Patricia Van Arnum

The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.

Growth in the global pharmaceutical market is expected to slow in 2007, based on the industry's increasing reliance on niche and specialty products and greater generic drug penetration, according to a forecast by IMS Health. Generic drugs, along with biotechnology and specialist-initiated products, are expected to outperform the overall market in 2007. Despite slower growth in the United States and Europe, growth in emerging countries, including China, is projected in the double digits.

Indianapolis, IN (Oct. 17)-Eli Lilly and Company agreed to acquire ICOS Corporation (Bothell, WA) for $2.1 billion.

New York, NY (Oct. 19)-Pfizer, Inc. plans to implement a new company-wide cost-cutting initiative in 2007 as part of strategy to improve operating performance. The cuts are in addition to a previous cost-reduction program that Pfizer launched in 2005.

CPhI Worldwide, Paris (Oct. 3)-Archimica, participating in its first CPhI Worldwide exhibition since being launched as new company earlier this year, outlined manufacturing expansions, technology additions, and recent projects at its facilities in the United States and Europe.

CPhI Worldwide, Paris (Oct. 3-5)-CPhI Worldwide, the large exhibition of pharmaceutical ingredient suppliers held in Paris last week, revealed two important themes.

CPhI Worldwide, Paris (Oct. 3)-The Synthetic Organic Chemical Manufacturers Association and the European Fine Chemicals Group have teamed to urge US and European regulatory authorities to increase inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs) to reduce patient risk from sub-par drugs, to increase national security, and to level the economic playing field.

CPhI Worldwide, Paris (Oct. 3)-Exhibitors at CPhI Worldwide reported expansions, enhancements in technology, and new projects last week in Paris.

CPhI Worlwide, Paris, (Oct. 5)-Following its recently announced acquisition of EaglePicher Pharmaceutical Aptuit, Inc. plans further investment in infrastructure and staff in building its capabilities in manufacturing active pharmaceutical ingredients (APIs).

CPhI Worldwide, Paris (Oct. 3)-Carbogen Amcis AG, a subsidiary of Dishman Pharmaceuticals and Chemicals Ltd., is planning several investments in its pharmaceutical chemical development and manufacturing activities.

CPhI Worldwide, Paris (Oct. 3)-NPIL Pharma has formed a new dedicated unit, NPIL Innovations or NPIL(i), to focus on developing and applying new technologies used in process development and production of active pharmaceutical ingredients (APIs).

Foster City, CA (Oct. 2)-Gilead Sciences, Inc. has agreed to acquire the biopharmaceutical company Myogen, Inc. for $2.5 billion.

SAFC, the custom manufacturing group of Sigma-Aldrich Corporation, announced at CPhI Worldwide that it will invest $16 million to expand its CGMP protein-purification capacity to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials.

Paris (Oct. 3)-In gearing up for opportunities in the generic drug market, Codexis, which specializes in biocatalysis for pharmaceutical chemical development, is expanding into direct sale of pharmaceutical intermediates with the receipt of its first commercial orders from generic drug manufacturers for ATS-8, a chemical intermediate in atorvastatin, the API in Pfizer's top-selling drug ?Lipitor.?

As single-enantiomer drugs dominate the pharmaceutical market (1), custom manufacturers and technology providers are developing novel routes using biocatalysis and chemocatalysis, alone and combined, to improve enantioselectivity, yield, reaction conditions, and the economics of manufacture.

Merck's new supply strategy involves combining internal and external manufacturing.

Increasing costs for Indian-based CMOs may be reducing their total cost of ownership advantage.

As the pharmaceutical industry gathers for the 2006 installment of CPhI Worldwide, the annual exhibition of ingredient producers, custom manufacturers, and contract service providers, it faces an expanding number of choices for connecting with suppliers.

The Drug, Chemical & Associated Technologies Association (DCAT) serves as a link between sourcing and procurement professionals in the pharmaceutical industry and suppliers of pharmaceutical ingredients.

As custom manufacturers and pharmaceutical ingredient suppliers gather for CPhI Worldwide in Paris, Oct. 3–Oct. 5, industry observers point to a mixed outlook for pharmaceutical custom synthesis. While industry performance for 2006 is better than 2005, the critical question remains the improvement in drug output. The slow rate of approvals of new molecular entities (NMEs) continues in 2006 as Big Pharma seeks to build pipelines of active pharmaceutical ingredients (APIs) through acquisitions, including capabilities in biologics.

Aptuit, Inc. (Greenwich, CT) has agreed to acquire the assets and operations of EaglePicher Pharmaceutical Services (EPPS, Lenexa, KS) as part of Aptuit?s strategies to build capabilities in active pharmaceutical ingredient (API) development and drug substance manufacturing.

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC) submitted a citizen petition to the US Food and Drug Administration (Washington, DC) requesting the agency to increase inspections of drug manufacturing facilities located outside of the United States.

High-containment manufacturing for highly potent active pharmaceutical ingredients (HPAPIs) represents a niche, but growing niche, in API manufacture. Strategies on serving this sector were discussed at a recent program, ?High-Potency Active Ingredients: Realizing the Opportunities,? organized by the Drug, Chemical, and Associated Technologies Association (Robbinsville, NJ) in conjunction with Pharmaceutical Technology.

The market potential for high-potency active ingredients will be influenced by growth patterns in the cytotoxic drug market. Strong growth is projected for cytotoxics through 2009, but the market then will see generic drug erosion, according to Sarah Terry Johnston, vice-president, healthcare, Datamonitor PLC.

Albemarle Corporation signed an agreement with DSM Pharmaceutical Products to buy the assets and the fine chemistry services and pharma chemicals business associated with DSM's South Haven, Michigan facility.

Merck KGaA has agreed to buy a majority stake in the European biotechnology company Serono SA for CHF 16.6 billion ($13.3 billion).

Chemir Analytical Services has launched IQsynthesis, formerly known as Gateway Chemical Technology, Inc. Chemir acquired Gateway Chemical Technology, which provides custom synthesis and process development services, in May 2006.

Select large custom manufacturers expand capacity, private equity firms buy companies in transition, and players from India and China build their positions.

Potent-compound awareness training for operators is important to understand why the containment and controls are in place.

The generic drug company Mylan Laboratories, Inc. (Pittsburgh, PA) plans to acquire a controlling interest (71.5%) in the Indian pharmaceutical company Matrix Laboratories, Ltd (Hyderabad, India) for $736 million.