Company and People Notes: GSK Forms Pact with Aspen Pharmacare; Sigma-Aldrich Chairman to Retire; More...

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Takeda to consolidate operations in Ireland; FDA to redesign website; Archemix names president and CEO; more...

Company Notes

Agilent (Santa Clara, CA) completed expansion of its Nucleic Acids Solutions Division (Boulder, CO), thereby enabling the company to produce several hundred kilograms of therapeutic oligonucleotides per year. The expansion is the second manufacturing expansion since 2006, and includes large-scale nucleic acid synthesis, purification, and drying capacity.

Biovail Laboratories International (Toronto, Canada), a subsidiary of Biovail Corp., entered into an agreement to acquire full rights to commercialize GlaxoSmithKline’s (GSK) Wellbutrin XL in the United States. The product is currently manufactured by Biovail and has been distributed by GSK in the US since September 2003. Biovail will pay $510 million to GSK and will obtain the right to launch an authorized generic formulation of the drug product.

Biovail and Acadia Pharmaceuticals (San Diego, CA) formed an agreement in which Biovail acquires the US and Canadian rights to develop, manufacture, and commercialize pimavanserin tartrate (a selective 5-HT2A inverse agonist) in a number of neurological and psychiatric conditions.

ChemWerth (Woodbridge, CT) and Tianjin Tianyao Pharmaceuticals Co. (Tianjin, China), a manufacturer of steroid active pharmaceutical ingredients, have formed a contract manufacturing partnership. The agreement will add capacity for the development and GMP manufacture of hormonal drugs.

GlaxoSmithKline (GSK, London) will extend its strategic relationship with Aspen Pharmacare Holdings (Durban, South Africa). The companies will collaborate on the commercialization of their current and future portfolios in Sub-Saharan Africa, excluding South Africa. In addition to acquiring a 16% shareholding in Aspen, GSK will divest eight specialist medicines to Aspen: Alkeran (excluding US), Kemadrin, Lanvis, Leukeran, Myleran, Purinethol, Septrin, and Trandate. GSK will also divest a manufacturing facility located in Bad Oldesloe, Germany.

In other news, GSK and Eurand (Philadelphia, PA) announced FDA approval of EUR-1048, to be marketed as GSK’s Lamictal (lamotrigine) orally disintegrating tablets (ODT) for the long-term treatment of bipolar I disorder in patients over 18 years of age. The product uses Eurand’s AdvaTab ODT technology that involves a proprietary granulation and tableting process and its Microcaps taste-masking technology that provides a coating that encapsulates drug particles using solvent- and aqueous-based coacervation.

Merck Serono (Geneva, Switzerland), a division of Merck KGaA, has launched a Glucophage powder for oral solution (metformin hydrochloride) for the treatment of Type 2 diabetes mellitus. The product is licensed in France and in the United Kingdome. Launches in other European countries are planned. The Glucophage powder is packaged in individual sachets for dissolution in water.

Neuocrine Biosciences (San Diego, CA) will restructure its workforce, cutting its staff by approximately 60 employees. The company will focus on its clinical programs and on preclinical development leads. The biopharmaceutical company specializes in developing therapies for treating neurological and endocrine diseases and disorders. 

Pfizer (New York) and Wisconsin Alumni Research Foundation (WARF, Madison, WI) signed a license for human embryonic stem cell (hES) patents. Pfizer will use WARF’s cell lines for the research, discovery, and development of new drug therapies, including medicines that may be able to improve the way stem cells regenerate damaged tissues, and to optimize the production of therapeutic cells.

Ranbaxy Pharmaceuticals (Jacksonville, FL) issued a voluntary recall of all lots of its nitrofurantoin USP 100-mg capsules (monohydrate/macrocrystals) in the United States. The company says that although the recalled product is unlikely to produce any serious adverse health effects, there is “a remote possibility that the nonconforming product may increase the incidence of local non-serious gastrointestinal adverse events ….”

