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Allergic Rhinitis
Brief Marketplace Overview

3Q, 2005

Sales force restructuring throughout the industry, rendering overhead reduction in response to the increasing challenges of face-to-face physician detailing, is significantly affecting strategic product planning.  Facilitated attrition of high earners is followed by induction of new hires at significantly more conservative salary levels.  

DTC campaigns for the 2005 Allergy season are proceeding, with Schering-Plough expenditures exceeding most industry participants.  Frequent TV spots have been apparent, with substantial sales force support, while sampling issues remain in certain areas.  The Sanofi-Aventis force promotes Nasacort AQ alongside Allegra and Allegra D, supported by moderate DTC budgeting.  AstraZeneca targets seasonal as well as Perennial Rhinitis in their detailing, with a DTC allocation similar to that of Sanofi-Aventis, and recent expansion of Rhinocort Aqua sales force coverage.  Merck, although utilizing substantial sales force support, has been trimming their DTC budget for Singulair’s Allergic Rhinitis promotion.  They are preparing a Phase IV trial utilizing Singulair in patients insufficiently controlled on intranasal steroids.

The Inhaled Steroid generic threat is composed of several ANDA filers defining a highly competitive marketplace.  Apotex, IVAX, Roxane, Hi-Tech, and potentially Dey, with the possibility of Bausch and Lomb and Barr, will contribute, following the exclusivity period, to substantial price competition.  Zyrtec, Clarinex, and Allegra continue to generate substantial revenue defining the OTC switch alternative as unlikely in the short term.

Loteprednol NDA preparation continues, with filing to occur in the short term.  The Ciclesonide NDA filing rapidly approaches as well, to be supported by Altana sales force enlargement as launch nears.  Rigel has initiated a comparative Phase II R-112 trial recently, with the intent of augmenting Pfizer’s interest and support.  Prehistin’s concept is a good one, although accompanied by a lesser probability of success in our view, while rEV131 will enter Phase III in the forthcoming year pending positive Phase II results now in compilation.
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