Merck’s EU Simponi® Marketing Rights — Likely Slightly More Valuable Now, With New (nr-axial SpA) Indication Pending

May 26, 2015 - Leave a Response

It seems that Kenilworth is likely to receive an expanded label for Simponi® — the therapy that Merck still controls marketing rights (from J&J) for, via an arbitration settlement out of the Schering-Plough transaction — in Europe, but not the US.

CHMP granted a thumbs up to an expanded nr-axial SpA indication, which supplements a number of existing indications in rheumatology and gastroenterology. That’s some good news for Merck. From the press release then, a bit:

. . . .Merck today announced that SIMPONI (golimumab) has received CHMP positive opinion for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Once the EU commission issues their EC decision, and if approved, nr-axial SpA patients can be considered for the once-monthly subcutaneous injection with SIMPONI (golimumab).

The CHMP positive opinion was based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with golimumab, compared with patients treated with placebo, over 16 weeks. . . .

And so — onward we go.

Early Head Start Funding: Improving Life-Long Health Outcomes, As Well

May 25, 2015 - Leave a Response

On Memorial Day 2015, I choose to reprint, in full, a blog post from our current U.S. Secretary of Health and Human Services — Sylvia Mathews Burwell — who was herself an Early Head Start kid.

For reasons I’ll not detail — and keep private — here, Early Head Start is one of my pet projects. I think it the most sensible investment we, as a society, can make in our own future. So here she is — from about a week ago:

. . . .Fifty years ago today, Head Start was launched across the nation. At the announcement in the White House Rose Garden, President Johnson called it “one of the most constructive, and one of the most sensible, and also one of the most exciting programs that this Nation has ever undertaken.”

A few years later, a class was established in my home town of Hinton, West Virginia.

In a rural town like Hinton, Head Start was one of the only early educational opportunities available. It meant a lot to the families there and still does today. I know, because it meant a lot to my family.

That’s right; I’m a Head Start kid.

In that little classroom, I hatched chickens, listened to stories, and made lifelong friends. Thanks to Head Start, and an excellent teacher, Mrs. Rita Pack, I learned to love learning, and that passion has stayed with me my entire life.

I did get a head start, and that’s a foundation all children should have.

Head Start was founded on the principles that education is the door to opportunity, and that everyone, no matter their background, deserves a shot at a productive life.

Since it was founded in the summer of 1965, Head Start, along with Early Head Start, has served more than 32 million children. This year alone, those programs will help more than 1 million children prepare for school and build a foundation for a healthier, happier life.

But this work doesn’t just help children; it strengthens families and our entire community.

Parents are powerful partners, and as the original multi-generation program, Head Start helps them create and implement family strategies and supports their ability to work.

It also has a long history of supporting the field of early learning. Using the best and latest developmental science and research, Head Start provides guidance on best-practices and promotes excellence in teaching.

Stronger students, families, and teachers have an impact on all of us. A Rand research brief found that high quality early childhood interventions generate a return to society ranging from $1.80 to $17.07 for each dollar spent.

And Head Start continues to grow and improve.

We recently awarded the last of the $500 million Congress budgeted for new Early Head Start-Child Care Partnership grants, adding up to 275 new grants. Those grants will serve over 30,000 new Early Head Start children.

In the coming month, we will issue the revised Head Start Performance Standards for public comment. These standards are rooted in evidence-based research and will improve classroom quality and program transparency. We also think they will make it a little easier to manage programs by eliminating out-of-date requirements.

As we look to the next 50 years and beyond, we can see that the need for Head Start is greater than ever.

Today, more than 16 million children in the United States – 22 percent of all children – live in families with incomes below the federal poverty level. And that includes a disproportionate number of children of color: nearly 40 percent of black children and 35 percent of Hispanic children. With the struggles that families in poverty face, less than half of these children go to school prepared with the skills they need to be ready to learn and they are 10 times as likely to drop out of high school.

