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.

Another Supposed “ObamaCare-Ender” Likely Resolved — By Agreement

May 16, 2016 - Leave a Response

This morning, clearly taking pains NOT to issue a deadlocked 4-4 opinion, the United States Supreme Court issued a per curiam (unamimous) opinion in the so-called contraceptive cases — remanding all of them for additional proceedings in the lower courts — in the main because the Court itself, at and after argument earlier this year, was able to find a middle ground that both sides said would be a feasible and acceptable fix to the currently articulated dispute. [Update: I should have been clearer, in my commentary, at lunch-time — a deadlock here would have meant that in five of the six cases, the Obama/HHS’s position would prevail, and in the sixth, the petitioners’. And so, had that occured — in a question of purely federal law, the outcome might have differed, depending on where one lived. That would be an entirely non-sensical result, as the federal law is supposed to be uniform, nation-wide. And so, by clever questioning, and a gentle cajoling of the broad terms for a compromise, the Justices have all but ensured a uniform outcome: the requirement to provide coverage for contraceptives, for all women, at no additional cost, will very-likely now come from the same insurer, even where one’s employer is a religious affiliate that objects to such coverage. And that will be the case nation-wide, without the religious affiliate having to file any papers, to claim any exemption. That is a very fine resolution — as no one on the HHS/Obama side of the table wanted to impinge on sincerely-held religious beliefs — they simply wanted women to be truly free to choose — for free.]

As of this morning, the Supremes have asked the lower courts to oversee the working-out of that broad compromise. This is very clearly one more affirmative notch in the continuation of ObamaCare — and a good one. I think five of six appeals level courts held in favor of the HHS (i.e., the Obama) position on the question of access to birth control free of charge, for all women. And the religiously-affiliated employers — like schools, or hospitals, run by the Little Sisters of the Poor — have apparently agreed that if they provide insurance that DOES NOT include birth control coverage, but their employees obtain it for free (perhaps even from the same insurer, at the same time, on their own), the Sisters’ free exercise rights (under our First Amendment) are not noticably diminished. Here’s a bit from the very-learned Lyle Denniston, at SCOTUSblog.com:

. . . .[T]he Supreme Court on Monday. . . cleared the way for the government to promptly provide no-cost access to contraceptives for employees and students of non-profit religious hospitals, charities, and colleges, while barring any penalties on those institutions for failing to provide that access themselves. Thirteen separate cases were sent back to federal appeals courts for them to issue new rulings on the questions the Justices left undecided. One immediate issue is how soon the government can work out the technical arrangements to provide actual access to the contraceptive benefits.


The Court largely shifted to six federal appeals courts the task of ruling on the mandate’s legality — the task that the Court had agreed last November to take on itself in seven of the cases. Five appeals courts had ruled in favor of the mandate, and one had ruled against. All were ordered to re-think those outcomes in the wake of new positions that the two sides in the controversy had made in recent filings in the pending Supreme Court cases. . . .

It is unusual to see the nation’s highest court working out settlement proposals, but this is what inexorably happens — when the Republicans controlling the “advise and consent” process for appointing a new Justice simply shirk their constitutional duties. Our highest court (ever resourceful, on its own quite considerable initiative) then starts to resort to “trial court” level tactics, to avoid a forever riven 4 to 4 deadlock, on a major issue.

In passing, I will also note that Justices Sotomayor and Ginsberg concurred and offered the following admonishment (aimed at one of the federal District courts — ouch!): “. . .Yet some lower courts have ignored [our] instructions. . . . (“[I]n Wheaton College, Little Sisters of the Poor, and Zubik, the Supreme Court approved a method of notice to HHS that is arguably less onerous than [existing regulations] yet permits the government to further its interests. Although the Court’s orders were not final rulings on the merits, they at the very least collectively constitute a signal that less restrictive means exist by which the government may further its interests”). On remand in these cases, the Courts of Appeals should not make the same mistake. . . .” Ooh! — that will leave a mark.

It shouldn’t escape notice that these two Justices (both women), signing the concurrence are. . . sending a very clear corallary warning, here: when the Court says the free contraceptive provision is constitutional, and thus must be available to all women — as the ACA of 2010 specifically contemplates — then that is precisely what must happen [i.e., no more trying to chip away at that right, by saying in effect “oh, some less onerous procedure will do. . . .”] Now you know.

