When it's not focusing on developing vaccines and antibodies against infectious diseases, Crucell NV leverages its PER.C6 technology through nonexclusive licensing agreements with pharmaceutical and biotechnology companies.
While the company, based in Leiden, the Netherlands, has worked on various projects with London-based GlaxoSmithKline plc, the two parties forged another agreement in which GSK will try to find new therapies to fill its pipeline.
"They have access to the PER.C6 technology for research and preclinical development on their recombinant monoclonal antibody products," said Elizabeth Goodwin, director of investor relations and corporate communications for Crucell.
Under the five-year agreement, Crucell and its contract manufacturer, DSM Biologics, of Sittard, the Netherlands, will receive an up-front payment and annual maintenance fees from GSK. Crucell and DSM formed a protein-production collaboration in December 2002 and have since marketed the PER.C6 technology, securing more than 10 licensees to date, including Malvern, Pa.-based Centocor Inc. and Chiron Corp., of Emeryville, Calif.
The alliance combines DSM's manufacturing capacity and production expertise with Crucell's cell line technology to produce recombinant proteins and monoclonal antibodies. In July, Crucell received a milestone payment from DSM. The new agreement with GSK represents more evidence that the Crucell and DSM alliance is "on track and doing well," Goodwin told BioWorld Today.
According to Crucell, the market for recombinant proteins and monoclonal antibodies is in excess of $36.4 billion and is growing 20 percent a year. GSK has not specified a therapeutic area in which it will focus, and it can use the PER.C6 technology for its entire portfolio of monoclonal antibody products, Goodwin said.
The PER.C6 technology provides Crucell with an ongoing revenue stream. And with the most recent agreement, it could go beyond the initial up-front payment and fees if GSK gets a product to the market.
"If they would go to a commercial phase with one of these products that come out of this research, and if they want to continue to use PER.C6, they would have to make a commercial contract with us," Goodwin said. "If it were to go to a commercial contract, there would be different terms, including looking at royalties and things like that."
In addition to its alliance with DSM for proteins and antibodies, Crucell has alliances with other contract manufacturing organizations, including U.S.-based Molecular Medicine Bioservices and Tokyo-based Gene Medicine Japan for the production of PER.C6-based recombinant vaccines and gene therapy products, and with Novavax Inc., of Columbia, Md., for the production of classical vaccines.
Crucell started as a gene therapy company in 1993 under the name IntroGene. The founders recognized the need for a better technology to develop gene therapy vectors and vaccines, and therefore, developed the PER.C6 technology in collaboration with Leiden University.
The technology was launched in 1997 for the commercial production of gene-based therapies. In 1999, it was expanded into the new fields of vaccines, proteins and monoclonal antibodies. Two years ago, Crucell launched it for fully human monoclonal antibodies.
IntroGene merged in 2000 with the Dutch company U-Bisys and changed the company's name to Crucell. U-Bisys brought its antibody technology, MAbstract, to the merged entity.
"Until last year, we focused on licensing our PER.C6 technology and developing our own oncology antibody products," Goodwin said.
But in 2003, the company began to focus on development programs against infectious diseases, including Ebola, influenza, malaria and West Nile virus. It is working in collaboration with GSK, the Walter Reed Army Institute of Research and New York University for a malaria vaccine. It also has an agreement worth $38 million with Aventis Pasteur, the vaccines business of Lyon, France-based Aventis SA, which was signed earlier this year for influenza vaccines, and another agreement with the U.S. National Institutes of Health for Ebola and malaria vaccines.
The company went public in 2000. Its stock (NASDAQ:CRXL) rose 12 cents on Friday to close at $6.97.