Longer Term (8 to 12 Months Out), ISI Group’s Schoenebaum (Like Almost All On Wall Street) Expects Opdivo® (Nivolumab) To Best Merck’s Pembrolizumab In US And Be Oncology Front Line “Standard Of Care”

July 10, 2014 - Leave a Response

So — while the potential October 28 date at FDA for Merck’s immuno-Anti-PD-1 candidate remains in place (and likely ahead of BMS’s timeline in the US — for melanoma), BMS is swiftly pivoting toward approvals in the US for lung cancer — the bigger market opportunity, by far – and is very likely to garner the first US FDA approval, for that mammoth indication. To speak more plainly, that will render Merck’s candidate quite clearly. . . a second-class citizen, in the most important market, I’m afraid.

This bears much more close watching — but it seems the horse race is now BMS’s to lose. It has the most important lead, here. From Investors’ Business Daily, then:

. . . .Nivolumab, now branded Opdivo, is Bristol’s lead drug in the much-anticipated anti-PD-1 class of cancer fighters and has achieved outstanding results in clinical trials against melanoma when combined with Bristol’s already-launched drug Yervoy. . . .

[ISI's Mark] Schoenebaum added that the combo will probably become the standard of care and overtake Merck’s anti-PD-1 pembrolizumab, which is in process for a melanoma approval perhaps eight months ahead of Opdivo’s. Opdivo is also already on the FDA’s agenda as a treatment for squamous-cell lung cancer and was approved for melanoma three days ago in Japan. . . .

So — if Merck reaches US FDA approval in melanoma first (though as of this morning, there isn’t even an Advisory Committee date on the FDA’s official calendar — for immuno-oncology candidates) — it will likely only be by a few months, as I’ve long held. The bulk of this perhaps $35 billion market opportunity will go to BMS. Just my guess. Do stay tuned.

Dutch Court: Mylan To Pay Merck Damages — For Sales In EU Of Generic Version Of Propecia®?

July 9, 2014 - Leave a Response

This patent litigation has raged hot and cold — including some country by country settlements — since early 2012. In October of this year, the central patent expires on finasteride. [Two of my many older backgrounders -- more generally, on the Merck hair loss drug's travails, here; and here.]

So — Mylan may well end up (at some distant future date) paying infringement royalties to Merck for the 2012 to date sales, at least in the Netherlands. I am sure Mylan will appeal. If it does, it will have to post a bond for at least a portion of the awarded damages. So I expect settlement talks are underway, now. Here is the item — and a bit (do go read it all):

. . . .[The patent] has been the subject of legal proceedings in various countries, with different outcomes:

▲ In the United Kingdom, the Court of Appeal held the patent to be valid.

▲ The German Federal Patent Court invalidated the patent for lack of novelty. On appeal, MSD and Mylan settled the case.

▲ In France, EP 724.444 B1 was held invalid by the first-instance court; the case is now on appeal.

▲ The Spanish first-instance court and the court of appeal invalidated EP 724.444 B1 for lack of inventive step.

▲ In Italy, EP 724.444 B1 was held valid at first instance, and MSD and Mylan settled on appeal. . . .

Do stay tuned. . . we will too. Have an excellent birthday – if today is your special day!

Merck’s Chief HR Officer Nets Over $5 Million In Open Market Sale — Cashless Option Exercise On Monday

July 8, 2014 - Leave a Response

Again (as was true with Mr. Deese last week), this HR EVP’s sale was all dictated by a so called 10b5-1 trading plan, so this doesn’t say much about the executive’s view on Merck’s fortunes or operations.

It just says that she has diversified her holdings — to the tune of $5.2 million. She still has over $5.5 million in Merck equity of various sorts. So, she is still keenly focused, I’d argue.

This automated robo-press-writing algorithm quotes a gross figure, not the net proceeds (and even then, the $5 million is pre-tax):

. . . .Mirian M. Graddick Weir sold 180,047 shares of the company’s stock on the open market in a transaction that occurred on Monday, July 7th. The stock was sold at an average price of $59.16, for a total value of $10,651,580.52. Following the transaction, the insider now directly owns 93,564 shares in the company, valued at approximately $5,535,246. . . .

Nice work — if you can get it.

Leerink Swann Had Merck At $57 Since February 2014 — Now. . . Target Is $60 (But CIti Targets Merck At $57)

July 8, 2014 - Leave a Response

Well, I think the overall message here — as a consensus — is that Merck is pretty nearly “fully valued”.

