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New items find work in busy allergy season

BY Michael Johnsen

There’s a lot happening in the allergy space right now. Chattem’s Nasacort Allergy 24HR recently hit store shelves, and in a little more than 10 weeks on the shelf the nasal corticosteroid has already generated $33.6 million in sales across total U.S. multi-outlets, according to IRI. Meanwhile, Merck’s allergy switch hopeful Singulair ran into a snag with the Food and Drug Administration’s advisory committee, which voted 11-to-4 against the switch. But with the FDA’s recent expansion as to which medicines belong in the self-care market, there are precedents in Procter & Gamble’s Prilosec OTC and Merck’s Oxytrol.

(For the full category review, including sales data, click here.)

And speaking of Merck, the pharmaceutical giant has agreed to sell its consumer division to Bayer, which includes the venerable Claritin franchise. It begs the question, is a possible Clarinex switch in the offing?

Meanwhile, Reckitt Benckiser has extended its Mucinex brand into the allergy set with the appropriately named Mucinex Allergy, and McNeil Consumer line extended its Zyrtec brand with a differentiated format — dissolve tabs.

All this as the spring allergy season is off to a fast start. “[Allergy], I can tell you, is roaring in the Northeast,” Matt Mannelly, president and CEO of Prestige Brands, recently told analysts.

And there are more sufferers as climate change is extending allergy seasons.

If Nasacort continues with its current momentum, the brand will have first-year sales exceeding $170 million, which would make it the fourth best-selling allergy remedy on the market behind Zyrtec ($318.7 million for the 52 weeks ended April 20 across total U.S. multi-outlets, according to IRI), Claritin ($212.9 million) and Allegra ($202.3 million).

“I’ve seen some very unique marketing tools that Sanofi is using that I haven’t seen with other products,” Laura Mahecha, healthcare industry expert for the Kline Group, told Drug Store News, referencing an interactive shelf display that gives a whole new meaning to the term “shelf talker.” With the press of a button, shoppers have the opportunity to watch a brief tutorial on what made Nasacort different and why they should consider Nasacort as their allergy remedy of choice. “It’s enough to get the launch going,” Mahecha said. “It did a good job of explaining what makes it different from the pills that are available and helps differentiate it from Allegra and Zyrtec.”

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Canada’s Federal Court says no price-control measures for generic drug companies

BY Michael Johnsen

Canada’s Federal Court ruled recently that the country’s Patented Medicine Prices Review Board — a federal tribunal that regulates pricing on branded medicines — could not extend price-control measures to cover generic drug companies, according to published reports.

The ruling covered two cases involving generic drug makers Ratiopharm (now Teva Canada) and Sandoz.

“The decision means that generic drug makers who do not hold patents themselves and do not exercise monopoly power need not file price information with the board,” Gavin MacKenzie of Davis LLP’s Toronto office, who represented Ratiopharm and Sandoz, told Canada’s National Post.

In the case of Ratiopharm, the court reversed a $65 million decision.

The PMPRB has been in operation since 1987 to ensure that drug manufacturers do not charge exuberant prices for medicines under patent protection and without market competition. In 2008, according to MacKenzie, PMPRB extended those price controls to authorized generics, arguing that because the medicines were still under patent protection that defined the generic manufacturers as “patentees.”

In separate cases, Ratiopharm and Sandoz challenged PMPRB’s classification of “patentees,” arguing that the tribunal had no jurisdiction over generic companies and charging that the board’s price-control powers may be unconstitutional.

“The board should confine its role to reviewing prices charged by patent holders, who benefit from a time-limited monopoly, to determine whether those prices are excessive,” wrote Federal Court Judge James O’Reilly in his ruling. He noted that under the terms of the Patent Act, the act is “not aimed at protecting consumers from high drug prices, generally, and the board’s role certainly does not extend that far. … Generally speaking, generic companies either help create or join a competitive marketplace, which helps keep the costs of patented medicines down,” he wrote. They “do not generally hold monopolies and, in fact, do not normally operate in a market where any monopoly exists.”

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Expanding Rx’s vaccination role

BY Richard Monks

As patients across North America continue to turn to their neighborhood pharmacy for vaccinations, state and provincial governments in the United States and Canada are widening the range of immunizations that can be administered by a pharmacist.

(For the full report, including charts, click here.)

“There’s been a recognition that pharmacists play a valuable role in maintaining patients’ health,” American Pharmacists Association chief strategy officer Mitchel Rothholz said. “Public health officials around the country have come to see providing vaccines as a critical component of that role.”

While all 50 states allow pharmacists with immunization training and certification to administer some vaccines, a handful continue to restrict pharmacists to providing just flu shots and a limited number of other immunizations.

All told, 43 states, the District of Columbia and Puerto Rico allow pharmacists with an existing prescriber protocol to administer any vaccine approved by the Centers for Disease Control and Prevention. Of these jurisdictions, however, 18 mandate that a patient have a prescription. In some cases that requirement is limited only to patients younger than 18 years old.

In Canada, six of the country’s 13 provinces and territories allow pharmacists to administer flu vaccines with some jurisdictions also permitting them to provide other immunizations.

Meanwhile, regulators across the United States continue to loosen restrictions on pharmacist-administered vaccinations.

In Louisiana, for instance, a bill introduced last month would let pharmacists administer all immunizations and vaccines without a prescription to patients older than 17 years.

That proposal comes on the heels of several other changes to state laws over the past year that have expanded pharmacists’ role in immunizations.

Among those moves, the one that has impacted the greatest number of patients has been California’s expansion of pharmacists’ scope of practice. The law, which went into effect in October, makes pharmacists in the state a more central part of a patient’s healthcare team, and authorizes them to administer drugs and routine vaccinations.

That same month also saw North Carolina begin to let pharmacists vaccinate against pneumonia, shingles, hepatitis B, meningitis and tetanus. Previously, they were only authorized to administer flu vaccines.

“States are making the right decisions,” National Association of Chain Drug Stores VP of media relations Chrissy Kopple said. “We anticipate that will continue to be the case.”

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