Schering AG and MediGene AG has announced the formation of a world-wide strategic alliance to develop and commercialise MediGene’s Viral Vaccine for the treatment of precancerous lesions of the cervix caused by human papilloma viruses (HPV). Schering has been granted a world-wide exclusive license with the right to grant sublicenses.
MediGene has an option for distribution of the vaccine in countries in which Schering decides not to commercialise.
The total deal value excluding undisclosed royalties on sales could amount to euro 55 million.
This amount includes the jointly agreed R&D budget to which MediGene will partially contribute up to proof of concept as well as up-front and milestone payments.
Under the terms of the agreement MediGene will be responsible for all research and pre-clinical studies.
The phase I/II study for proof of concept will be jointly conducted by MediGene and Schering.
Further clinical studies as well as registration and promotion will be undertaken by Schering.
MediGene will participate in Strategic Marketing meetings and develop a concept for medical education and vaccination in Asia and Latin America.
Prof. Dr. h.c. Guenter Stock, member of the Board of Executive Directors of Schering AG. commented, “The present treatments available for precancerous lesions very often become invasive and may cause infertility or heavy disorders in following pregnancies. For cervical cancer there is solely radical surgical treatment with serious side effects. MediGene’s therapeutic vaccine could offer a thorough treatment without any side effects to women with pre-cancerous lesions who are at risk for progression to cervical cancer. There is a need for this treatment and we believe in MediGene’s promising chimeric virus- like particles (CVLP) technology. Furthermore the unique advantage of the CVLPs is the combination of treatment and prophylaxis in one product which prevents re-infection of treated patients. Schering is the optimal partner for MediGene’s vaccine due to the company’s expertise in both gynecology and oncology”, commented Dr. Peter Heinrich, MediGene’s CEO. “This cooperation is a major step for MediGene as it underlines the potential of MediGene’s CVLP- technology. We will now be able to pursue the clinical development of the vaccine together with a strong, experienced partner, with great promotional strength in women’s health.” MediGene’s CVLP-technology is based on chimeric virus-like particles (CVLPs) built up by a HPV-L1E7 fusion-protein, which self-assembles into virus-like particles able to cause a pseudo-infection.
The CVLPs stimulate the immune system both to prevent infections (prophylactic immunization) and to destroy HPV infected cells (therapeutic immunization). The particles consist of a HPV 16 – L1E7 fusion-protein with the double function: L1 structural protein induces neutralizing antibodies whereas the shortened E7 regulatory protein induces a cytotoxic T cell response.