Hay fever isn’t the only thing causing brand-name prescriptionmanufacturers’ eyes to water this allergy season. Top-selling products for thetreatment of allergic rhinitis (AR) went off-patent during 2007, giving rise topopular generic alternatives and subsequent losses of market share amongstaples in the category. The situation has caused allergy brand sales to dip totheir lowest point in five years. Last year’s sales were down 22% to $5.2billion from 2006.
The sniffling pharmaceutical companies invested in allergyrelief will have to make tough decisions about where to put marketing dollars,whether transitioning to over-the-counter sales (Zyrtec), concentrating onreplacement brands with fresh patents (Veramyst) or drumming up awareness forpotential pipeline possibilities (Claritin/Singulair).
Due to the seasonal nature of allergy affliction, marketingefforts for AR products tend to focus on two peak seasons each year: spring(April, May and June) and fall (September and October).
The two most prominent categories for AR treatment are oralantihistamines (including combination antihistamines) and inhaled nasalcorticosteroids (INCs). Antihistamines are widely available OTC and arerelatively easy to use, although many physicians are recommendingcorticosteroids to patients. “Based on research we conducted last fall, thereis a notable uptick in physicians prescribing INCs,” says Sue Ramspacher, SVP,category business leader of respiratory, GfK Market Measures. “Inhaled nasalcorticosteroids are becoming the first line of therapy and are being used to amuch greater extent in terms of a physician’s perspective. Veramyst is beingprescribed, for example, because it addresses a broader range of symptoms.”
New AR drugs like Veramyst, and Xyzal, in the antihistaminecategory, have the ability to move quickly into positive sales figures.
“The AR market is driven by sampling and detailing,” saysRamspacher. “Literally weeks after the launch of Xyzal, there was a high levelof awareness among allergists.”
Ramspacher also mentions that the eagerly anticipated Claritin/Singulairpipeline compound is “at the top of the list in terms of physician awareness.”The new compound was formed through a Schering-Plough/Merck partnership and iscurrently seeking approval from the FDA. “[AR] is a crowded category with lotsof competitive players. Even though the market is crowded, there are stillneeds to be met, and areas where product attributes could differentiatethemselves,” she says.
Ramspacher cites long-term safety and the absence of reboundcongestion as two examples of attributes that could provide differentiation.This should be encouraging for companies itching to enter the market. However,recent safety issues regarding Singulair may give pause to physicians. InMarch, the FDA announced an investigation into a “possible association betweenthe use of Singulair and behavior/mood changes, suicidality (suicidal thinkingand behavior) and suicide.”
Approved in April 2007, GlaxoSmithKline’s Veramyst(fluticasone furoate) nasal spray is an emerging INC, which the company hopeswill help to offset Flonase’s market share losses to generics. Flonase was oncea leader of the category. “GlaxoSmithKline will not be advertising Flonase atall this season, on the consumer side or the professional side,” says RobinGaitens, product communications manager for GSK. A Veramyst TV spot fromSeptember 2007 drew questions and commentary from viewers, who reacted to aseemingly odd line of copy seen in the ad:
“The way Veramyst works is not entirely understood.” Gaitensconfirmed a 2008 DTC campaign in support of Veramyst, but declined to elaborateon campaign details.
In September 2006, UCB and Sanofi-Aventis entered into anagreement to launch and co-market the antihistamine Xyzal (levocetirizinedihydrochloride) in the US. Xyzal received FDA approval in May 2007 fortablets, followed by an oral solution in February 2008.
A DTC campaign featuring national TV spots, online and printads launched in March, according to Scott Ellis, product director, UCB.
“As part of the 2008 public relations program, the XyzalChallenge Your Course campaign was launched [in February], and is slated to runthroughout the entire year. We have implemented a comprehensive, integratedconsumer and professional awareness campaign for Xyzal as well, called X-Factor.”An X-Factor print ad contains copy reading: “Your indoor and outdoor allergiescan itch, sneeze and run. But they can’t hide.” The Challenge Your Course(www.challengeyourcourse.com) program is a “collaborative partnership with theAsthma and Allergy Foundation of America (AAFA) and Jill McGill, an LPGA golferwho suffers from indoor and outdoor allergies,” explains Ellis. “The Xyzalwebsite will incorporate the PR spokesperson Jill McGill as an ‘interactiveguide,’ detailing her experience as a nasal allergy sufferer.” Agencies workingon various aspects of the campaign include Ogilvy, HeartbeatDigital and PRagency Biosector 2.
Companies without new products immediately available formarket are dealing with patent losses in other ways. Zyrtec (cetirizine HCl),the nation’s top-selling prescription allergy medicine, went off-patent inDecember 2007. Pfizer ceded OTC manufacturing and marketing rights to McNeilConsumer Healthcare in 2006. Zyrtec, an antihistamine, began its life as an OTCin January, with in-store displays created by Henschel-Steinau Inc.
