Roche Carolina Inc. (RCI) has announced plans to expand its Florence, SC pharmaceutical manufacturing facility. The $60 million investment will involve the construction of a new multi-purpose production unit in an existing manufacturing building. The expansion will help enable Roche to meet production needs for current and future life-saving medications, according to a company statement. As a result of this investment, 25 to 30 new positions are expected to be created at the facility.

Construction is scheduled to begin in mid-2007 with completion by the end of 2008. An estimated 200 construction-related jobs, many to be provided through local contractors, will be required for the project.

"The decision to invest in Florence is a reflection of our past success and the willingness of Florence and South Carolina to encourage the growth of existing industry," said Dr. Frank Cox, president and general manager of Roche Carolina Inc. "We are grateful to the community for its support and recognition of the underlying importance of our business to improving human health."

Roche Carolina Inc., a pharmaceutical process development and bulk active ingredient manufacturing company, is an affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland.

SAFC, a member of the Sigma-Aldrich Group has completed construction of two new protein API facilities at its St. Louis, MO manufacturing campus. The new Biologics manufacturing facility consists of a 25,000-sq.-ft. cGMP purification and manufacturing suite for transgenic plant and other non-animal derived protein APIs and a 6,000-sq.-ft. facility for purification of animal-derived protein APIs. Validation for commercial operation of this $16 million expansion at the 400,000 sq. ft. St Louis manufacturing campus is expected by mid-year 2007.

"This expansion for SAFC Pharma further reflects our recognized market leadership in cGMP purification of therapeutic proteins from natural sourced material," said SAFC President Frank Wicks. "The expanded capacity responds to the increased demand for large-scale supply and will meet late-stage clinical trial and commercial manufacturing needs for both transgenic and naturally-sourced APIs."

The Biologics facility features some of the largest extraction and purification suites of their kind in the industry, according to SAFC. The Class 100,000 (ISO 8) and Class 10,000 (ISO 7) clean rooms will accommodate multiple one-meter chromatography columns and ultrafiltration operations, with API target quantities in the five-kilogram range. Also featured is a Class 10,000 (ISO 7) lyophilization suite.

Completely separated to prevent potential cross-contamination, the facility for animal-derived API purification also features Class 100,000 (ISO 8) and Class 10,000 (ISO 7) clean rooms. These will also include multiple one-meter chromatography columns and ultrafiltration operations to give API quantities in the five-kilogram range.

Bristol-Myers Squibb and Pfizer have announced a worldwide collaboration to develop and commercialize apixaban, an anticoagulant discovered by BMS being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. In a separate agreement, the companies will also collaborate on the R&D and commercialization of a Pfizer discovery program that includes advanced preclinical compounds with "potential applications for the treatment of metabolic disorders, including obesity and diabetes," according to a Pfizer statement.

Apixaban is currently in Phase III trials investigating its potential in the prevention of venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of stroke in patients with atrial fibrillation (AF). Phase II trials are studying apixaban in the treatment of acute symptomatic DVT and for the secondary prevention of cardiovascular events in patients with acute coronary syndrome.

Terms of the apixaban agreement include an upfront payment of $250 million by Pfizer to BMS. Pfizer will fund 60% of all planned development costs effective January 1, 2007, and BMS will fund the remainder. BMS may also receive additional payments of as much as $750 million based on development and regulatory milestones. The companies will jointly develop the clinical and marketing strategy of apixaban, and will share commercialization expenses and profits/losses equally on a global basis.

In the other program, Pfizer will be responsible for all research and early-stage development activities for the metabolic disorders program, and the companies will jointly conduct Phase III development and commercialization activities. BMS will make an upfront payment of $50 million to Pfizer as part of this agreement. The companies will share all development and commercialization expenses along with profits/losses on a 60%-40% basis, with Pfizer assuming the larger share of both expenses and profit/losses.

"By combining our company's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in this field, we can maximize the potential benefits of apixaban for patients. In addition, the metabolic disorders program complements existing research efforts in another area of significant unmet medical need where BMS is quite active," said Jim Cornelius, interim chief executive officer, BMS. "This collaboration supports our strategy to focus on serious diseases, maintain commercial emphasis on specialists and high-prescribing primary care physicians, and work with partners to offset the risks inherent with developing certain medicines."

"We're very pleased to collaborate with Bristol-Myers Squibb on the worldwide commercialization of apixaban, which has the potential to be a best-in-class product and would represent an excellent strategic fit with our global cardiovascular franchise," said Jeffrey B. Kindler, chairman and chief executive officer, Pfizer. "We see significant opportunities for an orally active anticoagulant with the clinical profile apixaban has demonstrated to date, particularly because of the clear need for new treatments to combat thrombosis and stroke. This agreement demonstrates our commitment to pursue revenue opportunities both through our business development and external alliances as well as our internal research and development pipeline."

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