Wednesday, July 23, 2014

Federal Funds Can -- And Will -- Be Used To Subsidize Federal Exchanges: Condor's Unsurprising Predictions Dept.

Of course, the marginalia -- the drafting oversight -- ought to be corrected, and of course, the Supremes will likely issue an opinion to that effect. But the black letter law in almost all analogous situations is pretty clear: the IRS may interpret federal revenue and expenditure laws, and issue regulations reasonably implementing the will of our Congress. That it has done.

With the Fourth Circuit (upholding -- with mostly Democrat appointees on the panel), and the DC Circuit (nullifying -- in an all Bush 41 and 43 appointed panel) issuing directly contradictory opinions within hours of one another yesterday, I predict (unsurprisingly) the Supremes will have to take the case.

Also unsurprisingly, the Supremes will -- I predict -- take the Fourth Circuit's opinion, nearly verbatim, as black letter law. The IRS plainly possesses the regulatory and rule-making power to make the laws of Congress work in what it sees as a reasonable way. Once a court concludes that "Congress’s intent in enacting [a specific provision] was not so clear as to foreclose any other interpretation", then the IRS's interpretation is to be given a wide berth.

The IRS has determined that it was an oversight in Congressional drafting, to suggest that federal money could not be used to fund subsidies for federal health exchange participants. And that determination is plainly a reasonable one -- one which furthers Congress's stated intent, in passing the ACA of 2010. Game -- effectively over (but it will be late 2015, before the Supremes offer a published opinion, here).

A bit of the New York Times on it, this morning -- do go read it all:

. . . ."You don’t need a fancy legal degree to understand that Congress intended for every eligible American to have access to tax credits that would lower their health care costs, regardless of whether it was state officials or federal officials who were running the marketplace," said Josh Earnest, the White House press secretary. "I think that is a pretty clear intent of the congressional law. . . ."

[Fourth Circuit] Judge Gregory said, the administration’s position helps achieve “the broad policy goals” of the Affordable Care Act. “The economic framework supporting the act would crumble if the credits were unavailable on federal exchanges,” he said. . . .

In a concurring opinion, Judge Andre M. Davis, a senior judge on the appeals court, said the plaintiffs’ argument “would effectively destroy the statute.” It would, he said, “deny to millions of Americans desperately needed health insurance through a tortured, nonsensical construction” of the law. Judge Davis and the other judge on the panel, Stephanie D. Thacker, were appointed by Mr. Obama.

The health law authorized subsidies specifically for insurance bought “through an exchange established by the state.” When the law was adopted, Mr. Obama and congressional Democrats assumed that states would set up their own exchanges. But many Republican governors and state legislators balked, and opposition to the law became a rallying cry for the party.

The lawsuit in Washington, championed by conservative and libertarian groups, was filed by people in states that use the federal exchange: Tennessee, Texas, Virginia and West Virginia. They objected to being required to buy insurance, even with subsidies to help defray the cost. . . .

I run -- again -- the graphic of that goof-in-chief, Ted Cruz (R), as he is among the named amici submitting briefs to overrule the IRS's interpretation of this provision of the ACA of 2010. He is one lost soul. And what to make of Governors Perry and Haslam, among otehrs? They tell the poorest people in their state -- as your leader, I will not allow you to receive federal funds, to defray 95 per cent of your health costs -- and as your leader, I will provide almost no state coverage for you. There used to be a term for that, on fuedal Europe -- it was aristocratic robber-king. And we know what the peasants' next move was. Right? Right. But here in the colonies, beheadings are now frowned upon. So, vote these jokers -- out of office. They have betrayed their own people. Just my $0.02.

Tuesday, July 22, 2014

Merck's Idenix Cash Tender Offer Clears US Antitrust Review: Hart Scott Waiting Period Popped July 18, 2014

Still very-likely a Q3 2014 closing -- on time, and on target, for this all cash offer for all the shares of Idenix.

From the as amended SEC tender-offer filing (formerly called a Williams Act filing, by old schoolers!), then -- a bit:

. . . .At 11:59 p.m., Eastern time, on July 18, 2014, the waiting period applicable to the Offer and the Merger under the HSR Act expired. Accordingly, the condition of the Offer relating to the expiration or termination of the HSR Act waiting period has been satisfied. . . .

Just like that, the potential (and negotiating strategy) for a Gilead patent royalty payment on Sovaldi® -- its multi-billion dollar titan Hep C drug (the most successful drug launch in history, even adjusted for inflation) is now. . . (as of the closing of the Idenix deal) pretty well consolidated into the very capable hands of Merck's lawyer-chairman. Smart move.

[Preliminary] Merck Spent $1.33 Million On Lobbying, In Q2 2014 -- $3.75 Million Through First Half Of 2014 -- 50 Percent Off, Compared To 2013

I'll update this when the final tally is in (likely later this week), but through 2 pm EDT today, Merck is at $1.33 million. Moreover, just as was true in the first quarter of 2014 -- this year is running at about half of what the 2013 lobby spend levels were.

Merck had lobbying underway on (among other matters):

. . . .Alzheimer's education (no specific bill); 340B (no specific bill); National Diabetes Clinical Care Commission Act (H.R. 1074, S. 539); Eliminating Disparities in Diabetes Prevention, Access and Care Act (H.R. 3322); Hepatitis C education (no specific bill); adult vaccine policies (no specific bill); medication adherence (no specific bill); DISARM (H.R. 4187). . . .

Comprehensive tax reform (no specific bill); transfer pricing of intangibles (no specific bill); territorial tax system (no specific bill); deferral of taxation of foreign earned income (no specific bill); tax base erosion (no specific bill); R&D tax credit (no specific bill). . . .

Non-interference in Medicare Part D (no specific bill); Medicaid-style rebates in Medicare Part D (no specific bill); Low Income Subsidy Copays in Part D (no specific bill); Independent Payment Advisory Board (S. 351, H.R. 351); sustainable growth rate (H.R. 4302). . . .

Trans-Pacific Partnership (no specific bill); biologic data exclusivity (no specific bill); trade promotion authority (no specific bill); treatment of intellectual property in India (no specific bill); Playing Fair on Trade and Innovation Act (HR 3167); additives in beef cattle (no specific bill); trade adjustment assistance (no specific bill); international trade barriers for beta-agonists (no specific bill). . . .

Deficit reduction (no specific bill); ADAP funding (no specific bill); omnibus appropriations; Patent reform (H.R. 3309, S. 1720 ); education on beta agonists (no specific bill). . . .

Now you know. More on the final numbers, soon.

Monday, July 21, 2014

Scholl Non-Americas Rights "Mystery", Clarified: Thanks To A Commenter!

It is truly. . . a gift that so many smart, well-informed, long tenured insiders read this goofy little corner of the pharma/life sciences sector chronicle. Within minutes of my mentioning the Scholl/Reckitt deal, a commenter had provided the whole back-story.

I just couldn't get to it until now, due to other responsibilities. [And, perhaps immodestly, I wanted to honor the commenter's effort, with a custom graphic. Check!] So, the Scholls ex-Americas shoe rights went out of Schering-Plough in the 1980s, per my erstwhile commenter. Nice catch!

Specifically, per my truly-enlightened help: The Reckitt purchase was not recent. Bob Luciano, Chairman of SPG at the time, divested the Scholl business outside North America in 1987 to Seton Healthcare which became Seton Scholl Ltd and the SSL International. Schering-Plough later bought back a small piece of the international footcare (non shoe) business in Latin America and maybe another market. Reckitt bought SSL International in 2010. I had thought their Scholl international business and desire to globalize it might have been a significant driver in their chase of the Merck Consumer Care business at the higher prices. -- /s/ Anonymous @ July 21, 2014 at 11:45 AM. . . .

That fills in all the gaps, nicely! Thanks so much. I had no idea -- just started following SGP around 2007. From a July 2010 Wall Street Journal blog posting then -- that Reckitt 2010 deal -- acquiring SSL International PLC:

. . . .It’s no secret that consumer health care is hot, but Reckitt Benckiser Group PLC’s proposed £2.5 billion offer for SSL International PLC has just slapped a massive 18.6x Ebitda multiple on the sector. . . .

