News

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

Langley, BC, Canada (Oct. 10)-AnorMED Inc. has determined that Genzyme's US $580 million offer to acquire all outstanding AnorMED shares at US $13.50 a share is a "superior proposal."

Altana, Macroflux, Pfizer CentreSource

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.

Cramlington, UK (Oct. 9)-Aesica, a supplier of active pharmaceutical ingredients (APIs), announced it had acquired a chemical-manufacturing facility at Ponders End, UK from Merck Sharp and Dohme Limited, the British subsidiary of Merck and Co., Inc.

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.

New York (Oct. 9)-Pfizer has positioned itself to enter the DNA-based vaccine market with its agreement to acquire UK-based PowderMed Ltd., which holds a pipeline of DNA-based influenza vaccines currently in clinical development for treating both seasonal and avian flu.

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.

Rockville, MD (Oct. 2)-The US Food and Drug Administration has issued its final Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.

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.

Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice?s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

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.?

Amgen, Ash Stevens, Aveo, Millipore

London (Sept. 29)-GlaxoSmithKline will invest more than ? 500 million in a vaccine-manufacturing plant in St-Amand-Les-Eaux, France. The investment will expand the company?s production capacity in formulation, filling, freeze-drying, and packaging in response to increasing worldwide demand for pediatric and adult vaccines.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has withdrawn three guidances for industry: ?Providing Submissions in Electronic Format?NDAs? (e-NDA), ?Providing Regulatory Submissions in Electronic Format?ANDAs? (e-ANDA), and ?Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.? These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.

GlycoFi's work could eliminate the need for mammalian cell culture and improve the performance of protein therapies.

More CMOs look to proprietary delivery technologies to enhance profitability.

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.

Bentley, Cardinal, Saltigo, Sanofi pasteur

UCB SA has offered EUR 4.4 billion ($5.64 billion) in cash and stocks to acquire Schwarz Pharma AG.

In a move that continues the consolidation trend in the generic drugs market, Hospira Inc. agreed to acquire specialty injectables company Mayne Pharma Limited (Melbourne, Australia) for $2 billion.

Millennium Pharmaceuticals, Inc. entered into an agreement to acquire biopharmaceutical company AnorMED, Inc. (Langley, BC, Canada) for $515 million.

Washington, DC (Sept. 26): A much-publicized Institute of Medicine report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," though devoted to the assessment and perception of risk, focuses on premarketing clinical reviews and postmarketing pharmacovigilance. It does not address or make recommendations on drug manufacturing or quality assurance.