Excellent And Balanced Take On Brexit — In U.K. BioSciences Arena

July 28, 2016 - Leave a Response

Given that the global giant we follow will announce Q2 2016 earnings tomorrow morning, I thought I’d post a global-looking item I ran across Sunday night. I think this is one of the best short form blog spots I’ve yet read — on what we might actually, soberly expect from Brexit, some time at least two years from now, should it all come to pass, along the lines people envisioned a month ago (that’s our original one on it — along the below lines, from June of 2016).

It is balanced, level headed and sets forth what a glacial process this will be — along with the high probability of some significant melting (material modifications to the process), along the way. Do go read it all:

. . . .[I]t is worth noting that Switzerland and Norway are able to benefit from membership in the European Free Trade Association without being EU member states (Complicating matters, control over immigration was one of the rallying cries for the Brexit “Leave” vote, but the EU trade agreements with Norway and Switzerland come with requirements for free movement of people).


So, in broad economic terms the UK could come out ahead. The UK has a trade imbalance with the rest of the EU; it imports more from the EU than it exports, so it is less reliant on EU as a market than the EU is on the UK for its market. Accordingly it is likely that the UK will be able to negotiate trade agreements on favorable terms. . . .

[And in equal time land, for those of you who need the counter-view — or a more alarmist take — go read this from people selling consulting services, about Brexit doom scenarios. They have a vested interest in making it all quite scary of course.]

Onward — soaring actually, after an earlier unhinged near treasonous melt-down by Mr. Trump at a press conference, and then, in perfect counter-point, a transcendent speech by our 44th President last night — perhaps the best one he’s ever given. He simply buried Mr. Trump’s home-grown demagogue rhetoric — in hope. The audacity of hope. That is the America I know and love.

Trivial Footnotes Alert — But I Simply Cannot Resist This One…

July 27, 2016 - Leave a Response

I really can’t stop laughing, about this — his blind spot is the size of. . . Pakistan. That’s big.

Mr. Hassan recently told an interviewer of the adversity he faced, growing up. [His ears must have been (virtually) burning, given that I haven’t typed his name in quite a while here, prior to Sunday night — in comments.]

This very morning, in a goofy non-story, in the capitalists’ paper of record, the Wall Street Journal — we read of Mr. Hassan’s “difficult” first job — in 1965.

Why am I noting it? Because by his own admission, he did this “back-breaking” farm job. . . wait for it: For. Three. Whole. Weeks.

It wasn’t all through high school, or even all through his college years, or college summers — no, it wasn’t even a whole summer. It wasn’t even a whole month — in one summer — in England.

This says so many things about him: but not I suspect, the things he hopes. He plainly thinks it is newsworthy that he worked a real job, for three weeks, over a half a century ago. This actually makes me feel better — about simply reporting what he did, to some 35,000 legacy Schering-Plough career scientists and office workers (circa 2010). Here’s the WSJ bit:

. . . .Mr. Hassan says his stint as a produce picker and cannery worker in the summer of 1965 “was a character builder.” He spent three weeks in rural Cambridgeshire, England, following his initial year of college studying chemical engineering in London.

Born and raised in Pakistan, that summer, Mr. Hassan harvested farm fields and canned fruit and green beans alongside students from other European countries. His free summer housing consisted of a small hut with six bunk beds.

Mr. Hassan says he cited that difficult experience years later while advising his son and two daughters about summer employment options during their college years. . . .

Some days, this stuff just writes itself — kinda’ like. . . I don’t know, the current GOP Presidential nominee (arguably within an eyelash of treason) offering to aid and abet espionage — by a foreign power (the KGB, no less) — in order to influence, or sway — a US election. Astonishing — except that we have come to expect this level of shamelessness, from Mr. Trump. He will lose by double digits in November.

Gilead’s Renewed West Coast Patent Spat JMOL Motion To Be Heard On August 4, 2016

July 27, 2016 - Leave a Response

Gilead essentially argues that Merck did not describe its claimed patents specifically enough in writing, so that a practitioner, ordinarily skilled in the art and science of bio-chemistry could make the invented compound, and see the claimed moiety. We should remember that Gilead has convinced the able Judge Labson Freeman in San Jose that Merck’s claims aren’t written with specificity precisely because (Gilead says) Merck simply copied these ideas from Pharmasset, during a later abandoned M&A due diligence process.

