|TranS1 surges on 510(k) clearance. Walgreens acquires drugstore.com|
|By BioMedReports.com Staff|
|Thursday, 24 March 2011 18:37|
Shares of TranS1 Inc. (Nasdaq:TSON) jumped today after the pioneer in minimally invasive approaches to lumbar spine surgery, today announced the 510(k) clearance of the AxiaLIF 1L+ product line, an instrumentation and implant system for L5-S1 lumbar fusion.
The AxiaLIF 1L+ system represents the next generation of the original AxiaLIF 1L system first launched in 2005 that has a clinical history of over 10,000 implants. TranS1 will commence a limited market release immediately with the new implant and instrumentation and anticipates full commercial release in the second half of 2011.
"Our new AxiaLIF 1L+ system further demonstrates TranS1's commitment to continuously advance our proprietary AxiaLIF core technology. The 1L+ system builds upon our successful 2L+ system launched last year," stated Ken Reali, TranS1's President and CEO. "The modular approach of the 1L+, coupled with the tapered tip design, allows for more precise distraction capabilities and improvement in pull out strength. Further, through our minimally invasive pre-sacral access, the 1L+ implant provides a biomechanically stable implant at the base of the spine."
8 million shares traded hands as the stock gained 87 cents or 27% to $4.13.
Walgreen Co. (NYSE:WAG) (NASDAQ:WAG) and online retailer drugstore.com, inc. (NASDAQ:DSCM) today announced a definitive merger agreement pursuant to which Walgreens will acquire drugstore.com in a transaction with a total enterprise value of approximately $409 million.
Shares of Drugstore.com surged $2.02 or 113% to $3.81.
Shares of POZEN Inc. (NASDAQ:POZN), moved higher Thursday after the company announced positive top-line results of a Phase 1 study of PA32540, a novel coordinated-delivery tablet of enteric-coated (EC) aspirin (325 mg) and immediate-release (IR) omeprazole (40 mg). The data from the Co-Rx Study suggest that PA32540 given in conjunction with clopidogrel, dosed at least 10 hours apart, resulted in significantly better inhibition of ADP-induced platelet aggregation (anti-clotting) when compared to a current standard of care (81 mg of EC aspirin, EC omeprazole 40 mg and clopidogrel). Additional data from this study are expected to be presented at an upcoming scientific meeting. Shares gained 17 cents to $5.10.
On heavy volume, shares of Unigene Laboratories, Inc. (OTCBB:UGNE.ob) gained 25% after the company announced that the statistically significant top-line results released by its licensee, Tarsa Therapeutics, validate its proprietary oral peptide drug delivery technology. The ORACAL study achieved its primary endpoint and the results support Tarsa’s plans for a New Drug Application submission to the Food and Drug Administration targeted before the end of 2011. The study design and endpoints were agreed with the FDA through a formalized Special Protocol Assessment (SPA) process. Tarsa also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2012.
Ashleigh Palmer, Unigene’s President and Chief Executive Officer, commented, "The positive results from the Phase 3 oral calcitonin trial represent the second game-changing event for the New Unigene since launching our turn-around strategy last quarter! The successful outcome of this study not only validates our propriety oral peptide delivery technology and state-of-the-art recombinant manufacturing capabilities, but highlights our overall competence in the peptide sector. Our mission is to become nothing less than the pre-eminent peptide powerhouse."
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), and SEEK, a leading UK privately-owned drug-discovery group, today announced that they have engaged J.P. Morgan to auction the theobromine assets of the joint venture. The auction will be for the global commercialization rights (excluding Korea) of theobromine. The decision to conduct an auction is based on the interest shown within the pharmaceutical industry for theobromine (BC1036), an antitussive drug candidate in late-stage development that addresses the significant need for a non-opioid, non-codeine treatment for persistent cough.
In South Korea, theobromine (BC1036) has already shown efficacy and non-inferiority versus codeine in a phase III study, and marketing authorization was granted to Ahngook, a South Korean company.
Shares of Pernix jumped $1.58 or 16% to $11.55.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) today announced that it has completed patient enrollment in its U.S. Phase 2 clinical trial (REO 015) using intravenous administration of REOLYSIN in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers.