Merck's GRASTEK® (Sublingual Timothy Grass Allergy Pill): Favorably-Reviewed By FDA Advisory Panel Yesterday

Merck posseses, by license, the North American rights to a new ragweed-antigen based daily oral drug candidate developed by ALK-Abelló. It has shown moderately positive results, at least as compared to a placebo, in a Phase III trial. The companies propose to sell it under the brand name Grastek^®.

Yesterday, a non-binding vote by the FDA Advisory Committee, after reviewing that study, and other data submitted by Whitehouse Station and ALK-Abelló, recommended that the full FDA approve the homeopathic candidate for sale in the United States. That could come within six weeks now. Here's the PharmaTimes story (courtesy a kind anonymous commenter who alerted us to the development) -- and here is a bit of Merck's presser of last night, once the panel voted (and here's my prior backgrounder):

. . . .GRASTEK (Timothy grass pollen allergen extract) is the proposed trade name for the company’s investigational sublingual tablet for the treatment of Timothy grass induced allergic rhinitis, with or without conjunctivitis, in appropriate adult and pediatric patients who are candidates for immunotherapy.

“We are pleased with the positive discussion of GRASTEK at today's advisory committee meeting,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “We believe GRASTEK has the potential to be an important new oral therapeutic option for allergy specialists and their patients who continue to suffer with Timothy grass pollen induced allergic rhinitis, and we look forward to continuing to work with the FDA as the agency completes its review of our biologics license application for GRASTEK.”

The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. Merck anticipates the FDA’s review of GRASTEK to be completed in the first half of 2014.

GRASTEK is designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect patients against Timothy grass pollen.

Merck has partnered with ALK-Abello to develop its investigational sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite induced allergic rhinitis in North America. . . .

This is good so far as it goes -- but the field is already deeply-crowded, and this sublingual pill doesn't likely offer the opportunity to premium price (with some strong barrier to entry), since other similar homeopathics are on-market, in the US. True enough, only Merck will be able to make health claims, in its TV advertising for the pill -- but I don't foresee more than $300 million in peak annual sales. Nice, but it is thus only one third of a blockbuster, and immaterial to the overall enterprise.