This melt-in-your-mouth pill -- called Grazax® in Europe, and Grastek® here and in Canada (where it won approval in March of 2012) -- is finally going to be available in the US with a prescription, beginning around Mothers' Day 2014. It enters a crowded field, likely to be dominated by Stallergenes -- a French pharma concern. [Thanks to my anonymous commenters for that insight!] And still it is good news. [See the anthropological implications of a "missing" blood moon (full lunar eclipse overnight), in all of this -- below the pull-quote.]
Here is a bit from Reuters overnight. Do go read it all:
. . . .The company, which developed the tablet with Denmark's ALK Abello, said it expects to launch the drug, approved for patients age 5 to 65, in the United States by late April. . . .
An advisory committee to the FDA unanimously recommended approval of the drug in December. Panelists also called for post-approval studies to test the product's safety in children, citing side effects such as lip swelling, throat irritation and oral blistering.
Earlier this month, the FDA approved Stallergenes' immunotherapy treatment for five types of grass pollen.
The French company has said it sees a potential U.S. market of nearly 3 million patients that will eventually be worth $1 billion in annual sales for these types of drugs.
Merck's pollen treatment received regulatory approval in Canada in February and has been available in Europe since 2006 under the name Grazax. . . .
As an anonymous commenter noted two weeks back, the Stallergenes prescription-only product is likely to garner the lion's share of this market. In fact, it already is. But this is still incrementally good news for Merck. Immaterial, but incremental. I'd guess around $300 million globally in peak annual sales in 2016 -- off-grid all morning; tending to other duties.
[On the O/T paleontologist in me: The blood moon was -- among our ancient forebears -- long associated with heightened spiritual-, sexual- and hunting- prowess. Here -- very, very late last night. . . it brought only. . . snow. Yep, the lunar eclispe was obscured by heavy snow clouds overnight, so there was no blood moon in the city of big shoulders. Even so, I guess a cleansing is. . . somehow auspicious. Heh -- a bath indeed, for mother Earth.] So it goes.
1 comment:
Condor, my recollection is that MRK explored this opportunity in the mid-2000s, turned it down, and that SGP eventually made the deal shortly afterwards. Interested to hear confirmation of that timeline.
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