Sinovac Receives GMP Certificate In Mexico For Vaccines. Johnson & Johnson Settles Charge in Risperidone Marketing. Print E-mail
By Staff and Wire Reports   
Thursday, 11 August 2011 19:25
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 11, 2011.

Sinovac Biotech Ltd. (NASDAQ:SVA) announced it has obtained the GMP certificate for its seasonal flu vaccine and hepatitis A vaccine from the Mexican regulatory authority, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) of Mexico Ministry of Health.

Sinovac is the Chinese vaccine manufacturer to be granted GMP certificate by COFEPRIS. The GMP certification follows the onsite inspection by COFEPRIS at Sinovac's Beijing headquarters in September 2010.

The GMP certificate is effective for 30 months with an expiration date of January 12, 2014, at which time a new GMP inspection shall be applied for the renewal of GMP certificate. Laboratorios Imperiales S.A. de C.V., a biopharmaceutical company with operations in Mexico since 1935, is the exclusive distributor of Sinovac's vaccine products in the Mexican market, pursuant to a prior distribution agreement signed in 2005 with its affiliate.

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Johnson & Johnson (NYSE:JNJ) has reached an agreement with the US Department of Justice on a misdemeanor charge related to the marketing of the company's antipsychotic drug risperidone (Risperdal), which went generic about 3 years ago after the company lost the patent.  In a regulatory filing with the Securities and Exchange Commission this week, the company said it has allocated an undisclosed amount for a proposed settlement of the charge.

"Discussions have been ongoing in an effort to resolve criminal penalties under the Food Drug and Cosmetic Act related to the promotion of [risperidone]," the company stated in the filing.

"An agreement in principal on key issues relevant to a disposition of criminal charges pursuant to a single misdemeanor violation of the Food Drug and Cosmetic Act has been reached, but certain issues remain open before a settlement can be finalized. The company has adjusted the accrued amount in the second quarter of 2011 to cover the financial component of the proposed criminal settlement."

J&J said that the Department of Justice notified the company of its plans to intervene or join in multiple lawsuits that have been filed against the company and its Janssen Pharmaceuticals division.

The various lawsuits, which date back to 2004, allege that the company promoted risperidone and a related antipsychotic drug, paliperidone (Invega), for unapproved uses, including dementia and mood and anxiety disorders, and downplayed potential risks, according to Bloomberg News. The drugs are both indicated for schizophrenia.


Also Thursday:


Avanir Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced that it has filed lawsuits in the U.S. District Court for the District of Delaware against Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc (collectively "Par") and Actavis South Atlantic LLC and Actavis, Inc. (collectively "Actavis").

Bacterin International Holdings, Inc. (NYSE Amex:BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, reported results for the second quarter ended June 30, 2011.

Bion Environmental Technologies, Inc. (OTC BB/QX: BNET) announced today that it has been notified by the United States Patent and Trademark Office that the patent application entitled "Micro-Electron Acceptor Phosphorus Accumulating Organisms" has been granted.

Cord Blood America, Inc. (OTC Bulletin Board:CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, today announced revenues of $2.89 million for the first six months of 2011, up 61 percent compared to revenues of $1.79 million in the same period in 2010.

GenVec, Inc. (Nasdaq:GNVC) today announced that its Board of Directors has approved the replacement of its Stockholder Rights Plan through the adoption of a new Rights Agreement. The new Stockholder Rights Plan is to become effective on September 7, 2011, which is the date that GenVec's existing Rights Agreement is set to expire.

Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, announced today that Timothy Whitten, President and CEO of Insmed, will be presenting a corporate overview at the 2011 Wedbush Securities Life Sciences Management Access Conference on Tuesday, August 16, 2011, at 8:00 AM ET, in New York.

InspireMD, Inc. (OTC BB: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ mesh protective stent system, today announced the election of two proven leaders to the Company's board of directors.

Interleukin Genetics, Inc. (OTCQB: ILIU) announced today that CEO Lewis H. Bender will present at the Wedbush Securities Life Sciences Management Access Conference at the Le Parker Meridien Hotel, 119 West 56th Street in New York City.

Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that Arthur T. Sands, M.D., Ph.D., Lexicon's president and chief executive officer, will present at the Wedbush 2011 Life Sciences Management Access Conference on Tuesday, August 16, 2011 at 1:15 p.m. Eastern Time in New York City.

MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) today announced that the Company will participate in the 2011 Wedbush Life Sciences: Management Access Conference on Tuesday, August 16, at 8:35 a.m. ET in New York.

Neurologix, Inc. (OTCBB: NRGX), a biotechnology company engaged in the development of innovative gene therapies for disorders of the brain and central nervous system, today announced its financial results for the three and six months ended June 30, 2011.

MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) today announced that the United States Patent and Trademark Office (USPTO) issued to the Company U.S. Patent No. 7,994,197, titled "Method of Therapeutic Administration of DHE to Enable Rapid Relief of Migraine while Minimizing Side Effect Profile."

Pacira Pharmaceuticals, Inc. (Nasdaq:PCRX), an emerging specialty pharmaceutical company, today announced financial results for the second quarter ended June 30, 2011, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL™, and updated its 2011 financial guidance.

Sequenom, Inc. (NASDAQ:SQNM), a life sciences company providing innovative genetic analysis solutions, today announced it has partnered with LifeCodexx AG, a company focused on the development of clinically validated Next Generation Molecular Diagnostics, for the commercialization of prenatal laboratory testing services in Europe.

ShangPharma Corporation (NYSE:SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it has achieved the initial milestones for two multi-staged projects in its biologics division, which portends strong growth for this segment in 2011.

Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced financial results for the three and six months ended June 30, 2011.

ULURU Inc. (NYSE AMEX:ULU) today announced that it has scheduled a conference call to discuss the second quarter ended June 30, 2011 financial results and to provide a general business update on Tuesday, August 16, 2011 at 9:00 a.m. Eastern Time.

Transgenomic, Inc. (OTC/BB: TBIO) today announced the following Webcast:  What:  Transgenomic, Inc. Second Quarter 2011 Financial Results and Business Update Conference Call.  When: Thursday, August 11, 2011 @ 5:00 p.m. Eastern.



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