Morphotek, Inc., a U.S. subsidiary of Eisai has entered into agreement with CMC Biopharmaceuticals of Copenhagen, Denmark for development, GMP manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.

"We are extremely pleased to have selected CMC as our contract manufacturer for this IgM monoclonal antibody," said Philip Sass, Ph.D., executive vice president and chief operating officer of Morphotek. "CMC has production and scaleup experience with IgM monoclonal antibodies and a team of dedicated scientists that have tackled difficult purification and analytical development programs. We are confident that CMC will meet both our production and quality goals as well as timelines for product supply to support our planned clinical trials."

According to Morphotek, its antibody development technologies and expertise have enabled it to successfully develop this unique IgM antibody and establish a process for large-scale production. Historically, IgM MAbs have been underrepresented in human therapeutic development due to production difficulties and other manufacturing constraints. MORAb-028 is being prepared to enter clinical evaluation in 2008.

Eden Biodesign Ltd. has been licensed by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture Investigational Medicinal Products (IMPs) at its new facility in Liverpool, UK. The UK National Biomanufacturing Centre came on-line for process and analytical development in May 2006. The MHRA inspection took place earlier this year to certify Eden’s processes and facilities as having reached cGMP standards. The new license will provide legal authority for Eden to manufacture biopharmaceutical drug substances under contract for clients for use in EU clinical trial sites.

Dr. Crawford Brown, Eden Biodesign's chief executive officer, commented, "Eden is now fully on track and able to deliver a full range of services for the production of mammalian, microbial and virus-based experimental medicines for a worldwide client base."

Following the successful inspection, the company will provide Cambridge, UK-based ImmBio with a range of development and manufacturing services to rapidly advance its influenza vaccine towards a Clinical Trial Application. Eden has also started to supply cGMP clinical manufacturing services to Onyvax, a private UK Biotech, for its ovarian cancer vaccine, and extended a project with Silence Therapeutics plc (formerly SR Pharma) to deliver a whole cell microbial immunotherapeutic for the treatment of asthma and as a therapeutic in cancer and tuberculosis.

Pfizer Global R&D president Dr. John LaMattina will retire from Pfizer by the end of this year, after 30 years with the company. Pfizer has begun a search both inside and outside the company for his successor, and Dr. LaMattina will remain during this period to ensure a smooth transition, according to the company. Chief financial officer Alan Levin has resigned to "pursue career opportunities outside Pfizer" after 20 years with the company.

Speaking on Dr. LaMattina's retirement, Jeff Kindler, Pfizer's chairman and chief executive officer, remarked, "Pfizer now has a significant array of early- and mid-stage product candidates across a range of important therapeutic areas, and John has made a critical contribution to building this foundation. With that in place, John felt it was the right time to retire as we look to the future and accelerate the development of our most promising compounds so that they will be ready for commercialization as rapidly as possible."

Mr. Kindler added, "During John's tenure we have grown our pipeline in oncology while substantially increasing our investment in biologics and vaccines, where we see attractive opportunities to combine our science with new technologies. Our progress in oncology, which was a relatively small program just 10 years ago, is especially noteworthy, and we are now in an excellent position to deliver important new cancer medicines."

Departing CFO Alan Levin commented, "I have been fortunate to work with many outstanding colleagues at this great company. Pfizer has grown in ways that none of us could have imagined, but always with a keen focus on serving patients and doing everything we can to address unmet medical needs. My colleagues in Finance, both in the U.S. and around the world, do an extraordinary job of managing the array of financial issues and challenges that come with a global corporation of Pfizer's size and complexity. I am proud of their dedication and of our many accomplishments. With a strong finance organization in place, and after 20 years of service with Pfizer, I feel that now is the appropriate time for me to explore career opportunities outside of the company. I have the deepest admiration for Pfizer and look forward to its success in the future."

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