Sep 3 2009
Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading provider of biopharmaceutical products in China, announced today that it has signed an agreement with Boryung Pharmaceutical Company Limited, a Korean manufacturer of pharmaceuticals, to collaborate on marketing efforts and possible vaccine supply efforts to the government of South Korea for Sinovac's H1N1 vaccine.
The agreement follows meetings between Sinovac and the Korean Food and Drug Administration (KFDA) and the Korean Center for Disease Control (KCDC) where Sinovac presented the scientific data of Sinovac's H1N1 vaccine. The deal gives Boryung exclusive rights to represent Sinovac in discussions with the KFDA and KCDC in the development of business opportunities in South Korea surrounding Sinovac's H1N1 vaccine. The price, volume, delivery schedule and other specific details about how Sinovac's H1N1 vaccine might be marketed and supplied to the government of South Korea have not been determined.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac commented, "We chose Boryung as our potential partner in South Korea because of their well-respected position in that country and familiarity with the regulatory bodies there. As part of our commitment to developing high quality vaccines to fight the spread of disease worldwide, we are pleased to explore the possibility of marketing our first in class H1N1 vaccine in South Korea."
On August 30 and 31, 2009, the State Food and Drug Administration (SFDA) organized and held an experts' evaluation conference focused on A/H1N1 vaccines to evaluate Sinovac's H1N1 vaccine, which has recently completed a clinical trial. Top-line results from the trial demonstrated Sinovac's H1N1 vaccine to have a good safety profile and immunogenicity factors that meet EU criterion after a single shot. No severe adverse effects were reported after inoculation. Based on the results of the evaluation, the experts unanimously agreed that Sinovac's H1N1 vaccine is suitable for all people from three to 60 years old and the vaccination schedule is a single shot. The result of the experts' evaluation conference will be submitted to SFDA on September 1st, which will be the primary basis for the SFDA to issue the production license.