Merck Investment Vehicle Now Holds Well-Over 10 Per Cent Of OpGen Inc. (With A Cubicin® Gram-Negative Connect)?

May 24, 2016 - Leave a Response

This afternoon, Merck updated its SEC ownership disclosures — of another of its public company investments (nominally held via its Global Health Innovation Fund, LLC). Merck affiliates now own — and/or hold rights to acquire — well over 10 per cent of this public company. OpGen bills itself as “a precision medicine company that uses molecular diagnostics and informatics to combat infectious disease.” The latest acquisition of rights in OpGen occurred just last Thursday, May 19, 2016. But Merck has had an investment here since before July of 2015.

I strongly suspect that Merck seeks a continued pipeline of information about (and likely eventual license rights to) this company’s rapid (just over 30 minute) diagnostics tests, especially as to so-called Gram negative organisms — like those Merck’s Cubicin®, or daptomycin as a chemical name (itself a late 2014 acquisition by Kenilworth) is designed to knock-out. With Cubicin likely subject to generic incursions (due to various patent spats) beginning in July of 2016 — might this rapid testing protocol eventually be linked to the branded offering, to contiune to keep the branded Cubicin at the fore-front, in US hospital deployments? We shall see.

In any event, the text from OpGen’s latest SEC Form 10-K, which accompanies the graphic in the lower portion, at right — is as follows:

. . . .Our suite of DNA-based products and products in development are intended to provide actionable, precise diagnostics powered by microbial surveillance data. The high resolution Acuitas DNA tests use multiplex PCR to help provide reliable and accurate detection of drug resistance. The QuickFISH tests are powered by PNA technology and provide rapid pathogen ID, typically in less than 30 minutes from a positive blood culture result. The Acuitas MDRO Gene Test is used for determining if ICU patients are colonized with MDROs. Positive samples are confirmed using microbiological methods and the Acuitas Resistome™ test for high resolution genotyping. Test results are maintained in the Acuitas Lighthouse™ data warehouse for subsequent interpretation by physicians and healthcare providers.

We are developing a new disruptive one-hour-testing paradigm that we believe could help address many of the current issues with testing for antibiotic resistance. Results from a new high resolution Acuitas DNA test designed to detect the key resistome profiles of Gram negative organisms will be informed by a smart cloud based clinical database that will provide molecular profiles to aid initial antibiotic selection and clinical decision making. Our proprietary Acuitas Lighthouse profiles distill large amounts of data into one actionable profile. We believe our disruptive approach will be globally applicable and could be an important new weapon in the fight against drug-resistant bacteria. The figure below describes the potential workflow and anticipated results from our new testing approach. . . .

So, yes, I think this OpGen stake/investment dovetails nicely with the Merck-acquired Cubicin franchises (and continued penetration plans for the same). Off to a board meeting and a workout, now. Namaste, one and all. . . .

O/T A Worthy Read, From Our 39th President — Candidly Assessing Race, In America In 2016. . .

May 24, 2016 - Leave a Response

It has been a fairly quiet early news week thus far for Kenilworth, so I will offer up a very worthwhile read — on the increasingly clear topic of just how dangerous a Trump nomination is likely to be. Dangerous to the cause of fundamental fairness, and equality, in America.

Honestly, I am now openly skeptical that the GOP will survive (as an intact party) in the near term, given the vast chasm he has torn-open, in that party. Like the Whigs, they may well turn out to be. . . . extinct, by 2020. But between now and then, we must do all we can to prevent complacency about this odious reality TV candidate.

And so, since I have mentioned him several times before on this blog — I will quote our 39th President, here — and point the readership to the morning’s New York Times, on it all. Do go read it — Mr. Carter is speaking truth, there — an uncomfortable truth to many white and black alike, but truth, just the same:

. . . .Mr. Carter said the election of Mr. Obama was a hopeful sign, but he added, “I think there’s a heavy reaction among some of the racially conscious Republicans against an African-American being president.”

He said recent reports showing high unemployment and incarceration rates among black people, “combined with the white police attacks on innocent blacks,” had “reawakened” the country to the realization that racism was not resolved in the 1960s and ’70s.

He said Mr. Trump had violated “basic human rights” when he referred to Mexican immigrants as criminals and called for a ban on Muslims’ entering the country. . . .

There is much more that is wise and true, at the link — do go read it.

