Manufacturing

Democrats are back on top in Congress and are mapping a broad agenda for change. Prescription drug pricing, medical product safety, and access to needed treatments are high on the priority list. Manufacturers will be in the hot seat answering questions about patent practices, high-risk products, and why drugs cost less in other countries than in the United States. The real challenge, however, will be to gain approval of a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) before the program expires on Sept. 30, 2007. Such legislation also would renew user fees for medical devices and continue the pediatric drug exclusivity program.

Industry will be challenged to embrace new methods of supply chain collaboration.

There are currently several hundred biotech-based drugs in clinical trials, representing around a quarter of all drugs in development - a proportion that looks set to increase.

In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.

Dec. 28, 2006 Company Notes: Albemarle, Clinical Data, Crucell, Merck, PDA, QLT, Sanofi Pasteur, Shimadzu

Pharmaceuticals current good manufacturing practice (CGMP) violations accounted for just 36 of the 441 Warning Letters issued by the US Food and Drug Administration in 2006.

US District Court for the Eastern District of New York Judge Joanna Seybert's Dec. 11, 2006 Order granting a preliminary injunction in RxUSA Wholesale, et al, v. FDA, barring FDA from enforcing some drug pedigree rules.

Astellas Pharma Inc. (Tokyo) will sell three European plants to the Temmler Group (Marburg, Germany), a pharmaceutical company and contract manufacturer. The move is part of Astellas's plan to reduce the number its production sites.

The US Food and Drug Administration has modified its requirements for drug pedigrees accompanying wholesale pharmaceutical transactions, following a US District Court preliminary injunction barring the agency from enforcing certain provisions of the rule that was to have gone into effect on Dec. 1.

Biotechnology stocks dropped 14% in 2006, giving up more than half of the value they'd picked up during a "stellar" 2005, according to G. Steven Burrill, CEO of Burrill & Company (www.burrillandco.com), the venture and merhant banking company. "Overall, it wasn't a great year for biotech," said Burrill in a year-end analysis, indicating that the biotechnology industry will finish the year with its collective market capitalization essentially unchanged, at approximately $490 billion. As for the future, biotechnology will continue to fuel a the transformation in healthcare, a tansformation emphasizing earlier disease detection, more targeted treatments, and adjunctive support through enhanced nutrition. We will see further progress on the personalized, predictive, preventative front...with new products targeting the "individualization" of medicine in the marketplace. Other predictions for 2007 include...

Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.

Basel, Switzerland (Dec. 5)-Lonza Group Ltd. and Singapore?s Bio*One Capital have formed a joint venture, Lonza Biologics Tuas, to build a large-scale mammalian cell-culture facility in Singapore for as much as $350 million.

Bothell, WA (December 12)?If the shareholders of biotechnology company Icos Corp. approve a proposed buyout by Eli Lilly and Co., all of Icos?s 700 employees will lose their jobs.

Princeton, NJ (Nov. 30)-Rockwood Holdings, Inc. agreed to sell its Group Novasep subsidiary for EUR 425 million ($567 million) to a consortium of buyers consisting of Glide Buyout Partners BV, Banexi Capital, and Group Novasep management.

Whitehouse Station, NJ, (Dec. 6)-Merck & Co., Inc. expects the initial phase of its cost-reduction program, first announced in 2005, to yield cumulative pretax savings of $4.5?5.0 billion from 2006 through 2010, with roughly $2 billion of that coming from implementing its manufacturing supply strategy.

Dublin, OH (Nov. 30)-Cardinal Health has announced plans to divest its Pharmaceutical Technologies and Services (PTS) segment, "a business that manufactures or packages 100 billion doses of medication every year for pharmaceutical and biotech firms, employs approximately 10,000 at more than 30 facilities worldwide and generates $1.8 billion in revenue," according to a company statement.

London (Dec. 8)-GlaxoSmithKline PLC agreed to acquire Domantis Ltd., a developer of antibodies for £230 million ($454 million) in cash.

This article describes the design and development of a material-sparing fluidization segregation tester for use with pharmaceutical powders. This tester offers several improvements over the current ASTM standardized test practice. Less than 20 mL of material is required to characterize the fluidization segregation potential of a sample. Features of the tester include powder containment for potent compounds, in-process monitoring of the fluidization conditions, and sample retrieval without the need for subsampling or riffling for typical analyses.

Brand-name manufacturers seek to protect their products.

Why do the biotech ventures mange to have such promising drug candidates while pharmaceutical R&D is facing a drug deficit?

EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

Crucell announces acquisition of SBL Vaccin AB

London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials.

Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.

Argonne, IL (Nov. 9)-Researchers from Argonne National Laboratory?s Chemistry Division and Xradia have developed a novel X-ray microscopy technique that allows molecular observations of the reactivity of solid surfaces at the nanometer scale, including interfacial reactions such as ion adsorption and catalytic reactions.

Washington, DC (Nov. 20)-The US Department of Health and Human Services awarded contracts totaling $199.45 million to Sanofi Pasteur, Novartis, and GlaxoSmithKline PLC to manufacture 5.3 million 90-?g doses of influenza vaccine designed to protect against the H5N1 influenza virus strain.

Alcan, China Biopharma, US FDA, MedImmune, more

Leverkusen, Germany (Nov. 9)?Bayer AG outlined its strategy for integrating Schering AG (Berlin) into the newly formed company, Bayer Schering Pharma. These moves follow Bayer's acquisition of Schering AG earlier this year.

Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.

South San Francisco, CA (Nov. 9)?Genentech, Inc. has agreed to acquire Tanox, Inc., for $20 per share, a total cash value of roughly $919 million. Tanox is a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology.