Thursday, June 30, 2016

At Noon Central Today: Webcast Press Event -- At NASA/JPL, Regarding Juno's Jupiter Orbit Insertion

If this sort of fare isn't your cup of tea, do feel free to scroll on by -- but I'll tune in at noon, and again at 1 PM CDT, so you won't have to -- as it portends to be fascinating (at least to me!).

Here's a bit, from NASA:

. . . .During the evening of July 4, Juno will perform a suspenseful orbit insertion maneuver, a 35-minute burn of its main engine, to slow the spacecraft by about 1,212 miles per hour (542 meters per second) so it can be captured into the gas giant’s orbit. Once in Jupiter’s orbit, the spacecraft will circle the Jovian world 37 times during 20 months, skimming to within 3,100 miles (5,000 kilometers) above the cloud tops. . . . providing new answers to ongoing mysteries about the planet’s core, composition and magnetic fields. . . .

At about 12:15 pm PDT today (2:15 p.m. CDT), mission controllers will transmit command product "ji4040" into deep space, to transition the solar-powered Juno spacecraft into autopilot. It will take nearly 48 minutes for the signal to cover the 534-million-mile (860-million-kilometer) distance between the Deep Space Network Antenna in Goldstone, California, to the Juno spacecraft. While sequence ji4040 is only one of four command products sent up to the spacecraft that day, it holds a special place in the hearts of the Juno mission team.

"Ji4040 contains the command that starts the Jupiter Orbit insertion sequence," said Ed Hirst, mission manager of Juno from NASA’s Jet Propulsion Laboratory in Pasadena, California. "As soon as it initiates -- which should be in less than a second -- Juno will send us data that the command sequence has started."

When the sequence kicks in, the spacecraft will begin running the software program tailored to carry the solar-powered, basketball court-sized spacecraft through the 35-minute burn that will place it in orbit around Jupiter.

"After the sequence executes, Juno is on autopilot," said Hirst. "But that doesn’t mean we get to go home. We are monitoring the spacecraft’s activities 24/7 and will do so until well after we are in orbit. . . ."

Also today, NASA announced a collaboration with Apple that will serve to enhance the agency's efforts to inform and excite the public about dramatic missions of exploration like Juno. "Destination: Juno" is a synergy between two seemingly disparate worlds: popular music and interplanetary exploration. The works resulting from this collaboration showcase exploratory sounds from artists who have been inspired by Juno and other NASA missions. . . .

Sailing right along now, entirely care-free, with one other copper colored, twisting shepherd moon-lette. Smile.

UPDATED: 1 PM CDT -- Apple has partnered with NASA/JPL and the Juno Mission team to create highly-inspired art -- music and videos, from the likes of the Oscar® winning duo Trent Reznor and Atticus Ross (and with tracks from Corinne Bailey Rae, GZA, Jim James featuring Lydia Tyrell, QUIÑ, Weezer, Zoé and Brad Paisley) -- all of whom call young artists and scientists to the wonders of space exploration. Go see the full video at Apple Music. This trailer of it was released at the second briefing -- now underway, as of 1 PM CDT (the team will replay the full long form video at 4 PM EDT, on NASA TV):

Merck MDL Update: Fosamax® "Failure To Warn" In Femur Cases Before Third Circuit Today

Just a minor appellate update squib here -- this flawless holiday morning, over hot coffee & cream, fresh-squeezed OJ, and a banana -- whole cherry yogurt coming up, next -- smile.

Recall that the trial courts have dismissed all the Fosamax® femur MDL "failure to warn" claims. That July 2014 ruling reduced the number of femur MDL claimants from over 1,000, to under 20. The MDL steering committee has appealed the able Judge Pisano's ruling to the Third Circuit. A full two years later now, that appeal will be heard today, it seems.

Here is the Reuters item noting it.

We will report if anything newsworthy transpires. Onward -- on a mountain bike -- on a glorious morning, eyes a-glow. . . .

Wednesday, June 29, 2016

Merck Vs. Gilead: What Use Should Be Made Of Hague Convention (French) Depositions, In Delaware Federal Patent Spats?

When one litigates high-stakes matters in several courts around the globe, simultaneously -- about one core set of dispositive issues (here a patent fight, on a pro-drug that ultimately became sofosbuvir, the central active ingredient in Gilead's Hep C wonder cures Sovaldi and Harvoni) -- it often happens that there emerges a whole host of "derivative" disputes, among the parties, about what use may be made of items adduced (testimony and documents, primarily) under the rubric of other countries' civil legal systems.

This is one of those times.

Recall that Idenix is the proxy for Merck, here (as Merck acquired Idenix) -- and recall that the issue of which company actually first had the original idea to "invent" sofosbuvir is now (at least according to the very able US District Court Judge Beth Labson-Freeman, in the Northern District of California) probably NOT Merck (since she has effectively ruled that a Merck employee may have usurped a Gilead subsequent acquitision target's teaching in the area). So, if Gilead can keep any additional unfortunate evidence out of the pending Delaware case, it has a pretty good shot at a win here, as well. That explains why Gilead is trying to keep the French scientists' opinions corraled under US rules. But the Hague Convention contemplates very different ideas -- making this an argument eminently worth watching. Here is a bit from Merck's latest letter:

. . . .In effect, Gilead desires to use the provision at issue to turn the court in France into a conference room in the U.S. and turn the depositions into ones that are governed solely by U.S. laws. That is directly contrary to the legal basis by which these depositions have been sought and ordered, i.e. that they be held in a French court. There are rules in France regarding discovery of its citizens, including the French Blocking Statute. It is Idenix’s understanding that one of the roles of the French Judge will be to ensure that the rights of French citizens are respected and that its laws are properly followed. Gilead’s proposal would preclude that and strips the French Court of its power to preside over the deposition, and essentially turn the French Judge into a "potted plant." Gilead provides no reason or basis to tie the French Court’s hands in this manner. . . .