Sending the last college son back north, by train, after a great weekend. . . all smiles here. . . .

UPDATE: Merck | West Point, PA | USW Local No. 10-86 Contract Ratification Vote, In Just Over 24 Hours. . .

May 15, 2016 - Leave a Response

Just as we reported almost six years ago, to the day (same graphic, at right, in fact) — that a three year agreement was ratified (and another one, in 2013, after a more drawn out process). . . . Tomorrow evening, the rank and file will vote on the new memorandum of understanding.

Given that the USW’s website leads with a story on the Verizon workers’ strike (members of the Communication Workers of America) now passing its 30th day, and those company-offered terms looking very, very thin — I do think it would be wise to vote to ratify. As I’ve said, usually a not perfect agreement is better than a strike. Here “the perfect is the enemy of the good.”

. . . .The Ratification Meeting is set for Monday, May 16, 2016 at the North Penn High School. Doors open at 6:15PM. AFTER everyone is properly registered and seated President Dan Bangert will call the meeting to order. . . . [The PDF of the MOU is available to members on the web-site, and has been distributed. . . .]

Onward, on a beautifully clear, if cool Sunday morning. . . . Whoosh!

High Praise: Pfizer Declares It Shall “No Longer Tinker With The Machinery Of Death”

May 14, 2016 - Leave a Response

There is a twisted (and more than occasionally sordid) back-story here — even though this development has been long-delayed, I won’t belabor it. I am all about heaping praise, this fine Saturday morning — on Pfizer.

So. . . I shout praise — thank you, Pfizer — and yes, thank you, Chairman Ian C. Read! The big blue pill company has made an excellent — and moral — choice. I applaud it. [My headline above is a quote from a famous Justice Blackmun dissent in a United States Supreme Court death-penalty case, of the last century.] I cannot say enough about how gratified I am (having worked toward this goal when I was an internal part of this industry) to learn that — as a now united, unanimous industry — FDA regulated multi-national pharmaceutical companies have turned their collective back on the small handful of states in our Union that still wish to use pharmaceutical grade injected posions to kill inmates.

Thus the final and effective end of the death penalty in America may be achieved not so much in the courts or legislatures — but in the lack of supplies: i.e., a court accepted mechanism for implementing it, consistent with all of our existing precedents under the Eighth amendment. Here is a bit of The New York Times on it, overnight (do go read it all):

. . . .”With Pfizer’s announcement, all F.D.A.-approved manufacturers of any potential execution drug have now blocked their sale for this purpose,” said Maya Foa, who tracks drug companies for Reprieve, a London-based human rights advocacy group. “Executing states must now go underground if they want to get hold of medicines for use in lethal injection.”

The obstacles to lethal injection have grown in the last five years as manufacturers, seeking to avoid association with executions, have barred the sale of their products to corrections agencies. Experiments with new drugs, a series of botched executions and covert efforts to obtain lethal chemicals have mired many states in court challenges. . . .

The arc of the dream that is America inexorably once again bends toward. . . progress — toward hope. Toward a more civil union, ruled by law — not men. And for that, I am grateful — on to a trail-bike ride, and workout, on brisk Saturday then. Onward!

Additional Thoughts — On Civil Investigative Demands, Out Of Manhattan AUSA’s Office: Who Really Is The Target?

May 13, 2016 - Leave a Response

To follow up on my earlier report about Merck and J&J’s disclosures (in the quarterly SEC filings of each) regarding civil investigative requests, this week — it occurs to me that both of the drugs which Merck named as being “asked about” by the able US Attorneys in New York, are not on the approved formulary lists, of any major pharmacy benefit manager, or PBM, in the US.

If the very-able Manhattan US Attorneys’ line of thought is that Merck somehow paid something improper, to gain favored access/placement on the major PBMs’ approved formulary lists, then the request likely would/should have asked about Merck’s formulary-favored drugs.

If on the other hand, the concern of the US Attorney has more to do with the power that PBMs increasingly wield, in making formulary approval decisions — I would think that the US Attorneys’ offices would want to see how certain drugs end up getting excluded from that coveted status, and how that might impact both the pricing of other (formulary favored) drugs in the same indication, and overall anti-competitive manuevering, in these US marketplaces. So — I now reiterate my guess that this may be more about a look at PBMs — than a look at R&D driven pharmaceutical manufacturers. [CVS and the like ought to be taking notes, here.]