In light of these facts, and as we celebrate this historic milestone, now is the time to rededicate ourselves to ensuring all children have the resources they need and deserve.

Early education is a top priority for this administration. That’s why President Obama’s budget requests over $10 billion to provide more children with more intensive high-quality Head Start services. Unfortunately, the Republican budget resolution would cut funding, closing off access to these important services for tens of thousands of children. We believe that ensuring America’s children have a strong foundation no matter where they come from is essential to our nation’s future, and we will continue to push for services that give children opportunities for success.

President Kennedy said, “Children are the world’s most valuable resource and its best hope for the future.” There is no better investment we can make than investing in the minds of our children, and with Head Start and Early Head Start, we know our returns will be great. . . .

Onward — and thanks, to all the Mrs. Rita Packs out there, today. So too, thanks, from the bottom of my heart — to all those living and dead, who have served our nation. You have preserved my freedoms, and the very lives — of my family. So, thank you, one and all.

“A Beautiful Mind” Makes His Return, To The Infinite — Near Monroe Township, New Jersey

May 24, 2015 - Leave a Response

I’ll readily admit it. The story of a troubled genius — almost any troubled genius — always captivates me.

John Nash, however, was in a league of his very own, in this regard. He was possessed of a quintessentially opaque but undeniably transcendent mind, for much of his mid-life. This small blue orb will miss his originality of insight, and yes, those demons who haunted him, even in his latter days, in more subtle ways. Here is a fine Bloomberg bit on his passing:

. . . .John Nash, the Princeton University mathematician and Nobel laureate whose towering intellect and descent into paranoid schizophrenia formed the basis of the Academy Award-winning movie “A Beautiful Mind,” has died. He was 86. [Image at right derived from a photo by Peter Badge.]

Nash and his wife, Alicia, were killed in an auto crash on the New Jersey Turnpike Saturday afternoon, New Jersey State Police Sergeant Gregory Williams said Sunday.

The Royal Swedish Academy of Sciences awarded the 1994 Nobel Prize in economics to Nash, John Harsanyi of the University of California-Berkeley and Reinhard Selten of the University of Bonn in Germany for their work in game theory, which seeks to understand how people, governments and companies cooperate and compete. . . .

Nash was honored for his early insights, still widely used in economics, into how rivals shift or maintain strategies and allegiances. The Nash Equilibrium describes the moment when all parties are pursuing their best-case scenario and wouldn’t change course even if a rival does. It has been widely applied to matters including military face-offs, industrial price wars and labor negotiations. . . .

. . .Nash, beginning in his early 30s, battled paranoid schizophrenia. . . the mental disorder derailed his academic career. . . .

After stays in psychiatric hospitals and a period wandering around Europe, he returned to Princeton and “became the Phantom of Fine Hall, a mute figure who scribbled strange equations on blackboards in the mathematics building and searched anxiously for secret messages in numbers. . . .”

In his autobiographical piece for the Nobel Foundation, Nash reported “thinking rationally again in the style that is characteristic of scientists,” though he said rational thought had a downside, since it “imposes a limit on a person’s concept of his relation to the cosmos. . . .”

Have a great ride now, John Forbes Nash, Jr. — the Infinite is again calling to you — but this time, it is bringing you, and your beloved, home. . .

“Equal Time” Update: This Is Why I Said The Pregnancy/Gender Case Would Be A Close Call

May 23, 2015 - Leave a Response

Late last evening, after Merck concluded its defense in the case, it filed a renewed motion for judgment as a matter of law. I attach the full 38 page brief, a PDF file, which sets forth Merck’s argument — to be let out of the case, right now.

What it all boils down to in my view, is that Merck says was undergoing a reorganization — and determined that no internal candidate was qualified for the position the plaintiff sought, upon return from her most recent pregnancy leave (Merck also decided against an internal Merck-employed male candidate, as being not qualified).