The proposal is also directly harmful to Idenix, given the breadth of Gilead’s proposed provision — seeking to prohibit all rulings on evidence and testimony. Idenix would be prohibited from seeking any guidance or ruling from the Court since the depositions relate solely to evidence and testimony. In the event that the French judge asks the parties to weigh in on any issue that may arise during the depositions, such as to provide their respective positions as to whether certain testimony or examination is appropriate under French law, Idenix would be precluded from answering in any way that would suggest that it is seeking a ruling as to whether such evidence/testimony is appropriate under French law. In effect, the French court would be deprived of its ability to hear from both parties and to manage its affairs in accordance with French laws. . . .

So -- we shall see. Do have sweet, safe and overly ripe watermelon-drenched holidays, one and all. Smiling ear to ear, as I'll be grabbing my West Coast dwelling young man, tomorrow evening, from the airport -- sweet, indeed!

Merck "Ups Its Ante" In Moderna -- To $300 Million; Deepens Collaboration In Immuno-Oncology

We last reported on this longer-term R&D bet by Kenilworth in January of 2015. Back then Merck put in $100 million -- it is adding $200 million today -- and still there is no proof of this bioscience concept in vivo.

Even so, it is a quite exciting validation of the work Moderna is doing -- and would dovetail with Merck's pembrolizumab penetration, globally in many cancers, should it all prove out. Here's a bit from the press release of this morning:

. . . .Moderna and Merck will develop personalized cancer vaccines that utilize Moderna’s mRNA vaccine technology to encode a patient’s specific neoantigens, unique mutations present in that specific patient’s tumor. . . .

Under the terms of the agreement, Merck will make an upfront cash payment to Moderna of $200 million, which Moderna will use to lead all research and development efforts through proof of concept. The development program will entail multiple studies in several types of cancer and include the evaluation of mRNA-based personalized cancer vaccines in combination with Merck’s Keytruda® (pembrolizumab). Moderna will also utilize the upfront payment to fund a portion of the build-out of a GMP manufacturing facility in suburban Boston for the purpose of personalized cancer vaccine manufacturing.

Following human proof of concept studies, Merck has the right to elect to make an additional undisclosed payment to Moderna. If exercised, the two companies will then equally share cost and profits under a worldwide collaboration for the development of personalized cancer vaccines. Moderna will have the right to elect to co-promote the personalized cancer vaccines in the U.S. The agreement entails exclusivity around combinations with Keytruda. Moderna and Merck will each have the ability to combine mRNA-based personalized cancer vaccines with other (non-PD-1) agents. . . .

We will keep an eye in this. Onward, as we wind down for the long holiday weekend, starting tomorrow. Smiling, just the same.

Monday, June 27, 2016

Looking Ahead: Space Science -- NASA Juno Mission's Jupiter Orbit Insertion On July 4, 2016

Jupiter is plainly the giant of our system. While standing on our home planet Earth, grilling on July 4, we each absorb about one third of a rad on a sunny day. Consider that little Juno will absorb over 20 million rad from its time in Jupiter's captive orbit.

We hope to learn much about what actually lies beneath the clouds -- and those now 700 year old storms, we see from high atop Jupiter, using Hubble or Earth bound telescopes. [The storm -- a tornado, several times the size of Earth -- is that reddish orange dot we see.]

If, that is -- if little Juno doesn't get clobbered by debris on the way in, or so irradiated that its little circuits conk out. The folks at JPL will be all white knuckle on July 4, while we barbeque. The first dip into orbit is by far the most dangerous. It will be blogged and tweeted, in near real time, from the NASA mission page. I will peek in from time to time, with my phone -- while at the grill, and later, by the pool at the club. But tomorrow, Tuesday -- the craft will pressurize its fuel cells. That's the next big event remaining, pre July 4:

. . . .On June 11, Juno began transmitting to and receiving data from Earth around the clock. This constant contact will keep the mission team informed on any developments with their spacecraft within tens of minutes of it occurring. On June 20, the protective cover that shields Juno's main engine from micrometeorites and interstellar dust was opened, and the software program that will command the spacecraft through the all-important rocket burn was uplinked.

One of the important near-term events remaining on Juno's pre-burn itinerary is the pressurization of its propulsion system on June 28. The following day, all instrumentation not geared toward the successful insertion of Juno into orbit around Jupiter on July 4 will be turned off. . . .

All of Juno’s instruments, including JunoCam, are scheduled to be turned back on approximately two days after achieving orbit. JunoCam images are expected to be returned from the spacecraft for processing and release to the public starting in late August or early September.

"This. . . is the start of something great," said Bolton. "In the future we will see Jupiter's polar auroras from a new perspective. We will see details in rolling bands of orange and white clouds like never before, and even the Great Red Spot. . . .

