Roche, Biogen report death during drug trial. Questcor's Acthar gets FDA nod. Print E-mail
By Mary Davila   
Friday, 15 October 2010 17:36

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 14, 2010.

Roche Holding AG (PINK:RHHBY) and Biogen Idec Inc (NASDAQ:BIIB) report one death in MS drug trial. Found within their experimental multiple sclerosis drug ocrelizumab's data from a mid-stage trial, there was reported on Friday that one patient died of an inflammatory condition.

Data presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showed some side effects were greater in the ocrelizumab arm than in the placebo arm, that the drug reduced disease activity by a significant amount as measured by the number of brain lesions and relapse rate.

In May, Roche of Switzerland and Biogen of Cambridge, Massachusetts, said they would discontinue studies of the drug as a treatment for rheumatoid arthritis after a safety monitoring board ruled that the risk outweighed the benefit in the RA population.

The decision followed reports of serious infections, some of which were fatal, as well as opportunistic infections that do not normally occur in healthy people.

The companies said that in the latest 220-patient MS trial no opportunistic infections were reported, and they said no causal link had been established between ocrelizumab and the patient death from systemic inflammatory response syndrome (SIRS). Roche said exhaustive analysis showed the condition in this case was not sparked by an infection, even though it sometimes can be.

There were no cases of SIRS in the placebo group or among patients who received the lower of the two doses of ocrelizumab. However, 1.8 percent of patients -- or one out of 55 -- who took the higher dose developed the condition.

U.S. health regulators approved Questcor Pharmaceuticals Inc's (NASDAQ:QCOR) Acthar gel to treat seizures in infants, and also granted a seven-year marketing exclusivity period for the drug, sending its shares up as much as 10 percent.

It is widely used by doctors to treat infantile spasms, a form of epilepsy, even without FDA consent. However, the regulatory approval will now let the company market the drug actively for the treatment of infantile spasms.

 

Here are other companies that made news on Friday:

Shamir Optical Industry Ltd. (Nasdaq: SHMR) ("Shamir Optical"), Kibbutz Shamir and Essilor International (NYSE Euronext: EI) ("Essilor") today announced that they have signed an agreement whereby Essilor will, through a series of transactions, acquire 50% of Shamir Optical.

Generex Biotechnology Corporation (NasdaqCM: GNBT) today announced that the sole matter for consideration by stockholders at the reconvened special meeting of stockholders being held tomorrow, October 15, 2010, will be to approve a proposal to adjourn the special meeting to Monday, October 18, 2010.

Green Bridge Industries, Inc. (PINKSHEETS:GRBG) announced today that the Company has posted its annual shareholder meeting proxy material online.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for the generic versions of Hyzaar® Tablets, 50 mg/12.5 mg and 100 mg/25 mg, and Cozaar® Tablets, 25 mg, 50 mg and 100 mg, both antihypertensives.

Novavax, Inc. (Nasdaq:NVAX) announced today that  Dr. Rahul Singhvi, President & Chief Executive Officer, and members of senior management will provide a corporate update and review of third quarter 2010 financial results via a webcast and conference call on Friday, November 5, 2010, at 10:00 a.m. Eastern time.

Omeros Corporation (Nasdaq:OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the BioCentury NewsMakers in the Biotech Industry Conference on October 22, 2010 at 1:30 p.m. Eastern time in New York City.

Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) will webcast its presentation at the 17th Annual NewsMakers in the Biotech Industry Conference on Friday, October 22, 2010.  The presentation is scheduled for 9:00 a.m. Eastern Time.  

Sun Healthcare Group, Inc. (NASDAQ:SUNH) today announced that subsidiaries of Sabra Health Care REIT, Inc. ("Sabra") plan to offer, subject to market and other conditions, $225 million aggregate principal amount of senior notes due 2018 (the "Notes") in a private offering to "qualified institutional buyers" as defined in Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), and outside the United States in reliance on Regulation S under the Securities Act.

TomoTherapy Incorporated (NASDAQ: TOMO) announced today that it will host an analyst and investor presentation in conjunction with the annual ASTRO (American Society for Radiation Oncology) meeting in San Diego, Calif., on Monday, November 1, 2010, at 8:00 a.m. PDT.




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