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In addition to our own research and development activities, Crucell has formed strategic agreements with several leading companies. Through these agreements, our technologies are playing a vital role in the development of a number of vaccine and antibody products.
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Over the years, Crucell and Merck have developed a close working partnership, entering into a number of agreements. In October 2000, Crucell entered into an agreement with Merck, in which Merck was granted an exclusive license to use Crucell’s PER.C6® cell line in developing a vaccine against HIV*.
In June 2003, Merck and Crucell expanded a Cooperation Agreement whereby the two companies agreed to work closely on matters relevant to maintenance of the PER.C6® Cell Substrate Biologics Master File. Merck and Crucell further expanded their relationship in December 2006, when both companies signed a cross-licensing agreement for vaccine production technology.
* The development of this vaccine was discontinued in September 2007 but this was unrelated to the use of Crucell’s PER.C6® technology.
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In December 2002, Crucell formed an alliance with DSM Biologics to license Crucell’s PER.C6® human cell line as a production platform for monoclonal antibodies and recombinant proteins. The combination of the PER.C6® human cell line and DSM's manufacturing services provides companies with a turn-key biologic manufacturing solution reducing cost, risk and time to market. Furthering this commitment to the PER.C6® cell line, Crucell and DSM have established a joint PER.C6® R&D Center in Cambridge, Massachusetts, named PERCIVIA. The innovations resulting from this partnership will be available to licensees to further enhance their development capabilities.
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In December 2003, Crucell signed a strategic agreement with sanofi pasteur to further develop and commercialize novel influenza vaccine products based on Crucell's proprietary PER.C6® cell line technology. The agreement covers both pandemic and epidemic influenza vaccines. Sanofi pasteur has the worldwide rights to develop, manufacture and commercialize PER.C6®-based influenza vaccines. Crucell has the commercialization rights for Japan, which represents 15% of the US$ 1.5 billion global influenza vaccine market.
In Europe, Crucell and sanofi pasteur combined as the only manufacturer for the FLUPAN program. FLUPAN intends to enhance EU preparedness for an influenza pandemic by improving on existing vaccine production techniques through the development of novel cell-based vaccines.
In April 2005, sanofi pasteur, with Crucell as a subcontractor, received a US$97 million contract by the US Department of Health and Human Services (HHS) for clinical development of PER.C6®-based influenza vaccine and other related activities. The objective of the contract is to accelerate the licensure in the U.S. of a PER.C6®-based cell-culture influenza vaccine and vaccine manufacturing facility. The project is part of the U.S. government's effort to increase influenza vaccine manufacturing capacity in the event of a pandemic or other influenza health emergency.
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In March 2006, the Korea Food and Drug Administration (KFDA) awarded licensure to Quinvaxem™, a fully liquid pentavalent pediatric vaccine. The vaccine is produced by Crucell in Korea and was co-developed with Chiron Corporation (now Novartis), which provides four of the five vaccine components as bulk.
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In October 2007, MedImmune and Crucell entered into an exclusive license and research collaboration to further develop and commercialize one of Crucell’s panels of bacterial antibodies primarily for the treatment and prevention of hospital-acquired bacterial infection. The partnership combines Crucell’s unique antibody discovery, research and development capabilities with MedImmune’s expertise in clinical development and commercialization of anti-infective antibodies.
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