I’ll Stick With My Guess On Peak Sales Of $250 Million. . . But Stallergenes Update, Via Comments

April 18, 2014 - Leave a Response

But first, some of what was going on at St. Pete’s, this afternoon:

I love crowd-sourced knowledge. So efficient!

Here is exhibit A — from my readership. Do read it all.

. . . .Anonymous said. . .

I don’t believe that Stallergenes has a ragweed product at the FDA right now. Checking the FDA site only turns up a 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.

April 18, 2014 at 1:56 PM

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. . . as there are already injections on market.

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

Thank you so much — as ever,

Namaste

April 18, 2014 at 2:21 PM. . . .

Here is a link to the remainder of this comment thread. . . as it evolves. Peace – during this season of renewal, repair and rebirth — to all.

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

April 18, 2014 - Leave a Response

We shall see. 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.

Merck Will Oppose Small Claims (Under $25,000 Each) Process — In Federal Fosamax® ONJ NYSD Settlement

April 16, 2014 - Leave a Response

Sad — but it seems that Merck will fight over even the smallest ONJ claims payouts. Unfortunate. It will slow down the payouts to these tiniest claimants. Backgrounder here.

Here is a bit of the plaintiffs’ lead counsel’s letter — explaining the briefing schedule to Judge Keenan:

. . . .I am writing for permission to file the PSC’s Motion to Establish Small Estate Procedure for those settlements at or under $25,000.00. I have conferred with Steve Marshall, counsel for Merck, who has advised Merck will oppose the motion.

I have also conferred with Mr. Marshall about a proposed briefing schedule, and we propose the following: April 4, 2014: PSC Motion to Establish Small Estate Procedure Due April 18, 2014: Merck Opposition Brief Due In order to expedite the ruling on this motion, the PSC will waive reply briefing and oral argument. If this is acceptable to the Court, I would appreciate the entry of the Court’s memo endorsement of this letter.

ENDORSEMENT: The application is granted. ( Motions due by 4/4/2014. Responses due by 4/18/2014) (Signed by Judge John F. Keenan on 4/4/2014). . . .

We will keep you posted — and I will bite my tongue about the small-minded pettiness, and mean spirits I see here — as the Easter weekend approaches.

On Market In EU Since 2006, Grastek® Wins US Approval — [Plus O/T Sidecar: Blood Moon Edition]

April 15, 2014 - Leave a Response

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.

Merck Proxy Now Filed With SEC; See What Top Five Made. Or Don’t.

April 14, 2014 - Leave a Response

I’ll not bother to analyze it in any real granular detail. All the named executives took overall pay cuts in 2013 compared to 2012.

That makes sense, given the decline in global sales. You can do all the additional analysis you like, for yourself. Click here.

Enjoy your evenings, one and all.

Mr. Frazier’s Recent — And Definitively Tiny — Stock Sale Means… Nothing.

April 14, 2014 - Leave a Response

The clearest message here is that. . . there is no message – we should infer nothing — up, down or sideways — about pending Q1 2014 Merck results, from his transaction. Why?

Well, of the most moment, the sale (the disclosing SEC Form 4 is linked here) represents less than three per cent of all his outright Merck holdings, and less than one and a half per cent of all his direct and “rights to acquire” stockholdings.

Second, just like the GC’s transaction of a couple of weeks back, Mr. Frazier’s was pursuant to a prearranged/automated plan. Mr. Frazier didn’t control the timing here, in any meaningful sense. He did raise a half million dollars, by flipping a small bit of his options, but nothing more. Y A W N. . . Here is one press account:

. . . .Kenneth Frazier unloaded 10,047 shares of Merck & Co. stock on the open market in a transaction dated Thursday, April 10th. The shares were sold at an average price of $57.24, for a total value of $575,090.28. Following the completion of the transaction, the chief executive officer now directly owns 310,494 shares of the company’s stock, valued at approximately $17,772,677. . . .

My guess? Tax Day is tomorrow. He is paying some taxes, and only incurring capital gains rates on this series of sales — so his tax burden on raising the cash is minimized. Snow is due here later this morning. Fabulous! What’s on tap for you — today? Do tell.