So, now you know. Thanks Anon.! G'night, all.

Did I Miss A Beat, Here? Scholls (Non-US) Rights Belonged To Reckitt Benckiser? Who Knew?!

Back in November of 2009, I suggested that rumors about Dr. Scholl's going to Reckitt seemed. . . unlikely.

Apparently, at some point recently, Reckitt acquired the non-Americas rights to the brand. Now Reckitt is selling those same rights on, to a private equity buyer. So, either I missed a step (an intervening sale -- in 2009 to 2013 timeframe), or this is a new transfer. No matter, Reuters has it all, this morning.

Of course, the US -- and rest of the Americas -- rights will belong to Bayer, as agreed this spring. Per Reuters, then:

. . . .German private equity firm Aurelius said on Monday it is buying Reckitt Benckiser's Scholl shoe business in its efforts to expand internationally, betting on the brand's growth potential.

Under the agreement, Aurelius would acquire the international rights for the Scholl footwear business, excluding North and South America.

The rights to that business in the Americas will go to German drugmaker Bayer as part of its $14 billion purchase of Merck & Co's consumer health business.

Aside from the Scholl shoe business, which is known for its focus on comfort, Reckitt Benckiser has a Scholl-branded footcare business that includes insoles and blister bandages. . . .

The cash Merck got for these legacy Schering-Plough Scholls lines is simply fantastic. Top dollar. Really a coup for Mr. Frazier, at those high valuations. So. . . Onward!

Sunday, July 20, 2014

So -- That Smallpox Story? Not So Uncommon, It Would Seem: NYT

Last Friday night, we talked about extremely dangerous smallpox vials -- forgotten for a half-century, and apparently left entirely unsecured -- in a cardboard shoe-box.

If we are to believe The New York Times -- and there is really no reason not to -- the occurence is not as isolated as we might hope. In fact (stoking some of our worst fears), it turns out that some scientists around the globe are actively researching ways to make such deadly viruses. . . even more communicable. And these are not crazed military "weaponizing" researchers -- in labs in North Korea, or Putin's Russia. No, these are ostensibly respectable researchers whose mission it is to figure out how, and why, a given viral strain might mutate into a global killer and be easily transmitted in open air. Or on open waterways. Truly creepy stuff. Do go read it all but here is a bit:

. . . .The recent mistakes at federal labs have opened the door to a much broader criticism of the risks posed by the expanding research into risky pathogens, especially the efforts to create dangerous strains of flu not currently circulating, or to manipulate already deadly flu viruses to make them more contagious.

Researchers who conduct that work, sometimes labeled “gain of function” research, say its purpose is, in part, to help scientists recognize changes in natural viruses that may help predict which ones are becoming more deadly or more contagious. But it provoked a public outcry in 2011 because of fears that a lab accident might release the altered viruses and start a lethal pandemic.

The studies were halted for about a year while governments and research organizations tried to develop safety rules, but the work has since resumed in several laboratories. . . .

What do you think? Is "gain of function" -- even in truly lethal viral loads -- something we ought to be studying? Is the risk of a mishap worth the benefit of some future possible insight -- that might help us eradicate such an outbreak? I am willing to be convinced, but I lean toward shutting this research down. We do know that weaponizing research is very likely underway in some nefarious labs in North Korea.

Will this competing research provide the defense, should such a weapon be used in the wild? I am puzzled, and more than a little concerned by the whole idea of it. You?

Friday, July 18, 2014

NEJM Formally Publishes Tredaptive Results We Reported In December of 2012 -- "Niacin Clanks" Chronicles

Truthfully, this scarcely qualifies as news. But it has been a slow summer dog's week around Whitehouse Station. These results were first released, on a top line basis, in December of 2012. And we covered them. But the message is clear: Niacin plus laropiprant is probably a dead letter -- and often exhibits a side-effect profile that should not be considered an acceptable risk. [Additional March 2013 vintage background here.] To be sure, it has taken a while -- for Merck's science speakers to come around to this plainly majority view. But it is definitive, now (even if the possibility of infections hadn't been seen -- the lack of outcomes benefit should be the end, all by itself).

