Merck Gets EU Nod In Melanoma; BMS’s Opdivo® Already On Market There

July 22, 2015 - Leave a Response

This is great news for Kenilworth, now adding the 28 member states of the EU to Canada — and the US — as approved Keytruda® geographical sales channels.

Yes, Opdivo® is already there — and yes, BMS is a year ahead, in the larger burden NSCLC (lung cancer), and renal cell cancer races. But having options is an extremely important development, for the patients, and the payers. Now there is the real possibility that Merck will ultimately engage in price competition, against BMS — to “win market share” in melanoma in the EU. And that will benefit both payers and patients.

[I suppose I should note that Keytruda was compared in these studies to BMS’s last generation therapy — not head to head, against Opdivo.] in any event, from the early morning presser, then:

. . . .”Today’s European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We believe that the broad data set supporting this approval helps illustrate the significant potential of KEYTRUDA to treat advanced melanoma, a devastating disease.”

“Merck has long-believed that innovation and access must go hand-in-hand, which is why we work to bring forward new innovations, and ensure access to those innovations,” said Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology. “Merck is committed to working collaboratively with governments and other stakeholders to ensure that KEYTRUDA will be made available to advanced melanoma patients in Europe as rapidly as possible. . . .”

And so, onward we forge, in the race to improve lives of cancer patients the world over. [Planetary science side note: A new range of Appalachian-sized mountains was just revealed in the Southwestern “Heart of Pluto”. New images at NASA — thrilling!]

US Judge Shadur: “Counsel For Merck And Bayer — Meet Me At The Woodshed” And. . . “Don’t Charge Merck For The Avelox® Rework!”

July 21, 2015 - Leave a Response

Well, first things first — Senior federal District Court Judge Milton I. Shadur is a very able jurist — and widely respected, here in Chicago — for being very precise in his handling of courtroom decorum and practice, under the federal rules. And so — this opinion will forever endear him to believers in plain English pleading (like myself).

Whether the plaintiffs here, Mr. and Mrs. Hobbs, have a good Avelox® products liability case is unclear, at this stage. What is clear is that the Hobbbs’ claim permanent nerve damage from being prescribed Avelox, or a companion antibiotic. Under the federal rules, then, they should be given notice of whether Merck feels it has responsibility here, in Merck’s Answer. After some 150 pages, Judge Shadur could not tell. And he’s a very sharp man — so he told Merck’s lawyer to pay a $200 fine, and redo the entire Answer, free of charge — and, this time, more faithfully comply with the federal rules for notice pleadings. Ouch. Here’s a bit, of this priceless opinion (and the full 6 page PDF):

. . . .After all, because the real function of federal notice pleading is to identify the respects in which litigants are or are not at odds with each other, it is really thoughtless on the part of defense counsel to thrust on their adversaries and the judicial officer to whom the case is assigned the task of wading through two separate Answers, occupying just under 150 pages instead of half that number, to become informed as to any respects in which jointly represented parties are or are not on the same page and the way (if any) in which they differ. . . .

It is of course oxymoronic for a party to assert (presumably in good faith) that it lacks even enough information to form a belief as to the truth of an allegation, then proceed to deny it. Because such a denial is at odds with the pleader’s obligations under Rule 11(b), that quoted language must be and is stricken from each of those paragraphs of the Answer. . . .

That then leaves for discussion the true absurdity of the vast proliferation of supposed Affirmative Defenses (“ADs”). In that respect defense counsel are first referred to App’x ¶ 5 to State Farm. But that is only the beginning, for what each pleading sets out under the caption “Separate Defenses” reveals a total misconception of what the pleading of ADs is about. . . .
Both of the current Answers (including their ADs) are stricken in their entirety, with defense counsel being granted leave to file a single combined Amended Answer on behalf of both Bayer and Merck on or before August 7, 2015. Any ADs that are included in that joint Amended Answer must conform to the limitations ordered in this opinion. And lastly, no charge may be made to Bayer or Merck by their counsel for the added work and expense incurred in correcting counsel’s errors. Defense counsel are ordered to apprise their clients to that effect by letters, with copies to be transmitted to this Court’s chambers as an informational matter (not for filing). . . .

Gosh — that is about as tough as I’ve ever seen him be. [And here’s the Hobbs’ 29 page complaint at law, for reference.] Onward.

Kenilworth Spends $1.85 Million On Lobbying, In Q2 2015 — Or $4.155 Million In First Half Of 2015

July 21, 2015 - Leave a Response

The trend had been toward reduced spending, on lobbying (2013 to 2014, full years) — and that was probably net-net, a pretty good thing. But now, as a new US Presidential (primary) election cycle gears up — so too does the lobby spend, at Merck — it would seem.

For the full first half year of 2014 (last year), Merck spent $3.75 million — and only $1.33 million in the second quarter of 2014, both of which were sharp reductions from 2013 levels. Here is the detailed list (but see graphic at right for trend-line):

. . . .340B (no specific bill), Oncology education (no specific bill), adult vaccine policies (no specific bill), adolescent vaccine policies (no specific bill), DISARM (H.R. 4187), ACA Implementation (no specific bill), biosimilars (no specific bill), 21st Century Cures (H.R.6), FDA Regulatory Issues (no specific bill), general pharmaceutical industry issues, Senate HELP Innovation Draft (no bill number). . . .

