Tuesday, May 26, 2015

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


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.

Monday, May 25, 2015

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


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.

Sunday, May 24, 2015

"A Beautiful Mind" Makes His Return, To The Infinite -- Near Monroe Township, New Jersey

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. . .

Saturday, May 23, 2015

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


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 -- Sovaldi® Wars


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



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.

Friday, May 22, 2015

BMS's Opdivo® Gets "Thumbs Up" -- In NSCLC, In The EU; Already Has It For Melanoma


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.

Thursday, May 21, 2015

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


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.]

Wednesday, May 20, 2015

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


'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



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.

Tuesday, May 19, 2015

Appearance Of Rare Ketoacidosis Side Effect, In SGLT2 Diabetes Therapies, May Lead To Slight Sales Uptick For Merck's Januvia®/Janumet®


The effect, seen in only 20 patients thus far on SGLT2 therapy regimens, is quite rare. But when it appears, it is severe: life threatening -- without immediate intervention, comas have been reported.

These newer classes of drugs, called SGLT2 inhibitors, had to now been steadily eating in to Januvia®/Janumet® (sitagliptin) market share -- here in the US. I suspect this FDA warning will add mildly to Januvia's results in 2015. We shall see. [As the graphic at right notes, there is also a very rare side effect: pancreatitis risk -- associated (since 2013) with sitagliptin, to be fair.] Per WebMD, then -- a bit:

. . . .A certain class of type 2 diabetes drugs can lead to a life-threatening condition called ketoacidosis, the U.S. Food and Drug Administration warns.

These prescription drugs are called sodium-glucose cotransporter-2 (SGLT2) inhibitors and include canagliflozin, dapagliflozin and empagliflozin. They work by prompting the kidneys to remove sugar in the blood through urine. . . .

The drugs are sold under the brand names: Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended-release), Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin). . . .


The reality of all of it is that diabetes is a very serious disease, and each therapy choice will have pluses and minuses -- patient by patient. So, as I say -- I'd expect only a very mild uptick for Merck's Januvia here. Chilly and cloudy gray here. . . but onward, just the same -- life goes on.

Monday, May 18, 2015

Merck EVP To Present In NYC Tomorrow At 10:30 EDT -- Keytruda® Ramp/Rollout In Focus


My very strong hunch is that nothing much of a material flavor -- beyond what was learned in last week's ASCO 2015 abstracts release -- will be dsclosed.

But we will be watching just the same. Per MarketWatch, then:

. . . .Merck. . . announced that Adam Schechter, executive vice president and president, Global Human Health is scheduled to present at the UBS 2015 Global Healthcare Conference in New York on May 19, 2015 at 10:30 a.m. EDT. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation. . . .


In any event, I'll likely listen in -- so you won't need to. I'll report anything materially new. This is the one time of year I wished I lived in the Big Apple. Mid-Spring there. . . is lovely. Onward!

Sunday, May 17, 2015

Should Pharma Take Comfort From The Interim India Patent Decisions, On Januvia®?


At least one commenter is suggesting that big pharma has overstated the dangers of some amorphous India governmental agency effectively "nationalizing" (taking) very valuable intellectual property -- in this case, drug-making inventions. While I do think PhRMA has overstated its case here, in the past, I do not think the latest interim Supreme Court announcement in the ongoing Januvia®/Janumet® (sitigliptin) wars provides the solace the commenter suggests.

It is an interim pronouncement, without a written opinion -- and it permits continued generic sales to 63 million Indians with diabetes through Q4 2015, at least. So it may not be all the victory it is suggested to be. I think the overall case will result in a settlement -- an authorized generic at Glenmark -- just as has existed, at Sun Pharma, in India, since at least early 2013.

Actually, though, it was another part of the published article that caught my eye. Here is that bit -- from BusinessToday -- just very curious, here:

. . . .In addition, when approving such marketing without authorisation, "Indian state governmental authorities reportedly do not have a mechanism to confirm whether the item to be manufactured is under patent. Recent cases such as Merck v. Glenmark and Cipla v. Roche illustrate this problem and underscore the need for greater regulatory coordination between officials in state and central governments. . . ."

In fact, the Indian Pharmaceutical Alliance in its written submission for the 2014 Special 301 Out-of-Cycle Review of India, had in October last year stated that "We submit that the difficulties in obtaining injunctions as well as apprehensions about the lack of patent linkage have been overstated to the USTR. There are several other cases where injunctions have been granted to pharmaceutical patent holders before the grant of manufacturing authorization. For example, Bayer has obtained injunctions in the Delhi High Court restraining manufacture against two parties developing Rivaroxaban under a development license, which is permissible under Section 107A(a) the Patents Act, a provision similar to the Bolar exemption in the US. . . ."


