Innogenetics acquires therapeutic vaccine program of Genencor

Innogenetics strengthens therapeutic vaccine pipeline in the fields of hepatitis B, human papillomavirus, and hepatitis C

30-Mar-2004

Gent (Belgium). Innogenetics announced that it has acquired the therapeutic vaccine programs of US-based Genencor International, Inc.. Innogenetics will be responsible for the clinical development and worldwide commercialization of all products arising from these programs. Through this deal, Innogenetics gains access to a broad technology platform, intellectual property rights, and licenses with respect to therapeutic and prophylactic vaccine applications for hepatitis B virus (HBV), human papillomavirus (HPV), and hepatitis C virus (HCV).

The newly acquired portfolio consists of a clinical vaccine candidate for HBV, a preclinical viral boost candidate for HBV, a research-stage lead compound for HPV, and a complementary discovery platform for future HCV vaccine products. Genencor filed an Investigational New Drug application (IND) with the FDA for its HBV vaccine candidate in 2003, and recently initiated a phase 1 clinical study in the United States to investigate the vaccine's safety and immunogenicity. After a short transition period with Genencor's assistance, Innogenetics will fully manage the current phase 1 clinical study of the HBV vaccine candidate.

Through this agreement, Innogenetics also acquired exclusive access to a broad portfolio of patented cytotoxic T lymphocyte (CTL) epitopes, complementary rights (including PADRE technology), and licenses in the fields of HBV, HPV, and HCV, as well as associated technologies. These immunotherapeutic tools were developed by Genencor's partner, Epimmune (NASDAQ: EPMN), and will now be further developed together with Innogenetics.

Under this agreement, Innogenetics will pay Genencor upfront license fees totaling est. EUR8.2 million. Upon achievement of various phase 2 development milestones, additional payments could total est. EUR4.1 million. Subsequently, should all phase 3 programs be successful and achieve regulatory approval in Europe and the United States, further payments could total up to est. EUR 67.4 million. Genencor will also receive royalty payments on product sales. As part of this deal, Innogenetics and Epimmune have agreed to collaborate through September 2005. Epimmune will earn milestone payments from Innogenetics upon successful completion of clinical development phases as well as royalty payments on any products sales, in accordance with the terms of the original license agreement with Genencor.

According to Dr. Guy Buyens, Chief Therapeutics Officer of Innogenetics, "We are pleased to have acquired Genencor's highly promising portfolio of therapeutic vaccine candidates. Such an acquisition clearly meets our objectives of initiating the clinical evaluation of at least two new therapeutic vaccine candidates in infectious diseases by 2006, and of broadening Innogenetics' technology platform. These new programs will be run within the 2004 R&D expenditure guidelines."

Furthermore, Philippe Archinard, Chief Executive Officer of Innogenetics, commented: "Through this major deal with Genencor, access to Epimmune's proprietary technology provides us with a unique engine for the development of future generation infectious disease vaccines. From a financial perspective, this agreement represents a unique opportunity for Innogenetics, by linking most future milestone obligations to successful completion of phase 3 clinical studies and regulatory approval of the developed products. Most importantly, this outstanding acquisition positions Innogenetics as one of the key players in the fast-growing, multibillion euro market for treatment of major infectious diseases.

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