And before I close — let me point to a Chief Justice Roberts authored opinion (handed down yesterday), holding (7-1) that a black man’s death penalty trial was infected with racism, in the jury selection process — and thus open to challenge, under the standards of Batson v. Kentucky, even 20 years on — with newly discovered evidence of bias. That is an encouraging sign, even if Justice Thomas was the lone hold-out — and clearly wrong — on the applicable prior common law.

I will now go in search of some light lunch fare, on a flawless spring day, here. . . . Onward!

Merck Foundation Sets Five Year, $15 Million US Cancer Therapies Access Initiative

May 23, 2016 - Leave a Response

As the stories of “survivability” — related to many life threatening cancers — are being rewritten, almost daily, in the patients’ favor — by these new immuno-oncology checkpoint inhibitors, it makes sense that Merck would use its charitable arm to improve access. Afterall, these are extremely expensive new therapies, and the bulk of people with cancer in the US are not independently wealthy, nor particularly well-insured. So whether you live in Compton or Kennebunkport, it ought to be true — in a “just” society — that we (the collective US health care system) will find a way to provide first rate care, and cutting edge therapies, to all equitably.

That is the aim of these awards — but in candor, much more will be needed, in order to achieve meaningful parity between Harvey, and Hyannis Port. From the press release then, a bit:

. . . .”Despite advances in diagnosis and treatment, access to high-quality cancer care continues to be challenging for some patients in the United States, especially those in vulnerable and underserved communities,” said Dr. Julie Gerberding, executive vice president, strategic communications, global public policy and population health, Merck and chief executive officer, Merck Foundation. “We are optimistic that the learnings from the Alliance’s activities will bring forward new approaches in the delivery of cancer care that can be implemented throughout the health care system. . . .”

The Alliance will be supported by the Merck Foundation for up to $15 million over five years. Awardees will be announced in early 2017. . . .

This is a welcome step in the right direction — but it is only a step. Onward, then — on a perfect May Monday morning, then. . . smiling. . . .

O/T: “The Great Society” — 52 Years Ago, This Evening. . .

May 22, 2016 - Leave a Response

It was exactly 52 years ago this evening, that LBJ proposed (and ended up tasking Bill Moyers with) what he called the “Great Society” initiatives. Though many of them were based upon President Kennedy’s “New Frontier” initiatives, it was President Johnson who saw them passed into law, after Kennedy’s assasination. Mr. Johnson’s vision came almost one year to the day after Dr. King’s Letter From The Birmingham Jail was first read by most Americans.

As opposed to tax cuts and other preferences for billionaires (Mr. Trump’s mantra), both of these Presidents (Kennedy and Johnson) sought a more equitable America — especially for the nation’s lower middle classes — and those mired in generational poverty. I would clearly add Mr. Obama’s name to these two (on health care reform).

Here is a bit of what the Great Society achieved — and had LBJ not insisted on escalating his war in Vietnam, he might have enjoyed much more credit, for transforming America into a more just society:

. . . .Between 1964 and 1968 the United States Congress passed 226 of 252 bills into law. . . .

The Food Stamp Act (1964) provided low income families with access to adequate food.

The Economic Opportunity Act (1964) created the Job Corps, VISTA, and other community-based programs.

The Tax Reduction Act (1964) cut income tax rates for low-income families.

The Civil Rights Act (1964) outlawed discrimination in housing, employment, and public accommodations. . . .

Federal funds transferred to the poor increased from $9.9 billion in 1960 to $30 billion in 1968. One million workers received job training from these programs and two million children experienced preschool Head Start programs by 1968. . . .

And so ends our “look back at history” weekend — but I may revisit these themes, in coming weekends’ posts — to highlight just how much of what is a “more just” America — that Donald. Trump. Just. Does. Not. Understand. Or. Care. For.

Mr. Trump is manifestly unfit to be President, if he sincerely believes he need not address the issues facing 47 per cent of Americans — the 47 per cent who struggle every day — from paycheck to paycheck. He is no one’s populist. He is. . . a fascist.

Scottish Nurse Cured Of Ebola In February 2016 Opens Up, On British Television. . .

May 22, 2016 - Leave a Response

This is very much a life-affirming story. A triumph as much of human will, as cutting edge bio-science — Ms. Cafferkey clearly was a fighter, throughout. In fairness, though it is even more a story of what world-class bio-science in the 21st century can do: it can take the near certainty of imminent death right off the table, and all in the space of under an elapsed week, to boot. She is back at regular duty, week in — and week out.

