News

This column provides a summary of the key trends that are occurring within pharma–biotech alliances, as well as looking at biotech–biotech. It will explore the changing balance of power in pharma and biotech deals, providing examples and insights into which areas alliances are becoming increasingly popular.

Xethanol Corporation's (New York, NY) subsidiary CoastalXethanol signed a letter of intent with Pfizer Inc. (New York, NY) to purchase Pfizer's pharmaceutical manufacturing complex in Augusta, Georgia.

Abraxis BioScience Inc., Bristol-Myers Squibb Company, Cambrex Corporation, Sigma-Aldrich Corporation, SkyePharma

Rutgers, the state university of New Jersey (New Brunswick, NJ), the New Jersey Institute of Technology (Newark, NJ), Purdue University (West Lafayette, IN), and the University of Puerto Rico (Mayag?ez, PR) won a $15-million, five-year grant from the National Science Foundation (Arlington, VA) to improve the manufacturing of pharmaceuticals, food, and agricultural products.

The CDER and CBER have released a new "Guidance for Industry: Q8 Pharmaceutical Development," outlining what drug manufacturers should include in the Pharmaceutical Development section of International Council on Harmonization (ICH) Common Technical Document (CTD) submissions.

Chemir Analytical Services (Maryland Heights, MO) acquired Gateway Chemical Technology, Inc., (St. Louis, MO), a provider of custom synthesis and process development services.

Spectrum Laboratory Products (Gardena, CA) recalled its active pharmaceutical ingredient, tacrolimus, after learning that some lots of the ingredient are subpotent. At least one injury has been reported.

Research and Markets (Dublin, Ireland) has released ?Annual Investment Analysis Report of the Chinese Pharmaceutical Logistics Industry, 2005-2006.? The report provides analysis of the pharmaceutical logistics characteristics, conditions, pharmaceutical market and pharmaceutical retail dynamics.

The US Food and Drug Administration (Rockville, MD) seeks volunteers to take part in a pilot project to test a Health Level 7 (HL7) data-interchange standard for submitting product stability data.

Boehringer Ingelheim, Crucell, Eisai, Laureate Pharma, Pall Corp., Tunnell Consulting

AstraZeneca PLC (London, England) has agreed to acquire the biopharmaceutical company Cambridge Antibody Technology Group PLC (CAT, Cambridge, England).

Roche (Basel, Switzerland) has entered into a nonexclusive agreement with Aspen Pharmacare (Port Elizabeth, South Africa) to speed up production and supply of a generic version of oseltamivir ("Tamiflu") for Africa.

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER, Rockville, MD) formally put into action its reorganization plan, effective May 15.

Seven automation suppliers have joined with users on the Instrumentation, Systems, and Automation Society (ISA, Research Triangle Park, NC) "Wireless Standards for Automation (SP100)" committee to develop wireless network structures for manufacturing plants.

Merck & Co Inc. (Whitehouse Station, NJ) has agreed to acquire two biologics companies: GlycoFi Inc. (Lebanon, NH), a specialist in yeast glycoengineering for $400 million, and the biopharmaceutical company Abmaxis Inc. (Santa Clara, CA) for $80 million.

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.

Johnson & Johnson, Mesa Labs, Mar Cor, FDA, Andrx

On April 28, the US Food and Drug Administration's Center for Drug Evaluation and Research (Rockville, MD) issued a Warning Letter to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb, Croatia).

On May 8, Thermo Electron Corporation (Waltham, MA) and Fisher Scientific International Inc. (Hampton, NH) announced they would merge in a tax-free, stock-for-stock exchange.

The US Food and Drug Administration?s (FDA, Rockville, MD, www.fda.gov) Center for Drug Evaluation and Research (CDER) is studying its own Advisory Committee Meeting system to identify best practices for this process.

The US Food and Drug Administration?s (Rockville, MD) Center for Drug Evaluation and Research (CDER) received 637 commercial investigational new drug (IND) applications in 2005, a 20-year high.

In a May 2 Federal Register notice (1), the US Food and Drug Administration withdrew its Jan. 17 direct final rule, "Current Good Manufacturing Practice Regulation and Investigational New Drugs" (2), which would have exempted manufacturing of drugs for Phase I clinical trials from most provisions of 21 CFR 211.

Clariant (Muttenz, Switzerland) has agreed to sell its pharmaceutical fine chemicals unit to the private equity firm TowerBrook Capital Partners LP (New York, NY) for CHF 110 million ($89 million). The price includes an earn-out participation of CHF 40 million ($32 million) to be paid in two years.

Cobra Biomanufacturing, Avecia, Dynavax Technologies, BASF, Codexis

Sigma-Aldrich Corporation (St. Louis, MO) has acquired Iropharm, Honeywell International's custom chemical synthesis business in Arklow, Ireland. Terms of the cash purchase were not disclosed.

Gottlieb challenges industry. First GenerationNext Awards. Implementing PAT. Optimizing site risk. RFID in the supply chain. Biodegradable polyketals. Global drug-market growth moderates.

The PAT market is developing and evolving rapidly as pharmaceutical firms strive to implement the framework set in place by the regulators. As with all new markets, people will engage at different times, at differing rates, and for different reasons. This editorial seeks to treat PAT in classical marketing terms, describing four phases of the PAT market evolution and discussing how the PAT market will likely mature.

Bang & Olufsen Medicom (Copenhagen, Denmark, www.medicom.bang-olufsen.com), a drug-delivery device solutions provider, and Bespak (Milton Keynes, UK, www.bespak.com), a medical-devices and inhalation-valve technologies company, established an exclusive partnership to codevelop and comarket the ?Assist Actuated Inhaler,? a single-increment, dose-counting inhaler. The integrated device features an assisted firing mechanism for easier patient use, according to a company release.

The biotechnology company Discovery Laboratories Inc. (Warrington, PA, www.discoverylabs.com) reports that analysis of ongoing stability data from "Surfaxin" process validation batches indicates that certain stability parameters have not been achieved, and additional process validation batches will likely have to be produced.

Agilent Technologies Inc. (Palo Alto, CA, www.agilent.com) announced April 17 that it acquired SynPro Corp. (Boulder, CO), a contract manufacturer of oligonucleotide active pharmaceutical ingredients. Earlier, Dalton Pharma Services (Toronto), announced that it had completed a multi-gram CGMP oligonucleotide production facility.