|RxNews Recap for Wednesday 01-20-10. Lexicon (LXRX) up on positive Phase II results|
|By Mary Davila|
|Wednesday, 20 January 2010 18:17|
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), shares soared more than 14% Wednesday on results released today from thier study of LX4211 in patients with type 2 diabetes mellitus. The Woodlands TX based biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained positive results from a recently completed Phase 2 study. LX4211 is a once-per-day, orally-delivered, small molecule drug candidate that inhibits the sodium-dependent glucose transporter 2 (SGLT2), lowering the accumulation of glucose in the body and reducing caloric load. LX4211, dosed as a single agent, provided improvements in glycemic control, demonstrating statistically significant benefits in the primary and multiple secondary efficacy endpoints.
"Results from this important first trial of LX4211 in diabetic patients exceeded our expectations," said Dr. Philip M. Brown, senior vice president of clinical development at Lexicon. "Rapid improvement in multiple parameters of diabetes, meaningful weight loss, a favorable safety profile and the fact that LX4211-treated patients exhibited improvements in clinically-important metabolic and cardiovascular parameters within four weeks on a single agent is remarkable."
Lexicon has three other drug candidates progressing through Phase 2 clinical trials: LX1032, a peripherally-available serotonin synthesis inhibitor for carcinoid syndrome; LX2931, an S1P lyase inhibitor for rheumatoid arthritis; and LX1031, a locally-acting serotonin synthesis inhibitor for irritable bowel syndrome, which recently completed a Phase 2a clinical trial with positive results.
"We believe the latest encouraging results with LX4211 demonstrate the potential for a therapeutic benefit for patients with type 2 diabetes," said Dr. Arthur T. Sands, president and CEO of Lexicon. "With positive results within the last few months from Phase 2 clinical trials of two candidates, we are proceeding with confidence that our drug discovery platform has produced investigational new drugs with great promise for patients."
In other news Wednesday:
Alcon Inc. (NYSE:ACL) today announced that it had formally responded to the January 4th proposal from Novartis AG (NYSE:NVS) regarding its attempt to acquire the minority publicly traded shares of Alcon pursuant to a compulsory merger under Swiss law. In its letter to Dr. Daniel Vasella, Chairman and CEO of Novartis and an Alcon Board member, the Committee stated that based on, among other things, advice from its independent financial advisor, it had determined that the price and other terms proposed by Novartis are grossly inadequate and that the financial analysis upon which Novartis' unilateral proposal is based is fundamentally flawed. Shares of Alcon traded higher on the news.
Covidien plc (NYSE: COV) today reported better than expected earnings for the first quarter of fiscal 2010. The company produced net sales of $2.7 billion which were up 7% from the $2.6 billion reported a year ago. A favorable foreign exchange of $121 million helped increase the quarterly sales growth rate by approximately 5%.
Our excellent performance in the first quarter of fiscal 2010 reflected the success of ongoing strategic initiatives focused on innovation and growth,” said Richard J. Meelia, Chairman, President and CEO. “Building on last year’s strong operational sales gains, we delivered exceptional growth in our largest business segment, Medical Devices, which generated broad-based improvement across its product lines. With higher-margin products increasing their contribution to all three Covidien business segments, our gross margin climbed sharply in the quarter, significantly exceeding our expectations. We are confident that this upward trend in margin improvement is sustainable and, as a result, we are raising our previously announced 2010 operating margin guidance.
“During the quarter, we continued to reshape and strengthen our portfolio, acquiring Aspect Medical Systems and announcing the sale of our U.S. radiopharmacies. We also received FDA approval for two major new Pharmaceutical products that we plan to launch in the next few months. We expect that these and other superior new products will fuel our growth in an increasingly competitive marketplace. We also expect to drive growth this year through key strategic investments funded by our continued strong cash flow,” Mr. Meelia said
OraSure Technologies (NASDAQ:OSUR) annouced today that it had entered into an agreement with Roche Diagnostics (OTC: RHHBY.PK) for the worldwide commercialization of homogeneous fully automated oral fluid drugs of abuse assays with OraSure's Intercept oral specimen collection device. The oral fluid assays use Roche's KIMS (kinetic interaction of micro-particles in solution) technology and are being jointly developed under an agreement previously signed by the parties. The commercialization agreement is structured to take advantage of each party's respective distribution strengths, including OraSure's established market presence with oral fluid testing and Roche's established base of analyzers and broad marketing capabilities.OraShares were down just over 3% on the day.
Sinovac Biotech Ltd. (Nasdaq: SVA), saw its shares trade lower after the bell. During the after-hours session the company announced that it plans to sell, subject to market and other conditions, 8,650,000 common shares of the company in an underwritten public offering. Sinovac, a leading China-based vaccine manufacturer, plans to grant the underwriters an option to purchase up to an additional 1,297,500 common shares to cover overallotments. Earlier in the session the company reported that it estimates that its sales for 2009 were between approximately $81 million and $85 million and its gross profit for 2009 was between approximately $61 million and $65 million.
Thoratec Corporation (NASDAQ:THOR), reported today that it has received FDA approval of its PMA (Pre-Market Approval) supplement, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) for Destination Therapy (DT). The maker of device-based mechanical circulatory support therapies to save, support and restore failing hearts says that the HeartMate II can be used to provide long-term cardiac support for patients suffering from advanced-stage heart failure who are not eligible for transplantation.
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