Hi-Tech moves higher on FDA approval. Sequenom surges. After the bell: Orthovita soars on 510(k) clearance. Optimer falls on offering Print E-mail
By BioMedReports.com Staff   
Thursday, 10 February 2011 20:01
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 10, 2011.

After the bell, shares of Orthovita, Inc. (NASDAQ:VITA), surged higher after the orthobiologics and biosurgery company, announced that it received 510(k) clearance from the FDA to market Vitoss BA Bimodal Bone Graft Substitute as a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine. Vitoss Bimodal is anticipated to launch in the United States in 9-12 months after the introduction of Vitoss BA2X which will be commercially introduced by Orthovita next week at the 2011 Meeting of the American Academy of Orthopedic Surgeons.

Vitoss BA Bimodal differs from previous versions of Vitoss BA by modifying the size distribution of the bioactive glass particles to accelerate resorption of the bioactive glass. Orthopedic and spine surgeons believe accelerated resorption is an important characteristic in grafting material.

"Surgeons need an array of spine and orthopedic bone grafting products with properties designed to fit the unique patient challenges that present each day," said Antony Koblish, President and Chief Executive Officer of Orthovita. "Our goal is to develop best in class orthobiologic products that meet these needs. By introducing a broader array of product offerings, we better serve the needs of patients, surgeons and hospitals."

In extended trading, shares of Orthovita traded as high as $2.95, 75 cents higher than Thursday close of $2.20.

Also after the bell shares of Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) traded lower after the company announced that it intends to sell shares in a public offering. Shares were trading as low as $11.58 in extended trading, down nearly $1.00 from Thursday's close of $12.57.

Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), after the market close on Thursday reported that they have filed a Special 510(k) application with the U.S. Food and Drug Administration (FDA). The application seeks marketing clearance for the Stealth 360 Orbital PAD System, a third-generation electric powered device for the treatment of peripheral arterial disease.

Earlier Thursday:

Shares of Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK) moved higher today after the specialty pharmaceuticals company, announced today that the FDA granted final approval for the Company’s ANDA for levofloxacin ophthalmic solution, 0.5% the generic for Vistakon’s Quixin ophthalmic solution, which had sales of $2 million for the 12 months ended December 2010 according to IMS sales data. The product is indicated for bacterial conjunctivitis. The Company is preparing to launch the product by the end of March 2011.
Shares gained $1.17 or 5.2% to $23.67.

Sequenom (Nasdaq:SQNM) jumped more than 7% today after the company announced publication in the American Journal of Obstetrics and Gynecology of Sequenom CMM's "locked assay" study for its Down syndrome prenatal detection test.

"This important study demonstrated that massively parallel shotgun sequencing is a potentially viable path for noninvasive prenatal diagnosis of fetal Trisomy 21 and warrants its validation in a larger clinical validation study," said Harry F. Hixson, Jr. PhD, chairman and chief executive officer of Sequenom. "We are very pleased with the results from the 'locked assay' study and are looking forward to the completion of the larger clinical validation study later this year."

More than 12 million shares traded hands as the stock traded as high as $7.74 before pulling back and ending the day at $7.19, up 48 cents.

Shares of Marina Biotech, Inc. (NASDAQ:MRNA) took a hit Thursday after the RNAi-based drug discovery and development company, announced the pricing of an public offering of 6.375 million units at a price of $0.80 per unit, for gross proceeds of $5 million. Marina Biotech intends to use the proceeds from this offering for general corporate purposes such as working capital and operational purposes as well as toward the clinical development of CEQ508, which is currently in a Phase 1b/2a clinical trial for the treatment of Familial Adenomatous Polyposis.

Shares of Marina fell 32 cents or 28% to close the day at $0.80.

Echo Therapeutics, Inc. (OTC Bulletin Board:ECTE.ob),soared nearly 40% today after the company announced that its needle-free drug delivery device, the Prelude System, is featured on the Fast Company magazine website.

The article headlined, "New Drug Delivery Device Will Speed Up Numbing, Sans Needle," notes that the Prelude System "promises to speed up the effects of lidocaine, a topical anesthetic, so shots, IVs, and other medical procedures will be less painful."

"We are pleased to have our technology featured by Fast Company magazine and to have Prelude's needle-free drug delivery benefits explained so clearly to its influential readership," stated Patrick T. Mooney, MD, Chairman and CEO of Echo Therapeutics. "Building on the positive momentum we have generated through much hard work, we are excited to increase the visibility of our needle-free platform technology as we near potential FDA marketing clearance."

Shares of ECHO gained $1.33 to $4.72.

Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) and Medicis Pharmaceutical Corporation (NYSE:MRX) today announced that the two companies have entered into a research and development agreement to discover and develop boron-based small molecule compounds directed against a target for the potential treatment of acne.

Under the terms of the agreement, Anacor will receive a $7 million upfront payment from Medicis and will be primarily responsible for discovering and conducting early development of product candidates which utilize Anacor’s proprietary boron chemistry platform. Medicis will have an option to obtain an exclusive license for products covered by the agreement. Anacor will be eligible for future research, development, regulatory and sales milestones of up to $153 million, as well as high single-digit to low double-digit royalties on sales by Medicis. Medicis will be responsible for further development and commercialization of the licensed products on a worldwide basis.