After a branded Spring Wonderland Dome was erected in NewYork City’s Central Park last January, McNeil most recently announced apartnership with the Asthma and Allergy Foundation of America (AAFA) andactress/comedian Molly Shannon. The campaign, “Allergies Are No LaughingMatter,” represents “part of Zyrtec’s overall educational campaign,” accordingto McNeil spokesperson Peggy Ballman. Ballman declined to comment further onadvertising for the brand.
Schering-Plough is probably the most experienced in dealingwith an OTC crossover in the allergy category. Claritin was approved for OTCback in 2002, and has continued to market its line of products. A new obstaclesurfaced in 2006 when an article in the Patriot Act banned all OTC sales ofproducts containing pseudoephedrine, a decongestant commonly used incombination with AR medications. Claritin-D, and now Zyrtec-D, are consequentlyheld behind-the-counter (BTC), and represented on the drugstore shelf byplacards urging consumers to “Take this tag to the pharmacy for purchase.”Commenting on the situation, Ramspacher explains that allergy medications arenow classified into three groups: prescription, OTC and BTC. “A notableSchering-Plough ad for Claritin has a patient saying ‘Thank you for notchanging your formulation,’ which is a direct statement on behind-the-countermedications.”
Marketing efforts for Claritin began targeting Zyrtec beforeit reached the shelves.
A Schering-Plough company release from November 2007 emphasizesZyrtec’s listed side effects this way: “While Zyrtec is approved forover-the-counter sale, consumers should be aware of its common side effectslike drowsiness and fatigue. In fact, Zyrtec prescription labeling carries acaution about the occurrence of drowsiness and urges consumers to exercisecaution when driving a car or operating dangerous machinery.” Thispassive-aggressive technique was augmented in January with Schering-Plough’sannouncement of a sponsorship agreement with “Allergy Sufferer and NASCARSprint Cup Driver Carl Edwards.” In the release, Edwards says, “When I’mdriving at 180 miles per hour, I can’t risk taking a medicine that makes medrowsy. That’s why I only use non-drowsy Claritin to treat my worst allergysymptoms.” The Edwards sponsorship deal extends through the 2008 Sprint Cupracing season.
Competition from generics in the AR market will not subsideany time soon. Sanofi-Aventis’s Allegra commanded 37% of the US antihistaminemarket in 2005, but has seen a steady decline – generic Allegra is currentlythe most prescribed antihistamine in the nation, capturing 36.2% of the marketshare for that category, according to IMS Health.
One important factor catalyzing generic alternative usage isthe “doctor’s offices vs managed care cost concerns,” says GfK’s Ramspacher.“Lots of generic competitors have been made available due to managed careprofessionals seeking the lowest cost alternatives.”
According to recent data from the American Academy ofAllergy Asthma & Immunology, as many as 50 million people suffer from twoforms of AR: seasonal and perennial. Seasonal allergies are caused by tree,grass and weed pollen. Perennial allergies are caused by frequent exposure toallergens like animal dander, mold spores and dust mites.
Many top-sellers in the antihistamine category are movinginto old age, or at least middle age, in terms of patent life expiry. MedaPharmaceutical’s Astelin (azelastine HCl) and Schering-Plough’s Clarinex(desloratadine) are both moving into the last couple of years of protection.However, most of the best-selling INCs are in good shape in terms of patentprotection, with Flonase (fluticasone propionate) being the single exception tothe rule – Flonase expired in 2004. Nasacort AQ, the third best-seller in 2007,expires in 2016, while AstraZeneca’s Rhinocort Aqua, the fourth best-seller,expires in 2017. Rhinocort Aqua won a MM&M award in 2007 for its “RhinoReader” campaign, created by Harte-Hanks. Generic Flonase was thesecond-best seller in 2007, according to research conducted by IMS Health.
Schering-Plough’s Nasonex, the nation’s best INC seller,will expire in 2014 at the earliest. “Nasonex sampling seems to be paying off.[The product] is holding its own against a large generic threat,” saysRamspacher. “Twenty-two percent of physicians overall prescribe [name brand]Nasonex compared with 20% prescribing generics.” Nasonex is known by many forits BBDO New York-created cartoon bee ads, which supersaturated consumer mediaoutlets beginning in 2004. A 2007 TV spot from the campaign was listed as thefourth most-recalled ad by IAG Research. Despite criticism, the ads haveweathered negative attention, and have been refreshed with new creative – stillfeaturing the bee – for 2008.
From the May 01, 2008 Issue of MM+M - Medical Marketing and Media