And so, Merck ultimately hired another woman for the position, from outside the company, who also happened to have multiple children. Do read the last nine pages, or so, for yourself. I felt it was only fair to provide it here, since I quoted Judge Chesler’s recitation of Mr. Scalet’s statements (each quite favorable to the plaintiff), earlier this week. So, we shall wait and see.

For this particular writer, though, there is nothing more. . . mystical, sublime and alluring, than a woman bearing new life — and with the growth, continuing our millions of years of evolution, in a serene form of endless symbiosis. So, onward, we forge. . . . smile.

New Patent Interference Suit Filed In Delaware Federal Court Overnight — Idenix, For Merck

May 23, 2015 - Leave a Response

In the ongoing, potentially multi-billion dollar patent war — over Sovaldi® — Merck’s proxy, Idenix, has filed yet another new lawsuit, overnight.

This one seeks a determination on patent interference, alleging that the patent authorities entered an erroneous earlier decision in favor of the entities and inventors now controlled by Gilead. Near as I can tell, the patent authorities relied, without prejudice, on a Canadian determination which is at the heart of Merck/Idenix’s claim of error. Merck seeks a declaration that it (through Idenix) owns the patentable invention here. So on we go. Here is the entire 14 page complaint (a PDF file), and a bit:

. . . .Pursuant to 35 U.S.C. §146, Plaintiffs have elected to file suit in this Court to review and reverse the PTAB’s decisions and Judgment and to decide all issues relating to the ’981 Interference. As of this date, Plaintiffs have not sought review of the PTAB’s Decisions by the United States Court of Appeals for the Federal Circuit. . . .

The PTAB erred in its decisions in the interference, including in rulings in the Motions Decision and the PTAB’s January 21, 2014, January 28, 2014, and February 27, 2014 Orders. . . .

The PTAB’s decisions, rulings and Judgment in the ’981 Interference are erroneous and, based on the record before the PTAB and any additional evidence Plaintiffs may introduce in this action, Plaintiffs are entitled to judgment correcting the erroneous decisions and Judgment of the PTAB. . . .

A jury trial has been demanded. We will keep you informed.

Small Update On May 20, 2015 Propecia® MDL Status Hearing — Eastern District Of NY

May 23, 2015 - Leave a Response

I am sorry (for all my commenters keenly interested in the topic) — but the PACER electronic record provides no additional color. [Backgrounder.] Here it is:

. . . .1. The parties provided updates on their negotiations concerning revisions to the discovery schedule and trial plan as well as the preparation of Defendants’ Fact Sheets; they expect to either reach a resolution or seek a decision from the court shortly.

2. The parties are encountering further issues concerning the defendants’ assertion of privilege, and advise that the court’s review and decision with respect to the documents that have been submitted for in camera review will assist them in determining what challenges to make in the future.

3. The plaintiffs will be required to make a motion to compel a non-party to comply with a subpoena.

Any such motion is to be made promptly and if supported by sufficient evidence that the subpoena was properly served the court will issue an order to show cause to the recalcitrant witness at a hearing to be held on June 19, 2015 at 11:00 a.m.

4. The next status conference will be held on June 19, 2015 at 11:00 a.m. . . .

So now we wait for June 19, 2015. Onward.

BMS’s Opdivo® Gets “Thumbs Up” — In NSCLC, In The EU; Already Has It For Melanoma

May 22, 2015 - Leave a Response

Merck reported some good news this morning: Keytruda® has the same provisional “thumbs up” from the EU’s regulator now for melanoma, as Opdivo® received in April of 2015.

BMS reports overnight that it now has the much much larger “thumbs up” for lung cancers — from the same regulator. So, again — BMS is likely 12 to 16 months ahead of Kenilworth, here. From Yahoo! News UK, a bit:

. . . .BMS today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that nivolumab, a PD-1 immune checkpoint inhibitor, be granted approval for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). . . .

