Company, People, and Regulatory Notes: Amgen and GSK Collaborate; WuXi Appoints VP of Pharmacology; More...

July 30, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more...

Company Notes

Agilent Technologies (Santa Clara, CA), manufacturer of analytical instrumentation, will acquire scientific instruments supplier Varian (Palo Alto, CA). Agilent will pay $52 cash per share of common stock for Varian, which represents a premium of approximately 35% to Varian’s closing price on July 24, 2009. The boards of directors of both companies unanimously approved the all-cash offer.

Almac (Craigavon, UK) added drug-product radio-labeling services to its offerings, enabling radio labeling for both large and small molecules. The company has received approval from the UK’s Medicines and Healthcare products Regulatory Agency for the service.

Amgen (Thousand Oaks, CA) will collaborate with GlaxoSmithKline (GSK, London) to commercialize Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis in Europe, Australia, New Zealand, and Mexico once the product is approved in these countries. Amgen will retain rights to denosumab in the United States and Canada and for all oncology indications in Europe and specified markets. GSK will commercialize the drug for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India, and South Korea. Amgen will receive $120 million in an initial payment and milestone payments, plus ongoing royalties.

Isogen (Newark, DE), a provider of advanced sterile manufacturing, completed its 20,000 ft2 sterile filling and manufacturing facility located in Newark, Delaware. The company has completed media fills at the new facility. 

Raptor Pharmaceuticals (Novato, CA) and TorreyPines Therapeutics (La Jolla, CA) will merge to form a biopharmaceutical company featuring mid- to late-stage clinical development candidates and preclinical drug-targeting platforms designed to improve drug delivery under the name Raptor Pharmaceuticals. The merger was unanimously approved by both companies and is expected to take place in the fourth quarter of 2009.

Terrene Pharma (Vadodara, Gujarat, India) inaugurated its new empty-capsule manufacturing facility. The facility, designed to comply with US Food and Drug Administration, EU European Directorate for the Quality of Medicines & Healthcare, and World Health Organization good manufacturing practice requirements, houses an independent instrument, chemical, micro, laminar flow and packing material testing lab.

Teva Pharmaceutical Industries (Jerusalem, Israel) and Ortho McNeil Janssen (Raritan, NJ) agreed to settle the patent infringement lawsuit in the US District Court for the District of New Jersey related to Teva's generic version of the oral contraceptive, Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol). Under the terms of the settlement, Teva will obtain a release for past sales of its generic product in exchange for an undisclosed royalty payment. Teva also will be able to relaunch its generic version of the drug on December 31, 2015, or earlier in certain circumstances. The settlement will not become effective until the court enters a proposed consent judgment upholding the validity and enforceability of Ortho's patent, according to a Teva press release.

The private equity firm Water Street Healthcare Partners has acquired AAIPharma’s (Wilmington, NC) Pharmaceutical Development division, which focuses on analytical chemistry, formulation development, clinical packaging, oral drug delivery and contract manufacturing. Water Street has committed up to $75 million in equity financing to expand the business’s capabilities, according to a press release. The new company is named AAIPharma Services Corp.

People Notes

Cellular Dynamics International (Madison, WI), a developer of stem-cell technologies for drug development and personalized medicine applications, appointed Junying Yu senior research fellow. Yu’s work will focus on induced pluripotent stem cells to reproducibly differentiate into essential cell types for drug discovery and development and eventually therapeutic use.

The outsourcing partner Dishman Group (Ahmedabad, India) appointed Juan Venceslao to the newly created position of director of the company’s generic active pharmaceutical ingredient business. Venceslao will report to Jay Vyas, managing director of the global pharmaceutical services provider.

Halozyme Therapeutics (San Diego, CA), a biopharmaceutical company, appointed Jonathan Leff vice-president and chief medical officer. Leff, previously served as the vice-president and global head of inflammation clinical development at Roche (Basel).

Onset Therapeutics (Cumberland, RI), a specialty pharmaceutical company focused in dermatology, added to its senior management team. Doug Abel was appointed general manager and Sheila Kennedy will serve as vice-president of marketing.

The biotechnology company Novavax (Rockville, MD) appointed John J. Trizzino to the newly created position of senior vice-president of international and government alliances. Trizzino will report directly to Rahul Singhvi, the company’s president and CEO. Trizzino previously served as vice-president of the vaccine unit at MedImmune (Gaithersburg, MD).

Watson Pharmaceuticals (Morristown, NJ) announced that Mark W. Durand, senior vice-president and chief financial officer, has taken a leave of absence from the company for health reasons. R. Todd Joyce, vice-president, corporate controller and treasurer, will serve as acting principal financial officer, effective immediately.

WuXi PharmaTech (Shanghai) appointed Chi-Chung Chan vice-president of pharmacology. He will report directly to Shuhui Chen, chief scientific officer.

Regulatory Roundup

The US Food and Drug Administration issued a final rule in the July 28 Federal Register to require new drug application (NDA) submissions to contain certain information regarding authorized generic drugs in its annual report. This rule is tied to the 2007 Food and Drug Administration Amendments Act, which requires the agency to publish quarterly a list of all authorized generic drugs included in an annual report since 1999. Specifically, the NDA holder must report whether it has marketed an authorized generic drug during the applicable time period; the report must be submitted within 60 days of the anniversary date of the NDA approval.

FDA also has amended its NDA and abbreviated new drug application (ANDA) rules to correct the agency’s address. Effective July 24, 2009, as published in the Federal Register, the new address of the Orange Book Staff in the Office of Generic Drugs is 7500 Standish Pl., Rockville, MD.

The European Medicines Agency (EMEA) is working to fast-track its review of data on H1N1 pandemic vaccines before the start of the Northern hemisphere’s flu season, which is expected to begin in September. Several vaccines are already under development, and preliminary data from GlaxoSmithKline (London) and Sanofi Pasteur (Paris) are under accelerated assessment by the agency’s Committee for Medicinal Products for Human Use (CHMP), according to an EMEA release. Four mockup vaccines-made using the similar H5N1 strain of influenza -from Baxter (Deerfield, IL), GlaxoSmithKline, and Novartis (Basel) have also been granted marketing authorization in the European Union. According to the EMEA website, all the manufacturers will be applying for a variation to the marketing authorization by including the new strain in the vaccines. The first of these could be submitted in September 2009 and the agency believes that the application will be processed quickly-possibly within five days. The CHMP also believes that the variation will not have a major impact on the safety and efficacy of the final vaccine.