RxNews Recap for Friday 02-26-10. iBio flys on license agreement. NuVasive soars on insurance deal. Print E-mail
By Mary Davila   
Friday, 26 February 2010 19:18


Below is a list of the companies that made news in the healthcare sector on Friday, February 26, 2010.

iBio, Inc. (OTCBB:IBPM) shares shot up today after the company announced today that it has agreed in principle to license its technology, the iBioLaunch™ platform, and provide technology transfer services to G-Con, LLC, a private Texas company, and its affiliates, for the development and manufacture of plant-expressed influenza vaccines at a new facility being constructed in Bryan, Texas. The "GreenVax Project" will show proof of concept for a large-scale vaccine production facility using Nicotiana plants grown hydroponically in a contained environment. In contrast to current methods of production, the iBio green plant technology platform holds the promise of shortening vaccine production from months to weeks and allowing rapid response to newly emerging viruses not possible with conventional vaccine technology. Although the Project’s initial goal is to produce candidate H1N1 vaccines, iBio’s technology is highly adaptable to other influenza strains, other infectious diseases, as well as cancer.

The iBioLaunch platform, the enabling technology for the GreenVax Project, was developed by the Fraunhofer USA Center for Molecular Biotechnology. The technology has been successfully applied to a wide range of vaccine and therapeutic targets, and in addition to the investments made by iBio, has attracted funding from the U.S. government and the Bill & Melinda Gates Foundation.

"We expect vaccines against influenza, including seasonal influenza, to be among the earliest applications of the iBioLaunch technology," said Robert Kay, Chairman and Chief Executive Officer of iBio. "In the new GreenVax facility, G-Con’s modular production technology should significantly enhance the economy, speed and flexibility advantages of our system for application to a broad range of biologic products."

Shares jumped up more than 40.23% or 35 cents to close the day at $1.22. Volume was more than 10 times the daily average.

NuVasive, Inc. (Nasdaq:NUVA), saw its shares explode Friday afternoon after the medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced that Aetna changed its spinal surgery policy to include coverage for the eXtreme Lateral Interbody Fusion, or XLIF procedure, published on February 26, 2010, a reversal from its previous policy that labeled XLIF as experimental and investigational.

The updated policy states that lateral interbody fusion is considered an acceptable method of performing a medically necessary anterior interbody fusion, in accordance with the North American Spine Society (NASS) recommendation letter dated January 5, 2010. NuVasive will update its reimbursement website accordingly.

The insurer had previously labeled the procedure, which involves surgeons operating on the spine through small incisions in the side rather than through a large incision in the back, experimental and investigational.

Shares of NuVasive shot up $10.31 or 34.73% to close at $40.00. After the bell the company announced that United Healthcare had also changed its lumbar spinal fusion policy. Shares rose another $1.00 in the after hours market to settle at $41.00.

In other news Friday:

Alexion Pharmaceuticals, Inc., (Nasdaq: ALXN) has joined the National Organization for Rare Disorders (NORD) and the European Organization for Rare Diseases (EURORDIS) in supporting the goals of the third annual Rare Disease Day, February 28, 2010.

Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2010, for the review of the lorcaserin New Drug Application (NDA). The acceptance of the lorcaserin NDA filing confirms that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.

Lorcaserin is Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, and is intended for obese patients or overweight patients with at least one weight-related co-morbid condition.

Jack Lief, Arena's President and Chief Executive Officer, stated, "With an October PDUFA date for the lorcaserin NDA, we are another step closer to our goal of improving the treatment of obesity. We believe that lorcaserin, if approved, will be well positioned as first-line therapy to help patients achieve sustainable weight loss in a well-tolerated manner."

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today provided a summary of its business overview webcast that was conducted on Thursday, February 25, 2010.

BioScrip, Inc. (Nasdaq: BIOS) today announced fourth quarter revenues of $341.6 million and net income of $40.7 million, or $0.99 per diluted share, which include the reversal of the Company’s deferred tax valuation allowance of $41.1 million, expenses of $1.8 million associated with BioScrip’s pending acquisition of Critical Homecare Solutions, Inc. (“CHS”) and $4.3 million of incentive compensation expense relating to the Company’s employee compensation program.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced it has obtained commitments from institutional investors to purchase approximately $18.2 million of its common stock and warrants in a registered direct offering.

At closing, Chelsea will issue 6,700,000 million shares of its common stock at $2.72 per share along with warrants to purchase up to approximately 2.3 million additional shares of common stock. The warrants have a 3-year term and are exercisable at a price of $2.79 per share any time after the six-month anniversary of the date of issuance.

