J&J Restructures

Posted on August 1, 2007 @ 09:42 am

Johnson & Johnson is restructuring and plans to reduce its global work force by 4% or approximately 4,820 jobs, in an effort to counter losses as a result of falling sales of its heart stents due to safety concerns and impending patent expirations for key drugs Risperdal and Topamax. The company expects to save $1.3 billion to $1.6 billion in 2008.

The company predicts that restructuring charges will be between $550 million and $750 million in the second half of 2007. According to the company, the restructuring primarily impacts its pharmaceuticals segments and its Cordis stent-making unit in Miami Lakes, FL. Under the restructuring, J&J will consolidate certain operations at the pharmaceuticals segment and integrate its Cordis business. J&J also plans to fire as many as 800 employees from its Alza and Scios subsidiaries.

"The actions we are taking are to ensure we've addressed the short-term pressures on the business," chief executive officer William Weldon told analysts during a conference call. "We believe we actually will be strengthening ourselves coming out of all of this."

"This type of impact is difficult but necessary," chief financial officer Dominic Caruso said, adding that J&J will use attrition and hiring freezes in certain areas of the business to lessen the impact on employees.

Abraxis Acquires Watson Injectables Facility

Posted on August 1, 2007 @ 09:40 am

Abraxis BioScience, Inc. has acquired a sterile injectable manufacturing facility in Phoenix, AZ, from Watson Pharmaceuticals, Inc. This facility currently manufactures products for both Watson and third parties and is capable of manufacturing lyophilized powders, suspension products, and aqueous and oil solutions. Under the terms of the agreement, Abraxis will serve as a contract manufacturer for certain injectable products currently manufactured in this facility for a specified period of time. Financial terms were not disclosed.

This fully equipped facility is approximately 200,000 sq. ft. and includes manufacturing and chemistry and microbiology labs. Abraxis expects that this facility, along with its manufacturing facility located in Melrose Park, IL, will manufacture the company's current and future products such as Abraxane for Injectable Suspension after completion of the planned separation of its proprietary product business -- Abraxis Oncology and Abraxis Research (the new Abraxis BioScience) from its hospital-based product business -- Abraxis Pharmaceutical Products (APP).

"Subsequent to the announcement of our pending separation, we have made a concerted effort to make strategic decisions that support the long-term viability and growth of each operation," said Patrick Soon-Shiong, M.D., chief executive officer and executive chairman of Abraxis. "The acquisition of this facility will allow us to expand our cGMP manufacturing capabilities to provide the necessary infrastructure for worldwide growth of the new Abraxis BioScience."

MDS Expands Services in Europe

Posted on August 1, 2007 @ 09:36 am

MDS Pharma Services is expanding its Development & Regulatory Services (DRS) business in Europe and will now offer full-service DRS consulting services to support development of new drugs and biopharmaceutical products for clients in Europe. The DRS organization will also be fully integrated with consultants in the U.S. and Canada to provide product development consulting, program management, and regulatory affairs services.

"This expansion in Europe will greatly broaden our consulting capabilities in development and regulatory services," said MDS Pharma Services president David Spaight. "We will now be able to provide expertise to support our biotechnology and Asian pharmaceutical clients in the process of commercializing their products in North American and European markets."

This expansion includes the appointments of two industry experts, Didier Saur, M.D. as vice president of medical affairs, and Sarah Roberts, Ph.D. as senior director of regulatory affairs. Based near Paris, France, Dr. Saur will lead the MDS Pharma Services product development consulting, program management, and regulatory affairs services in Europe. He will also be responsible for organizing and chairing the medical advisory board for DRS. Dr. Saur has more than 20 years' experience as a physician in the pharmaceutical and contract research industry.

Dr. Roberts will be based near London and will provide regulatory affairs consulting for clients on European regulatory issues. She has more than 10 years' experience and is an oncology research specialist. Dr. Roberts has worked with the Dana Farber Cancer Institute in Boston, MA and the Gray Cancer Institute in London. She has experience with regulatory agencies in both North America and Europe, and most recently served as a director for Smart Regulatory Solutions Ltd, an independent consulting firm she established.