Daiichi Sankyo Co., Ltd. has entered into an agreement to acquire U3 Pharma AG, a privately held German biotechnology company focusing on antibody research for the treatment of cancer. Daiichi Sankyo will purchase all of the stock and make a one-time payment of $235 million. The transaction is subject to customary closing conditions.
   
U3 Pharma was founded by Professor Axel Ullrich of the Max Planck Institute of Biochemistry, whose gene technology-based and oncology-focused research led to the development of the oncology drugs Herceptin and Sutent. U3 Pharma was established in 2001 and currently employs 27 people, the majority of whom work in R&D.
   
U3 Pharma's pipeline of targeted therapeutics includes programs focusing on fully-human antibodies as potential therapies for breast, lung and colorectal cancers, among others. The company's lead product, which is being co-developed with Amgen, is U3-1287 (AMG 888), the first fully-human anti-HER3 monoclonal antibody (mAb) to inhibit oncogenic signaling and tumor proliferation. The companies intend to initiate clinical development of this compound this year.
   
"Our acquisition of U3 Pharma is an ideal strategic fit for our oncology portfolio," said Takashi Shoda, president and chief operating officer of Daiichi Sankyo Co., Ltd. "We currently have three human monoclonal antibodies in development. Additionally, in March, 2008, we announced that we were expanding our joint research venture with another German company, MorphoSys AG, for its advanced Human Combinatorial Antibody Library and its phage display technologies. One of our goals for Daiichi Sankyo is to increase our presence in novel therapeutics in the oncology arena."

Almac Clinical Technologies, a division of the Almac Group, has signed a record $12 million worth of new studies within the past several weeks, including a global mega-study involving almost 20,000 patients.
   
Almac Clinical Technologies president Jim Murphy commented, "We are seeing an increase in the number of large, global, complex trials as well as smaller adaptive clinical trials, each requiring sophisticated randomization and drug management approaches. Sponsors seem to be turning to experienced global firms, such as Almac, with strong project management expertise and technologies to make those trials successful."

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. have updated the clinical development program for aflibercept, and provided results from a Phase II study in advanced ovarian cancer. The companies reported that a recent study did not achieve its primary endpoint of demonstrating that patients in either arm of the study achieved a RECIST (Response Evaluation Criteria in Solid Tumors) response rate that was statistically significant.
   
The two companies are now enrolling approximately 4,000 patients in the U.S., Europe, and other countries, in four Phase III studies that combine aflibercept with standard chemotherapy regimens. The studies include: second-line treatment for metastatic colorectal cancer in combination with folinic acid, 5-FU, and irinotecan; first-line treatment for metastatic pancreatic cancer in combination with gemcitabine; first-line treatment for metastatic androgen-independent prostate cancer in combination with docetaxel and prednisone; and second-line treatment for metastatic non-small cell lung cancer in combination with docetaxel. A Phase II first-line study of aflibercept in metastatic colorectal cancer in combination with folinic acid, 5-FU, and oxaliplatin is expected to begin later this year.
   
“We and sanofi-aventis are continuing to evaluate the data from this trial in order to determine the next steps for aflibercept in advanced ovarian cancer,” commented George D. Yancopoulos, M.D., Ph.D., president of Regeneron Research Laboratories.

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