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-2016Each 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

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!


FLOTUS Michelle Obama Just Closed Out — On Donald Trump. He’s A Pig. And He’s… Toast.

October 13, 2016 - Leave a Response

Her voice clearly quaking with rage — she has just buried Donald Trump, alive. She is truly the preeminent closer on the planet. Do watch all three minutes below.

I may not frequent these parts much, any longer — so this will serve as a final mile-marker, in how I see the race.

Good riddance, Donald Trump. So many people could learn so much, if they could just listen. . . listen to her.


O/T: Heisenberg’s Uncertainty Principle — In Action — Or… Not. Smile

October 12, 2016 - Leave a Response

Well. . . after about 3.8 million page-views, and well-over 2 million distinct viewers — over the last several years — this effort may be drawing to a close.

As only ironic fates might have it, it looks like my new law firm will be engaged to represent a company that I have previously blogged about (anonymously), here. And so, this commentary may well now fall silent.

As is true with other matters governed by Heisenberg’s sublime theorem, this may all change, upon additional observation and reflection — as we unfold, at the new digs — and inspect our merged capabilities.

[This may make it all easier for one in particular. . .] And, if we don’t speak again, do keep it all spinning in good karma. I will still write from time to time, at the satellite sites set forth in the left margin of the main website (as I had seen this coming, for a bit now). Do travel well — and do travel light. For we need not live high — to live well. . . . It’s been a privilege.