As the headline indicates, Seamus Fernandez’s firm has a new 12 month target of $60 on Whitehouse Station’s common stock. That’s up only five per cent from the last target — and only a percent or two above today’s NYSE opening price. Significantly, Citi has a 12 month target below today’s price — at $57, though that too was an increase, for Citi.

Last week, during the holiday lull, Barclays (the optimist of the bunch, at the moment!) set $61 as its new 12 month target. [Recall that Barclays inherited the Lehman Bros. analysts -- when the latter firm imploded in 2008.] Still not very much over the current NYSE MRK trading ranges. So it goes.

[BTW, I love that Matt Herper was able to pin Merck down -- on the record -- on the Italian Zetia MD ham-handing. Sometimes, at least, the little guys get. . . heard.]

Is “Sanity Making A Comeback?” Forbes’Matt Herper Says Merck “Regrets” Bullying Italian Doctor

July 7, 2014 - Leave a Response

I’ll — as ever — have more later tonight (after the usual day gig is put to bed). UPDATED 07/08/2014 | 4 PM EDT: I neglected to mention that (in his own updated material) Ed Silverman, an old friend of this blog (for going on seven years now), had the “Merck regrets. . .” lines several hours prior to Matt’s. My apologies! He’s ever vigilant, that Ed. And a true gent!

But my buddy Matt Herper got an apology (of sorts) out of the mouthpieces, up in the puzzle palace, at Whitehouse Station — as just printed in Forbes:

. . . .Merck says that it “regrets” using legal threats to push a leading Italian researcher to muffle his public critiques of one of the company’s cholesterol drugs.

Merck spokesman Steve Cragle writes:

“Merck is committed to the open and transparent exchange of scientific information. We believe this exchange should take place in medical meetings and peer-reviewed scientific publications. We believe this to be an isolated incident in Italy and regret how it was handled by our company. Merck has not taken any legal action in connection with this situation. . . .”

In a phone conversation, Cragle confirmed that the physician could post his arguments about the drug, ezetimibe, on his web site again without fear of legal reprisal coming from Merck. “We wouldn’t take any action against him,” Cragle said. Would the company take any internal action to keep this situation from repeating itself? “We’re certainly reviewing the situation,” Cragle said. . . .

I applaud the quite-egregiously-belated retraction — and wonder whether it would have ever been offered — had The British Medical Journal NOT surfaced this odious brand of MSD Italy strong-arming. And what of Merck’s loss (in court) in the 2004 Vioxx® debacle — in Spain that time, but along much the same lines? Gosh — don’t these folks pass on the learning/battle scar stories? They ought to. Truly. Being able to learn from past mistakes — that’s a hallmark of intelligent leadership. We need to see more of that in evidence, here — especially in the EU.

Filed Under “Told Ya’ So” Dept.: Nivolumab IS First Approved — WORLDWIDE

July 7, 2014 - Leave a Response

MRK-BMS-Nivolumab-App3 But first — the caveats — it is Japan, not the EU or the US. Japan’s market for unresectable melanoma is much smaller than the US or EU. But BMS’s nivolumab (now branded as Opdivo® in Japan, at least) broke quite nicely, here — from the gate. The global horse race is underway, proper.

And it is worth something to be. . . first. With the US FDA accepting a rolling submission on nivolumab — back in April — it is likely that the BMS jacket at FDA is nearly complete, in DC. Approval could come in October, maybe even slightly ahead of Merck — as Merck has an indicated decision date of October 28, here. Per PharmaTimes, then — do go read it all:

. . . .[BMS is] the first company in the world to get an approval for a PD-1 checkpoint inhibitor, as regulators in Japan gave the green light to nivolumab, developed with Bristol-Myers Squibb, as a treatment for melanoma.

The drug will be marketed as Opdivo for unresectable melanoma. . . .

Just a couple of weeks ago, B-MS stopped its Phase III study assessing nivolumab in melanoma after independent regulators found that it showed a superior survival benefit over dacarbazine. It is being studied in multiple tumour types in 35 different trials, notably for non-small cell lung cancer. . . .

So it goes — Whitehouse Station must have been expecting this — but it will be in high gear, now on pembrolizumab, at US FDA from now until its Advisory Committee meeting gets calendared. A huge leap forward in treating many cancers, dawns. . . right here, right now. Heady stuff. Onward!

MSD Italy Using Legal Process — To Stifle Scientific Dissent? Does The Case Of Zetia® Echo. . . That MSD Vioxx®-Era?

