Sinovac Reports Success with Bird Flu Vaccine

Sinovac Biotech Ltd. (SVA) released positive data from a Phase II clinical trial of its pandemic flu (H5N1) vaccine. In the stratified, randomized, double-blind test, the top two dosage levels of Sinovac’s vaccine met the EMEA evaluation standards for seasonal flu vaccines. The trial did not discover any safety problems.

The Beijing Centers for Disease Control and Prevention conducted the Phase II trial, enrolling 402 subjects between the ages of 18 and 60. The trial tested three dosage levels, each administered twice: 5 ug, 10 ug and 15 ug. Although all three produced a response, only the two highest levels met the EMEA standard, which indicates sufficient immunogenicity.

The positive results came from a Phase II trial of the whole viron (a complete virus particle) vaccine. At the same time, Sinovac’s split viron vaccine underwent Phase I and Phase II trials. Sinovac said the Phase I trial of its split viron vaccine was completed without causing any significant safety issues. The company did not report any measures of efficacy. The patient population included children, adults and elderly subjects.

Sinovac said it would use the Phase II results of the whole viron vaccine to determine dosing levels for the Phase III tests. It will also use the Phase I data of the split viron vaccine in designing the Phase II test for that version.

In September 2006, Sinovac published solid efficacy data from the Phase I trial of the whole viron vaccine in The Lancet. So far, all tests of this vaccine have shown both efficacy and a good safety record.

Sinovac is in the vaccine business, providing vaccine for seasonal flu, hepatitis A and hepatitis B, with most sales occurring in China.

Given the good news, Sinovac’s shares advanced 67 cents in Monday’s shortened session, closing at $4.73, a gain of 17%. In the last 52 weeks, Sinovac has had a range of $2.25 to $7.00. At its current price, the company has a market capitalization of $191 million.

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Disclosure: none.