Allergy Alarm

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The dynamics of the brand-name prescription allergic rhinitis (AR) medication market are nothing to sneeze at. In 2005 AR brand marketers were spending money on promotional efforts like their category was going out of style, and in some cases their category or brand, quite literally, was. Patent expirations loom over the branded AR market like a dark cloud. With few products in the pipeline, specific areas of the AR market as we know it may simply just fade away, analysts say.

“The main issue facing the AR market in the next few years is patent expiry,” says Melissa Stolper, a senior analyst with market research firm Decision Resources. “From a prescription-based perspective, there's a lot going on compared to other markets. Overall, the trend is going to be downward. You've got factors working against the market. Compared to other markets, where there is a lot of drug discovery and new products coming out, this market is really stagnant.”

But that hasn't stopped pharma companies with AR drugs in the twilight of their prescription product life-span from pulling out all the stops to create brand awareness. In 2005 more than $546 million was spent on US consumer promotion of AR brands, according to advertising research firm TNS Media Intelligence. 

The marketing approach to AR products appears to differ from that of other branded Rx categories, because AR marketers are trying to reach a unique patient base with seasonal needs.

According to Louise Gillis, lead researcher in the respiratory arena for the research firm GfK Market Measures: “Patients who are seasonal or mild sufferers are typically symptomatic for four months, while moderate and severe patients suffer for six to eight months out of the year. Predictably, the months in which seasonal and perennial AR patients are most typically symptomatic are April, May and September.”

The AR market consists mainly of products that fall into two categories—oral antihistamines (including combination antihistamines) and inhaled nasal corticosteroids. Merck's Singulair, a leukotriene blocker, and Medpointe's Astelin, a liquid antihistamine, are also key players. Prescribers consider oral antihistamines the first line of treatment for AR.

“Antihistamines are prescribed more frequently simply because they are mostly efficacious in patients with mild forms of AR and they offer the convenience of oral delivery,” Stolper says.

Pfizer's Zyrtec (cetirizine HCl) captured 39% of the US antihistamine prescriptions market, with $1.1 billion in US sales in 2005, according to healthcare information firm IMS Health. The brand, however, is scheduled to suffer what appears to be the fate of all antihistamines as it loses patent protection in 2007. 

Over the past five years, Pfizer has eased up on its DTC spending, letting its reputation serve as its selling point. “Zyrtec has a strong image for long-lasting 24-hour relief and being safe for children,” says Gillis.

Pfizer spokesperson Alison Lehanski says: “The new Zyrtec ad campaign is designed to educate patients that allergy symptoms can worsen over time and that new allergies can develop … and encourages patients to work with their physician to explore the many options that are available to find the most appropriate treatment. The print ad also includes information about Pfizer's patient assistance programs to help lower barriers to seeking appropriate treatment, such as lack of prescription medicine coverage, as well as educational information about how to best prepare for the allergy season.”

The No. 2 antihistamine in terms of US sales, Sanofi-Aventis' Allegra (fexofenadine hydrochloride), was almost neck-and-neck with Zyrtec, with 37% of the US antihistamine market in 2005. Sales also hovered around $1.1 billion, according to IMS Health.

However, Allegra's 2006 sales are destined to disappoint following the September 2005 patent expiration of its main compound. Allegra now faces competition from a generic version of fexofenadine. Analysts predict a sales erosion of 50%, with some estimates as high as 80%. Sanofi-Aventis, which declined to comment on its marketing strategy, may find hope in an OTC switch. “Claritin faced the same issue a couple of years ago,” explains Stolper. “The marketers switched it to OTC status. It will be really interesting to see whether drug companies opt to switch their products to OTC when they face patent expiry, or are they going to let the products go generic and maintain them as prescription products?”

Stolper adds: “Based on the success Claritin had as an over-the-counter product, I can't see why the marketers of Zyrtec, Allegra and Clarinex wouldn't necessarily do the same thing. But my hunch is that they will tap into the OTC market.” Clarinex was the No. 3 branded oral antihistamine in 2005, with US sales of $401million. 

Unlike their antihistamine counterparts, corticosteroids aren't primed for the leap to OTC as they go off-patent.

“I think the FDA would be more reluctant to allow the corticosteroids to go OTC,” says Stolper. “They are very safe, but if you don't use the spray correctly, you can actually get a lot of nasal irritation and bleeding as opposed to simply popping a pill and swallowing. With nasal formulations, you can't ensure it's the same level of distribution.”

That's unfortunate for GlaxoSmithKline's Flonase (fluticasone propionate nasal spray), which lead the inhaled nasal corticosteroid market in 2005, with $1.2 billion in US sales. Flonase faced immediate competition from a generic form of fluticasone propionate manufactured by Roxane Laboratories when GSK's patent on fluticasone propionate expired in February. Analysts told MM&M it was too early to tell to what extent the patent expiry would erode Flonase sales, and GSK declined to comment regarding the situation.

