|Momenta Pharma soars on landmark FDA approval. Genzyme up on takeover reports. NxStage surges on record revs. Emishphere plunges|
|By BioMedReports.com Staff|
|Friday, 23 July 2010 18:38|
Below is a list of the companies that made news in the healthcare sector on Friday, July 23, 2010.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application (ANDA) for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this product has been designated therapeutically equivalent to the reference-listed drug, Lovenox(R), which is marketed by Sanofi-Aventis.
"The approval of M-Enoxaparin marks a key milestone for Momenta, and we are extremely pleased," commented Craig Wheeler, President and CEO. "This is the first product based on Momenta's technology platform to be approved, and demonstrates our ability to characterize and develop a complex mixture drug like Lovenox."
Shares of Momenta surged an amazing 81.89%, gaining $9.77 to close Fridays trading session at $21.70.
The approval could have widespread implications in the Pharmaceutical/Biotech space as it may signal the FDA's willingness to approve generic versions of complex biological drugs.
Meanwhile, shares of Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) fell $1.29 or 4.21%. Also putting pressure on Sanofi-aventis shares today were the widespread media reports that the company was preparing an unsolicited bid for Genzyme Corp. (NASDAQ: GENZ). Shares of Genzyme soared more than 15% on the reports, jumping $8.35 to $62.52. Shares continued to rally in the after hours market, moving up another $1.28.
Emisphere Technologies, Inc. (OTCBB:EMIS) today announced that Novartis Pharma AG and its license partner Nordic Bioscience a/s (the "Sponsor") have reported the following in connection with their Phase III Study 2302 in osteoarthritis assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee. This study incorporates Emisphere's unique and proprietary Eligen(R Drug Delivery Technology for the improved oral absorption of salmon calcitonin.
An independent Data Monitoring Committee ("DMC") conducted a futility analysis of one-year data for all patients enrolled in this two-year study, including assessments of safety and efficacy parameters. The DMC concluded that although there is no reason to stop Study 2302 because of safety concerns, there is no reason to continue the study for efficacy. The DMC also concluded that the final decision whether to continue Study 2302 rests with the Sponsor.
A parallel two-year Phase III Study 2301 in osteoarthritis assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee is still in progress. In December 2009, the DMC conducted a futility analysis of one-year data for all patients enrolled in this two-year study, including assessments of safety and efficacy parameters, and recommended to continue with such Study.
The Sponsor currently intends to continue the clinical program of oral calcitonin in osteoarthritis, including both Phase III Study 2301 and Phase III Study 2302. Novartis and Nordic Bioscience will continue to work together to assess next steps once the final data of Study 2301 is available. This data is expected to be available in 4Q-2010. Additionally, the Sponsor currently intends to continue the clinical program of oral calcitonin in osteoporosis. Previously, in its quarterly earnings report for the period ended June 30, 2010, Novartis stated that oral calcitonin for the treatment of osteoporosis is planned to file with the regulatory authorities during 2011.
Shares of Emishphere plunged $1.66 to 94 cents, nearly 64% off Thursday's close of $2.60.
NxStage Medical, Inc. (Nasdaq:NXTM), a leading manufacturer of innovative dialysis products, today reported record financial results for the second quarter of 2010 ended June 30, 2010, with total revenue above the top end of its guidance range.
"Q2 was another great quarter in all respects: we delivered record revenue with all three of our markets outperforming, and Home delivering the strongest growth; achieved positive cash flow; and, continued operational execution across all our markets," stated Jeffrey H. Burbank, Chief Executive Officer of NxStage Medical. "With a strong first half of the year and continuing momentum, we are increasing our projections for sequential growth in Home and raising our revenue guidance for 2010 to a range of revenues between $170 and $175 million."
Shares of NxStage gained $3.18, nearly 23%, to $17.06
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE® IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer.
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that the Company has entered into a debt for equity exchange agreement with its chairman and CEO Michael T. Flavin, Ph.D.
Biovail Corporation (NYSE, TSX: BVF) today announced that it will host a conference call and Webcast on Thursday, August 5, 2010, at 8:30 a.m. EDT, for Company executive to discuss second-quarter 2010 financial and operational results.
Celera Corporation (NASDAQ:CRA) announced today that it will issue second quarter 2010 financial results on Tuesday, August 3, 2010.
China-Biotics, Inc. (Nasdaq: CHBT), the leading developer, manufacturer and distributor of probiotics products in China, today announced it will host a conference call at 08:00 a.m. Eastern Daylight Time on Monday, August 9, 2010 to discuss the fiscal year 2011 first quarter financial results for the period ended June 30, 2010.
Dynavax Technologies Corporation (NASDAQ: DVAX) reported that equity awards were made to two new employees under the Company's 2010 Employment Inducement Award Plan.
IDEXX Laboratories, Inc. (Nasdaq: IDXX) today reported that revenues for the second quarter of 2010 increased 6% to $281.5 million, from $265.7 million for the second quarter of 2009.
MiMedx Group, Inc. (OTC Bulletin Board: MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today its results for the second quarter ended June 30, 2010.
Novogen Limited (NASDAQ: NVGN) is listed on the Australian Stock Exchange and has an ADR program in place in the US through the Nasdaq Stock Market.An ADR for the Company represents a bundle of 5 ASX shares, therefore the bid price of an ADR on the NASDAQ is five times the ASX share bid price.
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that it will host a teleconference and webcast on Monday, July 26, 2010, at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) to provide a clinical update on carfilzomib.
Oragenics, Inc. (OTCBB: ORNI) announces it will unveil EvoraPro™ , a professional-strength version of the popular consumer-marketed all-natural probiotic oral care and teeth whitening mint EvoraPlus® at the RDH Under One Roof Conference in Orlando, FL, August 5-7.
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that it has completed the sale of $3.9 million of its common stock and warrants to a single existing institutional investor in a registered public offering.
Renhuang Pharmaceuticals, Inc. (NYSE Amex: CBP) a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM"), today announced that the Company was recently awarded an AAA(1) rating by Chinese Academy of International Trade & Economic Cooperation of Ministry of Commerce.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) commented today on the U.S. Food and Drug Administration’s response to a citizen petition questioning the approval criteria for a generic Lovenox® (enoxaparin sodium) injection and its subsequent approval of another generic filer’s Abbreviated New Drug Application (ANDA).
Titan Pharmaceuticals, Inc. (OTC Bulletin Board: TTNP) today reported that the company expects to receive a royalty payment of approximately $55,000 on second quarter 2010 sales of Fanapt (iloperidone) of approximately $693,000.
Unigene Laboratories, Inc. (OTCBB: UGNE) announced today that Novartis and its license partner Nordic Bioscience [the "Sponsor"] have decided to continue the companies’ two-year, Phase III Study 2302 assessing safety and efficacy of oral calcitonin in patients with osteoarthritis of the knee.
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.