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Sinovac Biotech (NSDQ: SVA) was granted SFDA approval to begin clinical trials of an inactivated vaccine for EV71, also known as Hand, Foot and Mouth Disease (HFMD). Monday, China Biologic also announced approval for trials of a similar HFMD vaccine. Sinovac, which filed for an NDA in December 2009, has been waiting for a year for official permission to begin the clinical phase of development.

Sinovac said about 90% of HFMD occur in children under the age of five. Although most cases are relatively minor, the disease can become severe and cause neurological problems. Outbreaks of the disease in Asia are not infrequent and are fueled in part by the lack of any treatment for the disease. China reported 876 deaths from HFMD in the first 11 months of 2010 and over 1.7 million cases of infection.

Sinovac reported that it began preclinical research of its EV71 vaccine in 2008, using an animal model built by researchers at Sydney University. The company has filed five patent applications in connection with its vaccine.

Sinovac had a very good year in 2009, when its combination of seasonal and swine flu vaccines were in high demand. This year, absent any pandemic fears, revenues are running about 50% below 2009 levels. As a result, Sinovac was forced to emphasize its non-flu vaccine products, such as its mainstay hepatitis A and B vaccines. The company has been steadily increasing its offerings, and the EV71 vaccine is part of that expansion.

Disclosure: none.

Source: Sinovac Adds EV71 Vaccine to Steadily Increasing Offerings