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Leiden, The Netherlands, January 31, 2001 - Crucell N.V. (EAX Amsterdam: CRXL; Nasdaq: CRXL), a leading Netherlands based biotechnology company, today announced that it has signed a production agreement with Annapolis (USA) based DirectGene Inc. to manufacture their therapeutic product for studies in the USA.
Under the terms of the agreement, Crucell will manufacture clinical grade batches of DirectGene's product for treatment of prostate cancer using its human cell line production platform PER.C6. It is expected that DirectGene's product will enter into clinical trials later this year. This production agreement follows the signing of a license agreement with DirectGene in 2000 for access to Crucell's PER.C6 technology. Financial terms were not disclosed.
"We are delighted with this first production agreement to produce clinical material on PER.C6 for DirectGene in our GMP facilities for use in the USA. " says Dinko Valerio, President & Chief Executive Officer of Crucell. "Several PER.C6 derived products are in or will soon be in clinical studies in both the USA and Europe. It has always been our strategy to have as many products as possible derived from PER.C6 go into clinical development. In order to support this, we facilitate our partners, specifically the smaller biotech companies, by manufacturing clinical batches for them. This first agreement is a good step towards executing that strategy. "
Crucell N.V. was formed in June 2000, through the merger of IntroGene B.V. and U-BiSys B.V., both from The Netherlands and listed on October 27, 2000 on both Nasdaq and Euronext Amsterdam. Crucell has two widely applicable technology platforms, a human cell line expression platform, PER.C6, and a subtractive phage antibody-display selection technology, called MAbstract, which provide a powerful and effective means to discover, develop and produce a variety of biopharmaceuticals for the treatment of human diseases, such as vaccines, human antibodies, therapeutic proteins and gene-therapy products. Crucell's technologies are fully human and, as such, enable biopharmaceuticals to be developed and produced that do not have the limitations inherent in many biopharmaceuticals currently available. Crucell has signed 15 license agreements for PER.C6 with major pharmaceutical and biotechnology companies. Crucell is investing in functional genomics through its joint venture with Belgian based Tibotec, called Galapagos Genomics. Crucell currently employs approximately 115 people in its facilities in Leiden, Utrecht and Leuven (Belgium).
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