That JPL trailer above is only two minutes long, but summarizes well all you'll need to know, for next Monday. This little remote controlled craft has been sailing the inky-black frigid sea of space for just shy of five years -- and is now (as I write this) exactly one week away from its mission objective achievement. That in and of itself is jaw-slacking. Do stay tuned. I do truly see you. . . . and I'm beaming tonight, little copper-colored shepherd moonlette. . . . Pax tecum.

UPDATED: On Tuesday morning, the New York Times began running a nice, but longer form (at almost 4 minutes) video story on Juno's Jupiter arrival. Do recall that in mythology, Juno was the only demi-god who could see through Lord Jupiter's cloud covered deceptions -- thus the name of the craft:

BREAKING: A 5-3 Majority Has Struck Latest Texas Abortion Restrictions Law

Texas law is struck nearly in entirety; Fifth Circuit reversed -- in essence, the Court holds both provisions were designed to place an undue burden on a woman's right to control her own body. To make a long story short, the Court struck down both provisions of Texas HB 2 -- the admitting privileges requirement, and the requirement that all abortion clinics have facilities comparable to an outpatient surgical center.

Here is the opinion:

. . . .Both the admitting-privileges and the surgical-center requirements place a substantial obstacle in the path of women seeking a previability abortion, constitute an undue burden on abortion access, and thus violate the Constitution. . . .

[Justice Ginsberg, concurring:] . . . ."So long as this Court adheres to Roe v. Wade, 410 U. S. 113 (1973), and Planned Parenthood of Southeastern Pa. v. Casey, 505 U. S. 833 (1992), Targeted Regulation of Abortion Providers laws like H. B. 2 that "do little or nothing for health, but rather strew impediments to abortion," Planned Parenthood of Wis., 806 F. 3d, at 921, cannot survive judicial inspection. . . ."

More soon -- on a train. But this is the best possible outcome. Well done, SCOTUS!

UPDATING, now -- as many others are opining, this likely means many of the southern states' amended anti-abortion laws are similarly invalid. That would include Mississippi, Alabama and presumably Louisiana as well, now. The Courts of Appeals in those cases will read today's Supreme Court case, and likely send the cases back, to the trial level courts, in each of these states -- with instructions to follow the law, as announced by the Supremes today. This means most of the copy-cat laws are going to be struck, almost entirely. This is a victory for reproductive freedom everywhere.

Justice Breyer wrote "Abortions taking place in an abortion facility are safe — indeed, safer than numerous procedures that take place outside hospitals and to which Texas does not apply its surgical-center requirements. . . ." after reviewing the evidence. "Nationwide, childbirth is 14 times more likely than abortion to result in death, but Texas law allows a midwife to oversee childbirth in the patient’s own home. . . ." That is particularly telling.

Sunday, June 26, 2016

[U] Supreme Court Watch: What Happens If We See A 4-4 Deadlock Tomorrow, On The Texas Abortion Rights Case

Updated: The Supremes invalidated almost all of the Texas law, in a 5 to 3 decision, as I guessed in March of this year. Thus, with Justice Kennedy joining the liberal wing -- and the death of Scalia -- and the Republicans' failure to do their job. . . it all made no difference. It would have come out the same way, even if Justice Scalia had lived on. This should be a warning to obstructionist Republicans. End, update.

Many Supreme Court observers expect to see the outcome (or perhaps, non-outcome) from the latest in the Texas state legislature's efforts to restrict lawful abortions in state, announced tomorrow morning.

Given what we saw last week on the immigration measures case, there is a more than passing chance that we see another "your government, NOT at work" 4-4 deadlock. At issue (primarily) is whether a Texas law requiring that doctors who provide abortions in Texas must have full admitting privileges at a near-by hospital, or a surgi-center on site in the office, in order to provide abortions is constitutional after Roe v. Wade and Planned Parenthood v. Casey.

Here is where the law would then leave women seeking control over their own bodies, in Texas, were that unfortunate stalemate between Justices to occur yet again.

In plain English, the last court to rule on the case would be the binding decision. In this particular case, that was the Fifth Circuit -- out of New Orleans.

That court struck parts of the Texas law, but upheld other parts of it. Here is some of that Fifth Circuit decision:

. . . .Because the Plaintiffs failed to prove that the ASC requirement imposes an undue burden on a large fraction of women for whom it is relevant, we conclude that the district court erred in striking down the ASC requirement as a whole as facially invalid. . . .

We [however] now know with certainty that the non-ASC abortion facilities have actually closed and physicians have been unable to obtain admitting privileges after diligent effort. Thus, the actual impact of the combined effect of the admitting privileges and ASC requirements on abortion facilities, abortion physicians, and women in Texas can be more concretely understood and measured. . . .

While women in the Rio Grande Valley could previously travel 150 miles or less to Corpus Christi to obtain an abortion, see Abbott II, 748 F.3d at 597–98, the abortion facility in Corpus Christi has now closed. The State argues that women in the Rio Grande Valley continue to be able to obtain abortions in San Antonio and Houston, where the abortion facilities now nearest to them are located. Indeed, Plaintiffs’ expert, Dr. Grossman, concluded that fifty percent of the women from the Rio Grande Valley were previously obtaining abortions somewhere other than Corpus Christi, even before that clinic closed. Nonetheless, the closure of the Corpus Christi clinic means that all women in the Rio Grande Valley will have to travel approximately 235 miles to San Antonio or farther to obtain an abortion. . . .
The Fifth Circuit went on to hold that the District Court was within bounds to find that one-third increase in distance -- to 235 miles of distance -- for an abortion, was an undue burden on the right of women to control their bodies under Roe, and Casey.

