Company and People Notes: Daiichi Sankyo Sues 13 Generic Drugmakers; Ischemix Appoints CEO; More...

Company Notes

Daiichi Sankyo (Tokyo) is suing 13 generic-drug companies for the substance patent (2008845) and usage patent (1659502) for Cravit tablets and fine granules (levofloxacin hydrate), according to a company press release. The company has marketed levofloxacin hydrate broad-spectrum oral antibacterial agents since 1993. The following 13 companies have received approvals to market generic versions of the drug: Shiono Chemical, Taiyo Yakuhin, Takata Seiyaku, Nichi-Iko Pharmaceutical, Nihon Generic, Mylan Seiyaku, Yoshindo, Ohara Pharmaceutical, Sawai Pharmaceutical, Taisho Pharm. Ind., Choseido Pharmaceutical, Towa Pharmaceutical, and Nipro Pharma Corporation. Daiichi’s patent for levofloxacin hydrate was originally extended until May 27, 2011 with the additional indication for Legionella pneumophila, but in late Nov. 2008, says the release, the Japan Patent Office invalidated the extension beyond Dec. 25, 2008. Daiichi is appealing the invalidation.

Endo Pharmaceuticals (Chadds Ford, PA) completed its acquisition of Indevus Pharmaceuticals (Lexington, MA) for $4.50 per share in cash and up to an additional $3.00 per share in cash upon achievement of certain regulatory and sales milestones.

Hospira (Lake Forest, IL) has launched Project Fuel, a multiphase initiative to improve the company’s margins and fuel its growth. By “optimizing its product line, evaluating nonstrategic assets, and streamlining its organizational structure” over the next two years, the company hopes to reduce its global workforce by approximately 10%, for an annual savings of approximately $110 million–$140 million, according to a company release.

Ranbaxy Laboratories (Gurgaon, Harayana, India) announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Australia's Therapeutic Goods Administration (TGA) issued good manufacturing practice (GMP) certificates for the company’s Paonta Sahib, India, site. GMP certification has been extended for a further three years by MHRA and for two years by TGA, according to a company release. This comes as good news after the company received FDA warning letters for its sites in Dewas and Paonta Sahib (see back story, FDA Issues Warning Letters and Import Alert on Ranbaxy Laboratories)

Teva Pharmaceutical Industries (Jerusalem) and Medicis Pharmaceutical (Scottsdale, AZ) announced on Mar. 18 that they have mutually terminated all legal disputes between them relating to Solodyn (minocycline HCl, USP) extended-release tablets, according to a Teva press release. Teva confirmed that Medicis’ patents relating to the drug are valid and enforceable. Teva therefore agreed to immediately halt shipments of the generic version of Solodyn. The company will be able to release its generic version starting in November 2011, according to the agreement, says the release.

Watson Pharmaceuticals (Corona, CA) issued a voluntary recall of one lot of propafenone HCL 225 mg tablets sold in 100-count bottles in the United States as a precautionary measure, according to a company release. Some tablets “may contain slightly higher levels of the active ingredient than specified,” says the release. The company has reported the recall of the drug product, used to treat cardiac arrhythmias, to the US Food and Drug Administration.

Regulatory Roundup

US Rep. Anna G. Eschoo (D-CA) introduced another follow-on biologics bill last week. With 50 cosponsors, H.R. 1548, the Pathway for Biosimilars Act, offers some different options compared with the biologics pathway bill H.R. 1427, also introduced this month, by Rep. Henry Waxman (D-CA) [see back story, Bipartisan Bill for Biosimiliars and Biogenerics Introduced in the House]. Both representatives had introduced similar bills in the 110th Congress. The most controversial difference between the two bills is their designated exclusivity period. Waxman’s bill calls for 5.5 years and Eschoo’s bill calls for 14.5 years. The Biotechnology Industry Organization has issued statements on both bills, but ultimately comes out in support of the Eschoo bill, stating that it’s “the right medicine for lowering costs, ensuring patient safety and providing fair, responsible incentives for continued biotech research.” The Generic Pharmaceutical Association (GPhA), on the other hand, released a statement that the Eschoo bill is the “wrong road for patients looking for safe and affordable biogeneric medicines, particularly during these difficult economic times. It is a long route filled with needless roadblocks that will keep patients from getting needed medicines in a timely manner.”

The US Food and Drug Administration is being forced to make the Plan B (0.75mg levonorgestrel) contraceptive drug available over-the-counter to women as young as 17. Federal judge Edward R. Korman of the New York Federal District Court issued the ruling this week, overturning FDA’s 18-year-old age limit from the year 2006, according to a Mar. 23 New York Timesarticle. FDA has 30 days to comply with the order. The World Health Organization, American Medical Association, and other public health groups have been pushing FDA to make the drug available over-the-counter since 2001 because of the product’s time-based effectiveness (it must be taken within 72 hours after intercourse).

People Notes

BioStorage Technologies (BST), a provider of sample storage and management services and cold-chain logistics, promoted Jennifer Benner to director of global quality assurance. Benner joined BST in 2003 and spearheaded the creation of the company’s quality assurance department. In her new role, Benner will oversee this department on both a local and global scale.

Innospec (Newark, DE) announced that the board of directors accepted the resignation of Paul W. Jennings as president, chief executive officer, and as a member of the board of directors. Jennings joined Innospec as chief financial officer in November 2002 and was appointed president and CEO in 2005. The company will be conducting a search for a new CEO, and Bob Bew, chairman of the board, will oversee the company in the interim.

Ischemix (Maynard, MA), a biotechnology company, appointed Robert "Duffy" DuFresne chief executive officer. DuFresne has served on Ischemix’s board of directors since May 2007 and will continue in this role moving forward. The company’s former CEO, Reinier Beeuwkes, will continue to advise as president and chairman.

Contract manufacturing organization OSO BioPharmaceuticals Manufacturing (Albuquerque, NM) appointed Suman Kathuria vice-president of quality. Kathuria will work closely with the senior leadership team to enhance customer focus and maintain compliance with the regulatory authorities.

Pfizer (New York) appointed Elizabeth Barrett US regional president of its Oncology Business Unit. Barrett will lead sales, field operations, and marketing. Most recently, Barrett held the position of vice-president and general manager of the Oncology Business Unit at Cephalon (Frazer, PA).

WuXi AppTec (Shanghai), a research and development outsourcing company with operations in China and the United States, announced the addition of three key senior professionals. Brian J. Xu joined WuXi AppTec as vice-president of toxicology and head of the Safety Evaluation Center at Suzhou, Yang-Dar Yuan joined the company as vice-president of operation and head of pathology of the Safety Evaluation Center, and Robert Coldreck joined the company as head of good laboratory practice quality assurance.