From the Monthly Prescribing Reference, then -- a bit:

. . . .Extended-release niacin with laropiprant does not reduce the risk of major vascular events in adults with vascular disease; and extended-release niacin may be associated with increased risk of certain serious adverse events, according to research published in the July 17 issue of the New England Journal of Medicine. . . .

"The findings concerning certain serious adverse infectious events associated with niacin have not been previously reported," Anderson and colleagues write. . . .

Go find a summer adventure this weekend -- I certainly intend to!

Tuesday, July 15, 2014

UPDATE: Google Gets A Highly Credible Partner -- In Novartis/Alcon -- To Develop Its Glucose Monitoring Contact Lenses

Back around Rev. Dr. Martin Luther King Day 2014, we highlighted a then-nascent Google-hardware project. Well, those folks at Google don't just sit around -- on good ideas.

Overnight, we learn that Novartis has signed on to help bring the concept to market. [Recall that Novaris now owns Alcon, here.] The current iteration will continuosly monitor sugar levels in tear-flow. Later versions may well adjust the contacts' optics, via microelectric charges, to sharpen the focus of diabetes patients' vision -- in near real time, via bluetooth, based on the sugar readings. Amazing. Via the British Globe and Mail online, then:

. . . .Swiss drugmaker Novartis has struck an agreement with Google to develop “smart” contact lenses that would help diabetics track their blood glucose levels or restore the eye’s ability to focus.

The device for diabetics would measure glucose in tear fluid and send the data wirelessly to a mobile device, Novartis said. The technology is potentially life-changing for many diabetics, who prick their fingers as many as 10 times daily to check their body’s production of the sugar. . . .

Yes, the future arrives -- right now. Is MRL up to the accelerating challenges -- of eye-blinking innovation -- and complex partnerships -- all in one? We shall see.

Monday, July 14, 2014

As Predicted Right Here, Zilmax® Not To Return To US Market Until 2015 (At The Earliest).

It would seem that -- as I predicted, in March and April of 2014 -- Merck will NOT be able to reintroduce zilpaterol before 2015, in the US. It further seems that Tyson and Cargill have repeatedly indicated they won't buy (from the feedlots) the supposed 250,000 head of cattle which were to be fed Zilmax® -- as part of the reintroduction study. But candidly, that was pretty clear, even last Fall. [More background here.]

From tonight's online Wall Street Journal, then -- do go read it all:

. . . .Merck has delayed plans to begin its field evaluation because of continued unease among Cargill Inc., JBS SA, Tyson and other meatpackers about animal welfare, as well as some packers' reluctance to try to market the beef that would be produced during the research, according to people familiar with the matter.

Merck confirmed the study has encountered setbacks. "This has become more time-intensive than we anticipated," said David Yates, a Merck manager who helped design the planned study. He declined to discuss details of negotiations with meatpackers, but said: "We continue to work on the process to make sure we have alignment with all parties."

The research requires the support of feedlot operators, which fatten cattle for slaughter, and the meatpackers that buy and process them into steaks and ground beef. The three-largest U.S. beef processors — Tyson Foods Inc., Brazil-based JBS and Cargill — account for about 60% of total production, according to industry estimates. JBS also operates one of the world's largest feedlot operations in the U.S.

Mr. Yates declined to specify a new target time period to begin testing Zilmax on cattle. . . .

While the brand sold about $156 million in 2012 -- its last full year on-market in the US -- I'd not expect anything like that, should it come back in the US, in 2015. Even at double that -- or $300 million -- it would remain definitively immaterial to Mother Merck. So it may well be that Merck will concede this market to Lilly (via its Elanco Optaflexx® brands) -- as the clear No. 1 leader, in the US space, now.

O/T Mondays: What Might Have Become, Of Roger Ebert -- Had He Taken Frost's "Path Less Traveled"?

A flick I saw over the weekend (actually, a documentary on the quiet, peaceful end -- to Roger Ebert's life, back in 2013) has put me in mind of "paths less traveled". . . . some 50 years on, now.