I am saddened, truly to even have to write about such scenarios as a possibility. Our founders would be ashamed of the Republican high-jinx here. 

Even so -- while much of the restrictive Texas measures would remain, the people of Texas will still be able to litigate, in new lower court cases, the issue of what constitutes an undue burden on women's rights to an abortion, on an "as-applied" basis. Far from optimal, but not a death-knell, either. Without a USSCT opinion, new parties may effectively re-litigate these issues, as they apply to them, in new fact patterns. Highly inefficient -- and a waste of judicial resources -- but that is apparently what the Republicans want.

Saturday, June 25, 2016

Waxing A Little Too Dramatic On A Saturday, In Forbes -- On Pharma Brexit Effects

It may be that, in time (like after 2018), we see a major global contraction in pharma and bio-science spending due to Brexit -- but I'd certainly not make that guess today. It is hard to know, here on day two of this news cycle -- but this seems just a little overblown.

One thing almost all of the larger multinational life science companies are blessed with is. . . cash. Lots of it -- conveniently sitting right there, in Europe, to boot. And very modest debt levels, relative to other very large companies, in almost all other industries. [The only notable exception to that general rule would be certain tech players, like Apple and Microsoft.] In almost all other cases, it will be pharma that will be likely to readily, and freely deploy cash (from its vast stored reserves of the stuff, in Europe, in particular) as needed -- to keep growing, in all these highly-lucrative developed markets.

So I'd say that this author is a little too "Chicken Little" for my tastes.

Pharma will adjust. It always does -- it always will. It may hit rough patches, for a quarter or two, as things get sorted out -- but it is as sound a sector as can be found, in uncertain times -- like these. Here's a bit of the Forbes froth (do feel free to consume with a truckload of salt):

. . . .The realities of newly uncertain markets will shake every major pharmaco. Based on what I’ve seen before, one of the first casualties becomes R&D. Next less profitable operations are quick to be shuttered. Finally when even more severe actions occur it will be easy to “Blame it on Brexit” for everything that goes bad or any type of corporate reshuffling. That won’t be pretty. . . .

As I say -- it could come true -- IF Germany votes to leave, and France does too -- while weaker economies wrestle to rope them back in. But that seems unlikely -- in fact, it seems that my cousins in Ireland, and those in Scotland, may hold referenda to rejoin the EU, and leave the UK. Either way -- I'm not much for the histrionics, here. I do think taxation will change among these economies -- but not until after 2018.

G'night to one and all of good will.

Friday, June 24, 2016

Unintended Consequences: What Of EU-Wide VAT Systems; EMEA HQ -- Now That England Is Exiting The EU?

UPDATED @ 11:15 PM EDT: Do read former British Prime Minister Tony Blair's reflection on today's fallout. His is clearly a voice of both experience, and reason. We would be wise to take heed.

And now, goodnight to all of good will.

Namaste. . . End, update.

As I write this, the continent is staggering under the weight of collateral fallout and unexpected implications from last night's British exit vote. That is no hyperbole.

There are precious few clear answers yet, so I'll just mention that the system of cross Europe transactional taxes may need to be reworked -- and that may have profound implications for all multinational life science companies.

However, one fairly clear immediate implication is that all the regulatory expertise currently housed in London, at the headquarters of the EMEA (sort of the EU version of our FDA) will. . . depart. It is not at all clear that if (for example) EMEA HQ is relocated to Frankfurt, Germany, or Paris, France (the two most likely candidates, in my estimation) the science staffers would be willing to relocate. So multinationals may face additional hurdles (and delays at least) in clearing drugs for sale in the European Union, as the agency's London HQ is wound down. It remains unclear however whether the UK will create a separate "whole cloth" regulatory scheme for drugs, devices and biologicals -- one that might well conflict with existing EMEA frameworks. In any event, here's a bit from Reuters, overnight:

. . . .The association of Germany's pharmaceuticals industry said the European Union's London-based drugs regulator, the European Medicines Agency, will have to relocate after Britain's vote to leave the EU, posing a considerable administrative burden for drugmakers.

"The administrative hurdles that we are now facing as a result of Great Britain's exit from the Union will require great efforts on the part of our member companies," the association said in a statement on Friday. . . .

It is almost as though the people of Britain are awakening this morning and collectively saying. . . "Wait -- I drank WHAT, last night? Sheesh." Global equity markets are tanking as well, as they open. Yikes.

In any event, it will be sorted out in due course -- but I'd not be shocked to see an undo referendum vote effort emerge, about a year from now, from the saner British quarters. Strange times, indeed. Onward, on a sunny warm Friday. . .

Thursday, June 23, 2016

O/T -- Looking In On A Split Pair, From The Supremes Today... With More To Come

Since we here often closely follow what we hold to be the salutory benefits of taking various forms of diversity of background into account -- as a plus factor -- in decisions about school admission, and hiring and promotion -- I will remark quickly on why the Texas case handed down today is. . . correctly decided.