So, according to Gilead, Merck had stong incentive to avoid such a precise description, for fear that it would then be plain that the claimed invention was just cribbed from Pharmasset’s prior work. Here is Gilead’s motion for Judgment as a Matter of Law, as a 13 page PDF file.

. . . .CLERK’S NOTICE RESETTING TIME OF MOTION HEARINGS. [432] MOTION for Judgment as a Matter of Law (Renewed) under Fed. R. Civ. P. 50(b), [434] MOTION for Attorney Fees pursuant to 35 U.S.C. Section 285. Motion Hearing set for 8/4/2016 01:30 PM before Hon. Beth Labson Freeman. . . .

Now you know. Onward, grinning ear to ear, about this evening. . . .

After Some Apparently Waifish Sales, Merck Hands Back Suite Of Sublingual Allergy Tabs — To ALK-Abelló

July 27, 2016 - Leave a Response

This entire relationship has been definitively immaterial to Kenilworth. After spending perhaps $120 million, by the time the relationships and clincial trials are transitioned, some six months from now, I expect that Merck has actually generated sales revenue of less than than half of that amount, life-time to date, on the franchises.

Back in April of 2014, here was our take on this licensed product suite: “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. . . .

[That seems to be almost exactly what transpired — with a renewed tip of the hat, to our well-informed EU commenter — who predicted it all.]

Here is some additional December 2013 background, on the relationship first struck in 2007 (prior to our beginning this blog coverage). And this morning — FiercePharma on it all — do go read:

. . . .Hørsholm, Denmark-based ALK expects to regain the rights to the immunotherapies–which address grass, ragweed and house dust mite allergies–early next year. Between now and then, Merck and ALK will work together on a six-month transition period. ALK has said it will use its resources in North America and its base in Denmark to smooth the transition, but with sales and marketing, registration activities and clinical development all in mid flow, there is potential for a bumpy ride. . . .


Merck has paid out more than DKK 700 million ($100 million) to ALK as part of the deal it struck in 2007 for the rights to the drugs, but its returns to date have been small. . . .

At one point, I had guessed $300 million in peak annual sales, figuring that Merck’s “hurdle rate” — for being interested in the deal, would need to be at least that high — to be worth the trouble of running the clinical trials. I now suspect that it never got close to $50 million a year.

To be clear, I think for smaller pharma concerns, that sales revenue likely still presents an attractive potential return (especially now that the clinicals are paid for), so I expect ALK-Abelló will find a new North American partner — albeit a smaller one. But the news caused an 18 per cent drop in ALK-Abelló’s stock price overnight. Onward on a glorious morning — baby-sitting a flawless new life, tonight! Woot!

Merck Vs. Merck Update: August 1, 2016 Conference Likely Scratched — Now In Mid-September 2016

July 26, 2016 - Leave a Response

While the able judge has not yet “so ordered” — and while there was to be a court hearing on August 1, 2016 in Newark’s federal District courthouse, on this spat over the two global titans’ asserted Lanham Act claims and counterclaims — it is highly likely that this hearing will be pushed back, into mid-September now.

Here’s the operative part of the joint letter — from both companies’ counsel, overnight:

. . . .We, along with Debevoise & Plimpton LLP, represent Defendant, Merck KGaA, in the above matter, and write jointly with McCarter & English, LLP and Hogan Lovells, LLP, counsel for Plaintiffs, Merck & Co., Inc. and Merck Sharp & Dohme Corp., to request that the Rule 16 Conference currently scheduled for August 1, 2016 be adjourned to either September 14, 15, 16, 19 or 20, 2016. We make this request because of vacation and trial schedules of counsel involved in this case. If this is acceptable to the Court, we request that Your Honor “so order” this letter with the new date and time for the Rule 16 Conference and enter it on the docket. . . .