Well. . . So Much For Any “Zen” Leadership Approach — At PhRMA! Heh!

April 13, 2014 - Leave a Response

On Friday, PhRMA elected a new chairman of the trade group (and lobbying concern).

He is. . . Ian C. Read, the Chairman of Pfizer — still the world’s largest drug company by global revenue. Well, that’s a return to old-school power-alley politics, sez me.

You may recall that I was suggesting a more measured, even “Zen-like” approach — to handling India’s threats of compulsory licenses — for various Merck, Pfizer and BMS essential, life saving medicines — each of which, at present, are completely out of reach financially for 99.9998 per cent of the ordinary people of India. Yet those same smart, hard working people of India are (to at least some extent) making these same medicines in-country for the pharma majors (and to a much greater extent, for the global generic manufacturers).

Friday’s election of Mr. Read likely ends any chance of a Zen solution — at least globally, out of PhRMA. Here is the Friday release — and a bit:

. . . .Ian C. Read, chairman and CEO of Pfizer, Inc, was elected chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA) today at the trade association’s annual meeting. Also elected were Kenneth C. Frazier, chairman, president and CEO of Merck & Co, Inc., as chairman-elect of the PhRMA Board of Directors, and George A. Scangos, Ph.D., CEO of Biogen Idec, as Board treasurer. . . .

Mr. Read is the Chairman and CEO of Pfizer. He began his career with Pfizer in 1978 as an operational auditor. . . .

While Mr. Read is a capable, results-oriented executive — he was, is and forever will be an old school “command, control and micro-manage” leader.

And permit me a moment’s personal pettiness, here — he is a very unpleasant sort, in-person, in any negotiations of meaningful moment. In short, he’s (sorta’) a. . . jerk.

Thus, I think the likely next window of opportunity for an India-palatable compromise (on drug IP rights — for essential medicines) to be put forth by PhRMA. . . will be when Mr. Frazier ascends to Mr. Read’s seat — in about two years’ time, all in. Of course, Ian could surprise me. But I am pretty sure he won’t.

Dr. Percy L. Julian Would Have Turned 115 Yesterday — A Founding Father — Of Modern BioScience/Medicine

April 12, 2014 - Leave a Response

There will always be some people, a precious few — who succeed — against long odds.

And then there are people like Dr. Julian. Amazing. Truly amazing. People like Dr. Julian — who were clearly the smartest in any room they entered — but spent a goodly portion of their life being marginalized by those too insecure to accept the undeniable existence of their “betters“. And Dr. Julian was (almost) everyones’ better. In every way. But he never gave anyone any outward hint of that. Certainly, inside, at least toward the end of his remarkable run — he must have known it though. Do go read more — at DePauw‘s website:

. . . .In 1920 Julian graduated first in his class and was elected to Phi Beta Kappa. Even with his outstanding academic record, however, Julian was denied an assistantship, fellowship or admission to graduate school, in the United States. [As times changed only slowly, he would complete his doctorate in Vienna -- over a decade later.] Instead, he found a position as instructor in chemistry at Fisk University. After two years at Fisk, he won an Austin Fellowship to Harvard University and earned a master’s degree in 1923. . . .

[In his industry careeer at Gliden,] Dr. Julian [was the first to] synthesize the female and male hormones, progesterone and testosterone, by extracting sterols from soybean oil. His biomedical research made it possible to synthetically produce large quantities of cortisone for the treatment of rheumatoid arthritis and other inflammatory conditions. His synthesis of cortisone reduced the price from hundreds of dollars per drop for natural cortisone to a few cents per gram. . . .

Here’s to Dr. Percy L. Julian — “Lord knows, there’s few like us. . . and few. . . like us!” Credit goes to the kind artists of Google’s doodles, last evening — for reminding me of his 115th. Enjoy a great Spring weekend, one and all.

[Sorry to close out here -- in a smallish burst of negative energy, but. . . I may now not write anything (more) on Secretary Sebelius. We shall see -- I must note that Tennessee Republican Shrill-Mistress Martha Blackburn ought to be ashamed of her singularly petty and childishly gloating tweets, of this week. What a purile little cyst -- on America's collective hind-quarters -- she has turned out to be. Ewww. Would somebody go get a pin, and pop that thing, already?!]

