MannKind reports AFREZZA is both effective and safe. IDEXX jumps on strong earnings Print E-mail
By BioMedReports.com Staff   
Friday, 23 April 2010 18:12
Below is a list of the companies that made news in the healthcare sector on Friday, April 24, 2010.

MannKind Corporation (Nasdaq:MNKD) today released data from two separate Phase III trials that indicate that its experimental inhaled insulin device, Afrezza, was effective in controlling blood sugar levels in patients with diabetes without causing meaningful changes in lung function.

The first study showed that diabetes treatment regimens containing AFREZZA Inhalation Powder, provide glucose control similar to standard insulin therapy along with weight loss and reduced incidence of hypoglycemia in patients with Type 1 diabetes and poorly controlled blood sugar levels.

"Standard mealtime insulin therapies are effective in managing blood sugars in patients with Type 1 diabetes, but are known to cause weight gain and severely low blood sugar levels," said Philip Raskin, M.D., Clifton and Betsy Robinson Chair in Biomedical Research, Southwestern Medical School, University of Texas. "Our study shows that treatment regimens incorporating AFREZZA offer glycemic control comparable to conventional regimens, with the added benefits of weight loss and less incidence of hypoglycemia, making AFREZZA a potentially important and useful new treatment option in the diabetes space."

In a second study, pulmonary function test results (PFTs) in patients treated with AFREZZA Inhalation Powder, at follow-up measurements were similar to PFT results observed in patients receiving standard antidiabetic therapy.

Results from the follow-up study suggest that the pattern and magnitude of changes in lung function associated with the use of AFREZZA in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful.

"Our findings add to the growing body of clinical evidence that indicates AFREZZA is comparable to standard of care insulin therapy in terms of lung safety," said Peter Richardson, MRCP, Corporate Vice President and Chief Scientific Officer, MannKind Corporation. "We are encouraged by these PFT data, which support our belief that AFREZZA, clinically shown to provide glycemic control similar to standard therapy with less risk of hypoglycemia and weight gain, is a promising new option that may address a poorly-met need in diabetes treatment."

Shares of MannKind surged on the news, jumping 73 cents or 11.66% to close the day at $6.99. Shares continued higher in the after hours session.

IDEXX Laboratories, Inc. (Nasdaq:IDXX), surged today after the company reported that revenues for the first quarter of 2010 increased 14% to $268.5 million, from $236.5 million for the first quarter of 2009.

"Overall for the quarter, our revenue growth was solid and our strong earnings growth exceeded our expectations from January," stated Jonathan Ayers, Chairman and Chief Executive Officer. "Having generated high single-digit organic revenue growth in an economic environment that remains challenging is a testament to our success in continued technology innovation and strong commercial execution across our markets around the world. Earnings were ahead of our projection in January, as we achieved operating efficiencies in our two largest lines of business, instruments and consumables and reference laboratories, and continued to tightly manage expenses."

"Today, we also announced our plans to introduce ProCyte Dx™, a new hematology analyzer that will complement our Catalyst Dx in the higher test volume segment of the veterinary market. ProCyte Dx is a compact bench-top analyzer that will provide a complete blood cell count with 24 different parameters in just two minutes. Together with Catalyst Dx, which provides results in eight minutes, ProCyte Dx will enable veterinarians to practice what we call "real-time care," which is about providing results from blood work easily and quickly during the pet owner's appointment, and thus delivering a higher standard of care, realizing valuable practice efficiencies, and improving pet owner satisfaction and compliance to the veterinarians' recommendations."

Shares of the leader in pet healthcare innovation gained more than 10%, rising $6.46 to $66.86.

In other news Friday:

Accuray Incorporated (Nasdaq:ARAY) a global leader in the field of radiosurgery, announced today that French and Italian Health Authorities recently ruled that CyberKnife treatments will now be reimbursed throughout France and the Lombardy region of Italy for the treatment of tumors located anywhere in the body. These decisions demonstrate the increasing recognition amongst European Health Authorities of the critical role that the CyberKnife System plays in the treatment of patients with inoperable and complex tumors.

