Sinovac Receives Certificate Of Approval To Distribute PANFLU.1 (H1N1) In Mexico

Main Category: Swine Flu
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 23 Oct 2009 - 3:00 PDT

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Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading developer and provider of vaccines in China, today announced that it has received a Certificate of Approval from the Secretaria de Salud to distribute PANFLU.1, its H1N1 pandemic influenza (swine flu) vaccine, in Mexico. The certificate is valid through October 13, 2014. 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. The application for Anflu was filed in Mexico as well.

PANFLU.1 is the first China-developed vaccine approved for human use in Mexico and the first H1N1 vaccine to be registered in Mexico. Sinovac will need to obtain permission from the Chinese government prior to exporting its H1N1 vaccine to Mexico. Sinovac is in the process of fulfilling existing orders for a total of 6.3 million doses of PANFLU.1 for the Chinese central government. As previously announced, Sinovac expects to complete the delivery of 4.5 million doses to the Chinese central government by the end of October.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Receiving the certificate of approval to distribute PANFLU.1 in Mexico is a significant milestone for Sinovac. Importantly, this approval is a continuation of our corporate strategy to register and distribute our vaccines in international markets through strategic collaborations. We appreciate the ongoing efforts of our distribution partner, Laboratorios Imperiales, who has worked closely with the Mexican authorities to obtain this certificate of approval. We will continue to collaborate closely with authorities in China and Mexico in order to facilitate the distribution of PANFLU.1, and potentially other vaccines in our portfolio, in this important market."

To date, there have been 45,809 confirmed cases of H1N1 pandemic influenza in Mexico, of which 271 have died.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac's vaccine products include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A and B), and Anflu(R) (influenza). Panflu(TM), Sinovac's pandemic influenza vaccine (H5N1), has already been approved for government stockpiling. Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, Japanese encephalitis, and human rabies. Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccines.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Source: Sinovac Biotech Ltd