Friday, April 18, 2014

Ragwitek® Gains FDA Nod; Peak (2016) Annual Sales: ~ $250 Million?


This is good news to be sure for Whitehouse Station -- but immaterial, especially given Stallergenes' market lead (background here). Now, let's get some church up in here:



. . . .have a meaningful Good Friday, one and all -- as "this too shall pass away". . . .

That is Kirk Franklin's "Hosannah" -- from Men of Gospo. . . .


Enjoy.

9 comments:

Anonymous said...

Hello Condor. just fyi: Stallergenes does not not have an approved product yet for ragweed.

The Condor said...

You are quite right, Anon.

My bad. I confused the two recent Merck approvals here in the US.

In the EU, Stallergenes (correct me if I am wrong) has an approved multi-function product. Including Ragweed.

My memory is that the Stallergenes ragweed product is only a few weeks from approval here in the US -- FDA Advisory Committee has already voted favorably on it. But it is a few weeks from being on market here.

Because the Stallergenes product covers a broader spectrum, the thinking of analysts is that Merck will only have second fiddle duties here. We shall see.

Thanks a ton for the keen eyes -- and do stop back.

Namaste!

The Condor said...

As I am running on some other M&A, I cannot run this last bit to ground right now.

Please correct me if I have misspoken, one and all.

Namaste -- be safe this weekend -- and be peace-filled. . . .

Anonymous said...

I don't believe that Stallergenes has a ragweed product at the FDA right now. Checking the FDA site only comes up with the grass tablet.

Yes, the current Stallergenes approved product for SLIT is a multi-perennial grass extracts (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergenic Extracts).

However, these grasses share immuno-crossreactivity. It is not clear that you need to do all or that 1 will cover for all.

Either way, neither cover ragweed. Hence, the development of the Merck product.

Both companies are working on house dust mite therapies. And Stallergenes is also pursuing tree pollen.

The Condor said...

I now bow before you!

Fabulous! Thank you Anon.!

Love my readership...

This is likely a new post, when I catch a breather -- likely Saturday...

Even so, I stick by the idea that Ragwitek will max out around $250M a year in peak sales...

Just my gut -- but as I was wrong about Stallergenes -- I could be wrong here too... So there is no ragweed product approved anywhere in the world? Wild!

Thank you so much -- as ever,

Namaste

Anonymous said...

Well, I didn't say that. I alluded to the fact there was no tablet formulation.

That said, there are drops of ragweed sold:
http://allergyspecific.com/content/ragweed-allergy-drops

I'm sure Greer labs makes stuff that is used for immunotherapy shots.

the impact here is all on a quick dissolving tablet under the tongue rather than drops or shots!

Remember, my comment about 'moving the needle.'

Anonymous said...

here's the list that Greer Labs is into for allergy testing and immunotherapy:

http://www.greerlabs.com/index.php/human_allergy/products/extracts/pollen/

The Condor said...

Nice. Made it all a new post!

To the extent that patients can avoid a shot, Merck will have traction.

But that will top out around $250 million, given the competitors on market -- or soon to enter -- here in US.

Do you think these sublingual a are really that much better than a homeopathic? I am unconvinced. The data is on the order of a ~ 20 per cent improvement over placebo. Placebo. Not even a competing homeopathic remedy.... But who knows?

Namaste -- truly, thanks for your well-informed take!

Anonymous said...

In agreement with you there.

It really comes down to how people like to take medicines~~once a day tablet is the 'most compliant.' Not that people are real good with that either.

Having to have to go to an allergist for a shot or a special mix is problematic for some. Also, I wonder how many internal med or GP drs will write Rx for this~totally cutting out the specialist.