Unlike Flonase, Schering-Plough's Nasonex (mometasone furoate monohydrate), the US corticosteroid market's No. 2 with $704 million in sales, finds itself uniquely poised for success. In late 2005 Nasonex's active ingredient was granted US patent protection until 2017—much longer that any prescription nasal spray currently marketed. Nasonex buzzed into the consciousness of the American public in 2005 on the wings of $124 million in spending on consumer marketing of the product in the US, a huge leap from the $10 million spent in 2004. 

The result was a barrage of heavily criticized DTC spots from BBDO featuring a cartoon bee flying through fields of flowers and other environments. One of the spots was named the most recalled of the fourth quarter of 2005 by the consumer ad research firm IAG Research.

“You can't turn the television on without seeing the bumble bee,” says Stolper. But the ads also became a target of criticism in November during an FDA public hearing on DTC advertising in Washington, DC. Ruth Day, a professor of psychology at Duke University, said her research on the ads revealed a lack of balance in the presentation of benefits vs. risks in DTC commercials. Schering-Plough denied MM&M's request for comment regarding the marketing of its AR products. 

Rounding out the corticosteroid category are Sanofi-Aventis' Nasacort AQ (triamcinolone acetonide), AstraZeneca's Rhinocort Aqua (budesonide) and GSK's Beconase AQ (beclomethasone dipropionate, monohydrate).

Like most other AR products, Nasacort faces a looming patent expiration—January 2007. Nasacort's sales remained flat for 2005, with US sales of approximately $348 million and a 13% market share.
Rhinocort Aqua sales were down 3% in 2005 to $325 million, according to IMS Health data. Consumer promotion of Rhinocort Aqua has fluctuated since 2001. In 2003 spending was at its highest at $16 million. In 2005 spending was at just over $3 million. AstraZeneca was unavailable for comment on Rhinocort Aqua's performance. 

GSK saw US sales of Beconase AQ sales dip by 12% to $40 million in 2005. As with its Flonase product, GSK would not comment on the marketing of Beconase.

Meanwhile, Merck's Singulair and MedPointe's Astelin, which don't fit neatly into the market's main subcategories, are gaining ground in the AR arena. In July 2005 the FDA approved Merck's asthma drug Singulair for the relief of symptoms of perennial AR or indoor allergies in adults and children. Singluair differs from other oral allergy medications, as it is not an antihistamine. Instead Singulair blocks leukotrienes, a contributor to indoor and perennial allergy symptoms. 

“Singulair is likely to see an increase in use in the next six months among physicians, mainly driven by pediatricians. … Physicians who have increased their prescribing of Singulair in the past year report doing so primarily for efficacy reasons. Safety and side effect profile are other common reasons for the increase,” Gillis says. 

Global sales of Singulair were $3 billion in 2005, a 13% increase over 2004, Merck figures show. However, it still has some hurdles to overcome in AR. “Singulair, while viewed as safe and best for relief of lower airway symptoms, is seen as less efficacious than the intranasal steroids for upper airway relief, especially decongestion. This is consistent with its frequent use as an add-on to an intranasal steroid.”

Merck told MM&M that its communication strategy regarding Singulair is considered proprietary and would not add further comment.

In February, privately held Medpointe Pharmaceuticals announced it was launching a major new program aimed at expanding the presence of Astelin Nasal Spray (azelastine HCI) in the AR market. 
The company commenced a DTC campaign, with work from McCann HumanCare, to support Astelin Nasal Spray. Astelin is a reworking of an older antihistamine into a nasal spray form developed by Wallace Laboratories. Medpointe would not disclose the level of its investment in the DTC campaign but did call it significant. “Medpointe has increased the size of its sales force to over 500 to promote Astelin to allergists, ENTs, ophthalmologists and primary care physicians,” the company said in a statement. 
“Astelin should see an increase in use in the short term,” says Gillis.

According to Gillis, the overall image of AR brands is good regardless of their market position. In her “Treatment of Allergic Rhinitis Study XII,” physicians rated a select group of agents to treat allergic rhinitis—Allegra, Clarinex, Flonase, Nasacort AQ, Nasonex, Rhinocort Aqua, Singulair and Zyrtec—as part of a competitive brand analysis. “Not surprisingly, prescription antihistamines have a strong safety image, as well as high marks for prolonged use not resulting in rebound nasal congestion, eye symptom relief, rapid onset of action and convenience to patients,” Gillis reports. “The intranasal steroids, as expected, maintain their top position for efficacy for nasal congestion, and efficacy for all types of allergic rhinitis, especially severe conditions … having minimal effect on cardiovascular function and treating the inflammatory process underlying rhinitis symptoms.” 
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