[In the US, the Bolar exemption is now codified as a statutory provision, in the federal Hatch Waxman Act.] I was unaware of the reported lack of linkage, in India, in that first quoted paragraph, above. I'm not sure how such a non-system could even function. I'll do some more digging -- to see if the commenter is correct in that assertion, as well. Will report back.

It Seems The End Draws Near, In Legacy Schering-Plough's Integrilin® Promotional Fraud Case: UPDATED California Federal Court Filings


Almost two months ago, I indicated that Merck would likely ultimately escape this qui tam style lawsuit, without having to go to trial on the merits. The latest filing, in the federal Courthouse for the Eastern District of California, confirms my hunch. It was a reply motion to a motion to reconsider, and in it Merck's lawyers forcefully make the point that Millennium is alleged to have done nothing different than legacy Schering-Plough. And Millennium was dismissed -- because these same claims were the subject of a prior public disclosure or three.

To be clear, it does seem the bad behavior alleged in the case actually happened -- and unsurprisingly, it was directed by Schering-Plough -- to gain an unfair advantage in selling the drug (allegedly). It just seems these matters were already disclosed, and likely resolved, in other court proceedings -- thus presenting a bar to any separate recovery here. In any event, here is a bit from the latest filing, but I expect we will hear little more of material import on this matter -- other than that it has been disposed of -- without a trial.

. . . .The first distinction between Schering and Millennium that Relator’s Opposition seeks to draw with respect to these claims is based on the flawed premise that the [complaint] somehow distinguishes what Millennium allegedly did to promote Integrilin off-label from what Schering allegedly did. But this is not in fact what the [complaint] alleges. . . . In an effort to manufacture support for his argument, Relator seeks to create the false impression in his Opposition that only Schering is alleged to have sent letters to doctors and to have used scientific studies to promote Integrilin off-label. . . .

[T]his Court has already reached conclusions indicating that the off-label promotional claims leveled against Millennium and Schering are essentially the same. In dismissing those claims as against Millennium, the Court found that the [complaint] alleges "Millennium caused the submission of false claims by ‘presenting physicians with false information about off-label uses of Integrilin and encouraging physicians to prescribe Integrilin for such uses . . . which were not approved by the FDA or any relevant drug compendium. . . .’" The Court also found, without distinguishing between Schering and Millennium, that the [complaint] alleges "Defendants, including Millennium, made false and fraudulent representations ‘to physicians that Integrilin was safe and effective for use in off-label patient populations. . . .’"

Tellingly, it was by comparing these allegations to the allegations in the 2007 federal complaints that the Court determined that Relator’s “off-label use allegations” against Millennium were “‘based upon’ public disclosures previously made” in those 2007 complaints. . . .


That seems pretty much rock-solid. Just to sure, though, we will -- as ever -- keep an occasional eye on this particular minor league game -- ice cream cone in hand. . . watching it melt away, on a perfect Spring night. So it goes.

Saturday, May 16, 2015

Guinea Runs Into Between 18 And 27 New Ebola Cases: Funeral Transmission?


Last we reported on this meta-narrative -- we had good news, out of Liberia -- where the outbreak is now officially over. No new cases in over 50 days, in Liberia, as of this morning.

Tonight, though, we have the sad duty of reporting a new, and likely large, re-infection in neighboring Guinea. It turns out that all the new Guinea cases (Guinea had been down to just a few active cases, prior to yesterday) share a common connection: all the sick were at the same funerals -- same churches. With 27 showing symptoms, and 18 of those already confirmed as having Ebola, this is the grimmer face biology more than occasionally shows. Per Global News Network, then -- a snippet:

. . . .Guinea has seen a spate of new Ebola cases due to transmissions at funerals, a worrying sign for the African nation as it seeks to stamp out a year-long epidemic that has killed over 11,000 people across the region, a health official said on Friday. . . .

"Today we have 27 sick in our treatment centres, including 18 confirmed cases," the department's spokesman Fode Tass Sylla told Reuters. "Yesterday alone we recorded five sick. . . ."


There is now at least a chance (in the land of looking desperately for some silver lining, in a horrific turn of events) that some of the ring-trials will reach an "n" large enough to definitively establish the efficacy of the Merck/NewLink vaccine candidate -- and perhaps even the GSK one, as well. But I think all involved would much rather see the latest outbreak arrested -- even if these ring studies end with too few study subjects to be statistically meaningful. Truly. Be kind to one another -- look with your better eyes; act with your warmer hearts.