We will keep you posted. Of course, this is also good news for Merck — it is just better news for BMS. This race is now officially in high gear. Here is my earlier backgrounder on it all.

The Agenda — For Yesterday’s Court-Ordered Status Conference — Propecia® MDL, In E.D., NY

May 21, 2015 - Leave a Response

I will report as soon as a minute order is entered in the electronic files, related to the below status conference (held before the very able Judge John Gleeson), of yesterday.

As you might readily discern, discussions continue between Merck and the plaintiffs’ lawyers about the privilege logs, and the summaries related to the underlying documents, requested in discovery some months back. Here is the item, in full:

. . . .The parties jointly submit the following agenda for this Court’s May 20, 2015 Status Conference.

1. Update on negotiations of proposed trial plan and request that DFS motion be tabled;

2. Update on status of privilege negotiations;

3. Update on status of third party production and likely motion to compel; and

4. Schedule the next status conference.

Dated: May 19, 2015. . . .

As ever, we will keep our readership informed, as several anonymous commenters are apparently keenly interested in this piece of federal multi-district mass-tort litigation. The plaintiffs claim an inadequately-warned about — but elevated — risk of sexual dysfunction side effects (in men) resulted from use of this baldness treatment, among other matters. More background, here, from New Year’s Day 2015. [And see the comments — to this one.]

Merck Has Been On Trial, In Federal Court In New Jersey, Since April 27, 2015

May 20, 2015 - Leave a Response

‘Lo these past almost four years, I have been quite circumspect about opining upon, or even covering, these gender and pregnancy discrimination allegations, for a host of reasons. Honestly one of those reasons had to do with Merck’s generally stellar record on these fronts (especially as compared to that of legacy Schering-Plough).

But as of last week, the mainstream legal media (AmLaw and Law360) were reporting (approvingly) on Merck’s motion for judgment as a matter of law, at the close of the plaintiffs’ case. It has now taken almost three full weeks of trial — to reach the end of the plaintiffs’ evidence. And last week, Merck essentially said “even if every bit of that is true. . . so what?” The plaintiffs have not — as a matter of law — made out a good discrimination claim, according to Merck’s legal team — on gender or pregnancy status.

Let’s take a moment here then — and look back. Back in 2012, the very able Judge Stanley Chesler ruled that the plaintiffs possessed enough evidence to proceed to trial. Here is a bit from that, in late in 2012 (just to balance-off the legal MSM reporting, of last week):

“. . . .While this might appear to be a smoking gun statement, it is not. According to the interrogatory, this statement was in regard to the position of Interim VP Global OE position, and not the VP Global OE position. As Defendants note, Plaintiff has expressly abandoned any claim for failure to hire for the Interim VP Global OE position, and the claim for failure to promote concerns only the VP Global OE position. Nonetheless, this evidence is probative of the proposition that Scalet considered Plaintiff’s maternity leave to be an important factor in making decisions about her employment – and, more importantly, a negative factor. . . .”

I will confidently predict that Judge Chelser will not grant Merck’s motion above. In fact, he won’t rule prior to mid-June on it. So, Merck is presently putting on its defense. That could take a week or more. We will keep you informed. I do expect that this will be a very close case — and the outcome is (in my opinion) far from predictable, even if we were all sitting in the courtroom each day. So we will all watch, wait and see. Sleep well, lil’ babies. . . those in-, and out-side all our villages’ various strong, loving and graceful mommas.

Claim Construction Chart: Merck Vs. Gilead Patent Spats

May 20, 2015 - Leave a Response

I primarily offer this item in case any of you wonder, from time to time, as to why patent lawyers are almost uniformly so highly compensated.

Just try and parse this (a 26 page PDF). It is proof of the formidable skill-set required to practice, at the intersection of patent law and organic chemistry.

And yes this means the patent battle is trudging forward — ever so slowly, but forward, in both federal courts: Delaware and the Northern District of California.

Background here.


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