Gilead Vs. Merck: Despite Raging Discovery Battles In California’s Northern US District Court, I STILL Expect This Will Settle Via ADR

March 29, 2015 - Leave a Response

As of the end of this week, there is a motion to compel pending, against Merck — and it offers some rather pungent assessments of what nearly sounds like an allegation of bad faith, on Kenilworth’s part — according to Gilead’s lawyers.

Meanwhile, globally the Gilead v. Merck/Idenix/Isis sofosbuvir patent spats march forward on at least seven fronts. The stakes are gargantuan (perhaps more than $10 billion in damages is at stake), but the lawyers’ bills must now be running over $75 million per year, world-wide, if we add up both sides’ legal expenses. And that, my friends just doesn’t make sense, for the shareholders of either company.

Remember, if there isn’t a settlement or other resolution before December 14, 2015 — a little under a nine months from now — the very able federal District Court Magistrate Judge Christopher J. Burke, sitting in Wilmington, Delaware, has ordered the beginning of an ADR processes. [Prior rundown of the international litigation status here.]

Each side knows that it ought to find a solution both can live with, by agreement, prior to then, or they will run the risk that a panel of arbitrators, or a mediator, will impose one upon them. This is, in my estimation, a smoke signal from the court that it feels the case ought to be settled — and settled soon. Here’s a bit of that order, entered on New Year’s Eve 2014:

. . . .IT IS ORDERED that a teleconference has been scheduled for Monday, December 14, 2015, at 11:00 a.m. with Magistrate Judge Burke to discuss alternative dispute resolutions. . . .

I would hope that, come December 2015, the central point of discussion will be whether Gilead might be willing to pay perhaps one half of one per cent in royalties to Merck — to “buy peace“. That would be a 20 fold discount (or a 95 per cent decrease, if you prefer), from Merck’s initial 10 per cent of all sales demand. As I’ve written before, if it settles prior to December 2015, my guess is that it will settle at a rate below 1.5 per cent of sales. And that would not even be a $200 million settlement. At $75 million a year in legal expenses, it sure makes sense to get this over with, capping it at $200 million. Just my musings, here.

Now when the Sun inexorably rises, I’ll be off for the northlands — (do enjoy Mass) on a fine Sunday morning, here. Be kind to one another. For in the end, only kindness matters.

Second Imposition Of Three Day “Stay At Home” Orders Underway In Sierra Leone, Tonight

March 27, 2015 - Leave a Response

We here in our lil’ shop continue to search the newswires diligently, for any signs of good news on the current and unspeakably tragic Ebola outbreak. Along those lines, we do know that the Phase II trials in Guinea have moved into Phase III — that is, the scientific consensus now holds that the vaccine candidates are completely safe. And so, the studies will henceforth focus on durability of the immune responses, going forward.

Against the backdrop of that rather hopeful news, we learn that Sierra Leone has imposed (for a second time) a three day ban on unneeded movement, for all her 6 million citizens. The idea is to avoid complacency — and continue to focus awareness on safe practices. Difficult times. . . require difficult measures. Here is the “Beeb” (BBC) on it all:

. . . .This lockdown comes amidst some rare good news. According to official figures from the World Health Organization, there were just 33 new confirmed cases last week – the lowest number since June 2014.

But with these falling figures there is danger of growing complacency, the government says.

This is one of the main reasons behind the lockdown – volunteers will remind people how to protect themselves against a virus that is still a real threat.

They will focus their efforts on northern and western areas where some infections still come as a surprise to officials – 16% of cases last week were not known Ebola contacts.

Experts have criticized previous stay-at-homes as too heavy-handed and top-down in their approach. Concerns were raised that some people did not have access to food.

The hope is, a year after the outbreak was declared, such logistical problems have been ironed out and that this measure will bring the country closer to its goal of zero Ebola infections by April 15, 2015 – an ambitious target that is just two weeks away. . . .

Sleep tight, one and all. And if you are so inclined, do ask the Infinite for some support here (I myself am bound by a differing covenant). Yes, tomorrow is another day.

Merck Q1 Results: April 28, 2015 — Before NYSE Opens

March 27, 2015 - Leave a Response

We will tune in on that morning.

. . . .Merck will hold its first-quarter 2015 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, April 28. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at merck.com. A replay of the webcast will be available at approximately 11:00 a.m. EDT on April 28 and will remain on the website for 12 months. The sales and earnings news release and supplemental financial disclosures also will be available in the Newsroom and Investor sections of the company’s website. . . .

Have a great weekend, one and all!

UPDATE: At Least Until April 28, 2015, Glenmark May Continue To Manufacture And Sell Generic Sitagliptin In India — Supreme Court Of India

March 25, 2015 - Leave a Response

In an update to our coverage of last week, the Indian news-wires are reporting this morning that the Supreme Court of India has granted Glenmark a stay on the injunction — through April 28, 2015 — when their Supremes will hear the Glenmark appeal. That means Glenmark is free to keep selling its “at risk” generic sitagliptin in India (a right the High Court allowed, in any event, to sell off Glenmark’s existing inventory).