If you don't yet know what happened in Birmingham, Alabama, on an early Sunday morning, at the 13th Street Baptist Church -- in mid September 1963 -- do go find out. Or watch Spike Lee's "4 Little Girls".

. . . .[Roger Ebert: ] The children of Birmingham did not really die in the State of Alabama, however, because Alabama is a state of mind, and in the minds of the [white] men who rule Alabama, those children had never lived. . . .

The governor [of Alabama], whose demented attempt to prove himself a white man, has ended in the demonstration that he may not wholly be a man at all, deserves not even pity. His life is his own to live, and his nights are his to sleep, if he can. . . .

And it happened in Alabama to children we did not know and would never have known. But because they died, it happened to us. And the blood is on our hands, because every one of us owed to those children a future. . . .

Their blood is on so many hands, that history will weep in the telling. . . . And it is not new blood. It is old, so very old. . . . It clings and waits, and in its turn, it kills again. . . .

Now click the image, at right -- to read the rest of what a then only 20 year old Roger Ebert (as Editor in Chief of the Daily Illini) was thinking, of it all.

His artistic and rhetorical reach here is. . . astonishing. Oh my.

What might have been. . . . not that he didn't lead an amazing life, as it was.

Just. . . what if he had focused on politics. . . or civil rights, as a principal -- and principled -- avocation? What if? Here is the full PDF of that day's paper (see page 8).

Sunday, July 13, 2014

Lawsuit Tug O' War: Fight Escalates -- Over Potential Lost Tax Revenue -- From Legacy Schering-Plough Site In Union, NJ

At the end of May 2014, we detailed a burgeoning legal spat, over the legacy Schering-Plough facility in Union, New Jersey, on Morris Avenue (see at right). Merck has vacated the place, and Kean University wants to get its hands on it. But that would take it off the real estate tax rolls.

Prior to the Kean University interest, it is claimed that Merck had agreed in principle to sell it to Russo Investments -- an entity that would keep it on the taxable, and tax-paying, parcel lists, in Union. Then enters (stage right), an heir to the vast Kean fortune, in New Jersey. It seems that running with the land was a covenant that should it be sold, the Keans had a right of first refusal -- via a trust which (it is claimed, again) expired in the 1990s. Even so, the Kean heirs have indicated their desire to exercise this right, and then sell on to Kean University. The property would nicely complement the existing Kean U. campus space -- as it is dead across the street from the main campus. Thus the escalation in rhetoric, and blue-backed legal pleadings. Smile.

From, we learn that Union township's mayor is pretty surprised -- and disappointed -- that a court is essentially allowing the sale to the University -- contingent only on a final court order that the same is proper (i.e., that the covenant still runs with the land, through the trust -- to the Kean heirs at law).

And so -- it does not look particularly good for all the other residents of Union, who rely on those tax revenues, for public school funding, snow plowing and garbage pickup. Here's the bit -- and do go read it all (as a story of more legacy Schering-Plough rust-creation, on the old iron shelves of the nation's medicine cabinet):

. . . .However, on June 30, Judge Katherine Dupuis granted the university's request to pursue the sale, and enter a purchase contract. The university, however, cannot not close on the property pending the outcome of the lawsuit.

"To our surprise it seems that they are moving forward," township [Union, NJ] Mayor Clifton People said. "They can do everything except complete the actual sale. . . ."

He estimated that the township would lose $4 million in property taxes annually if the university takes the property. Public institutions, such as universities, do not pay property taxes. . . .

Much could yet change -- as the lawsuits wind their way through the byzantine New Jersey state court system -- so we will keep you posted. [Go out and have a Sunday-style adventure! Ice cream on the beach or biking in the leaves. . . I will as well.] And, do go see the new posthumous Roger Ebert documentary (in limited release this weekened) -- very good stuff, for all movie fans -- and fans of a vastly gentle, but searing, intellect. What he wrote, at age 20 (on the University of Illinois daily paper's editorial page), about the "4 Little Girls" bombing in Birmingham that year -- will resonate with you, to your dying day. I promise.