Also Thursday:

Access Plans, Inc. (OTCBB: APNC) , a leading membership benefits marketing company, today announced its operating results for the first quarter of FY2011.

ADVENTRX Pharmaceuticals, Inc. (NYSE AMEX:ANX) today announced that the Company's Chief Executive Officer, Brian M. Culley, will present at the 13th Annual BIOCEO & Investor Conference on Tuesday February 15th, at 1:30pm. Eastern time, in the Conrad Salon at the Waldorf Astoria Hotel in New York.

Aethlon Medical, Inc. (OTC Bulletin Board:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that its President, Rod Kenley, was invited to present at the 4th Congress of the International Society for Hemodialysis (ISHD-2011) in India.

Amerigroup Corporation's (NYSE:AGP) Texas subsidiary expanded its footprint into Tarrant County (Fort Worth) offering health care coverage to approximately 30,000 new members in the STAR+PLUS Program beginning February 1, 2011.

Auxilium Pharmaceuticals, Inc. (Nasdaq:AUXL), a specialty biopharmaceutical company, today announced financial results for the fourth quarter and the year ended December 31, 2010.

BAETA Corp. (OTCBB: BAEA), an advanced provider of technology-enabled health improvement solutions, filed a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission relating to a proposed offering of the Company's common stock.

Caliper Life Sciences, Inc. (Nasdaq:CALP), a leading provider of tools and services for drug discovery, life sciences research and molecular diagnostics, today announced it has installed the 1000th IVIS preclinical imaging system, a milestone event in the continued rapid adoption of Caliper's proprietary in vivo imaging solutions.

Cephalon, Inc. (Nasdaq:CEPH) today reported 2010 net sales of $2.761 billion, a 28 percent increase compared to net sales of $2.152 billion for 2009. Basic income per common share for the year was $5.66.

Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX) manufacturer and distributor of the MedFlash®, the nation's premier Personal Health and Wellness Management System (PHM) for maintaining personal health records, announced today that membership in the MedFlash® program grew by forty percent (40%).

A new approach to research, along with public policies that support medical innovation, will help biopharmaceutical companies address stubborn diseases with potentially devastating personal and financial consequences, such as cancer and Alzheimer's disease, according to John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company (NYSE: LLY).

InterMune, Inc. (Nasdaq:ITMN) today announced that it will release fourth quarter and full year 2010 financial results on Wednesday, February 16, 2011 at 4:00 p.m. Eastern time.

Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.

Microholdings US Inc. (PINKSHEETS: CHU) announced today it has completed its filings with the OTC Markets and that securities are eligible to be traded without any restrictions or limitations, as a direct result of becoming a fully reporting company.Our status on with the OTC is now "OTC Pink Current Information."

NeoGenomics, Inc. (OTC Bulletin Board:NGNM), a leading provider of cancer-focused genetic testing services announced today that Kevin C. Johnson and Raymond R. Hipp have joined its Board of Directors.

Neuro-Biotech Corp. (PINKSHEET: MRES) (OTCQB: MRES) Dr Claude Poulin is pleased to announce that on February 9, MRES has received an unsolicited offer for the purchase of all the outstanding shares at $0.15 per share.

Neurocrine Biosciences, Inc. (Nasdaq:NBIX) today announced its financial results for the quarter and year ended December 31, 2010.

NeoStem, Inc. (NYSE Amex:NBS), an international biopharmaceutical company with operations in the U.S. and China, will be presenting at the 2011 BIO CEO & Investor Conference. Hosted by the Biotechnology Industry Organization (BIO), the 13th Annual CEO & Investor Conference will take place February 14-15 at the Waldorf-Astoria in New York.

Novavax, Inc. (Nasdaq:NVAX) a clinical-stage vaccine company, announced today that Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax will be presenting at the 13th Annual BIO CEO & Investor Conference on February 15th, 2011 at 11:00 am local time.

NuVasive, Inc. (NASDAQ: NUVA) and AlloSource, partners in the cellular allograft market for use in orthopedic surgical applications,announced today that AlloSource has licensed from NuVasive certain intellectual property related to bone growth products containing endogenous mesenchymal stem cells (MSCs).

Omeros Corporation (Nasdaq:OMER) today announced that research on the antifibrinolytic agents it is developing has been published in the February 11, 2011 issue of the Journal of Biological Chemistry and selected by the editors as one of the top one percent of papers reviewed by the Journal in terms of significance and overall importance.

ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today it has signed a product purchase agreement with Beike Biotechnology Co., Ltd , a leading stem cell and regenerative medicine company in China.

TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for the treatment of cancer and other diseases, today announced that University Clinic Heidelberg, one of the top radiation oncology institutes in the world, is expanding its cancer treatment capabilities with the introduction of the TomoHD™ radiation therapy system.

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2010.

VitaminSpice (OTCBB: VTMS) (German WKN: A0YE4L) a pioneer in the emerging Foodceutical industry, today announced the appointment of Marc A. Meyers, Ph.D., as Chief Scientific Officer (CSO) and Vice President of R&D, effective February 9, 2011.

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), a life sciences product development company advancing a diverse portfolio of promising hematology and cancer-related products at various stages of development, today reported operational and financial results for the second quarter of fiscal 2011, ended December 31, 2010.

 




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