India's Supremes On Januvia® (Sitagliptin) Patents: Still No Written Opinion; Glenmark Still Authorized To Sell Generic Januvia/Janumet


UPDATED: As we've written previously, we might expect a formal opinion on these Januvia®/Janumet® patent disputes in India, by the Fall of 2015, if the parties don't settle prior thereto.

And, as is often true, the embedded message from the very able justices of the Supreme Court, in India, is that the parties ought to settle, and in effect balance the 63 million lives -- almost all of limited means -- against a global juggernaut's "revenue enhancers", in country. From the Times of India then -- a bit -- but do go read it all:

. . . .The bench, which also comprises Justice N V Ramana, said, "In our view, in the present case, the above (balance of equities) would be best served if the existing stock of the two products, viz. Zita and Zita-Met are allowed to be sold in the market which, according to the petitioner itself, can take care of the current demand in the market for five to six months, i.e. September-November, 2015. . . ."


I'll have more -- with links -- at some future point.

~~~~~~~~~~ End, Update ~~~~~~~~~~


As we've been reporting for just under three years now, the burden of diabetes in India is staggering.

There are just so many people in India, and over 62 million people are afflicted, there -- most of them very poor, by Western standards. And so, there is a move afoot to have sitagliptin declared an essential medicine -- and either remove patent protection there, or broadly empower sales of it -- at "access priced" manufacturers, and outlets. To counteract this, Merck is vigorously protecting its patents in country, alleging infringement. [Just search "Glenmark" in the box above for all the dozens of background posts and history, here.]

The latest development this morning, US time, has Glenmark authorized by Indian courts to continue -- past April 28, 2015 -- to sell its generic sitagliptin salt, in country, despite Merck's trial court level win, in a patent infringement suit, there. Here is the Financial Express item, overnight:

. . . .A bench headed by justice Ranjan Gogoi while posting the matter for further hearing on May 12 continued its stay order that in effect allowed the generic pharma major to make and sell its anti-diabetes drugs Zita and Zita-Met, which allegedly amounts to infringing the patent rights of US drug major Merck Sharp and Dohme (MSD), which manufactures sitagliptin under the brand names Januvia and Janumet. . . .


We will report again, after the formal written opinion, should it come to that. Onward!


Thursday, May 14, 2015

Just To Complete The Record -- On Old Merck's 2004-Era Vioxx® Withdrawal -- And The Attendant Securities Fraud Claims


How to neatly summarize the nearly 25 years, from original R&D -- to withdrawal of this product, in 2004 -- and the now over ten full years of globe-spanning litigation, since?

In a word. . . I won't.

Just search Vioxx® in the search box, here. I've written about 55 posts worth -- just since 2008. I will note that it bothers me that Lexis and Westlaw want to charge people to read the opinion -- so here it is (a 51 page PDF) -- for free.

Our latest development, in this epic litigation? Well, just yesterday, the very able Judge Stanley R. Chesler in the Newark, NJ federal District courthouse released an opinion and order, essentially saying that the Zombie opt out Vioxx securities plaintiffs have survived a motion to dismiss, at least on the assertion that Merck's post-VIGOR opinion -- about the hypothesis supporting the putative safety of Vioxx was so ill-founded as to allow a jury to at least consider, and perhaps decide, whether the conduct reached the level of securities fraud -- from 2001 to 2004. Here is a bit of that:

. . . .In September 17, 2001, the FDA issued its warning letter to Merck, pointedly reprimanding Merck for “selectively present[ing]” the naproxen hypothesis despite the fact that it is “hypothetical, has not been demonstrated by substantial evidence, and that there is another reasonable explanation, that Vioxx may have pro-thrombotic properties.” (Id., Ex. 466.) A reasonable jury could conclude that, when only weeks after this warning, Merck nevertheless identified the naproxen hypothesis as not only a possible explanation but the favored one over Vioxx’s tendency to increase CV risk, it knowingly deceived investors by, in essence, knowingly misrepresenting that Merck and/or Scolnick were in possession of facts justifying this opinion. . . .

The record contains evidence upon which a reasonable jury could conclude that Defendants not only lacked support for this assertion of belief but, additionally, knew that it did not “fairly align” with other information in their possession. This evidence consists of, for example: Merck’s internal discussions revealing a very different assessment of the VIGOR data than that expressed to the public; its receipt of contrary advice from consultants regarding the naproxen hypothesis as the proper interpretation of VIGOR; Merck’s possession of data discrediting the underlying assumption that naproxen has cardioprotective qualities similar to aspirin; and the FDA’s specific and unequivocal warning regarding Merck’s public espousal of the naproxen hypothesis. . . .