Nice Early Data At EASL — For MK-5172 & MK-8742 — In Tougher Hep C Cases; FDA Clearance In 2016?

April 11, 2014 - Leave a Response

Yesterday, we analyzed the likely impact of the latest Phase II data on “easier” Hep C cases — today, the tougher ones. And to be sure, even on these smallish n‘s, the data Merck made public in London — at EASL overnight — is impressive. [But remember, there are others out there, lurking, too.]

In conjunction with ribavirin, Merck’s Hep C “cure” rates stay at or above 90 per cent — both in prior non responders, and even in those with some advanced liver tissue scarring. This clearly means Merck will proceed to Phase III studies, and pencils in an FDA approval date of early to mid 2016, for Whitehouse Station (soon to be Kenilworth). That is my guess. [For the record, Merck itself is not allowed under FDA rules, to make such prognostications, but I can -- as I am unaffiliated.] And that is good news.

However, in the mean time, Gilead will have had this next gen Hep C market to itself — at least until BMS and AbbVie arrive — likely in mid to late 2015. So, that puts Merck as a likely fourth market entrant — on the timelines as they now stand. And Merck will make money — just nothing like the likely $15 billion Gilead’s Solvadi® will garner in 2015. Nothing like it. Perhaps a tenth of that (in peak year 2018) — but with some obvious price competition, from AbbVie and others — perhaps even Gilead. Do go read it all, though, for yourself. Here’s a bit:

. . . .Viral suppression (HCV RNA levels less than 25 IU/mL) was demonstrated for treatment-naïve patients with cirrhosis, prior-null responder patients with and without cirrhosis and HIV/HCV co-infected patients by Treatment Week (TW)12. These levels were maintained at rates between 90 and 100 percent across patient subgroups through the completion of dosing and at the four-week treatment follow-up time point (FU4). . . .

Okay — perspectives on departing HHS Secretary Sebelius will be a weekend post — now, do go enjoy a stellar Friday, one and all! And so, “eventually, all things merge into one. . . and a river runs through it. . . .” I’ll spend time on a quiet river this evening (albeit with steel and glass canyons, on either side — as opposed to the Sawatch range). . . . as Spring is finally fully here. Sweet.

Merck Shows Impressive (If Smallish) “Easy Patient” Phase II Data In London — For “Next Gen” Hep C Candidate MK-5172 — Tougher Data Due Friday

April 10, 2014 - Leave a Response

Recall that we have said right along (since at least November of 2013) that Gilead has a two year lead on Merck with its Solvadi® regimen.

This Next Gen Hep C cure space is evolving at break-neck speed right now.

Do also recall that there are other competitors out ahead of Merck — aiming to meet Gilead — and they may arrive in about a year — or mid 2015. Finally recall that today’s data (an impressive 98 per cent “cure” rate) reflect only the easiest to treat patients: treament naive, and no cirrhosis of the liver. Oh, and this is only a sample size of 50.

Even so, this is good news for Whitehouse Station. Here is a bit of Reuters UK on it, overnight — reporting onsite at the EASL confab now underway in London — do go read it all:

. . . .Results of the study called C-Worthy were presented on Thursday at the annual meeting of the European Association for the Study of the Liver (EASL) in London. Researchers are due on Friday to present results of how the Merck pills fared in more difficult to treat patients, such has those who failed to be helped by prior treatments and those with more advanced liver disease. . . .

Gilead Sciences Inc, AbbVie and Bristol-Myers Squibb Co are also developing a new generation of all-oral hepatitis C treatments that in previous trials have demonstrated cure rates in excess of 90 percent, while cutting treatment duration to 12 weeks with few side effects.

Gilead, which later this year could have a one pill, once a day two-drug regimen approved in the United States, is widely perceived by Wall Street to be the best of the bunch with some analysts forecasting annual sales of $9 billion or more. . . .

I find myself unable to stop grinning this fine Spring morning. Can’t imagine why. . . .

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