Non-Merck Related Item: Paging Dr. Salmon — It Seems You Are Not Alone.

October 21, 2016 - Leave a Response

A long-standing, erstwhile and highly valued (note that he owns at least three graphical avatars, awarded here, long ago) “opinion-leader” contributor to the earliest days of this blog goes by the handle “Salmon”. Just search that name, above. [I do trust all that is written under his handle — so you should, too. Smile.]

After (mostly) skimming those “timeless raindrops, under the rocks from the basement of time“* — on the beds of my icy rivers silently for lo these last four or five years, Salmon re-surfaced, arching from the golden flecked ripples, this week to mention a biologic called Exondys 51 — and point us toward it, as part of our new non-Merck (did I say “new”?) coverage. Here is FierceBiotech on it — but we will await Salmon’s definitive take:

. . . .John Jenkins, who runs the FDA’s office for new meds, has not taken kindly to the regulator’s recent, and highly controversial, approval of Sarepta’s Duchenne med Exondys 51 (eteplirsen) after hitting out at bad trials with questionable data.

In a presentation given this week at the NORD summit in Arlington, called “Lessons learned from eteplirsen and other recent rare disease programs,” Jenkins spoke specifically of the biotech’s drug, saying: the “path taken by Sarepta NOT a good model for other development programs.”

A month ago, the FDA approved Exondys 51 against all odds. The approval was considered unlikely because many of the data used to back a speedy approval were based largely on a small study of a dozen children with no placebo control, comparing eteplirsen’s results against historical data in the muscle-wasting disease.

Back in April, an FDA panel of outside experts voted narrowly, 7 to 6, that Sarepta did not provide substantial evidence from “adequate and well-controlled” studies that the drug produced dystrophin at a level that was reasonably likely to produce a clinical benefit. . . .

And there you have it: an approval of — at least arguably — a rather poorly understood biologic. You are up, in comments, Dr. Salmon. Do hit it out of the park for us — this is one fat hangin’ juicy curve-ball, headed right out to the middle of Waveland Avenue. Goodbye, Mr. Spaulding! Smile.


* Apologies there — to the immortal prose of one Norman MacClean.


Federal Propecia®/Proscar® MDL Update: Post Status Conference of October 19, 2016

October 21, 2016 - Leave a Response

While I have been quite busy — joyfully paying close attention to one other particular development, there was a status conference and trial plan update in Brooklyn’s federal District courthouse — in that MDL addressing the erectile dysfunction claims against Kenilworth.

We should know the bellwether trial order, for the first six, by Halloween (and my earlier backgrounder on those cases); here is the rest:

. . . .The parties stated that they are proceeding on track with the schedule set forth in the Second Amended Discovery and Trial Plan PPO 10 [295]. They have submitted their selection of cases for the First Bellwether Tranche, which the Court will endeavor to select on or before October 28, 2016. The Court noted that a Daubert hearing will be held after full briefing, on a date to be determined, as stated in PPO 10 Order paragraph 13. The parties were directed to file a joint status report by March 3, 2017 reporting on the progress of discovery and raising any issues which need to be addressed. . . .

Now you know. What a glorious evening — sailing straight on (second star to the right), into morning, now. . . Cubs coming home to close out, and head to the Series — and small banking errands to be completed shortly. Smile. . . .


Last Night, Merck Had Good Phase III Clinical Trial News, On A Fast-Tracked CMV Antiviral — AiCuris’ Knock-On Effect, Too

October 20, 2016 - Leave a Response

This will likely help AiCuris as well, truth told. Back in 2012, AiCuris received a €110 million upfront payment — from Merck’s non-US family of companies. Under the terms of that out-license, AiCuris may receive additional payments if specific milestones are met — as well as post FDA approval- and market launch- royalty payments. Do go read it all, as linked below.

For now, I’ll let FierceBiotech tell the tale:

. . . .[Merck’s] fast-tracked antiviral letermovir has hit its primary endpoint in a Phase III test as the partners look to capitalize on Chimerix’s blowup.