Even so, she is quite right to feel rather humbled, insofar as she says that she is alive today, because she was admitted to the Royal Free, received those experimental Gilead medications (rushed from the US west coast — on an overnight transcontinental flight), and was afforded the very best Western medicine had to offer — all within hours of the re-emergence of Ebola viral loads, around her brain and spinal column. And so, her story is also a reminder — of all the over 11,300 others who were not quite so fortunate, in Guinea, Sierra Leone and Liberia. Here is a bit of The Guardian (UK) reprint, but do go watch the original ITV piece, at the top of the article:

. . . .Cafferkey told ITV: “I was crying so much to the point that I wanted to scream. I don’t know if I was scared of dying or [if it was] just sheer frustration of being there and wanting out. But the nurses were great; they would just come and sit with me, they would be with me and talk to me. . . .”

“I found it very soothing if they would stroke my hair and things like that to try and soothe me. I probably reverted back to childlike behaviour. I just tried to cope with it.”

“I had crazy hallucinations. [I imagined] there were a bunch of Sierra Leoneans and they also had Ebola, but they were outside the tent, and I was saying to the nurse: ‘Treat them, treat them.’ I suppose subconsciously I must have had a degree of guilt, like why I got the best of care, world-class care, and they didn’t. . . .”

And so it goes — as we await June 9-10 — and a new all clear in Africa. Love one another.

Merck Vs. Merck — First USDC, NJ Scheduling Conference Set: Lanham Act Suit

May 21, 2016 - Leave a Response

Regular readers will recall our continuing coverage of the latest federal lawsuit brought by Merck of Kenilworth, New Jersey — in the federal District court in that state, against the German Merck — over the use (or misuse) of the Merck name, under a series of antiquated agreements these two companies long ago signed.

I say antiquated — because they do almost nothing to account for completely borderless electronic global commerce — in an internet enabled age. For certain, they do not directly address what end-user/consumers (sitting at their screens, or increasingly on their phones) should expect as a consistent, clear and easily discernible line of demarcation — as to whether one is dealing with, or learning about, the German one or the United States one.

That is so, because the agreements were last amended long before the original DARPA-net evolved into a rich, graphical, seamless world wide web of information and commercial opportunities we now take for granted. The parties just never contemplated such a development. [At least not, it seems, on the consumer side of the equation — so most of the agreements cover notions about which company may use which naming conventions in which geographies, primarily in promoting themselves to “intermediaries” (pharmacies, hospitals and doctors) — not so much end user consumers, because DTC advertising barely existed then, as well.]

And so — the first scheduling conference — between the parties (on the US version of these fights) is now set for the afternoon of June 2, 2016 — in Newark:

. . . .Scheduling Conference set for 6/2/2016 at 2:30 p.m. in Newark – Courtroom 2C before Magistrate Judge Michael A. Hammer.

So Ordered by Magistrate Judge Michael A. Hammer on 5/19/2016. . .

Off for a workout, and a breezy afternoon bike ride by the lake. . . .

Keep it spinning in good karma, as 14 years ago tomorrow, the last of the criminals then-living, and responsible for the bombing of the 16th Street Baptist Church in Birmingham nearly four decades earlier — was finally convicted. It took nearly four decades for justice to roll, in the murders of Addie Mae Collins, Carole Robertson and Cynthia Wesley, all 14, and 11-year-old Denise McNair. Both Michael Blanton and Bobby Frank Cherry are long-dead now, but that sad, twisted story is a clear object-lesson to those who condone violence against people they do not understand, or hate — for no reason. And I am looking at Mr. Trump — once again, here. He gives his people “permission” — and so he is absolutely responsible for their actions, just as the Klan of Birmingham was responsible for the murder of those four little girls. Here endeth the sermon — but is in keeping with this weekend’s theme.

I may devote most weekends to such lower third marginalia — in direct opposition to the reality TV candidate. He is a dangerous and ignorant would-be demagogue. I will take him lightly, no longer. Any blood-shed he incites, at his rallies — is on his account. He will burn for it, in eternity — that is my belief-set.

