BRIEF—Generex out-licenses prostate cancer vaccine AE37 in China

Canada-headquartered Generex Biotechnology Corporation (OTCQB:GNBT) yesterday announced that its wholly-owned subsidiary, Antigen Express has entered into a license and research agreement with Shenzhen BioScien Pharmaceuticalsto develop and commercialize the Antigen Express AE37 immunotherapeutic vaccine for prostate cancer in China (including Taiwan, Hong Kong, and Macau).

Shenzhen BioScien will pay Generex a non-refundable, up-front license fee of $700,000.

Under the Agreement, Shenzhen BioScien will also make milestone payments to Generex of $1 million each on completion of the Phase II and Phase III clinical studies of the vaccine as well as a milestone payment of $2 million on regulatory approval of the vaccine in the territory.

Generex will also receive a 10% royalty on net sales of the product.

Under the Agreement, Shenzhen BioScien has responsibility for paying for and conducting the clinical trials, securing Chinese regulatory approvals, and the manufacturing, marketing, distribution, and sale of the product.

The clinical trials will be designed and conducted so as to meet the regulatory requirements of the US Food and Drug Administration and the European Medicines Agency and Antigen Express will have free access to all data for support of global regulatory filings and further development and commercialization initiatives outside the licensed territories.