Genentech, Roche, and GlycArt (a company wholly-owned by Roche) have entered into a collaboration that includes a license from GlycArt to Genentech for the joint development and commercialization of GlycArt’s GA101 molecule. The companies will develop GA101, a humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death, for the potential treatment of hematological malignancies and other oncology-related B-cell disorders such as non-Hodgkin’s lymphoma.
   
Under the agreement, the three companies will share certain development costs and Genentech will record $105 million in R&D expenses in 3Q08. Genentech will receive commercialization rights in the U.S. GA101 is currently in Phase I/II trials for CD20-positive B-cell malignancies, such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). GlycArt and Roche plan to provide Phase I data at the American Society of Hematology meeting in December 2008.
   
Pablo Umaña, chief scientific officer and co-founder of GlycArt, said, “With its unique mode of action, we believe GA101 has the potential to extend the therapeutic benefit over current standards of care, including treatment for patients who do not respond to current therapies.”
  
“This collaboration with GlycArt and Roche for the GA101 molecule complements our existing research program and our focus on innovative compounds,” said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We are pleased that through this program we may have the potential to offer a new option to treat patients with hematological malignancies.”
   
“Our early investment in pioneering technologies continues to provide new hope for patients,” said William M. Burns, chief executive officer, Roche Pharmaceuticals. “The exciting work in antibody engineering carried out by our scientists at GlycArt can now be taken to the next stage in developing clinically differentiated treatments.”

A federal court granted Amgen a permanent injunction prohibiting Roche Holding AG from selling its Mircera anemia treatment in the U.S., as well as upheld a jury verdict regarding certain patent-infringement claims.
   
Mircera is currently available in Europe and the FDA has approved the drug, but the legal dispute prevented its sale. The drug, if released in the U.S., would compete directly with Amgen's anemia drugs Aranesp and Epogen, which accounted for more than 40% of its revenue in 2007.  
   
In March, a Massachusetts district county judge pushed back his decision on whether to grant Amgen the permanent injunction, asking a third party to compare dosing and pricing of the companies' products. A jury had found last October that Roche's Mircera infringes 11 of Amgen's patents protecting Epogen.
   
"Amgen is pleased with today's ruling, which recognizes that Amgen is entitled to a permanent injunction against Roche and reaffirms the infringement and validity of our patents," general counsel David Scott said in a statement.

Alba Therapeutics Corp. has made several promotions. Linda Arterburn, Ph.D., has been promoted to vice president of preclinical development and program management. Francisco Leon, M.D., Ph.D., has been promoted to vice president, clinical development and medical affairs. Roberto Allen has been promoted to vice president, legal affairs and intellectual property. Mark Ginski, Ph.D., has been promoted to senior director of product and analytical development and Kate Huber has been promoted to director of clinical operations.
   
Prior to joining the company, Dr. Arterburn was executive director of discovery research at Market Biosciences where she initiated an inflammation research program and was lead inventor on two patents involving novel anti-inflammatory lipids. Previously she led clinical research and scientific affairs at Market Biosciences. Dr. Arterburn also spent seven years at W.R. Grace & Co., where she led an in vitro toxicology research program, and then served as manager of technology and planning.
   
Dr. Leon is an immunologist with training in basic and clinical immunology and a clinical development in the field of mucosal immunology. Prior to joining the company, Dr. Leon was a director of clinical development, inflammatory and respiratory diseases at MedImmune, where he worked on asthma and mucosal vaccination. He was a director of clinical discovery, oncology / immunology at Bristol-Myers Squibb, where he worked on Crohn's disease, rheumatoid arthritis, and transplantation.
   
Prior to joining the company, Mr. Allen was president of Respire Medical, Inc., a respiratory and home health care provider serving the Mid-Atlantic region. He was also counsel at Kollman & Saucier, P.A., where he practiced general corporate and labor and employment law. Previously, he was a senior associate in the business department at Saul Ewing LLP.
   
Dr. Ginski's has experience with lead candidate selection, preformulation and formulation development, development, transfer and validation of analytical and bioanalytical methods, and packaging, labeling and distribution of clinical trial supplies. Prior to joining the company, Dr. Ginski served as associate director of preformulation sciences at Shire, where he played an integral role in developing and implementing Shire's Proscreen and Optiscreen programs designed to facilitate lead candidate selection and product development. Additionally, he worked at Guilford Pharmaceuticals, where he was responsible for leading exploratory pharmaceutics and CMC programs for various development programs. He has published numerous R&D articles and is an inventor for numerous global patents.
   
Ms. Huber has more than 25 years of experience in the health care industry and has been involved in all aspects of the conduct of Phase I - III clinical trials. She has worked in managing complex projects in the areas of celiac disease, oncology, CNS, vaccines, and diagnostics for HIV, HbsAg, and tuberculosis. Ms. Huber joins the company from Nabi Biopharmaceutical and Guilford Pharmaceuticals, where she had increasing responsibilities in the vaccine, oncology and CNS arenas. She has extensive experience in the diagnostic business and previously worked for Ortho Diagnostic Systems, Inc. and Pharmacia, where she helped develop diagnostic tools for pregnancy, HIV, Hepatitis B, and blood banking reagents.