Alnylam Pharmaceuticals has earned a $20 million technology transfer milestone from Takeda Pharmaceutical Co. Ltd. as part of the companies' strategic alliance formed in May 2008. The payment is related to the transfer of Alnylam’s platform technology, including documents, materials, and intellectual property, to Takeda for the development of RNAi therapeutics. Alnylam also received a $100 million upfront payment when the deal was executed. Alnylam is eligible to receive an additional $30 million in technology transfer milestone payments.
   
“We are excited about the progress we have already made in enabling Takeda with Alnylam RNAi drug discovery capabilities and intellectual property,” said Barry Greene, president and chief operating officer at Alnylam. “We look forward to continuing our efforts in this strategic collaboration which is focused on advancing the development of RNAi therapeutics on a global basis, including Alnylam’s right to co-develop and co-commercialize certain Takeda RNAi therapeutic products in the U.S. market.”
   
The agreement provides Takeda with worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. It also includes a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi targets. Alnylam has opt-in rights to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S.

Genentech and Biogen Idec's Phase III study of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL), compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study.  
   
An independent review of the primary endpoint is being conducted for U.S. regulatory purposes. Data from the study, REACH, will be submitted for presentation at a future medical meeting.  
   
"REACH, the largest relapsed CLL trial ever conducted, is the first Phase III study of this treatment combination to show an improvement in progression-free survival for patients," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future.”
   
"Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy," said Cecil Pickett, Ph.D., Biogen Idec's president of R&D. "The REACH results are promising, and pending confirmation of the results by independent review, we look forward to submitting an application to the FDA for Rituxan’s potential approval in this indication."

Pharmatech Associates has been chosen by Pacific Biopharma Group (PBG) to provide the design for the first FDA- and EMEA-approved biomanufacturing facility to be built in China, which will represent the first reference document reviewed by the FDA as part of any licensure activity in China.
   
The new 181,000-sq.-ft. facility is a cGMP lab that uses single-use technology throughout the biomanufacturing process. The facility will be located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC). The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects from the California Institute for Quantitative Biosciences (QB3).   
   
“Pharmatech Associates understands every phase of the drug development lifecycle, not just pharmaceutical construction,” said Dr. S. Chang, vice president manufacturing, Pacific Biopharma Group. “Their ability to integrate the critical considerations necessary for international biological market approval is essential to the success of our program in China.”
   
“We are delighted that PBG chose Pharmatech for this endeavor. The project caters directly to our deep understanding of product development, technology and international compliance,” said Bikash Chatterjee, president and chief technology officer, Pharmatech Associates.