The Phase III test was looking at the efficacy and safety of letermovir once daily, in both tab and IV form, for the prevention of clinically significant cytomegalovirus (CMV) infection in patients that are seropositive recipients of an allogeneic hematopoietic stem cell transplant.

Data were not posted, but these will come at a future scientific conference, according to the company. The primary outcome measure was the percentage of participants with clinically significant CMV infection through 24 weeks after transplant.

The med is designed to inhibit the human CMV viral terminase and the Big Pharma got hold of the drug under a deal signed back in 2012 when Merck bought the worldwide rights to develop and sell letermovir from Bayer spinout AiCuris. . . .

Now you know. Even though the weather was a bit gray, and chilly throughout — it would be hard to imagine a better end to it. Ear to ear grinning, now. And. . . Go Cubbies! Up 1-0 early, in LA. . . . coming to the friendly confines to close it out.


Of Two Spacecrafts’ Status Tonight — At Two Different Planets, Products Of Two Continents — And Questions Still Abound…

October 19, 2016 - Leave a Response

life-jupiter-mars-2016UPDATED: 10.20.16 @ 11:55 PM EDT — It now seems likely that the Schiaparelli lander made a hard landing on Mars. The ‘chute seems to have opened, and then detached early, and the retro-rockets fired for only a fraction of the expected duration. All of which — along with the radio silence — would largely point toward an obliterating, catastrophic crash on impact. Disappointing news, if it holds up — to be sure. Yet onward, as ever. [End, updated portion.]

Each of the missions I’ve recently been reporting upon — originating on two different continents — and circling two separate planets, have now had some non-trivial issues in the last 48 hours.

We will be watching keenly, come dawn tomorrow when ESA next updates on its lander. However, a stable orbit for the ESA ExoMars methane gas monitoring orbiter (larger craft, at right in the circle) has been a clear interplanetary space engineering victory. Now we wait for updates:

. . . .The ESOC teams are trying to confirm contact with the Entry, Descent & Landing Demonstrator Module (EDM), Schiaparelli, which entered the Martian atmosphere some 107 minutes after TGO started its own orbit insertion manoeuvre.

The 577-kg EDM was released by the TGO at 14:42 GMT on 16 October. Schiaparelli was programmed to autonomously perform an automated landing sequence, with parachute deployment and front heat shield release between 11 and 7 km, followed by a retrorocket braking starting at 1100 m from the ground, and a final fall from a height of 2 m protected by a crushable structure.

Prior to atmospheric entry at 14:42 GMT, contact via the Giant Metrewave Radio Telescope (GMRT), the world’s largest interferometric array, located near Pune, India, was established just after it began transmitting a beacon signal 75 minutes before reaching the upper layers of the Martian atmosphere. However, the signal was lost some time prior to landing.

A series of windows have been programmed to listen for signals coming from the lander via ESA’S Mars Express and NASA’s Mars Reconnaissance Orbiter (MRO) and Mars Atmosphere & Volatile Evolution (MAVEN) probes. The Giant Metrewave Radio Telescope (GMRT) also has listening slots.

If Schiaparelli reached the surface safely, its batteries should be able to support operations for three to ten days, offering multiple opportunities to re-establish a communication link. . . .

That said — as to the NASA/JPL mission, it seems Juno will just do its science over longer orbital periods, tacking around Jupiter at 53 days per orbit. Overall, post debate, I am soaring now (even my Cubbies are up — and up big — tonight!) — right along with a sublime shepherd moon that re-emerged, in full. Let us hope these two do too — as to scientific and engineering capabilities. Fully. Smiles. . . .


