Capital Group's "Best & Brightest" list of 150 innovative leaders for 2011.

Telkonet, Inc. (OTCQB: TKOI), a leading provider of energy efficiency solutions, is pleased to announce the addition of Gerrit Reinders as Executive Vice President of Global Sales & Marketing. The move follows Telkonet's recent corporate rebranding and the release of its new EcoSmart Product Suite.

Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced results for the quarter ended December 31, 2010.



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