Pharmaceutical Development Services Ltd. (PDS) has opened an office in South Carolina to support expansion efforts in the U.S. Dr. Jeff Rudolph will guide U.S. pharmaceutical companies with drug development in Europe, covering regulation, quality management, European legal framework and the sourcing of local contractors.

Dr. Michael Gamlen, managing director of PDS, said, "Having established expert knowledge in European pharmaceutical development, we have built up a bank of expertise in our team that can considerably shorten the timescales and reduce the costs for American companies of introducing pharmaceutical products into Europe. Our business from U.S. companies has steadily increased and by opening a U.S. office with Dr. Rudolph as our main contact point, we are ensuring that we can effectively manage our expansion in the U.S."

Dr. Rudolph is an experienced pharmaceutical scientist with more than 30 years of experience with domestic and international development and management of branded, generic and OTC products. He held senior pharmaceutical development positions at McNeil Laboratories (J&J) and spent 23 years at AstraZeneca and its predecessor companies, where his responsibilities included vice president, international pharmaceutical development/R&D operations. Dr. Rudolph most recently provided consulting services to the healthcare industry in the areas of CMC, process optimization, production troubleshooting, device design, organizational and business development as well as serving as an expert witness on formulation/drug delivery patent cases.

MorphoSys AG will receive a milestone payment from Centocor Ortho Biotech, Inc. for the initiation of a Phase I trial using a HuCAL-derived, fully human antibody in the therapeutic area of inflammation.

"The advancement of a new HuCAL antibody into human clinical trials is an important step forward for MorphoSys," commented Dr. Simon Moroney, chief executive officer of MorphoSys. "Progress in the development of innovative biopharmaceutical agents by our partners is a key driver of our company's growth."

This is the second HuCAL antibody program derived from the companies' collaboration to enter clinical trials. With the new study, Centocor Ortho Biotech will be running three clinical trials of HuCAL antibodies.

Mylan Inc. and Biocon Ltd. have entered a definitive agreement to collaborate on the development, manufacture, supply and commercialization of multiple, generic biologic compounds.

Mylan's chairman and chief executive officer Robert J. Coury commented, "This unique collaboration combines Biocon's scientific expertise, excellent product development track record, appreciation of complex regulatory requirements, and state-of-the-art, cost-efficient and scalable biologics manufacturing with Mylan's one-of-a-kind global commercial footprint and our regulatory expertise around the world. Biocon also has a unique corporate culture that is very similar to Mylan's. All of these attributes will provide a critical synergy and create a strong and effective long-term partnership."

Biocon chairman and managing director Dr. Kiran Mazumdar-Shaw commented, "Biocon is extremely pleased to have found a partner as strong as Mylan to accelerate our work in generic biologics, especially with monoclonal antibodies, and take it to the next level around the world, especially in regulated markets. Monoclonal antibodies are emerging as the most dominant class in biologics. Through this partnership we hope to deliver high quality, affordable biogeneric antibodies and biologics, thereby addressing a critical need to lower spiraling healthcare costs in both the developed and emerging economies."

The two companies will share development, capital and certain other costs. Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand and in the EU through a profit sharing arrangement with Biocon. Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world. Financial terms and product details were not disclosed.

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