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.”
Walgreens taps veteran to head CCR
NEW YORK In a high-stakes campaign to fire up its front-end appeal, reaffirm its relationship with America’s consumers and rejuvenate its same-store sales, Walgreens has gone to its bench.
Walgreens has named one of its veteran operations people, Mike Arnoult, to the key post of VP in charge of Customer Centric Retailing. Until last month, the post was held by Chong Bang, who left the company in mid-December to oversee merchandising at Toronto-based Shoppers Drug Mart.
Unlike Bang, Arnoult is more a seasoned operations manager than a merchant. His appointment is a clear sign that Walgreens has moved beyond the conceptual and launch phase of CCR, and is ready to begin the next phase of the massive project: the expansion of a CCR-based store design across Walgreens’ coast-to-coast network of 7,147 drug stores.
Nevertheless, Arnoult inherits a critical challenge at the retail behemoth. CCR encompasses Walgreens’ massive effort to pull together a sprawling marketing and merchandising operation and focus its efforts more sharply on meeting and anticipating customer demands. Within two or three years, it will transform the chain’s front-end presentation and go-to-market strategy coast-to-coast with a leaner, more condensed merchandise mix; a sharper focus on health, wellness and patient education in the aisles; improved departmental adjacencies and signing; and — Walgreens merchants hope — a better overall shopping experience.
Bang took CCR all the way from conception to realization, streamlining assortments, cutting hundreds of redundant SKUs, and applying new rationale to categories, adjacencies and promotional strategy at the front end. He also oversaw the test and launch of a new Walgreens store prototype, based on CCR principles and a better read of consumer needs.
Arnoult will now take the CCR rollout from a 400-store pilot in Texas to nationwide completion. Given the chain’s aggressive plans for 2010 — nearly 3,000 stores scheduled for a CCR redesign by the end of the year — he’ll need to bring all his proven management skills to bear to coordinate local-market remodeling activities with Walgreens’ operations and merchandising teams.
“We’re evaluating the findings from the Texas stores and doing some tweaking,” company spokesperson Tiffani Washington told Drug Store News in December. “We’ll continue the rollout [of the CCR-based store overhaul program] starting in January.”
Arnoult brings to his task a strong resume in store, district and regional management. His 20-year career at Walgreens includes stints as store manager, district manager and store operations VP, followed by a year as head of online merchandising. He’s a 1990 graduate of Marquette University with a B.A. in communications.
“His ability to build relationships and collaborate across the organization will be invaluable,” Walgreens asserted.
Bartell to cease filling Medicaid prescriptions at 15 locations
NEW YORK The Medicaid storm is still intense in Washington as Bartell Drugs has announced that — as of Feb. 1 — it will no longer fill Medicaid prescriptions at 15 of its 57 stores. Limiting access to pharmacies with its payment cuts could spell an increase in other healthcare costs — costs that represent the majority of health expenditures.
As stated in the article, the decision stems from a court decision in Massachusetts in September 2009 that reduced the industry pricing standard.
Bartell stated that — unlike most other insurance providers, including other states — the Washington State Department of Social and Health Services has made no effort to offset this significant reduction, resulting in sizeable reductions in payments to pharmacies.
The intent, according to Bartell, is to return to the established level of compensation prior to the Sept. 26, 2009, court action. As it currently stands, Bartell simply can’t afford to fill the Medicaid prescriptions.
While Bartell currently is the only pharmacy retailer to take such action, it certainly isn’t alone in the battle.
In March 2009, Walgreens threatened to stop serving Medicaid patients in 44 of its stores in the state. The company at that time stated that it operates 111 pharmacies throughout the state, but the 44 pharmacies in question represented more than 60% of its total Medicaid business in the state. However, in May 2009, Walgreens stated that it would continue to serve Medicaid patients when the state agreed to make smaller cuts than it had planned.
But will the court decision in Massachusetts now prompt other pharmacies to follow in Bartell’s footsteps? Perhaps, but if you ask Doug Porter, the state’s director of Medicaid, he will likely say no. In a recent Seattle Times article, Porter was quoted as saying that Medicaid recipients should not worry about other companies following suit and he is “convinced pharmacies can weather this change.” As reported by the Seattle Times, several pharmacies and industry trade groups filed suit in U.S. District Court in Seattle trying to force the state to return its reimbursement rates to those it was paying before the Massachusetts settlement. A hearing is scheduled for Jan. 15.
Last year, the pharmacy groups filed another lawsuit, after an earlier attempt by the state to cut its reimbursement rates. That suit was withdrawn when the state agreed to make smaller cuts than it had planned.
“We are deeply concerned about the health of our patients. Pharmacists are on the front lines of our healthcare system protecting patients by ensuring safe and appropriate medication use. Commercial healthcare payers and Medicaid programs in some states have already adjusted pharmacy reimbursement necessary to maintain patient access to the essential care provided by pharmacies. If Washington Medicaid does not do the same, it can result in reduced access to medicine for our neediest and most vulnerable patients ultimately leading to expensive emergency room visits and hospitalizations,” stated Jeff Rochon, Pharm.D., CEO, Washington State Pharmacy Association, in an NACDS press statement issued in September.