Sepracor received a two-year extension on its patent for an insomnia drug, the drug maker announced.
The U.S. Patent and Trademark Office granted a patentterm extension to U.S. Patent No. 6,444,673, which covers the drug Lunesta (eszopiclone). The new expiration date for the patent is Feb. 14, 2014.
The company completed two studies of Lunesta in children in 2008 and 2009. The Food and Drug Administration had requested the studies in response to Sepracor’s efforts to win pediatric approval for the drug. The FDA placed a clinical hold on the studies in July due to concerns that some nonclinical data might be relevant to the administration of the drug to children, but it lifted the hold recently. Sepracor said it was working on determining the next steps of the clinical trials.
The FDA has approved an inhaler for reducing the risks of exacerbations associated with chronic obstructive pulmonary disorder.
Pfizer and Boehringer Ingelheim Pharmaceuticals announced the FDA’s approval of Spiriva HandiHaler (tiotropium bromide). The inhaler already is approved as a maintenance treatment for COPD, which includes chronic bronchitis and emphysema.
“Exacerbations of COPD are serious events that can negatively impact the lives of patients,” University of California Los Angeles David Geffen School of Medicine professor emeritus Donald Tashkin said. “People with COPD now have a once-daily treatment option that not only helps them manage the debilitating symptoms of COPD, but also can help them reduce the chance of an exacerbation.”
Merck & Co. will acquire Avecia Biologics, a contract manufacturer focused on microbe-derived biologics, under an agreement with Tees Valley, England-based Avecia Investments, through its British affiliate, which operates under the name Merck Sharpe & Dohme. Financial terms of the deal were not disclosed.
“At Merck, we continue to execute on our strategy of expanding our biopharmaceutical expertise and manufacturing capacity,” Merck manufacturing division SVP biologics and therapeutic protein operations John McCubbins said. “This transaction…will provide us with an operational facility staffed by an experienced workforce that is highly skilled in a broad portfolio of bioprocess systems.”
Novo Nordisk has signed a deal to pay $24 million upfront to Seattle-based ZymoGenetics to license a monoclonal antibody that inhibits the protein interleukin-21, or IL-21, which research has indicated can cause inflammatory diseases when over-expressed in the body.
Novo Nordisk hopes to develop the drug as a treatment for inflammatory bowel disease, lupus and rheumatoid arthritis, and may pay ZymoGenetics up to $157.5 million in milestone payments. The acquisition is part of Novo Nordisk’s efforts to develop treatments for autoimmune and inflammatory disorders.
The FDA has approved extended-release injectable suspension of the mental health drug Zyprexa Relprevv (olanzapine) by Eli Lilly & Co. for treating adults with schizoprenia, the Indianapolis-based drug maker announced. The drug, an intramuscular injection, sustains delivery of the drug for up to four weeks.
Nonadherence to antipsychotic drug regimens puts patients at risk of relapse. The new drug is designed to break the “revolving door” cycle often associated with schizophrenia by allowing doctors to keep track of when patients have received their medication and immediately detect nonadherence when patients don’t return for scheduled injections.
“There is a growing recognition among psychiatrists in the United States that nonadherence to medication is an even greater barrier to care for patients with schizophrenia than was previously understood, and that long-acting treatments can play a beneficial role in helping patients maintain a stable treatment regimen,” Lilly Research Labs VP John Hayes said. “Zyprexa Relprevv provides a new mechanism for helping appropriate patients benefit from the well-characterized efficacy of olanzapine.”
Kirby Lester has appointed a new COO, the pharmacy automation provider announced.
Dave Johnson will direct the company’s daily operation in his new position, having previously served as VP business development. Johnson has worked in the healthcare field for 25 years, including seven years with Amerisource-Bergen division AutoMed Technologies and positions at Baxter Healthcare and Major Pharmaceuticals.
“As we transition Kirby Lester from a company that manufactured and sold ‘plug-and-play’ automation products to today’s Kirby Lester where we are offering fully interfaced, system-critical products, the coordination of the operational details for superior new product rollouts and outstanding customer support and service is critically important,” Kirby Lester president and CEO Garry Zage stated. “With Dave’s leadership and experience, I am completely confident that Kirby Lester will continue to succeed in providing innovative technologies and responsive customer support.”