Vivante GMP Solutions Enters into License Agreements with Crucell
February 17, 2010 (PRLEAP.COM) Business NewsHOUSTON, Texas — Vivante GMP Solutions, Inc. ('Vivante'; www.vivante-gmp.com) today announced that it has finalized its license agreements with Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX).
Both a patent license and a vendor network manufacturing service license agreement were executed. The patent license agreement grants Vivante a worldwide, non-exclusive license of intellectual property to conduct development and manufacture using the adenoviral-based patent portfolio acquired by Crucell from Introgen Therapeutics, as announced by Crucell on August 11, 2009. The vendor network manufacturing service license agreement grants Vivante a non-exclusive license to utilize Crucell's PER.C6® cell line in the manufacture of gene therapy and vaccine products for Vivante's clients through Phase 1 clinical trials. Manufacture of products for use in Phase 2 clinical trials and beyond requires a separate license from Crucell.
"We are in the unique position of being able to offer our clients the ability to use the PER.C6® cell line to manufacture their products through Phase 1 trials," said David Enloe, Vivante's founder, President and CEO. "This provides a tremendous benefit for those clients such as universities and small biotechnology companies who are in the early stages of product development where entering a license agreement of their own may not make sense."
ABOUT VIVANTE GMP SOLUTIONS, INC.
Vivante provides its clients with flexible, disposable technology-dependent, scalable Good Manufacturing Practices (GMP) production capabilities, including the skills needed to convert early stage, lab-grade production into robust and scalable therapeutic product classes, suitable for clinical studies and commercial use. Vivante offers its clients access to its intellectual property portfolio, which includes patents, proprietary quality and validation systems, and broad GMP knowledge systems. Vivante operates a state-of-the-art GMP clean room facility which includes production and fill/finish capabilities, as well as facilities for research and development and Quality Control. In addition to its GMP manufacturing service, Vivante offers process development and optimization, Quality Control analytical testing, and on- and off-site GMP product storage and distribution to clinical trial sites. Notably, through its predecessor company, Vivante created the adenoviral reference material (ARM) that serves as the industry gold standard against which all other U.S. adenovirus-based materials are compared.
Vivante was created in 2009 as a result of the purchase of the process and production-related assets of Introgen Therapeutics, Inc., a company that had taken its lead adenovirus-based product from inception in 1993 through BLA and MAA filings in 2008. Concurrent with the asset purchase, the management and technical team joined Vivante, thus assembling the critical pieces of a new CMO focused on viral development and GMP production.
For more information about Vivante, please visit www.vivante-gmp.com.
Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6® production technology. The Company licenses its PER.C6® technology and other technologies to the biopharmaceutical industry. Important partners and licensees include Johnson & Johnson, DSM Biologics, Sanofi-aventis, Novartis, Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Argentina, China, Italy, Korea, Spain, Sweden, Switzerland, UK and the USA. The Company employs over 1200 people. For more information, please visit www.crucell.com.