I am uncertain about this, but it would surprise me if Glenmark didn’t already have enough inventory on hand to keep shipping through April 28, 2015. In the event that it does not, it is now free to manufacture enough to reach that date. Glenmark may still have to pay Merck a royalty on all these sales, but the people of India may still source cheaper generics from Glenmark. Here’s a bit, locally:

. . . .Supreme Court today stayed util April 28 the order of Delhi High Court barring Indian pharma major Glenmark Pharamceuticals from making, marketing or selling its anti-diabetes medicines in which US drug major Merck Sharp and Dohme (MSD) has claimed patent right.

“Up to April 28, there will be an interim stay on the order of the High Court,” a bench comprising Justices Ranjan Gogoi and N V Ramana said. . . .

So, even if the Indian Supreme Court decides that the High Court’s injunction will stand — Glenmark will likely only ever owe Merck a running royalty on sales — through the date of that decision. I do think the Supremes will ultimately enjoin Glenmark, and effectively force it to buy a license from Kenilworth, but I expect that generic sitagliptin therapies, from either “authorized generic” sources — or Glenmark and Aprica — i.e., non-authorized sources. . . are here to stay, in India. Merck has tacitly acknowledged this fact, by reducing its own pricing in country, since 2014.

Merck Replenishes Stock Repurchase Program — Incremental $10 Billion Equal To May 2013 Authority

March 24, 2015 - Leave a Response

Just as it did in May of 2013, Merck has once again added an incremental $10 billion of stock buyback authority, tonight, after the NYSE closed for the day.

A more jaundiced viewer might ask whether Kenilworth cannot find some higher — internal rate of return on capital hurdle exceeding — use for that $10 billion of capital, now deployed to the pockets of shareholders wishing to get liquid. Afterall, “investing” in a buyback just exactly meets one’s cost of internal equity capital. True enough — it won’t drag the return rate down — but it doesn’t bump it up, either.

And that is a fair view. Moreover, shareholders don’t mind the soft support a buyback program of size offers, should there be an anomalous dip in the NYSE price, on a temporary basis. Then the stock repurchase program can kick in — and act as gentle slow support to the price.

I do wonder though whether Merck might see a higher return on that capital, longer term, by investing more in a Keytruda trial/launch in yet another cancer. Here’s a bit, from PharmiWeb simply parroting the presser from Kenilworth:

. . . .With today’s announcement the company’s total outstanding share repurchase authorization is now approximately $11.7 billion which includes approximately $1.7 billion in authorized repurchases remaining under the program previously announced on May 1 2013.

Merck continues to expect average diluted shares outstanding will be approximately 2.86 billion in 2015. . . .

So — I’d look for a mild price rise, in the coming weeks — or at least less erosion than the general DJIA experiences, due in no small part to the cushion of a replenished $10 billion repurchase program.

Good News — But Unsurprising — Pembrolizumab (Keytruda®) Is An Effective First Line — In Melanoma

March 24, 2015 - Leave a Response

I’ll highlight it here, because it adds to the thesis: Anti PD-1 immuno approaches are the wave of the future — in many, many cancers.

Good news, for Kenilworth, and cancer patients. The high burden disease states await. Here’s the Merck presser:

. . . .[Merck] today announced that the randomized, pivotal Phase 3 study (KEYNOTE-006) investigating Keytruda® (pembrolizumab) compared to ipilimumab in the first-line treatment of patients with advanced melanoma has met its two primary endpoints of progression-free survival and overall survival. The trial will be stopped early based on the recommendation of the study’s independent Data Monitoring Committee. . . .

Enjoy a productive Tuesday now, one and all.

Doctors Without Borders Report: Last Week, The Ebola Outbreak Turned One. . .

March 24, 2015 - Leave a Response

However. . . rather than dwell on all the quite accurately-reported problems with the global response to this outbreak, from Doctors Without Borders, I’ll choose to highlight two old, but promising, antiviral agents that seemed to work, in at least a few post contraction human cases, to arrest progression of the hemorrhagic virus. [See graphic at right, and the European Community statements here.]

I suppose the enduring tragedy of it all will turn out to be that there was no need for the outbreak to see its first birthday. Had we, collectively, made finishing this vaccine candidate (long ago discovered in Canada) a priority, the outbreak may well have ended in just a few months – and not have claimed upwards of 11,000 lives. In any event, here is a bit from Wired, this morning:

. . . .Last week, the Ebola epidemic in West Africa achieved its first birthday. Though the viral outbreak has been contained, it is still not under control: According to the World Health Organization, cases continue in Sierra Leone and are rising again in Guinea. Liberia was about to record an entire incubation period without a new case — a signal that the chain of person-to-person transmission might have been broken — but on Friday, it announced that it had found a single new case. How that woman became infected is unclear; it is possible that she represents, not a new outbreak, but a brief interruption in an otherwise promising trend.

