Therapy Areas: Vaccines
Generex Receives USD 700k Fee from Shenzhen BioScien Pharmaceuticals
3 January 2018 - - US- and Canada-based biopharmaceutical company Generex biotechnology Corp. (OTCPink: GNBT) has confirmed its receipt of the USD 700k up-front license fee (net of applicable Chinese withholding taxes) payable by Shenzhen BioScien Pharmaceuticals Co. Ltd. under the license and research agreement entered into with Generex wholly-owned subsidiary Antigen Express, Inc., the company said.
The purpose of the agreement is to develop and commercialize the Antigen Express AE37 immunotherapeutic vaccine for prostate cancer in the People's Republic of China (including Taiwan, Hong Kong, and Macau).
A previously completed Phase I study of the vaccine conducted by Antigen Express in patients with prostate cancer demonstrated robust, long-term, and specific activation of cancer-fighting T cells in immunized patients.
In addition to the license fee, under the Agreement Shenzhen BioScien will also make milestone payments to Generex of USD 1m each upon completion of the Phase II and Phase III clinical studies of the vaccine as well as a milestone payment of USD 2m upon 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.
Generex Biotechnology is involved in discovery, research, development, and financing of new compounds, therapies, diagnostics, delivery systems, and medical technologies.