As ever, to be fair, J&J did not indicate which particular drugs its DoJ request asked about (so there is no way to know if J&J’s request fits with my hypothesis). And, in any event, I think (if memory serves) Merck has divested at least the Levitra rights, to Bayer (in the Consumer Health sale), post 2014. So again, this is all just idle speculation on my part. But it might well pan out.

Now, onward on a perfectly sunny Friday morning. . . smiling, and awaiting a great weekened. . .

Yawn. Current Legislators Cannot Sue Whenever They Don’t Like The Way The Executive Branch Enforces A Law Passed By A PRIOR Congress

May 12, 2016 - Leave a Response

Okay — in the land of “Condor predicts” tonight — I will confidently predict that when the SCOTUS gets this House of Representatives v. Burwell DC District Court decision, it will simply reverse without an opinion, or strike it, with an opinion and order holding that (no surprise) Congress cannot (constitutionally) grant itself standing to sue the Executive Branch, simply because the now-sitting House doesn’t like the way a prior Congressional enactment is being implemented, by the Executive Branch.

The obvious — and Constitutional — answer is that the present Congress must repeal or amend the prior law, not sue to overturn it. The House simply has no standing.

In fact, House Republicans acknowledged that without a specific bill they proposed in 2014, they would have no power to sue, here. And that bill itself failed to pass the Senate — and so it never became law. Yet, here the House sits today, suing to claim, on putative authority of a later law that did pass, that the prior law’s funding provisions weren’t specific enough. That later law is itself an unconstitutional abuse of separations of powers doctrines, but no one has bothered to bring a challenge — because it all seems so silly — since the SCOTUS will strike the very suit the House now attempts as unconstitutional, as well.

I am unsure whether the SCOTUS will take the trial court’s opinion directly, or let it work its way up the chain from the trial court, here. But do rest assured — without a Republican President, and a NEW law, passed by a subsequent Congress, this whole thing is nothing but political theater. [And I am on record that Mr. Trump will not be our 45th President.] This is all why (in part) the District Court stayed its ruling — until all appeals are exhausted. Here is the sensible, sane bedrock law on which I base these assertions — from a case the SCOTUS decided, called Raines v. Byrd 521 US 811 (1997). Here is a bit of the HHS memo of law quoting it, from the current case papers:

. . . .The cost sharing reduction payments are being made as part of a mandatory payment program that Congress has fully appropriated. See 42 U.S.C. § 18082.

In Raines, several Members of Congress challenged the constitutionality of the Line Item Veto Act of 1996, asserting that the statute had injured them by infringing on their power as legislators. 521 U.S. at 816. Although the Members had brought suit pursuant to a provision of the statute that authorized such a filing, the Supreme Court held that the plaintiffs lacked Article III standing. It noted that their claim asserted “a type of institutional injury (the diminution of legislative power), which necessarily damages all Members of Congress and both Houses of Congress equally.” Id. at 821. Because the plaintiffs’ “claim of standing [was] based on a loss of political power, not loss of any private right,” their asserted injury was not “concrete” for the purposes of Article III standing. . . .

“[T]he authorities appear to hold uniformly that an official’s mere disobedience or flawed execution of a law for which a legislator voted. . . is not an injury in fact for standing purposes. . . . The principal reason for this is that once a bill has become law, a legislator’s interest in seeing that the law is followed is no different from a private citizen’s general interest in proper government. . . .”

Sleep well, now — and know that this nonsense will not end Obamacare. Not a chance. Smile. . . .

On Q1 2016 Merck Vaccines Sales Growth Stories — Market Share… Matters.

May 12, 2016 - Leave a Response

This FiercePharma story has been out for a little over two days.

I generally find that outlet’s reporting to be top notch. I only link to the FiercePharma vaccines item, for a complete record, as I think it suffers from a lack of. . . perspective.

Though closely-guarded as a secret by each of the companies mentioned in the item — in my opinion, market share (the relative position of Kenilworth, compared to the others mentioned, in each vaccine space) explains the bulk of the “trend” described.

