Crucell signs three PER.C6 cell line deals

By Ted A. Knutson

Washington, Dec. 22 - Crucell NV announced Thursday it has signed three deals for its PER.C6 cell line.

Crucell has signed a PER.C6 contract manufacturing license agreement with the Saskatchewan Research Council of Saskatoon, Canada. That allows the council to sell services to PER.C6 licensees and not-for-profit organizations, for the manufacture of gene therapy products and vaccine products, using PER.C6.

This agreement also grants the council a research license in order to expand its expertise in the use of PER.C6 technology with a focus on veterinary and human vaccines. Under the terms of the agreement, the council will pay an initial license fee together with annual maintenance fees and royalties.

Crucell additionally has signed a second PER.C6 research license agreement with Merial, an animal health company.

The non-exclusive agreement allows Merial to use the PER.C6 cell line for the development of gene therapy in a specific field of companion animal medicine and includes an option for a commercial license agreement. The new agreement follows the October 2004 licensing deal, which allows Merial to use PER.C6 for the development and commercialization of veterinary vaccines for foot-and-mouth disease.

Crucell has also signed a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research to evaluate PER.C6 technology for the development of vaccines against the flaviviruses dengue fever and Japanese encephalitis.

Walter Reed is engaged in the development of a second-generation Japanese encephalitis vaccine to replace the current mouse-brain-derived inactivated vaccine, and a first-generation inactivated vaccine for dengue. Inactivated vaccines have been successful in preventing flaviviruses such as Japanese encephalitis and tick-borne encephalitis, but the approach has not been fully explored for dengue, largely because of the difficulty in growing the virus to sufficiently high titers.

Crucell's PER.C6 cell line has demonstrated susceptibility to dengue and Japanese encephalitis, and its ability to achieve the necessary growth of each virus will be explored under the development agreement with Walter Reed.

Flaviviruses are a mosquito or tick borne family of viruses of which West Nile virus is also a member. Crucell is developing a vaccine against West Nile virus based on its PER.C6 technology. As with West Nile, which has moved steadily throughout the United States since its emergence in New York in 1999, the endemic areas of dengue and Japanese encephalitis are also expanding at an alarming rate.

Dengue is the most important mosquito-borne viral disease affecting humans today; its global distribution is comparable to that of malaria, and an estimated 2.5 billion people live in areas at risk for epidemic transmission.

More than 45,000 cases of Japanese encephalitis are reported annually, with its geographic distribution recently expanding into the Pacific region.

Further financial details for the deals were not disclosed.

Crucell is a biotechnology company based in Leiden, The Netherlands, that develops vaccines and antibodies.

The announcements were made in 6-K filings with the Securities and Exchange Commission.

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