[But before I do -- it is entirely deplorable that -- due to the Republicans' refusal to schedule a vote on Supreme Court nomineee Merrick Garland, the question of immigration policy the Court accepted last term has been left unresolved. The 4-4 split means no opinion will be issued. This is the spill-over of Republican-led and engineered gridlock. This therefore means that the flawed (in my view) analysis of the lower courts will stand, on immigration -- for now. When President Hilary Clinton ("Gee, that has a nice ring to it!") sends a new appointee to what will likely be a Democratic Senate, in January of 2017, all of this will be straightened out in a future case -- thus securing the legacy of one of Mr. Obama's signature programs.]

So, then -- the good news: In a decision unlikely to have much meaning beyond the bizarre geography that makes up the Texas state funded school admission process, the Supremes just held that a white student cannot complain about diversity being a plus factor. The central reason that this is a very narrow decision is that, in Texas, the legislature has imposed (by law) a "set-aside" -- for a large number of seats, reserved solely for students who graduate in the top ten per cent of their high school class. The white student here complaining was not in the top ten per cent. She did not challenge the notion that the state had created that set aside. That left her with a very limited universe of slots, and a highly competitive set of students against which her admission papers were to be judged. And so she was not admitted. At bottom, this case simply -- and unsurprisingly -- holds that a less-qualified white student cannot complain when a more qualified diverse student is admitted ahead of her -- and in that regard, one plus factor may be the student's diversity. "Considerable deference is owed to a university," Justice Kennedy (depicted at right, writing for the 4-3 majority) wrote "in defining those intangible characteristics, like student body diversity, that are central to its identity and educational mission." He is right in that view. Here is the full opinion (a 75-page PDF file -- of which over 50 pages comprise Justice Alito's dissent) -- and a bit:

. . . .Petitioner’s acceptance of the Top Ten Percent Plan complicates this Court’s review. In particular, it has led to a record that is almost devoid of information about the students who secured admission to the University through the Plan. The Court thus cannot know how students admitted solely based on their class rank differ in their contribution to diversity from students admitted through holistic review. . . .

The fact that this case has been litigated on a somewhat artificial basis, furthermore, may limit its value for prospective guidance. The Texas Legislature, in enacting the Top Ten Percent Plan, cannot much be criticized, for it was responding to Hopwood, which at the time was binding law in the State of Texas. That legislative response, in turn, circumscribed the University’s discretion in crafting its admissions policy. These circumstances refute any criticism that the University did not make good-faith efforts to comply with the law. . . .

SO now you now. Onward -- on a foggy, steamily sweet sultry day. Smile.

Wednesday, June 22, 2016

[U] Merck v. Gilead Patent Battle, Out East: Judge Burke Is Hearing Argument Now

UPDATED: 06.22.2016 @ 2 PM EDT -- Judge Burke has ruled against Gilead. The motion has been denied; Gilead will have to comply with the discovery requested by Merck:

. . .Discovery Teleconference held on 6/22/2016. The Court heard argument from the parties and denied Defendants' request. . . .

Longer term, I still expect that the same problem faces Merck/Idenix as it faced in Northern California: There is now competent evidence, and more importantly, a District Court ruling, to the effect that Merck's patent rights rely on inequitable conduct -- as to a Gilead precursor (called Pharmasset). As such, at least one court has held that Kenilworth cannot enforce whatever patent rights it might have as against any successor to Pharmasset -- like Gilead. So, I expect this will settle, eventually, with no net inflow to Merck -- only an outflow, for the ultimate payment of Gilead's attornetys' fees, spent defending against Merck's infringement action. Now you know. End, update.

We will update this report -- when the electronic record is updated to reflect any dispositive order or other outcome, but as I type this entry, the two sides are live (by teleconference) appearing before the able District Court Judge Christopher J. Burke, in the US District Court in Wilmington, Delaware. I expect the hearing will take most of the morning, EDT.

Check back after lunch. Here's the latest, as of 9 AM EDT:

. . . .As a result of an oral order from Chambers dated June 21, 2016, and in response to Gilead’s submission filed on June 20, 2016 (D.I. 324) and Idenix’s responsive submission filed on June 21, 2016 (D.I. 333), the parties will present their respective positions consistent with the Court’s prior order regarding discovery matters during a teleconference on Wednesday, June 22, 2016 at 9:30 a.m. with counsel for Gilead to initiate the call.

Dated: June 21, 2016. . . .

Onward on a sullen, stormy and steamy walk in -- the city is brooding and hot, this morning -- as am I, too. Smile. . . .

Tuesday, June 21, 2016

After Ebola -- A Heart-Wrenching Long-Form Piece -- In The New Atlantic

We should all support and celebrate the brave, persistent -- and in many ways, lucky -- people of Africa who have survived Ebola. Sadly, as has often been true with prior pandemics, survivors are more than occasionally now ostracized and stigmatized, even in their own communities and families -- due primarily to unfounded fears. This is that story -- as told in the upcoming issue of The Atlantic. A worthy if somber read, indeed.

