Week of Aug. 31, 2009: Roche Purchases Lonza Facility; SCOLR Pharma Names CEO; More...

September 3, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more...

Company notes

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.

Genzyme (Cambridge, MA) provided an update on its remaining two lots of Cerezyme (imiglucerase for injection) that were finished before the Allston, Massachusetts, plant was shut down in June: one lot was released and the other is in the process of being released (after final quality assurance measures are taken). The company also said that inspectors from the European Medicines Agency visited the plant. Following the inspection, Genzyme received a letter detailing observations and requesting that the company respond to the observations. The company said the letter identified no critical observations, one major observation, and several other observations. Genzyme expects FDA and other regulatory authories to inspect the plant.

Orexo (Uppsala, Sweden) signed a licensing agreement with a Novartis (Basel) affiliate to develop and commercialize a product related to Orexo’s OX17 program. Under the agreement, Novartis will fund development of the new product and will receive an exclusive license to all related intellectual property. Orexo will receive milestone payments and royalties. Financial terms were not disclosed.

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.

Roche (Basel) exercised its option to purchase a cell-culture biologic manufacturing facility in Singapore from Lonza (Basel). The facility will be merged with the existing biologic manufacturing facility of Genentech Singapore, part of the Roche Group. It is expected to produce Avastin (bevacizumab) bulk drug substance. The facility has 80,000 L of fermentation capacity and is located on approximately 10 acres.

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.

People notes

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.