I might be so bold as to suggest that it may also allow for more time to work out an agreed settlement here, as well. That would be smarter for both. So. . . g’night all of good will — the Democrats (but particularly the FLOTUS 44) have been on fire, of late. And I for one am proud — of all of them. . . . They are the answer to Mr. Trump’s never ending stream of divisive invective — and small-minded hatred.

Update On The Delaware USDC Oral Arguments Today — Gilead Hep C Patent Spats Edition

July 26, 2016 - Leave a Response

Matching the order at the end of the day, today — to the agenda that preceded it by a few days — I might reliably offer at least a few fairly-solid conclusions, even just from this cold electronic record. Smile.

There was a long day of argument, and in the end, Judge Stark has reserved on the question of whether Gilead should prevail on summary judgment, at least as to the idea that Merck/Idenix had not provided a sufficiently precise written description in the patents in question — to avoid being invalid for vagueness (i.e., the written description invalidity contention mentioned below). SO now the new trial date (should the parties fail to settle prior to that time) is December 5, 2016. Here’s the full oral minue order, from the bench, transcribed electronically into PACER, an hour or so ago:

. . . .ORAL ORDER: For the reasons stated by the Court at today’s hearing, IT IS HEREBY ORDERED that:

(i) Plaintiffs’ Motion to Strike (C.A. No. 13-1987 D.I. 295) is DENIED;

(ii) Plaintiffs’ Motion to Strike (D.I. 326) is GRANTED;

(iii) Defendants’ Motion for Summary Judgment (D.I. 298) is DENIED WITHOUT PREJUDICE with regard to Defendants’ written description invalidity contention and DENIED with regard to the motion’s remaining grounds;

(iv) Plaintiffs’ Motion to Preclude (D.I. 305) is DENIED;

(v) Defendants’ Motion to Preclude (D.I. 308) is DENIED;

(vi) the Scheduling Order (D.I. 42) is AMENDED to remove the October 11 trial date and a jury trial will proceed on December 5, 2016, with a pretrial conference on Wednesday, November 23 beginning at 9:00 a.m.; and

(vii) the Parties SHALL submit a joint status report no later than July 29 containing (a) a proposed briefing schedule for supplemental construction of the relevant ‘054 and ‘597 patent claim terms, (b) a proposed briefing schedule for a renewed motion for summary judgment for lack of written description, and (c) proposed amendments to the Scheduling Order (D.I. 42) to account for the December trial date and reopening of fact and/or expert discovery related to the denial of Plaintiffs’ Motion to Strike (D.I. 295). ORDERED by Judge Leonard P. Stark on 7/26/16. . . .

Now you know. A big day, for both sides — and a delayed trial date, while the parties engage in the remaining discovery (from one another) — that each had sought to avoid, by filing these motions. Onward, with a smile. . .

Slightly Refining My June 1, 2016 Predictions — On Potential Supreme Court Drug-Makers’ First Amendment Case(s) — Thanks To My Commenter(s)

July 26, 2016 - Leave a Response

[Do go read the comments over the weekend, if you need the full back story, here.] My commentary, in reply:

I agree Anon. — and no worries — about tangents, here.

This entire website is one seven and a half year tangent, originally decrying some abuses of FDA (and SEC) rules, by one Fred Hassan — the ex-CEO of legacy Schering-Plough. Smile.

As to Merck’s GC (as noted on June 1) — I’ve long felt that a delicate balance need be struck, between drug makers’ commercial speech rights (which under long standing US Supreme Court precedents may be limited as to “time, place and manner(s)“), and the generally broad language of our first amendment.

Certainly, safety and accuracy should come first — i.e., be paramount — when a merchant speaks about “inherently dangerous” drugs and biologics (to use some 19th Century Cardozo court language) — if mis-used.

I will go out on a limb and predict that when our 45th President [a Democrat who orchestrated proposals (in 1992) for the series of reforms that ultimately became the ACA of 2010] is sworn in come January 2017 — and then she, in fairly short order, fills at least two Supreme Court seats — we will see the High Court’s support for “renewed vigor” in enforcing the FDA’s rules limiting manufacturers’ off-label touting, and other promotional notions.

