Protein Sciences (PSC) and UMN Pharma have expanded their 2006 agreement, under which PSC gave UMN exclusive rights to commercialize its influenza vaccine candidates FluBlok® and PanBlok® in Japan. The amendment allows UMN to enter into collaboration agreements with Astellas Pharma and IHI for the Japanese market and extends UMN’s exclusive commercialization rights to China, Hong Kong, Korea, Singapore, and Taiwan.
Astellas' role will be to support further development, licensure, and marketing of these vaccines in Japan. PSC received a portion of the up-front fee paid by Astellas and will be entitled to receive a portion of development and sales milestones as well as double-digit royalties. UMN will retain manufacturing rights and has partnered with IHI to establish a commercial production facility in Japan.
With UMN’s territories expanding, PSC received an up-front payment and will be entitled to milestones upon licensure and high single-digit royalties on sales in each country. In the event that UMN sublicenses such rights, PSC will be entitled to payments similar to those under UMN’s agreement with Astellas.
FluBlok is a seasonal recombinant trivalent influenza vaccine consisting of influenza hemagglutinin (HA) proteins. It is manufactured using cell culture instead of eggs, is highly purified (therefore does not require the use of thimerosal or antibiotics), and is low in endotoxins, according to PSC.
The firm filed a BLA for FluBlok with the FDA in April 2008, which was accepted in June 2008 and received Fast Track designation in July 2008. PSC anticipates that FluBlok may receive FDA approval within a few months.
PanBlok is a pandemic influenza vaccine candidate. It comprises purified recombinant hemagglutinin antigen from the H5N1 avian influenza. It is in Phase II development through a partnership with UMN Pharma in Japan.
In 2009, PSC was awarded a $34.5 million contract from the Biomedical Advanced Research and Development Authority to develop a technology for the production of recombinant influenza vaccines for pandemic preparedness. This contract could be extended up to a total of five years with a total value of approximately $147 million.