As a longer form read, it will take a moment -- but trust me -- well-worth your time invested. As much as this site has lauded the humanitarian efforts of both Merck and Gilead (even as they battled over patent rights, on other topics), we do feel compelled here not to just paint a "happy face" on the whole situation, as Ebola winds down, on the mother continent. This is in many ways, a still unfolding tragedy, even if no other acute case emerges. That is so, in no small part due to the suffering these brave people otherwise lucky enough to have over-powered the virus in their own bodies now endure -- at the hands of their own communities. Do go read it all:

. . . .Near one of the billboards, a survivor of the disease, Jenneh Getu, looked out a hospital window at the ambulances in the parking lot being pelted by hard rain, as the psychological-counseling session she’d come for began. "The sickness grabbed my husband," Getu said. "After four days, he died. We had just finished burying him when my son’s skin started getting hot." Getu brought her 3-year-old from her rural hometown to Monrovia for help. "My son died on my lap in the taxi," she said. "I was forced to hold that body tight so people didn’t know it’s Ebola."

Getu called the health team charged with handling Ebola cases in the capital, but no one came. For days, she sat with her son’s corpse in an empty house in Monrovia. Eventually, she got sick, turned herself in at a treatment center, and waited to die. But she didn’t. "I survived," she said. "But I feel like a different human being. I’m different from other people. Even my family rejects me now.” Emmanuel Ballah, the attending physician’s assistant, handed her a tissue. He and his colleagues at the Doctors Without Borders clinic within the hospital treat several hundred Ebola survivors for medical and psychological problems.

"There was a huge stigma against survivors," Ballah told me later, as we walked through the clinic’s lobby. "People saw terrible things in Ebola treatment units. But leaving the ETUs, their challenges were just beginning. . . ."

Saying that it was ever thus is not an answer, at all. We must do better, as a planet. As one people. All of us -- as citizens of this blue dot. Here endeth the sermon. . . .

While Gilead Seeks Its Attorneys' Fees Out West, Discovery Disputes In Delaware Elevated From Magistrate, To The Trial Judge

Now that the federal District Court, Northern California Gilead-pays-Merck $200 million patent infringement verdict has been wiped out, the lawyers for Gilead out west (as I previously said they would) are busily filing briefs -- to seek perhaps as much as $18 million in legal fees from Merck, the money Gilead would say it spent defending itself against Merck's "inequitable" patent infringement claims. By the end of next month those briefs, and counter briefs, will be filed.

Meanwhile, in Delaware federal District Court, the other Merck/Idenix v. Gilead sofosbuvir patent suit is deeply mired in the muck of a discovery dispute. [Backgrounder -- on why Idenix's name appears there, in the Delaware version of this patent litigation.] So bogged down, in fact, that the able trial judge has ordered the Magistrate to sieze control -- and, on a short time-table, resolve it. But even that process has now reached loggerheads, it seems.

Whatever the issue in the for-now sealed letter(s), the very capable Judge Christopher Burke, a trial judge, has ordered a phone call tomorrow, with him, in person. In this role, he's a lumberjack, looking to break the log-jam with a pry-bar and sharp hook, if need be.

I suspect that, given the rulings on the West Coast, the able judge has made it clear that those rulings will guide his views on this case, as well. And he is likely looking to advance the case to trial rapidly. To clear it off his docket, actually. Here is his order of this morning, in full:

. . . .ORAL ORDER Setting Teleconference:

The Court has reviewed Defendants June 20, 2016 letter regarding a discovery dispute. (D.I. 324 in Civil Action No. 13-1987-LPS, D.I. 273 in Civil Action No. 14-109-LPS, D.I. 313 in Civil Action No. 14-846-LPS).

It hereby ORDERS that the procedures for resolving a discovery dispute set out in paragraph 3(g) of the Scheduling Order will be altered as follows with regard to this dispute:

(1) The parties shall file a joint "Motion for Teleconference to Resolve Discovery Dispute," the text of which can be found in the "Forms" tab of Judge Burke's page on the District Court's website.

(2) A discovery dispute teleconference will be held on Wednesday, 6/22/2016 at 09:30 AM before Judge Christopher J. Burke.

(3) Any party opposing the application for relief may file a letter, not to exceed three (3) pages, outlining that party(s) reasons for its opposition by 5:00 pm today.

Ordered by Judge Christopher J. Burke on 6/21/2016. . . .

Now you know. But I would expect that this will, like the one out West, settle, with Merck paying at least some of Gilead's legal fees -- and no net recovery for Kenilworth. Onward, on a flawless Tuesday morning -- walking in. Smile. . . .

Monday, June 20, 2016

Scientific And Business Talent Does Not Discriminate: It Resides. . . Everywhere!

It is with deep satisfaction, and heart-felt pride, that I am able report this item, this evening. Encouraging diverse talent is core to Merck's missions -- and this is the way to nuture, water and grow that talent -- from seedlings to mighty oaks.

Do take a look. This is both smart policy -- and smart business, in the 21st Century. From the press release, this evening then, a bit:

. . . .The partnership is designed to introduce graduating seniors from Historically Black Colleges and Universities to Merck’s Leadership Development Program. The Leadership Development Program is an entry-level program designed to create a pipeline of emerging talent who can prepare for leadership positions of increasing responsibility and visibility within key divisions of Merck’s business.

"Merck is a great company with great opportunities. They just needed a channel to communicate these excellent opportunities to the many talented students coming out of the Historically Black Colleges and Universities," said Will Moss, founder and CEO of "These are the types of opportunities that are especially important for us to communicate within the African American and HBCU community, because they are opportunities that transform into leadership positions within a global company! We should be striving for these types of opportunities that offer great pay, great experience, and great exposure."