I now think FDA may see expanded, as opposed to contracted authority, here. And thanks to you, I’ll make a new post of it, in a moment.

Do stop back by — thanks for the thoughts — travel well; but travel light.

And the comment that led most directly to these revised thoughts:

July 26, 2016 at 6:34 AM — By: Anonymous.

. . .I feel it pertinent to note how this guidance letter potentially dovetails with what ‘struck [you] as news-worthy’ in your June 1, 2016 posting. In your referenced Bloomberg Law article, Merck’s position on first amendment speech appears, at first glance, that pharmaceutical companies can say whatever they want about their products. However, taken at face value I do not feel that what Holston is implying should be afforded [as law], if recent history may serve as a guide.

In a 2005 article appearing in the New York Times, Dr. Sandra Kweder, acting director of the FDA’s center for Drug Enforcement and Research, was quoted within the context of lessons learned from negotiating labeling with Merck for their blockbuster selective COX-1 inhibitor, Vioxx. In this article Kweder said that the power to change a label “would be very helpful.”[1].

I hope what we are witnessing here is the FDA attempting to re-gain some ‘teeth’ in carrying out basic duties with which we as a public have continuously expected from this Public Health Service Division.

~~~~~~~~~~~~~~~~~~~~~~~~~~

[1] Harris Gardiner (2005) FDA Official Admits ‘Lapses’ on Vioxx. New York Times.

Not Any Real Surprise, From Seamus Fernandez — As Both Merck And BMS To Report Q2 Results This Week…

July 25, 2016 - Leave a Response

MRK-Leerink-Q2-Est-2016 If you’ve been reading our regular updates on the two competitors in the checkpoint inhibitor space, you will not be surprised to hear that Leerink Swan analyst Seamus Fernandez is lifting his full year 2016 estimate on BMS’s Opdivo® sales. He sees that franchise as accelerating its growth.

Meanwhile, he does still expect growth from Merck’s Keytruda® when it reports on this coming Friday morning, but he is reducing his full year estimate on the very pricey immuno oncology treatment due to trendlines in IMS scrip data he’s recently reviewed. [I will say we made much the same call, over a year and a quarter ago, now — and without the benefit of the expensive IMS weekly data subscription.] In any event — here is what to look for, as this busy week for drug company and bioscience earnings wears on (per Investors’ Business Daily):

. . . .”Together with Yervoy, Bristol-Myers maintains 85% share of the checkpoint inhibitor market,” Fernandez wrote, referring to the class of cancer drugs to which Opdivo belongs. “Based on these trends, we have increased our full-year 2016 Opdivo sales by $450 million (to $3.8 billion) and expect strong uptake in Japan will improve royalty revenue from Ono. . . .”

Merck, reporting Friday morning, is in a similar situation, but its growth is expected to be more modest — in single digits on the bottom line and flat on revenue. Its blockbuster diabetes franchise is facing increasing competition, even as Opdivo competitor Keytruda takes off.

“We have lowered our near-term estimates for Keytruda and the Januvia franchise based on sales and prescription data, respectively; however we see greater long-term opportunity for each relative to our previous forecasts,” Fernandez wrote. “The recent announcement of an overall survival benefit for Keytruda from Keynote-024 trial raises the prospects for the drug in first-line non-small cell lung cancer (NSCLC). . . .”

Now you know. And now. . . it is just simply too wonderful, outdoors, to stay in any longer — off for a summer afternoon walkabout. Smile!

Important Hearing Tomorrow Morning, In Delaware US District Court — For Gilead And Merck: Patent Spats

July 25, 2016 - Leave a Response

I am in a bit of a hurry now — on a train — but tomorrow’s hearing in Delaware, before the very able Judge Stark portends to set the tone for the rest of the East Coast chapter of the patent fights over Gilead’s Hep C mega blockbusters Harvoni® and Solvaldi®.

I expect that the embarrassing loss of a $200 million jury damage award, in California’s Northern District, will ultimately mean that Merck must settle here — but we shall see. Back with more when I have some free time, this afternoon:

