Diagnostic Lab, Genoptix, acquired by Novartis. FDA accepts Optimer's NDA. Furiex Pharma gets FDA Fast Track. After the bell: Amgen buys oncology company Print E-mail
By BioMedReports.com Staff   
Monday, 24 January 2011 19:44
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 24, 2011.

After the bell, Amgen (Nasdaq:AMGN) announced that they have agreed to acquire BioVex Group, Inc., a privately held, venture-funded, biotechnology company headquartered in Woburn, Mass. BioVex is developing OncoVEX, a novel oncolytic vaccine in Phase 3 clinical development, that may represent a new approach to treating melanoma and head and neck cancer.

Under terms of the agreement, Amgen will pay up to $1 billion: $425 million in cash at closing and up to $575 million in additional payments upon the achievement of certain regulatory and sales milestones.

Earlier Monday:

Diagnostic Lab, Genoptix, Inc. (Nasdaq:GXDX) announced today that it has agreed to be acquired by Novartis in an all cash deal for $25.00 per share or $470 million.

Genoptix focus is diagnosis of cancers in bone marrow, blood and lymph nodes which will help Novartis expand its companion diagnostics, tests that are designed to identify which patients may benefit most from a given medication.

Genoptix' Chief Executive Officer, Tina S. Nova, Ph.D., stated, "We believe this transaction provides substantial value and liquidity to our stockholders. We are excited about becoming part of the Novartis Molecular Diagnostics (MDx) unit and continuing to enhance the value that we bring to our core community oncologist customers. We share Novartis' strong commitment to transforming patient care, improving health outcomes for patients and enhancing the suite of diagnostic tools for our physician customers."

Shares of Genoptix soared $5.10 or 25.81% to close the day at $24.86.

Shares of Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) moved higher today after the company announced that the FDA has accepted for filing the NDA for fidaxomicin. The drug is intended for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI. The FDA has also granted the Company's request for six-month Priority Review, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The FDA also intends to review and discuss the NDA at a meeting of its Anti-Infective Drugs Advisory Committee on April 5, 2011.

Stated Pedro Lichtinger, Optimer's President and CEO; "In Phase 3 clinical trials, fidaxomicin not only showed a high clinical cure rate, but also demonstrated a statistically significant improvement in reducing recurrences, one of the major problems in the current management of CDI."

Optimer gained 56 cents or 5% to $11.40.

Furiex Pharmaceuticals, Inc. (Nasdaq:FURX) jumped today after the company announced that its novel diarrhea-predominant irritable bowel syndrome treatment called MuDelta, now in Phase II clinical trials, has been granted Fast Track designation by the U.S. Food and Drug Administration.

"We are extremely pleased our MuDelta program has been granted Fast Track designation by the FDA," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "The agency recognizes a significant unmet need for new treatment of diarrhea-predominant irritable bowel syndrome. We believe we are making significant progress with the Phase II trial, and this designation allows us to potentially get MuDelta to market faster."

The stock jumped $1.28 or 8% to $17.29

China-Biotics, Inc. (Nasdaq:CHBT) gained more than 11% Monday after the leading developer, manufacturer and distributor of probiotics products in China, announced preliminary revenues for fiscal year 2011 third quarter ended December 31, 2010.

Preliminary unaudited fiscal year 2011 third quarter revenues were between $32 million and $33 million compared with $23 million for the same period in fiscal year 2010. The strong top line growth was mainly due to the ongoing demand of the company's retail nutritional supplement products and growing acceptance of its bulk additive and cultures probiotics products by Chinese animal feed and dairy producers.

Shares surged $1.77 or 12.5% to $15.93.

As reported earlier today here on BioMedReports, Northwest Biotherapeutics (OTC Bulletin Board:NWBO.ob) announced today that the Company is resuming enrollment of additional new patients into its ongoing 240-patient, double blind, randomized, placebo controlled Phase II clinical trial of DCVax® for Glioblastoma multiforme brain cancer.

Senesco Technologies, Inc. (NYSE Amex: SNT) today announced that the Company has filed an Investigational New Drug application with the U.S. Food and Drug Administration for company's lead drug candidate, SNS01-T for treatment of multiple myeloma.

"Our first IND submission is a significant milestone for Senesco," stated Leslie J. Browne, Ph.D, President and Chief Executive Officer of Senesco Technologies Inc. "SNS01-T could be a new way of reprogramming cancer cells to respond to natural death signals. It is designed to regulate what we believe is an important growth control switch that induces programmed cell death, also known as apoptosis. Senesco plans to evaluate SNS01-T in patients with relapsed or refractory disease who have failed at least two standard treatment regimens. If this therapeutic approach is successful, we believe it has the potential to change the progression of the disease and significantly impact patients' lives."

On heavy volume, shares of Northwest jumped nearly 9%.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Pantoprazole Sodium Delayed-release (DR) Tablets USP, 20 mg (base) and 40 mg (base), the generic version of Wyeth's Protonix DR Tablets, a treatment for the irritation of the esophagus caused by gastroesophageal reflux disease also known as GERD.