What We Expect To See Confirmed — By ESA — As Of Noon Eastern Today…

October 19, 2016 - Leave a Response

UPDATED: 10.20.16 @ 11:55 PM EDT — It now seems likely that the Schiaparelli lander made a hard landing on Mars. The ‘chute seems to have opened, and then detached early, and the retro-rockets fired for only a fraction of the expected duration. All of which — along with the radio silence — would largely point toward an obliterating, catastrophic crash on impact. Disappointing news, if it holds up — to be sure. Yet onward, as ever. [End, updated portion.]

[Earlier] UPDATE: 1 PM EDT — still no signal confirming that the Schiaparelli lander has made a safe touch-down, but the Indian tracking station may have been unable to lock on to the signal — it may be safe; we just don’t have proof of it yet. So we are (still) in white knuckle mode, here. [End, updated portion.]

Well — this is a moment when Europe “dares mighty things.” Again. White knuckle time.

And a computer animation of the first non-NASA engineered soft landing on Mars:

ESA LiveStream

[My apologies if that embedded framed link above doesn’t work on your browser. Here’s a solid in-line link.] Onward, to all of good will. . . a soft landing ahead, and hoping that estimable twisty copper colored space engineering prowess is rewarded — in Europe, later this morning. . . smile. . . .


European Space Agency To “Drop A Package By” Mars Overnight: ExoMars & Schiaparelli…

October 18, 2016 - One Response

At about the same time this post comes online, the main engine burn — to slow the ExoMars probe into a safe capture orbit — will have begun.

I’ll have more in the early morning, tomorrow, depending on how the ESA engineering effort turns out. Here’s a bit:

. . . .As for Schiaparelli, its role is just to land intact. Its only mission is to demonstrate that ESA and Roscosmos have the necessary technology to safely land scientific hardware on Mars. That’s key for the next phase of the ExoMars mission, which involves landing a 680-pound rover on the Red Planet in 2021 to explore the surface and look for signs of biological life. The same technologies used to land Schiaparelli will be used to land the ExoMars rover as well. . . .

We wish them — and in truth, all wayward shepherd moon-lettes — the best of luck. . . . I’ll be right here, waiting. After-all, it is a vast, wonderful but cold, dark ocean out there, and this is but a tiny row-boat, to be sure. Smile. . . .

[Oh, and as a post scriptum — Kenilworth has opened a bio-similars explainer website (with differing portals for doctors, patients and insurers — and differing content) — to help educate various audiences, about this important part of the cost-constrained, emerging medical delivery landscape (and a part in which Merck plays an increasingly active role). Now you know.]


More News Due From Jupiter: JPL/NASA Juno Team Will Conduct A Press Briefing — On Valve Glitch — Late Afternoon Eastern, On Wednesday

October 17, 2016 - Leave a Response

mrk-jpl-nasa-glitch-juno-2016 As we were first to report, world web-wide it seems, on this past Saturday morning — the basketball court sized Juno orbiter has experienced a bit of a hiccup.

I don’t expect this small glitch to interfere with any of the main science mission — but that is why NASA is briefing the press, come Wednesday. Either they’ve solved the glitch, or they’ve figured out that both the involved valve’s main circuit, and/or backup circuit(s) are likely fried. I expect we will hear that the mission is still all green lights, either way. In any event, here are the press conference details — it will be streamed over live NASA TV, as well:

. . . .Team members of NASA’s Juno mission to Jupiter will discuss the latest science results, an amateur imaging processing campaign, and the recent decision to postpone a scheduled burn of its main engine, during a media briefing at 4 p.m. EDT Wednesday, Oct. 19. The briefing will air live on NASA Television and stream on the agency’s website. . . .

The briefing will take place at the meeting of the American Astronomical Society’s (AAS) Division of Planetary Sciences and European Planetary Science Congress (DPS/EPSC) at the Pasadena Convention Center in Pasadena, California. To attend the Juno briefing in person, media should request a press registration form at the event registration desk.

For access to the event live webcast, media should send their name and media affiliation to AAS Press Officer Rick Fienberg at, or call 857-891-5649, by 1 p.m. Wednesday. . . .