Merck is looking for HBCU Students primarily graduating in December of 2016 and May of 2017 as the program will start in the summer of 2017, but interested candidates that may have graduated recently and are interested in learning more about the program are also encouraged to apply. . . .

And so, as ever -- Onward. . . beginning to feel myself again -- turning an important corner, finally, now. Smile.

Thursday, June 16, 2016

Until We Return, Then... Of Dr. Roy Vagelos

While we post this, Merck is announcing some of its latest pembrolizumab immuno-oncology study data -- supporting an additional, first line, lung cancer indication smartly. That's good current news. And, since we tend to look back from time to time, as we did in 2010, and 2015 -- at Dr. Vagelos, we will mention this fine Australian article this morning.

It reminds us that here in the 21st Century, while we can never simply "forget" stockholders, there was a time when leaders focused on the science, first.

The Australian Business Insider piece is notable primarily for its comparison of the legendary Dr. Vagelos, to the far more prosaic Brent Saunders, a more than occassionally tone-deaf Fred Hassan protégé. Do go read it all, as we have followed him closely here as well, over the years. I think the arc of the narrative gets it just right:

. . . .At Merck & Co., in the middle of the 20th century, the idea that patients came before profits, “was a big part of our culture,” said Scott Lucas, who worked in sales at the company for more than 30 years, starting in the 1970s.

Lucas and other workers describe an era of the highest ethical and moral standards. Drug trials were halted over the most tenuous rumour that a similar drug in development by a competitor was running into issues. Sales staff took pains to educate doctors about the downsides of Merck’s treatments.

In the second half of the 20th century, Merck really was a company where shareholder value was the result, not a prime motivation. . . .

Keep it spinning in good karma until we return -- and, as a house-keeping note -- the project following the bankruptcy of KaloBios is now concluded. Onward, to the Mountain West, by jet this morning -- for entirely heart-breaking family duty, through the weekend.

Tuesday, June 14, 2016

"The Martin Shkreli Files" Update: KaloBios May Very Well Clear Chapter 11 Hurdle Tomorrow

And in the process of garnering bankruptcy court exit approval, the new management of that company has cut a deal with Mr. Shkreli. The new company and its management will be able to force a below market price "call" of all his shares, during the next 24 months. Wipe him out, that is. Should it choose to do so.

The Delaware federal Bankruptcy Court PACER docket was just updated with the terms of Mr. Shkreli's settlement -- now due to be discussed in court tomorrow. I predict approval.

The settled terms allow New KaloBios to acquire all of Mr. Shkreli's remaining shares at a 10 per cent discount to then-current market value, post exit, at any time. In addition, he is generally barred from taking any action with respect to these shares.

The company will -- if it intends to call his shares -- raise money elsewhere to do so (i.e., not impact the exit financing). There will likely be no reason to do so, though -- as the mere threat of a call at below market prices will make him very docile. Very.

Doubly so, where this is his bail money on the eight felony counts (in Brooklyn's federal District courthouse).

Here's the bit:

". . .For a period of 120 days following the Effective Date (the “Initial Period”), the Debtor [KaloBios] will have the exclusive right to repurchase (the “Repurchase”) from Mr. Shkreli any or all of the Shares (the “Repurchase Right”) at a price which is a 10% discount to the previous two week volume-weighted average price (the “VWAP”) (the “Market Discount Price”). As it pertains to the Debtor’s exercise of its Repurchase Right, the Market Discount Price may not be less than $2.50 per Share (the “Minimum Purchase Price”). The Debtor will provide written notice to Mr. Shkreli of its intent to exercise the Repurchase Right (a “Call Notice”) and will have two weeks following the delivery of such notice to fund the Repurchase (the “Funding Period”). . . ."

I'll predict that this settlement is accepted by the able Judge Silverstein, tomorrow -- and will allow Black Horse, et al., to run the show and thus effectively ignore the lil' guy. For all they care, he doesn't exist. And the shares hang around, as a potential funding vehichle -- for all the other complaining parties, against Mr. Shkreli, personally (all those from whom he will secure no releases, via this process). It looks like that pot of money will not be less than $5.18 million, if KaloBios exercises the call. After 120 days, it may fall below that amount, though -- and it is unlikely to be freely trading any time soon -- as it is his bail, afterall.

So, net, net -- this is essentially the same as Mr. Shkreli's not owning the shares, at all -- in terms of voting control. He is required to vote with New KaloBios management on all matters, and may not try to organize any group to seek changes to management, at any time.

Bub-bye, Martin. More at the main KaloBios Review site -- all day tomorrow.

O/T: Our President Is Right -- This Is The America I Support. The One My Grandfathers Served. Not "The Dark Ages" Mr. Trump Seeks.

We cannot ban an entire religion. It simply cannot be done. It is impossible -- and wildly dangerous. And it is exactly the wrong approach -- it helps ISIS and ISIL frame the conflict as "Americans hate all people of a certain faith." And that is simply false.

Just watch all of it. And remind yourself that a man who thinks he can judge people by their facial appearances wants to have his hands on nuclear weapons.