July 6, 2014 - Leave a Response

A very dear friend of the blog, online — and in life, since the 1990s — has pointed me to this. If she’ll consent, I’ll give her public credit — via a link to her fine evidence based life sciences blog, right here. [Hint Hint.] Now, on with. . . the show!

It seems that (in an eerie echo of the 2002 to 2004 Vioxx® era spats) a local Italian MSD affiliate has threatened a recalcitrant academic with a lawsuit, to end his advocacy about the clinical outcomes benefit (or lack thereof) of Zetia® (ezetimibe). Of course, the global scientific debate about that has been raging since 2006 at least. So this seems just a little bit over the top. Doubly so, if one believes that some time in December of this year, we may finally learn whether Zetia with a statin, called Vytorin® (in IMPROVE-IT) is showing any real clinical outcomes benefit — for some 32,000 cholesterol management patients, worldwide. [That is to say, the proverbial fat lady is clearing her throat now, at least. And, as in Vioxx, Merck may end up eating quite a bit of crow, if as many now suspect -- IMPROVE-IT actually generates a null-result. See count-down clock, at left margin of the main site.]

Here (do go read it all!) is The British Medical Journal, on it — just published July 4, 2014:

. . . .The Italian branch of the drug company Merck Sharp and Dohme (MSD) has stopped a leading public health doctor and administrator from circulating texts to GPs advising them about the use of one of the company’s drugs.

In the texts, Alberto Donzelli—the head of education, appropriateness, and evidence based medicine at the public health authority of Milan (Milan Healthcare)—had analysed the published evidence on the cholesterol lowering drug ezetimibe and discouraged its prescription in addition to statins.

A letter telling Donzelli to “cease and desist” was sent in February by MSD’s medical director, Patrizia Nardini, and was cosigned by the company’s director of legal affairs. They accused Donzelli of serious misconduct and a breach of medical ethics and threatened to sue him and Milan Healthcare for as much as €1.3m (£1m; $1.78m). The letter was addressed to Donzelli, with a copy sent to Milan Healthcare’s director general and to the president of the Order of Physicians of Milan (the doctors’ regulatory body), Roberto Carlo Rossi. . . .

Enjoy those last few beach-side open fired S’Mores. . . I know I will. And thanks, Marilyn!

And — The Earlier (VIOXX®) Version — Which MSD Lost, For Background

July 6, 2014 - Leave a Response

Oddly, I had it in mind that I had previously covered this little Vioxx® kerfluffle. But it appears I hadn’t, so here is that background — as a historical reference companion — to my post of this holiday Sunday morning, over coffee, orange juice and a banana.

Here is the much earlier 2004 CMAJ original — as a PDF item — and a bit:

. . . .The debate about the safety of cyclo-oxygenase 2 (COX-2) selective inhibitor drugs reignited in February [2004] when a Spanish court rejected a lawsuit brought by the pharmaceutical company Merck, Sharpe & Dohme (MSD) against the editor and publisher of Spain’s independent drug bulletin, Butlletí Groc. The company sued over a July 2002 article entitled “The so-called advantages of celecoxib and rofecoxib: scientific fraud.” The article drew on previously published commentaries in BMJ (2002;324:1287-8) and The Lancet (2002;360:100-1), which slammed the organization and interpretation of 2 pivotal studies on the safety of rofecoxib (Vioxx) and celecoxib (Celebrex) in comparison with nonselective nonsteroidal antiinflammatory drugs (NSAIDs). . . .

The manufacturer of rofecoxib used Spain’s laws on “rectification” to ask the bulletin to print a retraction it had drafted. When the bulletin’s publisher, the Catalan Institute of Pharmacology, refused, the company took legal action. In February, the Madrid court rejected this demand and ordered MSD to pay court costs. . . .

Suing to stop the sort of debate that plays out on the editors’ pages of medical journals — even ones wrongly-perceived to be of lesser import — seems like a recipe for disaster. Even if Merck wins — it loses. The courts of law are no place to work out competing scientific claims, of this sort. That is the province of jousting journal editorial pages. Heh.

In today’s case, moreover, Merck appears to try to stop scientific debate — in the name of protecting commerce. You may well recall that, in the end, Merck withdrew Vioxx. And I suspect, in the end, IMPROVE-IT will look very much like a null result — making the critical texts of Dr. Alberto Donzelli absolutely libel-proof — truth being an absolute defense here. So — the whole episode strikes me as unusually not well-thought through, by MSD Italy. That’s my $0.02.

