BioWorld International Correspondent
LONDON - KS Biomedix Holdings plc agreed to a licensing deal worth up to US$60 million for its TransMID 107 brain cancer treatment with Nycomed Group.
The license includes rights to the initial indication in recurrent glioma, plus additional indications including newly diagnosed and metastatic brain cancer. If all indications succeed, KSB would receive total payments of $60 million, plus royalties, and also would manufacture the product.
Since acquiring the product last year when it took over Avicenna Inc., of Edmonton, Alberta, KSB has signed TransMID deals with a total potential value of up to $85 million, plus product sales.
Shares in KSB, based in Guildford, rose by 7 pence to 21 pence when the deal was announced last week.
CEO Steven Powell said signing the license was a major milestone in the TransMID development program. "In appointing Nycomed we are working with a partner that has a large and experienced hospital sales force capable of ensuring the product achieves wide market reach across Europe." Nycomed, of Roskilde, Denmark, has more than 1,000 sales and marketing staff members and a number of distributors.
Nycomed also will contribute regulatory and clinical expertise, to help patient recruitment into the European pivotal trial, and with the regulatory submission in Europe. The Phase III trial in recurrent high-grade glioma is due to start in North America and Europe in the last quarter of 2002.
TransMID consists of modified diphtheria toxin designed to selectively kill cancer cells. A Phase II U.S. study showed an improvement in survival times in patients with recurrent brain cancer. The product has FDA fast-track and orphan drug status. KSB intends to retain the North American rights.
In May 2002, KSB signed a $25 million Japanese development and marketing deal with Sosei Co. Ltd., of Tokyo, for TransMID. Sosei is applying for approval for a pivotal trial and for orphan drug status, and a Japanese trial is expected to take place in 2004.
Keith Redpath, an analyst at WestLB Panmure, said the Nycomed deal highlights the value that is inherent in the portfolios of some European biotechnology companies. "Deals with larger partners will continue to be secured by emerging companies, despite current investor sentiment toward the sector.
"While the product is in a niche indication," he said, "the deal does help reduce the company's cash burn, demonstrates the commercial ability of the management and improves the company's chances of securing more funds."