Also Monday:

BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI.ob), a leading developer of adult stem cell technologies and therapeutics, today announced the recruitment of a highly experienced drug developer, Adrian Harel, Ph.D., as its Chief Operating Officer and Acting Chief Executive Officer.

Athersys, Inc. (Nasdaq:ATHX)  , a clinical stage biopharmaceutical company, today announced that its January 11th Retail Investor Conferences.com presentation is available for on-demand viewing. Gil Van Bokkelen, PhD, Chairman and Chief Executive Officer of Athersys, presented to retail investors through the virtual investor conference platform.


Amgen (Nasdaq:AMGN) reported adjusted earnings per share (EPS) of $1.17 for the fourth quarter of 2010, an increase of 11 percent compared to $1.05 for the fourth quarter of 2009.

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 presbyopia and hyperopia, also known as farsightedness.

CAE Healthcare (NYSE:CAE) (TSX:CAE) today announced that it has launched its CAE Caesar™ trauma patient simulator at the 2011 International Meeting of Simulation in Healthcare (IMSH) Conference held in New Orleans.

Cephalon, Inc., (Nasdaq:CEPH) will hold a public memorial service to celebrate the life of the company's founder and late Chairman and CEO on February 1, 2011, at 6:00 p.m. at The Franklin Institute, 222 North 20th Street, Philadelphia, Pennsylvania.

China-Biotics, Inc, (Nasdaq:CHBT) the leading developer, manufacturer and distributor of probiotics products in China, today announced preliminary, unaudited revenues for fiscal year 2011 third quarter ended December 31, 2010.

eHealthInsurance (NASDAQ:EHTH), the leading online source of health insurance for individuals and families, published answers to frequently asked questions for consumers who wish to enroll their children in individually purchased "child-only" health insurance policies in the state of Maryland.

Fresh Start Private (OTCBB: CEYY), a leader in the alcohol treatment and rehabilitation industry, announcedtoday that it has signed world renowned TVA Productions (TVA) to help manage its media campaigns including production and placement of television commercials.

Genesis Biopharma, Inc. (OTC Bulletin Board:GNBP), a biotechnology company developing targeted cancer therapies, today announced the company's support of the FDA's newly drafted "Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination."

Given Imaging (NASDAQ: GIVN), today announced that the company will host conference calls on Wednesday, February 16, 2011 to discuss fourth quarter and full-year 2010 financial results.

Kraig Biocraft Laboratories, Inc. (PINKSHEETS: KBLB) announced today that Dr. Joe Cunning, a leading figure in the textile industry and member of the Textile Institute's governing board, with 45 years of experience in the fibers, textile and apparel industry, has joined the Company's Board of Advisors.

Medisafe 1 Technologies Corp. (OTCBB: MFTH), a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the company expects revenues in 2012 to exceed $10M .

mPhase Technologies, Inc. (OTCBB: XDSL) said that it has been negotiating a worldwide sales channel agreement for its award winning mPower Emergency Illuminator™ design.

MMRGlobal, Inc. (OTCBB:MMRF) today announced that it has added New Zealand to its list of Patent awards for its Method and System for Providing Online Medical Records in connection with its MyMedicalRecords Personal Health Record product and services.

Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), announced today that clinical data from the switchover trial of taliglucerase alfa in patients with Gaucher disease and preclinical data on the oral enzyme glucocerebrosidase will be presented at the 7th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2011 being held February 16-18, 2011 in Las Vegas, Nevada.

SciMeDent Health, Corp. f/k/a Trend Exploration, Inc. (PINKSHEETS: TRDX) is pleased to announce, Preferred Distribution, Inc., its medical and dental supplies distribution subsidiary, has recently been approved as a distributor for Hospira, a global pharmaceutical wholesaler.

Shire plc (LSE: SHP, Nasdaq:SHPGY), the global specialty biopharmaceutical company, today announced that the Project Atlas manufacturing facility in Lexington, Massachusetts has been recognized with an honorable mention in the ISPE (International Society for Pharmaceutical Engineering) Facility of the Year Awards program.

Spherix Incorporated (Nasdaq:SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the closing of previously reported agreements to sell $2.77 million of shares of its common stock and warrants to purchase shares of its common stock in a registered direct offering to institutional investors.

TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for the treatment of cancer and other diseases, today announced that Swedish Cancer Institute (SCI) has installed the first TomoTherapy® radiation therapy system in the Seattle area at its new, community-based Radiation Treatment Center on the Ballard, Wash. campus.

UV Flu Technologies, Inc. (OTCBB:UVFT) announced today that the Company's flagship product, the ViraTech UV-400 indoor air purifier, is now being distributed through the Perfect Touch Beauty Network targeting the growing need for improved air quality at beauty salons across the country.

 




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