Merck Serono and
Flamel Technologies have entered into a collaboration to investigate the applicability of Flamel's Medusa technology for the extended release of a therapeutic protein of Merck Serono’s portfolio. Merck Serono will make an upfront payment of $2.8 million to Flamel for investigating the therapeutic protein and will fund R&D efforts performed by Flamel. Financial terms, including a license agreement to cover potential commercialization, were not disclosed.
"We are delighted to enter into this partnership with Flamel, as it gives Merck Serono access to a technology that may further improve the therapeutic potential of compounds in our portfolio," said Bernhard Kirschbaum, Merck Serono's head of research. "As Flamel's Medusa technology allows for longer intervals between administrations of injectable proteins compared to standard formulations, we hope to offer an improved convenience for patients requiring treatment by injection. As a consequence, we anticipate that employing this technology will lead to better treatment outcomes for patients."
Stephen H. Willard, Flamel's chief executive officer, remarked, "We are pleased to have reached an agreement with Merck Serono. The Medusa platform is a best-in-class technology for the controlled delivery of proteins, peptides, and other molecules. This applicability to a wide range of molecules is a key strength of the platform, as is the ability to sustain release without affecting bioactivity. Merck Serono is the ideal partner for this project and we look forward to working together on such an exciting opportunity."
MPI Research and
Shanghai Medicilon have formed a joint venture in preclinical services. Medicilon-MPI Preclinical Research (Shanghai) LLC will be located initially at the Zhangjiang Hi-Tech Park in Shanghai, China. The group will open a 50,000-sq.-ft. preclinical testing facility in the Chuansha Economic Park in early 2008. This new facility will meet the regulatory standards set forth by the US FDA and other regulatory agencies worldwide, according to a joint statement.
The JV is intended to provide current and future customers access to a broad range of both GLP and non-GLP preclinical services. By 2009, the new company will be fully operational, in terms of conducting FDA/IND enabling studies, offering additional preclinical support services, submitting INDs and NDAs, and will have AAALAC accreditation.
"With one fourth of the world's population, China is an important force in shaping the global pharmaceutical and biotechnology markets," said William U. Parfet, chairman and chief executive officer of MPI Research. "We have carefully looked for more than three years to find a CRO partner that shares our values and commitment to excellence, and we have finally found one in Shanghai Medicilon. We look forward to forging a future together as a worldwide leader of preclinical research services."
Dr. Chun-Lin Chen, co-founder of Medicilon, Inc. and Shanghai Medicilon, will serve as the chief executive officer of Medicilon-MPI Preclinical Research. Dr. Chen received his Ph.D. from Oklahoma State University and completed post-doctoral training in the U.S.
A multidisciplinary team of experts originating from MPI Research headquarters will relocate to Shanghai and form a GLP Advisory Board to oversee FDA GLP compliance. This team will have a broad range of experience in small and large animal toxicology, safety pharmacology, pharmacokinetics, animal care, quality assurance, report writing, pathology, and study direction. In partnership with the MPI Research team, more than 70 Shanghai Medicilon professionals will be joining the newly formed organization.
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