Comprehensive tax reform (no specific bill), orphan drug tax credit (S.1128), R&D tax credit (no specific bill), base erosion (no specific bill), territorial tax system (no specific bill). . . .

Medicare Part D (general education, no specific bill), changes to low-income subsidy structure in Medicare Part D (general education, no specific bill), sustainable growth rate (H.R. 2, the Medicare Access and CHIP Reauthorization Act), Medicare Part B (general education, no specific bill), Preserving the Integrity of Medicare Act (H.R. 5780). . . .

Intellectual property (general education), patent reform (H.R. 9, the Innovation Act; S.632, the STRONG Patents Act). . . .

These are the matters upon which Merck itself reported having lobbied Congress from April 1 through June 30 of this year — but that is not an all-inclusive list of the issues for which it hired lobby firms. Now you know — nope; nothing to hide here.

At Some Point — In The Last 60 Days. . . Too Distracted. . .

July 20, 2015 - 4 Responses

We had our millionth visitor, here. Sweet. Thank you, one and all!

MRK-One-Mil-Visits-2015
I admit I was plainly too distracted to notice, precisely, who or when — but it looks as though the 1,000,000th visitor was an EU dweller. Excellent.

Again, thank you one and all. Onward.

BMS Lands Squamous Non-Small Cell Lung Cancer Approval For Nivolumab: 28 EU Member States

July 20, 2015 - Leave a Response

This particular mid-July Monday is chock full of good immuno-oncology news for Bristol Myers Squibb, it seems.

BMS just announced that the EU has cleared Opdivo®, in a particularly wide array of lung cancers, opening a vast market to the franchise — based on some other CheckMate series study results. Earlier this morning, BMS stopped the CheckMate -25 study early, due to superior efficacy over standard course, in certain renal cancers. Now — at least inside the US — we may safely bet that some oncologists will start writing off-label, for these other cancers — relying on the data just cleared by the EMEA arm. But the meta-narrative here continues to be that Merck is at least a year behind BMS now, in several cancers, in the EU.

Here is a quote from the press release:

. . . .”With the EU approval of nivolumab, patients in Europe have for the first time in more than ten years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care,” said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb. “Bristol-Myers Squibb is passionate about changing survival expectations and the way patients live with advanced cancers, and is committed to continually deliver, with speed and urgency, new approaches to pursue this goal.”

Approval is based on the results of CheckMate -017 and -063. In the Phase III CheckMate -017 study, nivolumab demonstrated superior clinical benefit across all endpoints versus docetaxel, the standard of care, regardless of PD-L1 (programmed death ligand-1) expression status, including a 41% reduction in the risk of death, significantly superior OS rate of 42% versus 24% for docetaxel at one-year and superior durable antitumor activity. In the Phase II CheckMate -063 study, nivolumab showed an estimated 41% one-year survival rate and a median OS of 8.2 months. The safety profile of nivolumab is consistent with previously-reported trials, and in Checkmate -017, is also favorable compared to docetaxel. . . .

Perfect. . . . and. . . I must say, just as we repeatedly predicted. Onward.

BMS’s Opdivo® Posts A Solid 12 Month Lead, In Metastatic Renal Cell Carcinoma, Over Merck’s Keytruda®: Immuno-Oncology Race

July 20, 2015 - Leave a Response

This is materially good news for Bristol-Myers. It very-likely gives the Opdivo® franchise yet another high burden cancer in which it will hold a one to two year advantage over Merck’s competing Anti-PD L1 candidate. This CheckMate study (one in a series of like-named studies, in other cancers) was stopped early because the advantage was so clear, over existing options.

I would exepct that BMS will file with FDA on this data before year end — and get clearance for renal cell carcinoma in late Q1 2016. We are seeing the face of oncology transform, and mature, overnight here. This is a $35 billion set of treatments, across all the cancers in which the BMS (and Merck) emerging offerings are likely to be of material benefit. A heady time, indeed. Here’s a bit from the presser:

. . . .BMS announced that an open-label, randomized Phase III study evaluating Opdivo (nivolumab) versus everolimus in previously-treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.

“The results of CheckMate -025 mark the first time an Immuno-Oncology agent has demonstrated a survival advantage in advanced renal cell carcinoma, a patient group that currently has limited treatment options,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival. . . .”

We have been following this race for two years solidly, now. The most recent June 2015 background is here. And. . . that’s a perfect start, on this hot, moist July Monday — so. . . onward, friends!

No Cause For Alarm — But European Medicines Agency Post-Hoc Review Of HPV Vaccines Announced This Past Week

July 18, 2015 - Leave a Response

The EMEA stresses that the safety and efficacy of the vaccine is considered well established, but that it is monitoring for relatively rare adverse events — and collecting data, from multiple manufacturers.

Here’s a bit from the press release:

. . . .As for all licensed medicines the safety of these vaccines is monitored by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). The current review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness).

Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established. Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected.

In its review the PRAC will consider the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the Committee will decide whether to recommend any changes to product information to better inform patients and healthcare professionals. While the review is ongoing there is no change in recommendations for the use of the vaccine. . . .

Onward.

O/T: Sputnik Planum — On Pluto — One Of Thousands Of Selfies, To Come. . . Words Don’t Suffice

July 17, 2015 - Leave a Response

Great briefing just now, from NASA. Have a great weekend, one and all. I’m out!

Can You Be A “Senior Advisor” To House Majority Leader Rep. Eric Cantor (R), AND Work For Williams & Jensen, PLLC — As A PharmaCo Lobbyist?

July 16, 2015 - Leave a Response

Apparently so. Take a look at the penultimate page of that link. It was just filed with the US Senate office of disclosure — under the Lobbying Disclosure Act — this morning. Cheryl Jaeger is. . . “a shared employee, Office of the Speaker and Office of Virginia’s Seventh Congressional District; Senior Policy Advisor, Majority Leader, Rep. Eric Cantor; Sr. Advisor, Majority Whip, Rep Roy Blunt; Prof. Staff House Committee on E&C; Sr LA to Rep. Christopher Cox. . . .

I wouldn’t have guessed that the applicable federal lobbying laws and regulations allowed this. Dual or “shared employees?” Really? I am no lobbyist regulatory lawyer, but it strikes me that allowing Williams & Jensen to lobby Congress, and Rep. Cantor, in particular, on behalf of Kenilworth, and others. . . isn’t in the best interest of the citizenry — or an open and transparent republic — with the sole consent of the governed. Perhaps she is prevented (by rule) from lobbying any of the persons named above, directly. In any event, here is her bio — from a coming Fall 2015 speaking engagement (presumably it is thus current, and correct) — and yet no mention of the lobby-firm involvement. But the LD-2 filed by Williams & Jensen lists her. Odd.

. . . .Cheryl Jaeger is the senior health policy advisor to the Majority Leader of the U.S. House of Representatives, Eric Cantor. In this role, She leads the advancement of health care reform legislation to improve patient choice, lower health care costs, and expand innovation. Jaeger previously served as a senior advisor to the former Majority Whip Roy Blunt. Prior to serving as a leadership aide, Jaeger worked as a professional staff member for the Committee on Energy and Commerce. She was the lead staff negotiator of the NIH Reform Act of 2006 in addition to several other pieces of legislation. Jaeger began her tenure on Capitol Hill nearly 14 years ago as a legislative aide to former Congressman Christopher Cox. Jaeger earned a Masters in Public Policy from Georgetown University and is a graduate of the University of Virginia. . . .

I’ll have more on this — when the rest of the quarterly federal LD-2 lobby reports are filed — in the coming five days, but it sure doesn’t smell. . . quite as fresh as a Summer rain, to me. . . .

Maybe someone in the readership better understands lobby lawyering here — is this relatively common, across other industries? Am I just out of touch, on this issue?

Much Sadder News — From Africa — Our Cradle: Now Six New Ebola Cases In Liberia; Two More Deaths

July 16, 2015 - Leave a Response

From the truly transcendent and joyous news of yesterday — a space odyssey, likely some two million years after homo habilis first wandered about in Eastern Africa — to far sadder developments, in the state of affairs, in Paynesville, Liberia — this morning. We (as a planet) need to better protect our own cradle, people.

The story: yet another of the latest six patients, in the post May 2015 re-appearance of the Ebola virus, has died. This makes NewLink/Merck’s effort to prove out an effective safe vaccine all the more urgent — per The Gray Lady, herself, then — a bit:

. . . .Even though her name was on a contact list, monitors at first failed to detect that the woman had become symptomatic, according to Tolbert Nyenswah, a deputy minister who heads Liberia’s Ebola response system.

The woman, who was the sixth Liberian to become infected since May 9, was being quarantined in her family home in Paynesville, a city on the edge of Monrovia. Another member of the household who had been infected was removed from the home earlier. According to the health officials, all six of the Ebola patients were part of the same cluster as a 17-year-old man whose body tested positive for the virus before he was buried in another community a short distance from Liberia’s international airport.

According to health care workers, people whose names are on the contact list and are under quarantine are supposed to be visited daily by monitors who take their temperature and assess their health. Mr. Nyenswah said the woman had reportedly taken medicine to suppress her fever, and he ordered an investigation to determine “what went wrong with this case that somebody was on a contact list, that they were not picked up immediately.” He said monitors were being retrained to assess each contact’s overall condition.

“She was home, and the home was being monitored,” Mr. Nyenswah said. “People should not panic and be afraid”. . . .

It was July first when last we mentioned this unfolding human tragedy. If we can hit a 100 by 150 kilometer box, from three billion miles out, and do so over a period of nine plus years, and then retrieve the data at a KB a second, henceforth. . . we simply must find the will (and economic and scientific ability) to vaccinate the people living in poverty in our own cradle, against this dread curse. To do any less would be. . . inhumane.

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