I’ll try to catch the replay late night on Wednesday night, or early Thursday morning, like 1 AM EDT — on NASA-TV. . . As ever — onward she sails, that mysteriously vexing, ever intoxicating twisty copper colored shepherd moon-lette, blissfully unaware of any potential peril that might befall my mission. And that, her unwasted grace is noble too, in its own way. . . smile. . . .


Fascinating: Some Ancient WW II History Means Merck’s Choice Of Law Argument Will Likely Prevail

October 16, 2016 - Leave a Response

mrk-choice-of-law-10-14-16 [Ahem — check the new masthead — it tells a new story, and will likely mean the continuance of this blog, in some form.] Now, in the ongoing multi-national litigation about an old 1970 agreement, on the contours of the rights to use the term “Merck” — by the German company, and the US based one — an even older bit of history, will now likely control this rather arcane “third year of law school” question. [Most students take “conflicts of laws/choice of law” in their third year.] Even though this is no longer solely a Merck-focused blog, I was captivated by these new details — ones I never knew. [So we start our run, as a non-Merck focused blog — with a Merck focused post. Irony — that’s for me (no more alts., though). . . smile.]

It turns out that in the argument over whether US (New Jersey) law, or German law should govern how the agreement is interpreted, the US government (during World War II) stepped in under the Sherman Act, and had a judge invalidate a prior version of the agreement — as an unlawful restraint of trade. Much has happened since, but the general principle is that this action for violation of the subsequent 1970 contract was brought in the US, has long been interpreted in the US, and in fact was negotiated at a ABA meeting in St. Louis, Missouri, several decades ago — by the GCs of each company. I think it likely that US law will govern. [I say this despite the fact that German law is governing the French lawsuit, and UK law is governing the British one. Those make out different claims under local “country-by-country” law.] Here’s Friday’s filing — a 31 page PDF — and the bit that caught my eye, below:

. . . .The earliest Agreement between the parties was entered into in 1932 (“1932 Agreement”). The 1932 Agreement recognized the right of Merck’s predecessors (“Merck Predecessors”) to the term “MERCK” in the United States, its territories and dependencies and Canada, and the right of KGaA’s predecessors (“KGaA Predecessors”) to the term “MERCK” in the rest of the world, with certain designated shared territories. See Exhibit D.

In 1943, the U.S. Department of Justice filed a civil complaint in the District Court for the District of New Jersey under the Sherman Anti-Trust Act alleging that the 1932 Agreement was an unlawful contract in restraint of trade. In 1945, Judge Forman, Judge of the District Court in Trenton, New Jersey at the time, issued a Final Judgment (the “1945 Decree”) cancelling the 1932 Agreement and requiring that Merck Predecessors notify the Department of Justice of any intention to enter into arrangements or agreements with KGaA Predecessors. Section VII of the 1945 Decree, see Exhibit E. Judge Forman also expressly retained this Court’s jurisdiction over the enforcement of the 1945 Decree:

“Jurisdiction of this cause is retained for the purpose of enabling any of the parties to this decree to apply to the Court at any time for such further orders and directions as may be necessary or appropriate for the construction or carrying out of this decree, for the amendment, modification, or termination of any of the provisions thereof, for the enforcement of compliance therewith and for the punishment of violations thereof. . . .”

So, the parties apparently could not reach agreement on choice of law, as I had earlier guessed they might. All of that would seem to militate in favor of retaining US law as the law governing this Lanham Act, and contract breaches claim — in the New Jersey federal District courthouse. A decision will be forthcoming in the next few weeks, by the able judge.

Off for a workout, on a gray but warm Sunday late-morning here. Hang in there you little copper colored twisty shepherd moon-lette!


