Archive for March 4th, 2012

Merck To Enter Crowded, Lower-Priced Homeopathics (Ragweed Allergy Remedies) — By 2014?
March 4, 2012

I’ve long believed that there are at least some homeopathic remedies that actually work, against a range of conditions and diseases. It would seem that Whitehouse Station is (becoming) a believer, as well.

The long term problem has been — as to the homeopathics — that they generally lack the rigorous study data FDA requires to make an allergy-relieving/health care labeling claim. Once again, it seems that Merck is looking to change that — at least as to ragweed antigens, and grass antigens. [It will in part cannibalize the OTC versions of Claritin®, etc. -- I guess.]

While Merck is pitching it as an alternative to allergy shots (in doctors’ offices), as well, it will also have to go head to head with numerous (generally low-priced) homeopathic pills and capsules. I’ll be curious to see whether the study data will support “pharmaceutical-grade” as a pricing differentiator.

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. These studies were just reported at a conference in Orlando, Florida this weekend.

From Reuters, this morning — just a bit — do go read it all:

. . . .Merck & Co on Sunday said it would seek U.S. approvals next year for separate allergy pills that help tame the immune system’s reaction to ragweed and grass, and the drugmaker released favorable data from a late-stage trial of the ragweed medicine.

The pills are meant to be an alternative to traditional allergy shots given in doctors’ offices, which include a mixture of proteins that gradually weaken the immune system’s response to ragweed, grass, foods and other allergy triggers.

The Phase III study involved 565 patients 18 to 50 years old prone to ragweed-induced allergies, with or without asthma. Patients took Merck’s once-daily tablet for 52 weeks, at one of two available doses, or took placebos.

The active ingredient of the pill is Ambrosia artemisifolia, the chemical name of the ragweed allergen, or protein, that causes runny noses, sneezing and other miseries for millions of Americans. . . .

Specifically, the pill reduced allergy symptoms during peak ragweed season by 17 percent and 14 percent, respectively, at the higher and lower doses. . . .

The studies will support the thesis, no doubt — but will they be enough to push the homeopathics to the side — or will Merck’s spend on an FDA approval backfire, and bolster demand for the homeopathics (many of which contain the very same active ingredient)? Only time will tell. At least Merck is looking everywhere, for new revenue, it seems.


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