Astellas Pharma Inc. (TSE:4503.to) announced today that it has extended its all-cash tender offer for $52 per share for all of the currently outstanding shares of common stock (including the associated stock purchase rights) of OSI Pharmaceuticals, Inc. (Nasdaq:OSIP) to 5:00 p.m. New York City time on Monday, May 17, 2010, unless further extended. The tender offer was previously set to expire at 12:00 midnight New York City time on Friday, April 23, 2010.

Bond Laboratories, Inc. (OTCBB:BNLB), an innovative manufacturer of functional beverages and nutritional products, today announced that its Fusion Premium Beverages (FPB) division has entered into an agreement with Zink Distributing Company to market FPB’s successful Resurrection™ Hangover Prevention Drink. Zink is the Anheuser Busch distributor in the greater Indianapolis metro area. The relationship introduces Resurrection™ into a demographic-rich Mid-Western region that is an ideal market for the product.

CPEX Pharmaceuticals Inc., (NASDAQ: CPEX) today recommended that its shareholders take no action at this time in response to the announcement by Arcadia Capital Advisors, LLC through RSR Acquisition Co. and its principal Richard Rofé that it has made an unsolicited conditional tender offer to acquire all of the outstanding shares of CPEX for $16.00 per share in cash.

Consistent with its fiduciary duties and in consultation with its financial and legal advisors, the CPEX Board will review and consider Arcadia’s offer, and within 10 business days, will advise CPEX’s shareholders of the Board’s position regarding the tender offer as well as its reasons for that position.

Arcadia Capital Advisors Managing Director Richard Rofe announced today that he has commenced a $16.00 per share all-cash tender offer for CPEX through RSR Acquisition Co., a wholly-owned subsidiary of Shelter Bay Holdings, LLC.

HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced that data from its international clinical trial and commercial experience of the HeartWare® Ventricular Assist System showed a survival rate of 90 percent at six months and an actuarial survival rate of 86 percent at 12 months post implant. The results were presented by Martin Strueber, M.D., cardiothoracic surgeon at Hannover Medical School, at the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) held in Chicago this week.

Misonix, Inc. (Nasdaq:MSON), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, has entered into a new, three year, exclusive distribution agreement with Suministros Medicos Multimedicas, based in Caracas, Venezuela, for the distribution of the SonaStar™ Ultrasonic Surgical Aspirator, the BoneScalpel™ Ultrasonic Bone Cutter, and the SonicOne® Ultrasonic Wound Debrider. The agreement provides Suministros with the rights to sell and distribute in Venezuela, and includes minimum purchase requirements.

NeuroMetrix, Inc. (Nasdaq: NURO), a health care company transforming patient care through neurotechnology, today announced that the Compensation Committee of NeuroMetrix's Board of Directors granted an inducement stock option to purchase up to 100,000 shares of common stock to Krishnamurthy Balachandran, its newly appointed Senior Vice President & General Manager, International on April 19, 2010.

OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, today announced that it has applied for the voluntary delisting of OXiGENE common shares from the Stockholm Stock Exchange (SSE). The company will continue to be listed on the NASDAQ Global Markets exchange. The Company believes that the listing of its common shares on the NASDAQ exchange provides shareholders sufficient liquidity and has concluded that the cost of maintaining the listing of its common shares on the SSE outweighs the benefits of continuing such listing.

Proteo, Inc. (OTCBB: PTEO; WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today the successful completion of patient recruitment for the Phase II clinical trial on the intravenously administered study drug Elafin. In this blinded, randomized, controlled Phase II clinical trial the effect of Elafin on the postoperative inflammatory reaction is being investigated in patients undergoing esophagectomy for esophagus carcinoma. The trial is being conducted at 3 German university hospitals - Kiel, TU-Munich and Muenster. Birge Bargmann, CEO of Proteo: "We expect to have preliminary data on the efficacy of our elastase inhibitor in the near future and we are optimistic that the results of the trial will meet our expectations."

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that a jury returned a verdict in the U.S. District Court for the District of New Jersey finding that Nycomed’s U.S. Patent No. 4,758,579 is not invalid. The Court has reserved decision on the issue of what, if any, effect to give to the jury's determinations in connection with the obviousness-type double patenting defenses, which Teva has argued is to be decided by the Court. A decision by the District Court judge independent of today's jury verdict would be sufficient to invalidate the patent.