As Oft’ Happens — A Smallish (Potential) Mission Glitch Emerges — For NASA JPL’s Juno Spacecraft…

October 15, 2016 - Leave a Response

mrk-jpl-nasa-glitch-juno-2016 Considering the harsh environment (crazy hot radiation @ 20 million RAD; a magnetic field 20,000 times stronger than Earth’s — and mostly minus 280 degrees Fahrenheit, hurtling 163,000 mph through space), at 520 million miles from an Earth repair (when it takes over 48 minutes one-way, for data traveling at the speed of light, to reach it) — this is, I suppose, to be expected. [Earlier backgrounder here.]

Overnight, NASA and Cal Poly’s JPL announced that the basketball-court sized Juno spacecraft will stay in its longer, more elliptical orbit (taking another 53 days to loop around the top of Jupiter) for one additional pass at least. Thus the tightening of its belt around Jupiter, to around 14 Earth-days per loop — will have to wait a tic. Or a tock.

The craft will still collect all the expected data — and is in a stable position to keep the mission rolling, but if the glitch is not solved, it may take several more months (at the longer 53 days per loop) to garner a statistically meaningful amount of data on what lies beneath those wildly boiling Jovian cloud-tops. [The spacecraft gets just completely hammered by massive doses of Jovian radiation, each time it dips in close — to those tempestuous clouds. Perhaps the valve controller circuits (including backup controller circuits) have already been mostly fried.]

Here is the full release — and a bit:

. . . .The decision was made in order to further study the performance of a set of valves that are part of the spacecraft’s fuel pressurization system. The period reduction maneuver was the final scheduled burn of Juno’s main engine.

“Telemetry indicates that two helium check valves that play an important role in the firing of the spacecraft’s main engine did not operate as expected during a command sequence that was initiated yesterday,” said Rick Nybakken, Juno project manager at NASA’s Jet Propulsion Laboratory in Pasadena, California. “The valves should have opened in a few seconds, but it took several minutes. We need to better understand this issue before moving forward with a burn of the main engine.”

After consulting with Lockheed Martin Space Systems of Denver and NASA Headquarters, Washington, the project decided to delay the PRM maneuver at least one orbit. The most efficient time to perform such a burn is when the spacecraft is at the part of its orbit which is closest to the planet. The next opportunity for the burn would be during its close flyby of Jupiter on Dec. 11. . . .

[It has occurred to me (over my Saturday morning coffee and a banana) that I may still write on some ancillary matters related to pharma and life sciences — and of course, my beloved space sciences — mostly on weekends. So do look for more robust activity — on weekends here, from time to time. We will keep a good thought for the solving of this glitch, if a glitch it be.]

Even so, she herself is sailing right along now, entirely care-free, with one other copper colored, twisting shepherd moon-lette I have long admired, mostly from afar. Smile. . . .


In Which Mr. Shkreli Tries To Jam Up A Pub — Unannounced… Oh — And A Crim. Pro. Update From Brooklyn

October 14, 2016 - Leave a Response

As to Mr. Greebel, there are still a few wrinkles left — but as to Mr. Shkreli, it seems the parties worked out all matters related to the former need for a bill of particulars. I’ll attach the two page letter that pre-dated the agreement entered today, by a day — so the readers may see just what level of specificity Mr. Brafman was asking from the government — and he has now apparently received the same.

Here is the order, as entered today, in Brooklyn’s federal District courthouse:

. . .Defendant Shkreli and the Government advised the court that the issues raised in Shkreli’s Motion for a Bill of Particulars have been resolved. . . .

As only Mr. Shkreli might, as he left court, he then (“his treat!”) invited his Twitter followers out for a beer (but perhaps only to the extent that any of them are more than 11 years old).

Then, the pub he named told him — and his “fans” — they were not welcome at the pub.

He apparently found another venue, but what sort of a tool tries to show up to a tiny neighborhood bar — with at least the potential of some 5,000 people — unannounced?

Naturally — only Martin. Only Martin the cad-oh-so feckless.

Keep it spinning in good karma folks — g’night — truly a fine day’s end, indeed!