O/T Civil Rights: Fifty-Three Years Ago, Yesterday — The New York Post Sunday Magazine, Echoing Through To Today’s “Reality TV” Candidate

May 20, 2016 - Leave a Response

I meant to get to this, yesterday — but the time got away. I’ve run versions of this in 2011, and 2014 — but because 53 years ago yesterday, most of the world first read the words quoted in blue below — I’ll run it yet again. It never gets old — it never will become irrelevant. As we listen to a purported billionaire (and reality TV-style purported presidential candidate) tell us to turn our backs on, and shun, so many of our brown brothers and sisters — these words have renewed, and immediate currency.

Perhaps no one black man in America — in the last sixty-five years — has so changed the futures, and fortunes of so many, permanently — and for the better (and so his portrait will return to my masthead for the weekend):

. . . .My friends, I must say to you. . . . it is an historical fact that privileged groups seldom give up their privileges voluntarily. Individuals may see the moral light and voluntarily give up their unjust posture. . . .

Frankly, I have yet to engage in a direct action campaign that was “well timed” in the view of those who have not suffered unduly from the disease of segregation. For years now I have heard the word “Wait!” It rings in the ear of every Negro with piercing familiarity. This “Wait” has almost always meant “Never.” We must come to see, with one of our distinguished jurists, that “justice too long delayed is justice denied.”

We have waited for more than 340 years for our constitutional and God given rights. The nations of Asia and Africa are moving with jetlike speed toward gaining political independence, but we still creep at horse and buggy pace toward gaining a cup of coffee at a lunch counter. Perhaps it is easy for those who have never felt the stinging darts of segregation to say, “Wait.” But when you have seen vicious mobs lynch your mothers and fathers at will and drown your sisters and brothers at whim; when you have seen hate filled policemen curse, kick and even kill your black brothers and sisters; when you see the vast majority of your twenty million Negro brothers smothering in an airtight cage of poverty in the midst of an affluent society; when you suddenly find your tongue twisted and your speech stammering as you seek to explain to your six year old daughter why she can’t go to the public amusement park that has just been advertised on television, and see tears welling up in her eyes when she is told that Funtown is closed to colored children. . . .

[W]hen you take a cross county drive and find it necessary to sleep night after night in the uncomfortable corners of your automobile because no motel will accept you; when you are humiliated day in and day out by nagging signs reading “white” and “colored”. . . .

Of course, the above is quoted from the letter from the Birmingham jail — April 16, 1963. Namaste all. Serve wisely; serve well.

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

. . . .Anonymous said…

Amazing, heart-felt, “goose-bump” words you wrote. Your writing brought tears to my eyes … thank you for reminding all of us reading your blog that discrimination should NEVER happen. We are all different, but not one better than another. We all need to treat each other with dignity as that’s how we would want to be treated ourselves. Thank you for your eloquent words.

MLK was always one of my heroes when I was a young child. I wrote a paper on him when I was in grade school and, although I didn’t understand the ramifications of what he was trying to do at the time, I certainly do today. Young minds are very impressionable. We all need to teach our children about this great man.

January 18, 2011 at 10:53 AM . . .

And so, I urge you my friends (and even those I do not yet count as friends) — over the coming weekend — and every day thereafter — at least for a moment each day — do serve wisely; serve well. He would have done the same. And he would have said the Donald’s “vision” of America. . . is no vision, at all.

Immuno-Oncology Races Heat Up: Roche/Genentech Nabs An FDA-Cleared Checkpoint Inhibitor Approval — Tecentriq®

May 18, 2016 - Leave a Response

Well, the immuno-oncology wing of the FDA is popping today. [Of course, there is no formal immuno-oncology wing at FDA — I just made that up. Smile. it sounds pretty cool though, right?] More seriously, the revamped FDA review process is certainly on full-display, this week. Nicely done, staffers! And it is no exaggeration to call this an emerging three way revolution, in cancer combatting agents — as of this afternoon. Very gratifying, from a bio-science perspective.

Once again, significantly ahead of earlier time-line expectations, another checkpoint inhibitor immuno-oncology candidate has been green-lighted, by FDA. This new one, called atezolizumab, and branded by Genentech as Tecentriq®, was just approved for a common form of bladder cancers. It is Roche’s first entry into this generation of agents — and while priced on a par with both BMS’s Opdivo and Merck’s Keytruda — it is sure to put some heat on Merck, the No. 2 player, in the near term. It is highly foreseeable that some oncologists (with patient consent) will use it off-label, in an experimental fashion, in other cancers. That will likely pressure Merck more than BMS — as our graphic this morning made plain.