This makes it marginally more likely that Kenilworth will need to settle for some higher figure with these opt out claimants. But I do not foresee a trial on the merits here. That's just my very experienced opinion -- in such (alleged) mass tort cases. We will keep the readership informed. Have a great long weekend, one and all. I certainly will.

Wednesday, May 13, 2015

More On The ASCO 2015 Abstracts -- Some Other Day. . .


UPDATED: I should have been clearer. BMS manufactures ipilimumab, branded as YervoyTM. An astute commenter reminds me that I should have mentioned that. So both the yellow and purple bars below accrue to Bristol Myers Squibb.

I'm just a little crispy tonight, so I'll just use a picture -- here is what at least one analyst ($ subs. req'd.) sees as the market, now to 2020.

Note that this crosses all cancers, and still has BMS's nivolumab (in yellow below, branded as Opdivo®) as the clear leader. Here it is:



Sleep well, one and all. More some other day. I'm out.

Vast Bolus Of Cancer Study Abstracts To Be Released Tonight: ASCO 2015 Coming Up In June


As was true last year, this is yet another great year to have ASCO here in Chicago. I'll very likely pop over. This is a very heady moment -- in the now exploding scientific developments -- around human immuno-oncology candidates, to be sure. . . .

Many a preview will be released later tonight. [And to be very clear here -- I still look for BMS's Opdivo® to keep a solid 12 month lead in NSCLC.] The next battleground (after the current trio) is shaping up to be head and neck cancer -- let's listen in, to CNBC's coverage, shall we? Yes, let's:

. . . ."Key is whether [AZ's] MEDI4736 can achieve similar efficacy compared to Merck's pembro but with a better toxicity profile," Scala wrote in a Wednesday preview note. "The ASCO update should indicate whether AstraZeneca or Merck has the lead in head and neck cancer," Scala wrote. That's important because it's likely the first type of cancer outside of melanoma and lung cancer for which Merck will file for approval.

Scala also highlighted several studies of Bristol-Myers' Opdivo, also known as nivolumab, in renal cell carcinoma and nonsmall cell lung cancer. A study in the latter indication was stopped early for positive efficacy in January, "but this is the first time that we see full data," Scala wrote. . . .


Busy with the day gig, here -- do stay frosty. I'll update this item if we learn something remarkable later tonight -- around 11 PM EDT. Onward.

Tuesday, May 12, 2015

One Blogger's New Departure Point -- Advice To HR And Benefits Professionals, Nationwide: ACA of 2010 Implementation Edition


I don't usually feature HR specific guidance, but this one caught my eye. It also happens that I am just a lil' vexed by the small handful of public carrier insurers trying to cash federal checks, while pretending not to know that "free" really means. . . free. And so, Mr. Obama is quite right, here: the law simply requires complete coverage for truly free birth control, one product in each category of drug or device -- at a minimum. So do take heed.

Here is the great resource provided by EBN.com -- do go read it all:

. . . .For example, health plans must cover – without cost-sharing – at least one form of contraception in each of the 18 method categories defined by Federal Drug Administration. “For the hormonal contraceptive methods, coverage therefore must include (but is not limited to) all 3 oral contraceptive methods (combined, progestin-only, and extended/continuous use), injectables, implants, the vaginal contraceptive ring, the contraceptive patch, emergency contraception (Plan B/Plan B One Step/Next Choice), emergency contraception (Ella), and IUDs with progestin. Accordingly, a plan or issuer may not impose cost sharing on the ring or the patch,” according to the FAQ. . . .

Moreover, plans cannot limit sex-specific recommended preventive services based on an individual’s assigned sex at birth or recorded gender. The FAQ notes that where a health care provider determines that a recommended preventive service is medically appropriate for an individual – “such as, for example, providing a mammogram or pap smear for a transgender man who has residual breast tissue or an intact cervix” – the plan or issuer must provide coverage for the recommended preventive service without cost-sharing.

“That’s a level of detail I don’t think we’ve seen elsewhere either in the preventive services guidance under ACA or the other ACA guidance,” notes Bergner.

The FAQ also notes that plans must implement an exceptions process so that if a patient’s medical provider recommends a different contraceptive based on medical necessity within a certain category, that contraceptive must also be covered without cost-sharing. . . .


Savvy HR professionals will take note -- and make sure that their employers, and their plans, and those from whom they buy coverage, provide this truly free coverage. There are now rather substantial penalties for even negligent non-compliance. It is the law, folks -- and it is important to preserve a woman's meaningful right. . . to choose. Onward.