Merck Lays Out New Management and Organizational Structure
Merck & Co. outlined a new organizational structure and named top management and senior leaders for the company, effective upon the completion of its merger with Schering-Plough.

FDA Issues Final Guidance on OTC Drug Labeling
The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

REACH Program May Carry Six Times the Expected Cost
Implementing Europe’s Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) program will require a massive increase in animal testing and cost six times more than previously estimated.

USP to Develop Standards with Mexican Commission
The US Pharmacopeial Convention and the Permanent Commission of the Pharmacopeia of the United Mexican States signed a memorandum of understanding last week.

One-Shot H1N1 Vaccine Gets Chinese Thumbs Up
An H1N1 vaccine developed by biopharmaceutical company Sinovac Biotech has passed the experts evaluation organized by the Chinese State Food and Drug Administration, and the company is expected to obtain a production license before the week’s end.

Q&A With Compliance Expert Barbara Jentges
Pharmaceutical Technology spoke with Barbara Jentges, PhD, the managing director at PhACT, about changing regulatory expectations, with a focus on Europe.

Agilent Technologies (Santa Clara, CA) will collaborate with Persistent Systems (San jose, CA), a provider of software product-development services, and joined the DriverCentral.net instrument driver portal in an effort to enable open systems for chromatography-data systems. The company said in a press release, “Multivendor instrument connectivity is a core need in many laboratories because scientists often operate diverse instrumentation from multiple vendors in a single laboratory. For efficient lab operation and easy sharing of instruments and data, labs require a single data system to manage all their instruments and create reports in a common format.”

Astellas Pharma (Tokyo) broke ground for its Fermentation Technology Research Building in the Toyama plant of its subsidiary Astellas Toyama Co., Ltd. The 9000-m² unit will meet the standards applicable in Japan, the United States, and Europe for manufacturing and quality control for clinical trial material active pharmaceutical ingredients. It is also equipped with facilities for scale-up research. Construction will begin in September 2009 and be completed in October 2010.

DURECT (Cupertino, CA) signed an exclusive long term excipient supply agreement with King Pharmaceuticals (Bristol, TN) for two excipients used in the manufacture of Remoxy (oxycodone). Remoxy, based on DURECT's Oradur technology, is an investigational drug that is a controlled-release formulation of oxycodone designed to reduce potential risks of unintended use.

Pfizer (New York) will open a $1.5-billion biotechnology manufacturing facility in Strangnas, Sweden. The 6000-m² flexible plant will manufacture the active pharmaceutical ingredients for Genotropin and Somavert, as well as produce E. coli. The new plant will be connected to the existing site. Pfizer expects the facility to operate commercially in 2011.

Pfizer (New York) will pay more than $2 billion to settle several whistleblower lawsuits concerning past marketing practices for four drugs. The company announced that it finalized a previously reported agreement in principle with the US Department of Justice (DOJ) to settle an investigation regarding past off-label promotional practices related to the painkiller Bextra (valdecoxib), which Pfizer voluntarily withdrew from the market in 2005. The agreement also resolves other DOJ investigations involving alleged past off-label promotional practices concerning the antibiotic Zyvox (linezolid), the antipsychotic Geodon (ziprasidone HCI) and the antiseizure drug Lyrica (pregabalin), allegations related to certain payments to healthcare professionals involving these and nine other Pfizer medicines, and several related qui tam actions. Pfizer previously disclosed a related $2.3-billion charge to its fourth-quarter and full-year 2008 earnings in connection with the DOJ agreement in principle on January 26, 2009. No additional charge to the company’s earnings will be recorded in connection with this settlement. In addition to the $2.3-billion payment, Pfizer will pay a total of $33 million to 42 states and the District of Columbia to settle state civil-consumer protection allegations related to its past promotional practices concerning Geodon and will take a charge in that amount to third-quarter 2009 earnings.

sanofi aventis US (Bridgewater, NJ) will close its Kansas City, Missouri, manufacturing site, which mainly makes solid-dose forms of oral medications. The decision to close the site is based on a North American decline in demand for products manufactured at this site, according to a company press release. sanofi expects the site to be closed by mid-2012.

Silence Therapeutics (London), a biopharmaceutical company focused on RNA interference, entered into a collaboration with Dainippon Sumitomo Pharma (Osaka, Japan) to demonstrate the functional delivery of Silence’s proprietary siRNA molecules to specific targets. Financial details were not disclosed.9.

The US Food and Drug Administration announced in the Aug. 31, 2009 Federal Register that the Office of Management and Budget (OMB) approved the Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level under the Paperwork Reduction Act of 1995. The guidance’s proposed collection of information was submitted to OMB in April for approval because valid OMB control numbers are required for a collection of information. The approval expires on Aug. 31, 2012.

FDA issued several enforcement letters during the past two weeks. Cambrex (East Rutherford, NJ) received a Warning Letter relating to an inspection of the company's generic active pharmaceutical ingredient manufacturing facility in Milan, Italy, in March 2009, according to a company release. The observations are primarily related to the collection and maintenance of certain laboratory data, and Cambrex has addressed several of the FDA observations already, according to the release. FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a letter to Johnson & Johnson (Skillman, NJ) regarding a journal advertisement for its Ertaczo (sertaconazole) cream. The ad “broadens the approved indication, contains unsubstantiated efficacy claims about the product, and omits important risk information,” according to the letter. DDMAC also sent a letter to Pedinol Pharmacal (Farmingdale, NY) regarding a professional direct mailer for Nalfon (fenoprofen calcium). According to the letter, the mailer contains false or misleading information about the product.

Avid Bioservices (Tustin, CA), a contract manufacturing organization, appointed Truc Le chief operating officer and Christopher Eso vice-president of business operations.

Affitech (Copenhagen, Denmark), a biopharmaceutical company focused on antibody medicines, appointed Robert Burns as its CEO. Former Affitech CEO Achim Kaufhold is leaving the company. Additionally, Alexander Duncan was appointed senior vice-president of research and development.

China Medicine (Guangzhou, China), a provider of prescription and over-the-counter pharmaceuticals, traditional Chinese medicines, nutritional and dietary supplements, medical devices and medical formulations, appointed Richard P. Wu as its chief financial officer. Wu replaces Huizhen Yu, who had served as CFO since February 2006. Yu now serves as controller of the company and its subsidiaries. Additionally, Robert Lu was appointed to a newly created position of finance manager.

Cytovance Biologics (Oklahoma City, OK), a biopharmaceutical contract manufacturing company, named Jeffrey Su vice-president of bioanalytical development. Su will lead the bioanalytical development laboratory. 

The emerging specialty pharmaceutical company LifeCycle Pharma (LCP, Hørsholm, Denmark) announced today that the company’s board of directors and Jim New have agreed to terminate the contract with New, who will step down as the president and CEO of LCP. The termination is related to different views on how an international company based in Scandinavia shall be managed, according to a company press release. The company is searching for a new CEO. Meanwhile, Paul Edick, chairman of the board, and Thomas Dyrberg, constituted deputy chairman of the board, will work with the board to ensure LCP's uninterrupted business.

Mark Erion, the president, CEO, chief scientific officer, and a member of the board of directors for Metabasis Therapeutics (San Diego, CA) resigned as an officer and director of the Company effective October 31, 2009. Erion will consult for the company after that date. David Hale, Metabasis’s current chairman of the board, was appointed as executive chairman.

The specialty pharmaceutical company SCOLR Pharma (Bothell, WA) appointed Stephen J. Turner as its CEO and president. The employment of Bruce S. Morra in these positions terminated on Aug. 28, 2009 by mutual agreement. Morra will continue to serve as a director of the company.