The erstwhile John Carroll (at FierceBiotech) has more of the details, here — do go read it all:

. . . .The drug will be marketed by Genentech as Tecentriq and sold for $12,500 a month, in parity with rivals Opdivo and Keytruda.

The accelerated OK is based on Phase II data and comes four months ahead of the PDUFA date on the agency’s decision, highlighting once again the FDA’s intense interest in speeding along a new class of cancer drugs that has been making a deep impression on their therapeutic potential.

While Merck and Bristol-Myers made their mark with PD-1 drugs, Roche has been concentrating on PD-L1, a complementary pathway involved in the deceptive game cancer cells play to avoid an immune system attack. And Roche has been paying careful attention in identifying the patients most likely to benefit. . . .

I should also mention that we will expect additional indications, pretty shortly, for the Roche candidate, as well. But this is a high burden cancer, right now. We are now off on foot, in search of soup, on a fine Spring afternoon, awaiting son’s arrival by train this evening — for dinner. . . smile. This is great news for cancer patients. Pax tecum, one and all.

BMS’s Opdivo® Clears FDA Four Months Early, In Classical Hodgkin Lymphoma — Should Extend Lead In Sales

May 18, 2016 - Leave a Response

As proof of how the FDA’s “new look” — at approvals — is rapidly evolving, I would note at the top that this Opdivo® follow-on indication had an expected PDUFA date of September 1, 2016. Let that sink in, a moment.

Yet FDA has approved it overnight — nearly four months ahead of even that accelerated schedule. Where the benefit is clear, and the potential to prolong quality time, or save lives is evident, it seems the “new” FDA will truly step-lively, to get an approval jacket completed. Of course, in this particular case, Opdivo has already been FDA-vetted in several other cancers, and represents almost no incremental risk profile to the agency, since FDA is well-aware that many oncologists are already using it off-label for cancers (such as cHL) — where it is not yet formally approved.

I would expect that when Q2 2016 results are available in late July 2016, we will see an additional widening of BMS’s sales revenue lead, over Merck’s Keytruda®, across all cancers (see Q1 2016 chart, at right). To be sure, there will be lots of revenue for Kenilworth, but it looks like BMS has cemented its hold on the No. 1 spot. Here’s a bit, from a press release:

. . . .The U.S. Food and Drug Administration has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.

This accelerated approval is based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This first approval of a PD-1 inhibitor for cHL patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is based on a combined analysis of data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials. . . .

We are quite encouraged — and offer Kudos here, to all the FDA staffers.

Now it occurs to me — in a small plug for my occasional one-off blog — that while Chagas is not cancer, and even the “New” KaloBios is certainly not BMS, today’s news does make the more general point that if FDA wants an effective Chagas treatment, it might well reach approval very rapidly, given that there exists over 30 years of safe, effective use, in various studies’ data, on the benznidazole candidate drug — in Latin America. Off now, for a sunny, breezy walk in. . . smiling widely.

USW Local 10-86: By A 3 to 1 Margin, New 4 Year Contract Ratified At Merck West Point, PA

May 16, 2016 - Leave a Response

I am smiling quite widely, even though it is well-past my normal bedtime, here. I knew it would come (like Christmas night) — late. . . but it came. . . .

The USW’s Local 10-86 membership has just ratified a new four year agreement — and the salient terms are below — do take a look. [With the Obama administration now having to wade into the 39,000 member strong, 30 day strike at Verizon, to get people talking again — and with no raises offered at present by Verizon, I’d say the Negotiating Committee for USW Local 10-86 did a very skillful job here, in a very tough job environment. Kudos!]

. . . .Membership this evening ratified the tentative agreement between Local 10-00086 and Merck, Sharp and Dohme. We don’t have the exact count at this time. Unofficially the numbers appear to be 3 to 1 in favor of accepting the proposal.

The contract is for 4 years with raises of 2.5% each year and a signing bonus. . . .

Thank you to all who supported us through a tough process.

President Dan Bangert

2016 Negotiating Committee. . . .

This has to be a relief to many, many of the affected families. And so, a fond goodnight, to all of good will, here. Pax tecum.

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