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Company and People Notes: BASF raises prices on excipients; Verus Pharmaceuticals appoints president and CEO; more.
Wilmington, NC (Nov. 6)-AAIPharma will expand its operations in Central and Eastern Europe with the addition of a new office and seven-member team in Budapest, Hungary. The group in Hungary will provide clinical monitoring, project management, and regulatory affairs services across Phase II-IV. AAIPharma has two other offices in Croatia and Russia. With the recent addition of an office in South Africa, AAIPharma now has operations in 14 countries worldwide.
Ludwigshafen, Germany (Nov. 12)-With immediate effect, BASF is raising its prices for pharmaceutical excipients worldwide by as much as 9%. This product group includes binders, disintegrants, coatings, solvents and solubilizers for the production of pharmaceuticals. The company said the price increases are necessary because of higher energy and transportation costs as well as high raw material costs.
Leverkusen, Germany and West Haven, CT (Nov. 5)-Following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the US Food and Drug Administration, Health Canada, and other health authorities, Bayer has elected to temporarily suspend worldwide marketing of “Trasylol” (aprotinin injection) until final results from the Canadian BART trial can be compiled, received and evaluated. Bayer took this action following direction from the German BfArM and requests from FDA and other regulators that the company temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients. Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether the data have any impact on the positive benefit-risk assessment for Trasylol.
Somerset, NJ (Nov. 9)-Catalent Pharma Solutions, a provider of development, manufacturing and packaging services, completed the first influenza vaccine manufacturing campaign from its new prefilled syringe manufacturing facility in Neder-Over-Heembeek, near Brussels, Belgium. The influenza vaccine production, for several major customers serving global markets, exceeded 21 million prefilled syringes for the 2007 campaign. Catalent received initial European regulatory approval for this facility in July 2006, and expects to have the first FDA-approved product at the facility in 2008.
In other news, Catalent recently announced the addition of a Phase I sterile vial-filling suite in its Research Triangle Park, NC, facility, which will complement existing clinical and commercial manufacturing capabilities in its nearby North Raleigh facility. The new suite, expected to be completed in early 2008, will be equipped to fill vials with most highly-potent compounds, traditional small molecule drug and biologics, as well as DEA Schedule 1-5 compounds, and will offer liquid fill and lyophilization capabilities.
New York and San Carlos, CA (Nov. 13)-Pfizer and Nektar Therapeutics have resolved all outstanding contractual issues in connection with “Exubera” (inhaled insulin) and Nektar’s next-generation inhaled insulin (NGI) product in Phase 1 clinical development. Under the terms of the agreement, Nektar will receive a one-time payment of $135 million from Pfizer in satisfaction of all remaining obligations under existing agreements relating to Exubera and NGI. Last month, Pfizer decided to stop investment in Exubera and took a $2.8-billion charge for the product.
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Toronto, Canada (Nov. 9)-PharmEng International opened a new 46,400-ft2 pharmaceutical manufacturing facility in Cape Breton, Canada. The facility includes offices for PharmEng’s pharmaceutical consulting division, pilot laboratories for formulation development, and rooms with various capabilities such as high-shear mixing, container blending, and equipment for modified-release technology. The facility will provide formulation development and testing services to manufacture and package solid and liquid dosage forms. Production at the facility is expected to begin in the first quarter of 2008.
Rockville, MD (Nov. 7)-Ranbaxy Pharmaceuticals (Princeton, NJ) initiated a voluntary Class III recall of 73 million gabapentin tablets (600-mg and 800-mg tablets in 100- and 500-tablet bottles) on the basis that the product may exceed impurity specifications during shelf life, according to the US Food and Drug Administration’s Nov. 7, 2007, Enforcement Report. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences, according to FDA.
Rockville, MD (Nov. 8)-The US Food and Drug Administration will hold a public meeting on Dec. 5, 2007, to solicit comments on a proposed rule that would amend FDA’s regulation on the use of ozone-depleting substances in self-pressurized containers to remove the essential-use designation for oral pressurized metered-dose inhalers containing epinephrine. In addition, FDA has extended the public comment on the proposed rule to Dec. 19, 2007. FDA published the proposed rule in the Sept. 20, 2007 edition of the Federal Register.
Rockville, MD (Nov. 5)-The US Food and Drug Administration and the Consumer Healthcare Product Association will hold a public workshop on Dec. 6 and 7, 2007 on adolescent over-the-counter (OTC) drug product use. Information from the workshop and submitted comments will be used to identify when it would be most appropriate for consumer studies on OTC drugs to enroll adolescents and to define the type of consumer research and study designs needed to support OTC drug product approvals for adolescents. Written or electronic comments are due by Jan. 31, 2008.
Munich and Jena, Germany (Nov. 7)-Wacker is investing around €15 million ($22 million)in its biopharmaceutical operations for the GMP expansion of its Jena production facility and the construction of a new building there for process development and quality control.
Somerset, NJ (Nov. 6)-Catalent Pharma Solutions, a provider of development, manufacturing, and packaging technology and services, appointed Tracy Tsuetaki as group president of packaging services, and Samrat (Sam) Khichi as senior vice-president and general counsel.
Princeton, NJ (Nov. 12)-Cytogen announced that Kevin G. Lokay will assume the position of president and chief executive officer, effective immediately. Lokay, a member of Cytogen’s board of directors for the past six years, replaces Michael D. Becker, who resigned as an officer and director to pursue another executive position.
Wayne, PA (Nov. 13)-Encorium Group, a contract research organization, appointed Linda Nardone, PhD, to the newly created position of chief operating officer and executive vice-president. Nardone will report directly to Kenneth M. Borow, MD, the company’s president and chief executive officer.
Auckland, New Zealand (Nov. 12)-Neuren Pharmaceuticals, a biopharmaceutical company, announced that CEO and Managing Director David Clarke will leave Neuren at the end of the year. Because of the increasingly international range of operations across Australia/New Zealand and the US, Neuren will now organize the company’s business activities across both markets. Dr. Parmjot Bains, Neuren’s chief operating officer, has been named CEO of the Australian/New Zealand business unit, and Larry Glass, Neuren’s executive vice-president, based in Washington DC, has been named CEO and president of US operations and subsidiaries. Both Bains and Glass will report to Neuren’s board of directors.
Kalamazoo, MI (Nov. 13)-Pfizer CentreSource, a provider of active pharmaceutical ingredients and dosage-form manufacturing, appointed of Jeff Frazier to vice-president of fine chemicals, from the position of director of strategic initiatives and business planning.
Rockville, MD (Nov. 5)-The US Food and Drug Administration selected 15 voting members to serve on its Risk Communication Advisory Committee. The committee will advise FDA about how best to communicate to the public about the risks and benefits of FDA-regulated products. FDA announced the establishment of the advisory committee in June of this year. The list of members is available here.
San Diego (Nov. 12)-Verus Pharmaceuticals, a pediatric-oriented specialty pharmaceutical company, appointed Robert W. Keith as president and chief executive officer. Prior to the promotion, Keith served as president and chief operating officer.