Week Of April 19, 2010: Company And People Notes: FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

April 22, 2010
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

Company Notes

Abbott Laboratories (Abbott Park, IL) announced that the Utah Department of Health is one of five US agencies participating in its PLEX-ID Biopreparedness Evaluation Program. The program involves Abbott, the Association of Public Health Laboratories, and five state public-health laboratories. Its goal is to assist public-health authorities in identifying and characterizing a wide range of microorganisms in surveillance activities for infectious diseases, food safety analysis, and biodefense readiness.

The US Food and Drug Administration sent warning letters to Astellas Pharma (Tokyo), GlaxoSmithKline (GSK, London), and Novartis (Basel) for allegedly using misleading promotions for cancer, pain, and bladder drugs. FDA officials said that a GSK advertisement omitted important information about the safety and effectiveness of the cancer drug Arzerra. FDA also alleged that a promotional webpage overstated the effectiveness of GSK’s and Astellas overactive-bladder drug Vesicare. FDA warned Novartis about misleading claims about its pain reliever Voltaren gel.

Celgene (Summit, NJ) and the biopharmaceutical company Agios Pharmaceuticals (Cambridge, MA) agreed to a collaboration targeting cancer metabolism. Under the terms of the agreement, Agios will receive a $130-million upfront payment, including an equity investment. In return, Celgene receives an initial period of exclusivity during which it has the option to develop any drugs resulting from the Agios cancer-metabolism research platform.

Charles River Laboratories International (Wilmington, MA), a contract-research organization, received a Certificate of Good Laboratory Practice compliance from Belgian’s Organization for Economic Cooperation and Development.

The contract manufacturer DPT Laboratories (San Antonio, TX) expanded its aseptic manufacturing and development capabilities at its Center of Excellence for Sterile and Specialty Products in Lakewood, New Jersey. DPT’s sterile center will focus on aseptic production of sterile dosage forms, including small-volume parenterals, ophthalmic preparations, preservative-free nasal sprays, and sterile ointments.

Pfizer (New York) and Stemgent (Boston, MA), which provides research tools and services to institutions, companies, and universities, agreed to a research and licensing agreement through which certain research reagents developed or discovered by Pfizer will be made available to the global research community through Stemgent.

The pharmaceutical company Perrigo (Allegan, MI) was named an authorized generic partner by Ferndale Laboratories (Ferndale, MI), a provider of products for the relief of dermal pain or anorectal discomfort due to hemorrhoids and anogenital pruritus. Perrigo launched an authorized generic of Analpram HC Cream and will have future opportunities to launch other Ferndale products as its authorized generic distributor.  

PRA International (Raleigh, NC), a clinical-research organization, established operations in New Zealand, which is a research hub for studies in skin cancer, multiple sclerosis, asthma and several other conditions.

Sandoz (Holzkirchen, Germany) signed a definitive agreement to acquire Oriel Therapeutics (Research Triangle Park, NC), a specialty pharmaceutical company focused on respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease. Terms of the deal were not disclosed.

Thermo Fisher Scientific (Waltham, MA), a provider of equipment, software, and services for research, analysis, discovery, and diagnostics, announced that the Nigerian National Agency for Food and Drug Administration and Control successfully field-deployed several Thermo Scientific TruScan hand-held Raman instruments for the rapid identification of counterfeit and substandard drugs.


People notes

Bristol-Myers Squibb (New York) appointed Charles Bancroft as its chief financial officer effective Apr. 8, 2010.

Patheon (Research Triangle Park, NC), a provider of contract development and manufacturing services, appointed Mark Kontny as its president of global pharmaceutical development services and as its chief scientific officer.