Biotech signs vaccine deal MedImmune to work on viral infection

$85 million potential

Drugs

December 12, 1997|By Mark Guidera | Mark Guidera,SUN STAFF

MedImmune Inc., the Gaithersburg biotechnology company developing infectious disease treatments, said yesterday that it has signed an agreement with SmithKline Beecham to co-develop and market a vaccine for a viral infection considered the leading cause of cervical cancer.

The deal is potentially worth more than $85 million to MedImmune, the company said. But it will be years before it is clear if the companies will be successful in their effort.

Under the agreement, SmithKline receives the worldwide rights to MedImmune's vaccine technology for a disease known as human papillomavirus, or HPV.

The infection causes cervical cancer if untreated. Men are considered carriers of the virus, and in rare cases they develop genital cancer from the virus.

HPV causes about 65,000 cases of malignant cervical cancer annually in the United States. About 5,000 women die annually from cervical cancer, according to the American Cancer Society.

The virus is considered more problematic in parts of Asia and elsewhere overseas where good screening for it is not available.

The disease has emerged as a leading focus of biotechnology research in an effort to develop a vaccine and diagnostic tests.

Wayne T. Hockmeyer, chairman and chief executive officer of MedImmune, said SmithKline was "an excellent partner for development and commercialization of our HPV vaccine,` because the Pennsylvania-based company's strength lies in developing and marketing vaccines.

"By working together we can accelerate our efforts and increase our chances to successfully develop vaccines against HPV," said Jean Stephenne, senior vice president of SB Biologicals, the vaccine division of SmithKline Beecham.

SmithKline will pay MedImmune an undisclosed signing payment and will fund development of the vaccine.

If a vaccine is developed and marketed, MedImmune would also stand to receive additional payments if certain sales levels are reached and royalties on sales.

The company estimated that even without sales royalties, payments from SmithKline could total more than $85 million.

MedImmune will be responsible for animal and early human clinical trials and manufacturing batches of the vaccine for the studies.

SmithKline is responsible for final development of the vaccine, getting it through the regulatory review process, as well as manufacturing and marketing.

MedImmune also said yesterday that it has filed for Food and Drug Administration clearance to begin early human clinical trials next year on its first HPV vaccine candidate, Medi-501.

The company said the study would be conducted at the University of Rochester Medical Center and expected the trial to last about a year.

Medi-501 has been tested on dogs. In that study, scientists found that the vaccine protected the animals against warts caused by the virus.

Pub Date: 12/12/97

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