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FDA rejects EMD Serono’s MS drug

BY Alaric DeArment

ROCKLAND, Mass. The Food and Drug Administration has declined to file a regulatory approval application from the U.S. subsidiary of Merck KGaA for a multiple sclerosis drug.

EMD Serono announced that the FDA had responded to its application seeking approval for cladribine tablets with a refuse-to-file letter, which indicates that the application is incomplete. EMD Serono said it would request a meeting with the FDA concerning the application.

“The company will work closely with the FDA to fully understand FDA’s concerns and define a path forward for a successful resubmission of this application at the earliest point in time,” Merck KGaA head of pharmaceuticals and board member Elmar Schnee said in a statement. “We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options.”

Merck KGaA is a separate company from the U.S.-based Merck & Co.

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Zegerid OTC approved as heartburn remedy

BY DSN STAFF

NEW YORK The digestives aisle will be altogether crowded come early 2010, especially with two new proton-pump inhibitors on the shelf. And while there may be some question as to just how large sales of antacids can get, one thing is for sure: There will be a slew of advertisers vying for their own increased share of stomach.

Procter & Gamble will be fending off new-to-the-market PPIs in Novartis’ Prevacid 24HR and Merck’s Zegerid OTC; McNeil Consumer has already stepped up comparison ads for its Prevacid Complete against Prilosec OTC and Tums with the “Works now. Works later.” tagline; Boehringer Ingelheim is also likely to step up advertising against its Zantac franchise; and GlaxoSmithKline has reinvented the tried-and-true heartburn reliever Tums every time a new competitor comes to market. This time, GSK plans to market Tums as a conjunctive therapy to PPIs.

That’s a whole lot of advertising.

 

Regarding solely PPIs, Merck and its Schering-Plough Consumer division will have its work cut out in raising brand awareness around Zegerid. Unlike Prilosec and Prevacid, Zegerid doesn’t have nearly the number of patients to make the crossover from prescription-only to OTC at the time of its switch. And even though Zegerid contains two heartburn-relieving ingredients (omeprazole and sodium bicarbonate), it doesn’t appear as though Schering-Plough will be able to promote Zegerid OTC as “immediate release” — a claim that Santarus makes in promoting prescription Zegerid — for fear that consumers will confuse that message with “immediate acting.”

 

But it’s lack of brand awareness pre-launch that has industry analysts like Laura Mahecha at Kline & Co. projecting only $100 million in first-year sales of Zegerid OTC. Prevacid 24HR is expected to reach more than $200 million in sales in its first year, especially if Novartis executives realize their goal of making Prevacid 24HR a top-five OTC brand. Zegerid OTC is expected to break that $200 million marker within three years, however, Mahecha told Drug Store News.

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MinuteClinic, Humana expand partnership’s focus on chronic illness management

BY DSN STAFF

NEW YORK The expansion of MinuteClinic’s partnership with Humana not only further illustrates the important role that retail-based clinics play in the U.S. healthcare system and the model’s growing acceptance among third-party payers, but it also underscores the significance of worksite clinics.

As stated in the article, Humana is working with MinuteClinic, as well as LifeSynch, to open a health clinic for its employees and their dependents at a Humana facility in downtown Louisville, Ky. The site will offer health screenings, on-site health coaching and integrated health and well-being services for clinic visitors through LifeSynch.

Worksite health clinics are not a new concept, but they have grown in popularity in recent years. Employer-sponsored workplace health programs have been in existence for some time with the concept actually dating back to the 1930s and 1940s, and initially (read: pre-2000) focused mainly on occupational and health safety. Today, however, the model is much more robust, and it has proven to not only curb healthcare costs for employers and increase employee productivity, but also improve medication compliance and adherence — two of the biggest drags on healthcare costs and patient incomes in America, today.

CVS Caremark has been very vocal about its goal of reducing healthcare costs and improving patient outcomes, in large part through improved medication adherence, so it comes as no surprise that chronic illness management is a key focus of the expanded partnership.

For example, research by CVS Caremark has underscored the importance of adherence to diabetes medication showing that for every $1 spent on medication for the treatment of diabetes, $7 is saved in disease-related costs.

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