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Climate changes to exacerbate suffering

BY Michael Johnsen

The U.S. Global Research Program in May issued an 800-page National Climate Assessment report that does not bode well for the more than 50 million Americans with allergies and asthma — their already terrible symptoms are about to get worse.

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

According to the American College of Allergy, Asthma and Immunology, such extreme climate changes as temperature increases, wildfires and superstorms can wreak havoc among allergy and asthma sufferers. Here’s how:

  • Length of the growing season. Warmer temperatures will lead to longer growing seasons — a good thing for farmers and gardeners, but it could mean increased misery for allergy sufferers because it escalates the time pollen and mold are present.
  • Erratic weather. If weather fluctuates greatly between warm and cold spells, it can result in more intense periods of pollen release during warm temperatures when plants take the cue to grow and release pollen. Once allergy sufferers are exposed to pollen, their immune system is primed to react to the allergens, meaning there will be little relief even if temperatures cool down.
  • Rainfall. Rain can be either a good thing or a bad thing for allergy sufferers, depending on when it happens. The worst allergy seasons are often preceded by rainfall, which promotes rapid plant growth later on. But rain can also provide a much-needed respite for those with allergies, as a heavy rainfall can help clear the air of pollen.
  • Wind. Dry and windy weather is not kind to people with allergies, as the wind spreads pollen and mold.

“Allergy and asthma can strike at any age. Even those who have never had symptoms can suddenly develop the conditions, especially as these climate changes continue,” said allergist Clifford Bassett, ACAAI fellow.

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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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