Arena, Eisai receive complete response letter for lorcaserin
SAN DIEGO The Food and Drug Administration declined to approve a regulatory approval application from Arena Pharmaceuticals and Eisai for a drug to treat obesity, the two companies said Saturday.
The FDA issued a complete response letter for the drug lorcaserin, designed for weight management and weight loss in patients who are overweight or obese and have at least one co-morbid condition. The FDA issues a complete response letter when it finishes reviewing an approval application, but issues remain that preclude final approval.
The FDA told the companies that it found problems regarding tumors in the mammary glands of rats receiving the drug and issues surrounding the efficacy of the drug in some patients.
“This is an important step for us toward the FDA’s approval of lorcaserin,” Arena president and CEO Jack Lief said. “While the complete response letter provides us with recommendations from the agency, we intend to meet with the FDA to obtain further clarity on the approval path and timeline.”
Rexall’s efforts sure to pay off
WHAT IT MEANS AND WHY IT’S IMPORTANT Leave it to our creative retail neighbors to the north to find a fun way to merchandise over-the-counter products and wellness.
(THE NEWS: In sweeping overhaul of its retail mission, Rexall unveils ‘Healthy Living’ prototype. For the full story, click here)
The flagship Rexall division of Canadian drug store giant Katz Group has spent two years crafting a new and appealing approach to the retailing of preventive health products and services and the management of chronic disease. And Tuesday, Rexall Healthy Living Pharmacy was ready for its close-up.
Rexall execs and planners proudly displayed the results of that two-year effort Oct. 19, with a media walk-through at the company’s 16,000-sq.-ft. prototype Healthy Living store in the Toronto suburb of Milton, Ontario. Five top Rexall managers — including CEO Andy Giancamilli, COO Warren Jeffery, marketing and advertising chief Denise Darragh, chief merchant Ron Lalla and Tracey Phillips, head of pharmacy services, marketing and supply — gave Drug Store News an exclusive, nearly hour-long interview to explain the evolution of the new concept and its goals.
Much like what is happening in the United States, the Canadian healthcare system is under duress as costs continue to skyrocket and physicians are overwhelmed by patient caseloads. The new Rexall concept, said ex-pat and former Kmart COO Giancamilli, will “bridge the gap” between patient and doctor by offering up accessible, community-based care by specially trained pharmacists, wellness advisers and skin care experts, and by giving shoppers and patients the information they need to make more informed decisions about products, health services and healthier modes of living.
It’s a tall order. But Rexall’s pharmacy and merchandising teams have labored to make the six Healthy Living pilot stores fun and informative, with interactive kiosks and “health information touch points” scattered throughout the store to guide purchases and provide advice. And among the roughly 20 Rexall employees who staff each of those stores is a healthy living advisor, installed in a specially marked “focal point” station near the front of the store to guide customers through each department.
Rexall called each of the advisers “a specially trained health and customer experience ambassador,” and said they will be key to the expansion of the Healthy Living concept to more stores going forward [including a seventh prototype store, set to open in Kelowna, B.C., in spring 2011]. But the advisers won’t act alone: They’ll be part of “an increased level of interactivity between store staff and customers … throughout the store, including in the Skin Health area,” according to the company.
Also new: Interactive terminals where patients can use touchscreen technology for information on health topics, disease, prevention and OTC medicines.
The goal: to “help Canadians live their healthiest” and “inspire them to take charge of their health,” Lalla said. That means elevating Rexall’s image and draw as a health-and-wellness destination, and building on its already strong links with family physicians.
Some 150 stores within the Katz Group’s 1,800-store retail network across Canada are already linked with doctors’ offices; in some cases, those primary-care physician practices are even housed within the store as walk-in clinics. The partnership likely will expand as the country looks for new solutions to its own healthcare crisis.
Diamyd Medical to divide business
STOCKHOLM Diamyd Medical will split its business into separate divisions for pain relief and diabetes, the drug maker said Friday.
The Swedish company said its diabetes business would consist mostly of the investigational antigen-based drug Diamyd, for Type 1 diabetes, while the pain business would comprise of development projects using its nerve-targeting drug delivery system platform to administer drugs directly to the nervous system to treat pain.
The company will begin the division process during the new 2010-2011 fiscal year.