Teva’s Pantoprazole Sodium DR Tablets are the AB-rated generic equivalent of Wyeth's erosive GERD treatment Protonix® DR Tablets. Teva began commercially shipping the product in December 2007.

Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH) today announced the opening of a new Zimmer Institute training center at its Trabecular Metal Technology (TMT) facility in Parsippany, New Jersey. The Zimmer Institute at TMT will be Zimmer's first full-time BioSkills training center outside of the Zimmer Institute's headquarters in Warsaw, Indiana. The new learning center includes both orthopaedic BioSkills and dental labs and will provide training courses to clinicians from around the world.

Also Friday:

Abbott's (NYSE:ABT) diversified strategy continued to deliver superior growth and performance in 2009, Chairman and Chief Executive Officer Miles D. White told shareholders today at the company's annual meeting.

Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced today that it will host a conference call and live audio webcast to report its financial results for the first quarter 2010 on Friday, April 30, 2010 at 8:30 a.m. ET before the U.S. financial markets open.

BioScrip, Inc. (Nasdaq: BIOS) today announced that the Company will release its 2010 first quarter financial results before the market opens on Friday, April 30, 2010.

BioPharm Asia Inc. (OTCBB:BFAR), a rapidly growing pharmaceutical company in China, today announced that it is preparing its Annual Report on Form 10-K for the year ended December 31, 2009.

EpiCept Corporation (Nasdaq: EPCT) announced today that stockholders are invited to the Annual Meeting of Stockholders on June 3, 2010, at 10:00 a.m. Eastern time at the Dolce/IBM Palisades Executive Conference Center, 334 Route 9W, Palisades, New York 10964.

Fero Industries, Inc. (OTCBB:FROI) announced that they have entered into a Letter of Intent with GVEST Inc., an Ontario Corporation, and the owner of certain intellectual property and other rights related to the production, marketing and distribution of Sucanon®, also known as Diab II a treatment for Type II diabetes and Pharmaroth SA de CV, a company incorporated in Mexico which markets and distributes Sucanon® in Mexico and Latin America.

MannKind Corporation (Nasdaq: MNKD) will release its 2010 first quarter financial results on Friday, April 30, 2010.

MedQuist Inc. (Nasdaq: MEDQ), a leading provider of technology-enabled clinical documentation services, today announces that it has completed the purchase of the domestic business of Spheris Inc.

Merck & Co., Inc. (NYSE: MRK) today provided information on the expected impact of the recently enacted U.S. Health Care Reform legislation.

NXT Nutritionals Holdings, Inc. (OTCBB: NXTH) developer and marketer of SUSTA Natural Sweetener, the great tasting, all-natural, healthier sweetener, today announced that Eddie George, legendary NFL running back, Ohio State Buckeye and winner of the Heisman Trophy, is partnering with NXT Nutritionals to host a VIP event celebrating healthy living.

NeuroMetrix, Inc. (Nasdaq: NURO), a health care company transforming patient care through neurotechnology, today announced that the Compensation Committee of NeuroMetrix's Board of Directors granted an inducement stock option to purchase up to 100,000 shares of common stock to Krishnamurthy Balachandran, its newly appointed Senior Vice President & General Manager, International on April 19, 2010.

Omnicare, Inc. (NYSE:OCR) will release its financial results for the first quarter ended March 31, 2010, on Thursday, May 6, 2010, before the opening of trading on the New York Stock Exchange.

Proteo, Inc. (OTCBB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG announced today the successful completion of patient recruitment for the Phase II clinical trial on the intravenously administered study drug Elafin.

RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that senior members of its management will be presenting at upcoming conferences and will highlight critical aspects of the development of RXi's next generation rxRNA therapeutic platform as well as specific preclinical data generated with this platform.

Urigen Pharmaceuticals, Inc. (OTCBB:URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that it has filed a request for an FDA meeting to advance the URG101 clinical program and mutually agreed with Oceana Therapeutics, Inc. to terminate their Consulting Agreement effective immediately.

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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