It is hard to imagine that some of the California results will not have already spilled over, into the discovery spats now underway, in Delaware. Moreover, it seems that there is a reasonably high probability that Gilead’s motion for summary judgement might be granted, at Item (3) below (after a few weeks reflection, and time to prepare a well-supported opinion, in Judge Stark’s chambers) — based on what was learned in California. We shall, as ever, see:

. . . .ORAL ORDER:

IT IS HEREBY ORDERED that with respect to the hearing tomorrow, July 26:

(i) the parties shall be prepared to address, all pending motions, as well as the issues raised in the recent status letters to the Court;

(ii) the order in which matters will be argued is as follows:

(1) Idenix motion to strike reports of Dr. Secrist;

(2) Idenix motion to strike good faith defense;

(3) Gilead motion for summary judgment;

(4) Idenix motion to preclude;

(5) Gilead motion to preclude;

(6) status of attorney-client privilege issues; and

(7) trial scheduling; and

(iii) each side will be allocated up to ninety (90) minutes for its argument.

ORDERED by Judge Leonard P. Stark on 7/25/16. . . .

Now you know — with more analysis, as time permits. Big grins!

FDA Breakthrough Designation; EMA “PRIME” Designation — For Merck/NewLink V920 Ebola Vaccine Candidate

July 25, 2016 - Leave a Response

We must remark once again just how hard it is — to overstate the importance of this vaccine candidate — in arresting the last Ebola epidemic, in Africa. The so-called V920 rVSV∆G-ZEBOV-GP vaccine has thus far proven 100 per cent effective, when deployed in a ring fashion, against the virus in people who’ve come in close contact with an active Ebola carrier.

So it makes sense that both the European Medicines Agency, and the US FDA would put the candidate on a fast track to approval. And that’s just what both have done, as of this morning. While Kenilworth certainly deserves generous plaudits for its work in both finishing the R&D, and actually mass-producing the vaccine — and getting it intact and active, into the very difficult geographic environment Africa presents — we should not forget the ten years plus worth of solid work of Canadian Public Health Agency scientists, and the NewLink Genetics team. Here’s a bit from the story, out of Ames, Iowa this morning — do go read it all:

. . . .Merck, known as MSD outside the United States and Canada, [along with Ames, Iowa-based NewLinks Genetics] has reached two key regulatory milestones for the Ebola Zaire vaccine candidate known as V920 (rVSV∆G-ZEBOV-GP). The U.S Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has provided the vaccine candidate PRIME (PRIority MEdicines) status.

V920 was initially engineered by scientists from the Public Health Agency of Canada and subsequently licensed to NewLink Genetics. In late 2014, when the peak of the Ebola outbreak in western Africa was at its worst, NewLink Genetics licensed V920 to Merck, with the goal of accelerating the development, regulatory approval, and availability of this candidate vaccine. Merck is responsible for the research, development, manufacturing, and regulatory efforts in support of V920. Since that time, Merck continues to work closely with NewLink Genetics and their external collaborators to accelerate development and licensure.

“These regulatory designations reflect great credit upon the extraordinary public-private partnerships which have allowed the vaccine candidate to be included in 12 Phase 1, 2 and 3 studies on three continents in less than two years,” said Thomas P. Monath, M.D., Chief Scientific Officer and Chief Operating Officer of the Infectious Disease Division of NewLink Genetics. Charles L. Link, Jr., M.D., Chairman, Chief Executive Officer and Chief Scientific Officer of NewLink Genetics emphasized that, “While the Ebola Public Health Emergency of International Concern (PHEIC) is over, we know the threat of re-emergence remains. We are encouraged by these FDA and EMA decisions which we hope will aid progress of the candidate vaccine towards potential licensure. . . .”

And bit by bit, the world’s bio-science community is putting the WHO in a position to much more quickly arrest future outbreaks. Sadly, it is an inescapable fact of biology that the virus will eventually reappear — but it need not become an epidemic, the next time around. Smiling widely — on a clear mid-summer Monday morning, now — brimming with optimism on my walk in, here. Be excellent to one another.

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