Roche (Basel, Switzerland) and Tekmira Pharamceuticals (Vancouver, Canada) agreed to advance Roche’s first two RNA interference (RNAi) product candidates into human clinical testing. Both candidates are based on Tekmira’s stable nucleic acid-lipid particle technology. Under terms of the agreement, Roche will pay Tekmira up to $18.4 million to support advancement toward the filing of an investigational new drug application (IND). Both companies expect to file an IND for the first product candidate before the end of 2010.

The Society of Chemical Manufacturers and Affiliates (SOCMA, San Francisco, CA) has acquired ChemAlliance, an online compliance assistance center formerly funded by the US Environmental Protection Agency. The ChemAlliance.org website has served to provide compliance assistance to the chemical manufacturing industry since 1996. SOCMA plans to expand the focus beyond environmental regulatory compliance and include health, safety, ad chemical security.

Takeda (Osaka, Japan) will consolidate its two manufacturing operations in Ireland. The company will transfer the assets of active ingredients manufacturer Takeda Pharma Ireland (Dublin) to Takeda Ireland (Kilruddery) on July 1, 2009. Akira Nakatani will remain as president of Takeda Ireland.

Umicore (Brussels, Belgium) and Solvias (Basel, Switzerland) have entered into a collaborative agreement toward the industrial-scale production of chiral ligands and chiral metal complexes. Each company will have access to each other’s respective asymmetric catalysis technologies, including licenses for the ligands and metal-ligand complexes.

Vetter Pharma International (Ravensburg, Germany), a contract manufacturer of prefilled application systems, and West (Lionville, PA), a manufacturer of components and systems for injectable drug delivery, have launched a water-for-injection (WFI) prefilled syringe for reconstituting lyophilized drug products. The syringe features a plunger with West’s FluroTec barrier film and Vetter’s V-OVS tamper evident closure.

Regulatory roundup

The US Food and Drug Administration has announced that it will be launching a redesigned website soon. After research with consumers, health professionals, and industry groups, the agency has identified ways to make the website more user-friendly. For example, the new site will offer updated page navigation and reorganized content and categorization.

FDA recently posted its report to the Office of Management and Budget regarding investigational new drug (IND) regulations. The report details estimates gathered from industry and FDA about the reporting and recordkeeping requirements for INDs overseen by the Center for Drug Evaultion and Research and the Center for Biologics Evaluation and Research.

People Notes

ACORN CRO (Memphis, TN), an oncology-focused contract research organization, appointed Kristie H. Lively to its senior management team to the position of vice-president. Lively will oversee all aspects of the company’s operations and services. 

Archemix (Cambridge, MA), a biotechnology company, named Kenneth M. Bate president and chief executive officer. Bate has more than two decades experience in the industry. Current President and Interim CEO Duncan Higgons will leave the company for a position at another biotechnology company.

Covance (Princeton, NJ), a drug-development services company, elected John McCartney to its board of directors. McCartney currently serves as chairman of the board of A.M. Castle (Franklin Park, IL), a provider of specialty products, services, and supply chain solutions. He was formerly president and chief operating officer of US Robotics (Schaumburg, IL), a provider of information access technologies.

Logical Therapeutics (Waltham, MA), a biotechnology company, appointed Peter A. Lankau chief executive officer and as a member of the company's board of directors. Lankau was most recently president and CEO of Endo Pharmaceuticals (Chadds Ford, PA), a specialty pharmaceutical company.

Mylan (Pittsburgh, PA) announced that its cofounder and chairman Milan "Mike" Puskar stepped down as chairman of the board and will retire as a director, effective Oct. 1, 2009. The board elected Robert J. Coury, Mylan's vice-chairman and CEO, to succeed Puskar as chairman.

Sigma-Aldrich (St. Louis, MO) announced that David R. Harvey retired as chairman. He will continue as a director of the company. Jai Nagarkatti, currently president, CEO, and a director of the company, was appointed to the additional position of chairman. Barrett Toan, currently a director, was appointed presiding director of the company.