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RxNews Recap for Wednesday 01-20-10. Lexicon (LXRX) up on positive Phase II results

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:


Affymetrix, Inc. (Nasdaq: AFFX) today announced that it will release operating results for the fourth quarter and fiscal year 2009 after close of the stock market on Wednesday, February 3, 2010.

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.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and GlaxoSmithKline (NYSE:GSK), announced today that they have chosen BIO Ventures for Global Health (BVGH) to administer an Intellectual Property (NYSE:IP) Pool that was established in February 2009.

Antares Pharma, Inc. (NYSE Amex:AIS) announced that Mr. Pavan Handa has joined Antares Pharma as Senior Vice President of Business Development. Mr. Handa has over 20 years of business development and venture management experience in the global biopharmaceutical industry with both drug delivery and specialty pharma companies.

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular disease, today announced that the paper “An alpha-2C-Adrenergic Receptor Polymorphism Alters the Norepinephrine Lowering Effects and Therapeutic Response of the Beta Blocker Bucindolol in Chronic Heart Failure” was published in the January 2010 edition of the peer-reviewed journal Circulation: Heart Failure (circheartfailure.ahajournals.org).

BioClinica, Inc., (NASDAQ: BIOC) a leading global provider of clinical trial services, will be presenting at the Jefferies Inaugural Global Healthcare Services Conference on January 27, 2010 at 4:30 p.m. EST in New York City.

BioTech Medics, Inc, (PINKSHEETS: BMCS) announced today that the corporation has filed a civil lawsuit in the Clark County District Business Court against Wells Fargo Bank, N.A., 1st Global Stock Transfer, LLC, Helen G. Bagley, Stacy Ewing, & Securities Transfer Agents Medallion Program, Inc. (STAMP).

Catalyst Health Solutions, Inc. (NASDAQ:CHSI) announced today that Hai Tran, Chief Financial Officer, is scheduled to present at the Jefferies 2010 Global Healthcare Services Conference on Tuesday, January 26, 2010, at approximately 10:15 a.m. (NYSE:ET) in New York City.

China Pediatric Pharmaceuticals, Inc. (OTC Bulletin Board: CPDU) ("China Pediatric Pharmaceuticals " or the "Company"), today announced it has applied for listingapproval on the NASDAQ Capital Market (“NASDAQ”).

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

Diamyd Medical (STO:DIAMB) (Pink Sheets:DMYDY) announces today that the company executes a 2:1 division of shares (i.e. a split), meaning that each share is divided into two shares of the same class.

ImmunoCellular Therapeutics (OTC.BB: IMUC) today announced the results of a study in which it was shown that certain specific antigens are highly expressed on cancer stem cells (CSCs).

McKesson Corporation (NYSE:MCK) at its board meeting today declared a regular dividend of twelve cents per share on the Common Stock, payable on April 1, 2010, to stockholders of record on March 1, 2010.

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.

Phase Forward Incorporated (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced its senior vice president and chief financial officer, Chris Menard, and senior vice president of products and services, Steve Rosenberg, will present at the Jefferies 2010 Global Healthcare Services Conference at the Mandarin Oriental Hotel in New York City.

pSivida Corp. (NASDAQ:PSDV) a leader in the development of tiny, sustained-release drug delivery technologies, with two of the only three ophthalmic sustained-release delivery products approved by the FDA for treatment of back of the eye diseases, announced that its chief executive officer, Dr. Paul Ashton, will discuss ocular drug delivery in diabetic retinopathy during a presentation at the 6th Annual Diabetes Conference in London, on Friday, January 22.

Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of simulation and modeling software for pharmaceutical discovery and development, announced today that its board of directors has authorized a renewed share repurchase program effective Monday, February 15, 2010.

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.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will announce its fourth quarter and full year 2009 financial results on Thursday, February 4, 2010 after thefinancial markets close.