Will we ever hear the Republican nominee admit that perhaps -- just perhaps -- the shooter's own internal conflict (and blooming mental illnesses, it would seem), over his apparently closeted gay status, had at least something to do with his actions -- and that like so many things, the reality that now emerges is significantly more nuanced and complex, than it appeared at first blush? Of course not. But I will point it out, anyway.

In Praise Of "Forming Smart Questions": Evidence Based Medicine & The FDA's Role

We have written of this before, repeatedly, but when smart doctors like Harlan Krumholz and Steve Nissen ask uncomfortable questions (even ones to which the answer may turn out to be "no"), then pursue data, and formulate hypotheses from that data -- we all, as consumers of health care, ultimately benefit.

We all benefit, provided that FDA serves its role as well -- and asks for solid evidence as to new drug candidates. The way science more than occasionally works is that we learn new things, on our way to studying other things.

Matt Herper has a nice piece up in Forbes, this morning, describing an ongoing shift in diabetes treatments that was originally animated by doctors asking questions about safety and efficacy, and doing large scale longer term studies. All of which -- even if the questions turned out to be mostly misplaced concerns -- brought Lilly's Jardiance to prominence, in a crowded field of diabetes treatments, a year ago. Here's a bit -- but do go read it all:

. . . .Jardiance, a pill sold by Eli Lilly LLY and Boehringer Ingelheim, presented its positive results just last year. Researchers say that the new results could change the way that doctors treat diabetes, shifting the treatments doctors reach for after metformin, the tried-and-true first-line drug, which is generic.

"There’s a building momentum that maybe we do need to rethink the way diabetes is cared for in America," says John Buse, the University of North Carolina, Chapel Hill researcher who led the study, which was funded by Novo Nordisk.

And doctors and Novo Nordisk itself give credit to the new diabetes data to a surprising source: Tougher regulations for diabetes drugs from the Food and Drug Administration, which many in industry had previously decried, saying it was keeping new drugs from the market and hurting patients.

"I can almost guarantee you that these trials would not have been done if it had not been for the FDA regulations," says Buse, who has been a consultant to many companies for years. "Before the guidance I was constantly pushing on companies to do these trials. . . ."

So it is that often, just being unafraid to ask questions -- smart questions, controversial questions -- ones that no one can answer -- leads to improvements in patients' lives. And we are smiling widely, this fine warmly sunny June morning.

Monday, June 13, 2016

O/T Weekend Holdover Marginalia: I For One Am THRILLED That The Presumptive Republican Nominee Is Out Revoking Press Credentials

In truth, there should have been some discussion within his camp -- about the function of a free press, in a free society -- but really, why bother? It's all over his sloped, jutting, mono-browed forehead.

It's like talking about the merits (for humans) -- of bicycles, to. . . fish. And he's the fish. As long as he's busy "revoking" the fourth estate (one he cannot revoke), though -- it keeps his lil' head busy NOT trying to make any coherent policy about anything related to. . . anything -- especially on guns, terror, religion, immigration, equality or security.

Do rest assured, the Wa Po will still cover him -- they have zero need for "access" to his "double secret probation" credentials. Hell, I could cover him more than adequately, from my office -- never laying eyes on the man. In the electronic age, his "banishment" belittles only him (and sadly, the nomination of the party he purportedly seeks). Here is the money quote -- from the editors of The Washington Post, late this afternoon:

. . . .As the country mourned the wanton slaughter of 49 people early Sunday, the presumptive Republican presidential nominee took a victory lap, hinted darkly that President Obama is an enemy of the nation, libeled American Muslims and, in grotesque punctuation, finished up with a vindictive attack on the media. . . .

"When coverage doesn’t correspond to what the candidate wants it to be, then a news organization is banished. The Post will continue to cover Donald Trump as it has all along—honorably, honestly, accurately, energetically, and unflinchingly. We’re proud of our coverage, and we’re going to keep at it. . . ."

If this is his inclination now, imagine how he might wield the powers of the presidency. . . .

Indeed. And now it is up to all of us to vote, and be certain that is never a possibility. Onward. He is a cretin, who knows nothing of (or holds disdain for) at least three core American freedoms -- free speech, free press and free exercise of religion. You are nearing the end, Mr. Trump. You may reliably trust that.

A Little Tardy On This One: Merck v. Merck Federal Lanham Act Name Fight First Scheduling Conference Moved To July 14

I really meant to get to this before I left town, but I'm getting to it now that I'm back in the saddle.

The first date for a meeting to schedule discovery and related matters in New Jersey's federal District courthouse has been moved from June 2, to July 14, 2016 -- at 3:30 PM EDT.

We aren't likely to learn much in court, then -- but we may get a sense of how things are shaping up elsewhere around the globe -- in these same naming/internet branding disputes, in other courthouses -- and whether the parties will settle, and try to hammer out a 21st Century agreement -- or continue to fight on, with little in the way of clarity for either combatant.

Here's the bit, from the PACER electronic docket:
. . . .Per counsel's request [17], the Scheduling Conference set for 6/2/2016 is adjourned to 7/14/2016 at 3:30 p.m. in Newark - Courtroom 2C before Magistrate Judge Michael A. Hammer. . . .

I'll be off-grid once again, later this week -- from Thursday morning until next Monday morning -- considerably more somber duties (testifying), this time.

Onward, nonetheless. . . and do keep Orlando in your meditations. Namaste.