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.

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

May 19, 2015 - One Response

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.

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

May 18, 2015 - Leave a Response

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!

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

May 17, 2015 - Leave a Response

At least one commenter is suggesting that big pharma has overstated the dangers of some amorphous India governmental agency effectively “nation- alizing” (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

May 17, 2015 - Leave a Response

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.

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

May 16, 2015 - Leave a Response

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

May 16, 2015 - Leave a Response

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!


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