That is, one has lots of room to grow at the sales line, when one is a small player — and far less room, when one is nearly the largest, or the largest, player. The more salient question — to my mind — is what’s going on with margins, in each vaccine — by player? That’s my $0.02.

Like Several Of Its Large Peers, Merck Has Received A Civil Investigation Request From US DoJ — Re Pharmacy Benefit Manager Contracts

May 10, 2016 - Leave a Response

Among others, Johnson & Johnson disclosed in its latest SEC filings that it too has received this sort of a civil request. Merck disclosed the request it received in its Q1 2016 SEC Form 10-Q, which filed overnight. It matters greatly that this is a civil as opposed to criminal investigative request — thus presumably, even if it were to turn out badly (which is highly unlikely at this stage), it would not result in debarrment from governmental programs. In general, most government payers expect that they will end up paying at a no worse (nor a better) rate, than a pharma company’s best customers. The trick is in figuring out what that might mean, in actual day-to-day practice, with many many layers of contracting — between the manufacturer (like Merck), and the final buyer.

In the main, it looks like the capable AUSAs in the Southern District of New York are just gathering industry background data (using the big R&D pharma companies as a reference point) — to sort out how pharmacy benefit managers (via these complex contracts) impact the final price a consumer or insurer or government pays for a given drug. [Note that Valeant and Turing are the subjects of much more far reaching versions of these requests — and I think the Valeant ones haven’t yet ruled out a criminal process.] Even so, the focus may well be on the PBMs, and not on these traditional (i.e., non-Valeant, non-Turing) pharma companies, like Merck and J&J, themselves.

In time we shall see — but I would not be too terrribly concerned about it all. Merck has responded to several similar requests in the past decade, and not much came of those. Merck is not Valeant or Turing — that much is clear. In any event, we will watch it — and here is the operative quote from page 19 of the SEC Form 10-Q, filed overnight:

. . . .The Company has received a civil investigative demand from the U.S. Attorney’s Office for the Southern District of New York that requests information relating to the Company’s contracts with, services from and payments to pharmacy benefit managers with respect to Maxalt and Levitra from January 1, 2006 to the present. The Company is cooperating with the investigation. . . .

Onward — we will keep you apprised. Possessed of an increasing (4X!) end of day grin — saw zip for two long days, here. But definitely smiling now. . . .

Might BMS’s Yervoy® Be Useful — To Treat Acute Ebola Sufferers? New Research, In Nature — Points To Hope

May 8, 2016 - Leave a Response

Some startling viral epidemiological life-science news just caught my eye on this sunny Mother’s Day morning. To be sure, we are a long way from a therapy, here — and the cost barrier may be insurmountable (as ipilimumab, a biologic, is very very expensive to manufacture and distribute) — but the finding is well-worthy of note.

A European scientist working with samples of Ebola-infected patients’ blood, from Conakry, Guinea, has shown that those who died from the Ebola virus expressed the protein CTLA-4 in high amounts — not entirely unlike patients who are most at mortality risk — from melanoma.

So, it would stand to reason that a biologic, like Yervoy® (the BMS brand name for ipilimumab) — which takes the brakes off of our immune system, to help fight some cancers — at the CTLA-4 protein site, might be of use — in combating acute cases of Ebola. Since Yervoy is already FDA approved, the path through animal models, and then Phase II/III studies could be expedited. But any therapy (in Africa) will have to address the economics of delivering it, as well.

Just the same, here’s a bit from The Guardian last week, in London (and a link to purchase the article published in the journal Nature) — but do go read The Guardian article, in full:

. . . .Scientists have identified a key feature in the human immune system that determines whether someone will live or die from Ebola. . . .

A study of blood taken four days after the onset of symptoms in 157 patients in Conakry, Guinea, showed that a significantly high level of a protein known as CTLA-4 – which acts as a brake on the immune system response mounted by the body during an acute infection – indicated that a patient would not survive.

The research, published in the journal Nature, found that Ebola survivors had much lower levels of CTLA-4 and generated an Ebola-specific T cell response. . . .

A very long road yet to travel, from Phase I to a working, economically sustainable therapy in humans, but this is quite exciting — and welcome news. Onward, on a joyous Mother’s Day — with love, to one and all!

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