HAMBURG, Germany - MediGene AG and Schering AG entered into a strategic alliance to develop and commercialize MediGene's viral vaccine for the treatment of precancerous lesions of the cervix caused by human papillomavirus.

Under the terms of the agreement, Berlin-based Schering will pay up to EUR55 million (US$52.4 million) in research and development fees, as well as up-front and milestone payments. In addition, MediGene, of Martinsried, will receive royalties on sales of products developed from the collaboration. Schering has been granted a worldwide exclusive license for the vaccine. In countries Schering decides not to market, MediGene may commercialize the vaccine.

The companies jointly will conduct the Phase I/II clinical study for the proof of concept, while Schering will be responsible for further clinical studies, as well as for registration and promotion.

MediGene's vaccine is directed against human papillomavirus (HPV) infections, the main cause of cervical carcinomas. Each year, 500,000 women develop cancer of the cervix, the second most prevalent cancer in women. Survival rate is less than 60 percent. Currently, there are no vaccines to prevent this potentially serious infection. The vaccine is based on chimeric virus-like particles (CVLPs), which can be used for both the prevention and therapy of cervical cancer and genital warts.

"CVLPs cause a pseudo-infection," Christine Bohner, spokeswoman of MediGene, told BioWorld International. "The particles consist of a fusion protein with a double function. One subunit induces neutralizing antibodies, while the other one induces a cytotoxic T-cell response to destroy cells already infected by HPV."

She said the clinical trials starting later this year would focus only on the therapeutic effect. "The vaccine will be tested with women who developed lesions already," Bohner said. "Clinical studies to evaluate the preventive vaccination will start later." So far, common treatments for such precancerous lesions include conization and laser or cryo-surgery.

Bohner said CVLPs would be useful in women already infected with HPV, but without lesions, and could be offered to women undergoing treatment for cancer. "However it is also possible to vaccinate pubescent girls to protect them against HPV."

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