MannKind soars on debt sale; AstraZeneca, Bristol-Myers Announce Positive CHMP Opinion Print E-mail
By Staff and Wire Reports   
Friday, 23 September 2011 19:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 23, 2011.

MannKind Corporation (Nasdaq: MNKD) soared 18%, and continued to climb after hours to $3.90- the most since Aug. 12, to $3.74. The biotechnology company plans to sell $370 million in debt to help fund development and product trials. The company stated that if the offering is consummated, the net proceeds from the offering of the notes would be used for development and operating capital, including completion of the Phase 3 clinical trials of MannKind's lead product candidate, AFREZZA®, preparing for commercialization of AFREZZA®, continuing the build-out of MannKind's Danbury, Connecticut manufacturing facility, ongoing research and development efforts, and general corporate purposes.

AFREZZA® is an ultra rapid-acting insulin with a pharmacokinetic profile that is different from all other insulin products.

AstraZeneca PLC (NYSE:AZN), a global, innovation-driven biopharmaceutical business, and Bristol-Myers Squibb Company (NYSE:BMY) said Friday the Marketing Authorization Application for komboglyze [saxagliptin and metformin HCl immediate-release fixed dose combination] received a positive opinion from the Committee for Medicinal Products for Human Use, or CHMP, as an adjunct to diet and exercise, for the treatment of type 2 diabetes in adults who aren't adequately controlled on metformin or those already being treated with the combination of saxagliptin and metformin as separate tablets.

Positive opinion was reached after the CHMP reviewed data from a Phase 3 clinical program that involved 4,326 patients with type 2 diabetes, including 2,158 individuals receiving saxagliptin plus metformin.  CHMP's positive opinion on komboglyze will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

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On Friday, Fitch Ratings lowered Pfizer Inc.'s (NYSE:PFE) long-term issuer default rating to A+ from AA- as its deleveraging is below expectations.

Fitch noted that Pfizer had demonstrated financial discipline by reducing its debt that nearly tripled with its $68 billion buyout of Wyeth in October 2009. "However, leverage is still not commensurate with an AA- category rating almost two years after the acquisition, as had been originally anticipated by Fitch," the ratings agency said.

Fitch also cut its rating outlook to stable from negative.


Also Friday:


Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today announced details of the 2011 International Conference on TomoTherapy (ICT), which took place September 16-17, 2011 hosted by the University of Heidelberg, Germany's oldest University and world famous research center for cancer and microbiology.

Allezoe Medical Holdings, Inc. (OTCBB:ALZM) announces today its intention of carrying out a global rollout of its HPV diagnostic technology.

CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, announced that as part of its controlled-market release of CytoSorb™, it will exhibit at the European Society of Intensive Care Medicine Congress in Berlin, Germany from October 2-5, 2011 in Booth #71 at the International Congress Center Berlin.

Cytori Therapeutics (NASDAQ: CYTX) has entered into a Celution® System agreement with Apollo Hospitals, one of Asia's largest private healthcare groups, to offer the technology initially at select cosmetic surgery centers in India.

CytoDyn Inc. (OTC:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, HIV/AIDS, announced today that it has filed a provisional patent application in the United Statesfor its humanized version of its lead product Cytolin®, a monoclonal antibody for the treatment of HIV infection.

Delcath Systems (NASDAQ: DCTH) announced today that James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine, will present updated investigator results from the Phase 3 randomized trial of Delcath's chemosaturation system with melphalan in patients with hepatic metastases from ocular or cutaneous melanoma.

eHealth, Inc. (NASDAQ: EHTH) will be participating in a panel on new tools for insurance benefits and purchasing at the Health 2.0 conference in San Francisco on Sunday, Sept. 25, 2011.

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera®, combining Gilead’s Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor Edurant® (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in antiretroviral-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL.

InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a company focused on the development of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that its collaboration with the Miami Project to Cure Paralysis will be featured at the Buoniconti Fund to Cure Paralysis 26th Annual Great Sports Legends Dinner fundraising event, to be held Monday evening, September 26 at the Waldorf Astoria New York Hotel.

NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today commented on the just-released findings of an NIH sponsored study which shows that event rates, including mortality, were significantly higher for patients following the long (2-day) interdialytic interval associated with a three times per week dialysis schedule ("conventional dialysis").

RegeneRx Biopharmaceuticals, Inc. (OTC BB: RGRX)
today announced that treatment and follow-up have been completed on 69 patients in the Company’s Phase 2 clinical trial with RGN-259 for the treatment of dry eye syndrome, five more than the number of evaluable patients contemplated in the trial’s protocol.

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, announced today that an overview of the Company’s business strategy will be given at the Jefferies 2011 Global Healthcare Conference, being held in London, England.

YM BioSciences Inc. (NYSE: YMI), a drug development company advancing a diverse portfolio of promising hematology and cancer-related products, today reported operational and financial results for its 2011 fiscal year, ended June 30, 2011.



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