Cleveland BioLabs, Inc. (NASDAQ:CBLI) announced today that it has signed an agreement with various institutional investors for the private placement of an aggregate of 1,538,462 shares of its common stock and warrants to purchase 1,015,385 shares of its common stock for an aggregate purchase price of $5,000,000, or $3.25 per share. The warrants are exercisable commencing six months following issuance, have a term of exercise of 4.5 years and an exercise price of $4.50. The shares issued to the investors and the shares underlying the warrants have not been and will not be registered under the Securities Act of 1933, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Genomic Health, Inc. (NASDAQ:GHDX) today announced results from an analysis demonstrating that the Oncotype DX breast cancer test has similar clinical relevance in estrogen receptor-positive, early-stage breast cancer patients in Asia Pacific (AP) countries as it does in a comparable U.S.-based patient population. The analysis showed that this advanced diagnostic test consistently identified more than 50 percent of hormone receptor positive early-stage breast cancer patients in AP countries as having low Recurrence Scores, similar to what has been shown in U.S. and European clinical studies evaluating the Oncotype DX breast cancer test. These results were presented in a poster presentation at the Organisation for Oncology and Translational Research (OOTR) 6th Annual Conference in Kyoto, Japan, on February 26.

HemaCare Corporation (OTCBB: HEMA) today announced that its Board of Directors approved a plan to purchase and retire up to 1,000,000 shares of the Company's common stock, or approximately 10% of current shares outstanding, over a twelve month period.HemaCare anticipates that the purchases will be made from time to time, depending on market prices, from cash on hand.

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that Arthur A. Koch, Jr., its senior vice president and chief financial officer, will appear on the Generacally Speaking panel at the RBC Capital Markets 2010 Healthcare Conference on Tuesday, March 2nd, at 1:35 p.m. Eastern Standard time.

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that it plans to report fourth quarter and full year 2009 financial results on Thursday, March 4, 2010 before the market opens.

Mannatech, Incorporated (NASDAQ: MTEX), a global pioneer in the development of high-quality health, weight and fitness and skin care solutions based on nutritional science, announced the promotions of Natalie Clark to senior vice president, North America; Gary Spinell to senior vice president, finance and administration; Landen Fredrick to vice president, North American sales; Sandra McLean, PHR, to vice president, human resources; and Matt Rumpsa to vice president, international expansion, as part of an ongoing effort to support global expansion initiatives.

Regenerx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that a university research team has published an article ahead of print in FASEB Journal, a high-impact scientific journal, describing novel biological properties of several Thymosin beta 4 (T?4) peptide fragments. The researchers summarize related published studies and report on their work showing that T?4 and these smaller peptides were able to block inflammation, reduce fibrosis, promote cell survival and block apoptosis, stimulate stem/progenitor cell differentiation, induce angiogenesis, and promote cell migration. Other activities include the induction of various genes encoded for important proteins involved in cell development (such as laminin-5, MMPs, TGF beta, zyxin, terminal deoxynucleotidyl transferase, and angiogenesis-related proteins) and activate signaling pathways that influence cell and tissue survival (such as ILK/PINCH/Akt). The paper also describes the potential clinical use of these small peptides.

Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) today reported financial results for the three months and year ended December 31, 2009, ending the quarter with $108.2 million in cash and short-term investments, an increase of $29.6 million from December 31, 2008. In October 2009, the Company raised $61.4 million in cash, net of $4.3 million of offering costs from a secondary offering. For the fourth quarter of 2009, the Company had a net loss of $0.2 million, or $0.00 per share, on total revenues of $0.9 million. For the year ended December 31, 2009, the Company had a net loss of $90.9 million, or $1.51 per share, on total revenues of $3.0 million."During the second half of 2009, we enhanced our cash position and significantly reduced our operating costs. We enter 2010 well positioned to continue to execute on our core objective of seeking FDA regulatory approval for KRYSTEXXA," stated Paul Hamelin, President of Savient. "Over the past several months, we believe that we have successfully addressed the outstanding items identified by the FDA in its July 31, 2009 complete response letter as necessary for resubmission of our BLA. We believe these achievements keep us on track to file the BLA resubmission for KRYSTEXXA to the FDA in March 2010. If approved, we believe that KRYSTEXXA will prove to be a transformational drug for the treatment of chronic gout in patients refractory to conventional therapy."

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has completed its previously announced acquisition of Ahura Scientific, a leader in handheld Raman and FT-IR (Fourier-transform infrared) spectroscopy instruments that are used worldwide in the identification of chemicals for safety, security and pharmaceutical applications.

Watson Pharmaceuticals, Inc. (NYSE:WPI), a leading specialty pharmaceutical company, announced today that Paul Bisaro, Watson's president and chief executive officer, will provide an overview of the Company's business at the CLSA/Asia Investor's Forum on Tuesday, March 2, 2010 at 4:30 pm Eastern Standard Time at the Westin St. Francis in San Francisco, CA.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

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