It has been decades since there was an epidemic of this persistence and magnitude. No other Ebola outbreak matches it; nor does the 2003 epidemic of SARS. You would have to go back to the early days of HIV in the 1980s, or to the flu pandemics in 1968, 1957 or even 1918, to find an outbreak that sickened so many people, challenged international response capacity so much, and instilled such fear in other countries. . . .

Even so, with at least two vaccine candidates showing promise, and these antiviral agents, we may be just a few steps away from turning the corner, here. Onward.

Courtesy of RAPS “Regulatory Focus”, The Full Delhi High Court Decision — On Sitagliptin

March 23, 2015 - Leave a Response

My sincere thanks here, go out to the RAPS folks, for sourcing this PDF (~1.8 Mb).

The ruling speaks for itself, and I covered it all, last week. So. . . do enjoy. Onward.

Some Sad News Concerning Liberia; Even As “Ring” Ebola Vaccine Candidate Trials Continue for Merck, In Guinea

March 21, 2015 - Leave a Response

As is so often true, out in the wild, biological life forms just. . . find a way. They adapt. They evolve. Just as we all inexorably do. But we will certainly hope that these viral agents do not mutate — not too quickly, nor too radically, this time around.

This is all a stark reminder that all science is only as good as the biology that supports it. I suppose I should, on a positive note, remark that in Guinea the large scale “ring” trials of Merck and NewLink, as well as those of GSK, continue to enroll robustly (due in no small part to a series of payments, roughly equal to ten-weeks’ full-time wages, to recruit volunteers in-country). It would be reassuring to know that we — as a planet — have a safe, effective vaccine or two in hand, as these outbreaks reappear. [And if history has taught us anything, it is that they will reappear.]

But for now, we will worry that it evolves or mutates before it can be tamped down. Here is the latest bit, out of Monrovia (Liberia’s capital city), from DM Akadamie – do go read it all:

. . . .Officials in Liberia were scheduled to meet in an emergency session on Saturday in the latest chapter of the Ebola epidemic.

The cause of the meeting was announced the evening before when health officials confirmed that a woman in the capital city Monrovia had been diagnosed with the hemorrhagic virus.

“This is a new case after we have gone more than 27 days without a single case. It is a setback,” government spokesman Lewis Brown said.

The last confirmed Ebola patient in Liberia was discharged from hospital on March 5, prompting a 42-day countdown to begin until the West African country could be declared free of the fatal disease.

Since the outbreak of the epidemic in December 2013, the United Nations has counted over 10,000 Ebola-related deaths, nearly all of which occurred in across Liberia, Guinea and Sierra Leone. Health officials, while hopeful that Liberia would report no new cases by mid-April, remained aware of the threat posed by the neighboring West African nations still crisis-ridden. . . .

With this bit of disheartening news, we will look forward to a quiet and reflective Sunday, here. So it goes.

Januvia® Patent Litigation In India Continues — Over “At Risk Launched” Generic Sitagliptin (-Phosphate) — But Merck Wins A Round

March 20, 2015 - Leave a Response

We’ve been waiting for a little over 21 months for clarity on this request for an injunction by MSD India, the local Merck & Co. affiliate there.

This very morning, as various and sundry Indian news outlets are reporting — the Delhi High Court three-judge panel has granted Merck an injunction, keeping any new inventory of the Glenmark generic form of sitagliptin off market there. However, Glenmark will be allowed to sell out its existing inventory of Zita and Zita-met, the knockoffs of Januvia®, and Janumet®.

As we first reported in June of 2013, MSD India was granted a similar order, barring another generic maker — Aprica — from selling a generic form of sitiagliptin phosphate in India.

. . . .The Delhi high court on Friday restrained Indian firm Glenmark Pharmaceuticals from manufacturing, marketing or selling its anti-diabetes drugs Zita and Zita-Met, saying it has “prima facie” infringed the patent of US drug major Merck Sharp and Dohme (MSD). . . .

The court also set aside its single-judge’s 5 April 2013 order refusing to restrain Indian company from manufacturing and selling its medicines meant for treatment of Type-2 diabetes. . . .

The bench, however, on Glenmark’s oral plea to allow it to sell its goods already in the market, clarified that it “may sell such of the products which are already in the market i.e in possession of its distributors and retailers”. . . .

I still think there will be a global settlement here, with all the generic makers — since diabetes represents such a high-burden disease in the relatively limited means populations of India. But we will keep you apprised.

For now, Merck has been able to take another extremely low price alternative off-market in India. Even so, Merck sells its own branded sitagliptin (Januvia) at a big discount in India, compared to what it charges in the US, and EU. On a global basis, company’s sitagliptin sales growth (in dollars) has slowed for Kenilworth, since mid to late 2014, in part due to these factors we have been steadily covering. Now you know. [NB: Weekend outage alert — traveling and out of pocket.]

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