[And now, as a house-keeping matter, I'll move this one under the lead for the day -- as it is historical background primarily.]

New York Times Front Page “Woodshed Session” For Vaccine Makers — Mostly Pfizer; But Some Merck Too

July 3, 2014 - Leave a Response

Some may recall that back in December 2010, on an exclusive basis, we provided much similar analysis, even predicting rapidly rising prices — as a result of Merck’s decision not to resume production of Attenuvax® (Measles Virus Vaccine Live), Mumpsvax® (Mumps Virus Vaccine Live), and Meruvax® II (Rubella Virus Vaccine Live).

Pfizer has taken the Merck crash-course, and amplified its object lesson. By reformulating single old-school vaccines — into fixed combinations of three or more (and correlatively, grown up in higher efficiency meida environments) — Pfizer has rendered its (and others’) older vaccines obsolete. Actually designed the obsolesence. [There is no evidence that the combos are significantly safer or more effective than the old school singles.]

And Pfizer has engaged in significant pricing “touch-ups”. Repeatedly.

So much so that now many government payers cannot afford to fully reimburse the combo-vaccines’ cost — to the providers of it. And still parents of limited means are not allowed to enroll their children this fall without them. That is a national health disgrace — in the richest nation on Earth. Pfizer’s vaccine combos are not that much more expensive to produce. This is simply a monopolists’ standard state of affairs. I’ll hush now — do read the New York Times on it all — but here’s a bit:

. . . .[Fixed combinaiton vaccine] prices have gone from single digits to sometimes triple digits in the last two decades, creating dilemmas for doctors and their patients as well as straining public health budgets. Here in San Antonio and elsewhere, some doctors have stopped offering immunizations because they say they cannot afford to buy these potentially lifesaving preventive treatments that insurers often reimburse poorly, sometimes even at a loss. . . .

Childhood immunizations are so vital to public health that the Affordable Care Act mandates their coverage at no out-of-pocket cost and they are generally required for school entry. Once a loss leader for manufacturers, because they are often more expensive to produce than conventional drugs, vaccines now can be very profitable. . . .

I might note that Pfizer has been more magnanimous and charitable with vaccines in Africa, than at home.

These are challenging times, indeed — and pharma should be allowed to reap a fair profit. But it does seem a tad irresponsible and unpatriotic — to leave the neediest American families holding the bag — just so that Pfizer can book another $5 billion in combo vaccine sales this fall. Just a touch. Unpatriotic. Ponder that as you watch your fireworks, tomorrow. Be excellent to one anotehr.

Small PSA Dept: If You’ve Filed A Fosmax® Claim — Especially YOU: Kathy Herring, And Sheila Ann Rahey — Check In With Your Lawyer

July 3, 2014 - Leave a Response

As long as we are sweeping up around the old joint — for the long (mothballed-machinery style) weekend — on most matters alendronate sodium (branded as the osteoporosis drug Fosamax®), I’ll encourage the people who haven’t done so recently to check in with their lawyers.

The two people mentioned above are likely Minnesota residents, and have gone missing according to their lawyers. And so, their cases may be adversely affected by the entry of a Lone Pine order shortly — if they do not turn up. This PSA is applicable to perhaps two dozen other similarly situated claimants. If your lawyer cannot reach you, or you haven’t checked in with your lawyer in the last year, and your medical expert papers are not yet available — or are not in order — and/or you are making an “atypical” claim, your case may get dismissed due to your own non-responsiveness. See this non-opposition motion, as typical of the non-responder group:

. . . .Pursuant to the Court’s Order of June 9, 2014 (Doc. No. 1666), Plaintiffs Kathy Herring and Sheila Ann Rahey, by and through their counsel, hereby respond to Merck’s Third Motion for Entry of a Lone Pine Order. . . .

Plaintiffs’ counsel has been unable to contact Plaintiffs Kathy Herring and Sheila Ann Rahey. See Declaration of Charles H. Johnson, dated June 27, 2014. Counsel for Plaintiffs takes no position on Merck’s Motion for Entry of a Lone Pine Order. Counsel for Plaintiffs will continue to try to reach Plaintiffs Kathy Herring and Sheila Ann Rahey. . . .

If you know either of these two — let them know, and tell them to call their lawyer, Charles H. Johnson of New Brighton, Minnesota [he's definitely listed in the white pages -- and the yellow ones(!)]. Now, if you are traveling for the long holiday weekend — please be safe — and have yourself a great adventure!

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