Saturday, July 12, 2014

Federal Fosamax® Femur MDL Update: The Gaynors Take Their Bellwether Trial, On Appeal To The Third Circuit, On SUmmary Dismissal By Judge Pisano

About ten days ago, we noted that the very competent US District Court Judge Joel Pisano (sitting in Newark) had dismissed the Gaynors' suit against Merck -- saying that there were essentially no claims left (even if proved) -- that would entitle the Gaynors to a judgment against Whitehouse Station.

So the jury never got empaneled -- to hear, or deliberate -- on their case. Now they appeal that ruling. Meanwhile Judge Pisano continues to look for other bellwether cases to help line out the likely settlement posture for the parties -- and get a handle on whether the damages (if any are found to be attributable to Merck's conduct in selling Fosamax®) will warrant any form of a global offer from Merck. We are keeping tabs:

. . . .PLEASE TAKE NOTICE that Barbara Gaynor and Robert Gaynor, plaintiffs in Barbara Gaynor and Robert Gaynor v. Merck Sharp & Dohme Corp., appeals to the United States Court of Appeals for the Third Circuit from each and every part of the Opinion and Order entered on June 17, 2014 [MDL Dkt. Nos. 3855, 3856], and from all prior and subsequent opinions, orders, and rulings adverse to Plaintiff, including without limitation the Letter Order entered on August 13, 2013 [MDL Dkt. No. 2887] and the Order to Show Cause entered on August 15, 2013 [MDL Dkt. No. 2895].

Dated: July 10, 2014. . . .

We will keep you up to the minute -- as this appeal progresses, but I see only a small chance that Judge Pisano is overruled here.

Merck's Indian Affiliate Likely To Settle With Glenmark -- Over "Generic" Sitagliptin Phospate Sales In India: Januvia® Chronicles

The wider narrative lines here are fascinating, manifold -- and complicated (we have been following this developing story closely, for nearly 18 months, now). And it has important implications -- for US policies on intellectual property -- as the same affect multinational enterprises in India. There are many facets to the issues more broadly presented, each reflecting a different three or four hues of the rainbow, as the facets of the diamond are rotated in the morning sunlight. So I ask you, dear reader -- to bear with me as I likely over-indulge in this metaphor(!).

First, there is the facet that refracts cool blues, to royal purples -- the rights (and obligations) of a branded innovator (Merck) seeking to recoup the undoubtedly billions of dollars invested in a proprietary drug development program -- even in the poorest, most disease afflicted nations on Earth. Then there are the warm oranges, which stray into angry reds -- the health ministers of India (and their bretheren, the local patent examiners), seeking to provide life-saving, but affordable diabetes management medications to all of India -- the nation with very nearly the highest "burden of the disease" index -- on the planet. There are more than 30 million diabetics in India (likely doubling, by 2030) -- and the bulk of those routinely die of the disease, for lack of any affordable care.

In addition, as we rotate the diamond in the sunlight -- we see soft pinks, fading into pale, almost translucent golds. . . these are the World Trade Organization, and its Doha Declarations, which purport to allow poorer nations, via TRIPS, to assert an "emminent domain" of sorts, over needed IP for humanitarian, life-saving goals. There is an ongoing global debate, on that topic -- which underlies all these Indian IP disputes. Will the nation simply "confiscate" medical IP, in order to save the lives of tens of millions of their citizens? We shall see.

Finally -- in a pulsating glow, from the heart of this highly polished carbon crystal -- always and forever -- is a deep, deep green: money. Not all (and perhaps not even most) of the actors here do so from a charitable point of view: in fact, there is some competent evidence that Glenmark will charge a nearly as exorbidant price for the "generic" it seeks to make -- in other nations, around the world, as Merck does. Afterall, in the end, there are literally tens of billions to be won, via slight shifts in regulatory attitudes, and in patent court invalidation proceedings -- which, by their terms, might allow Glenmark various export rights. Here, MSD India, Merck's local affiliate, is awaiting the ruling of a high court in Delhi, which may find that Merck's patent on sitigliptin does not cover the phosphate polymorph of sitagliptin. Should that ruling be handed down, Glenmark, and all Indian manufacturers, Sun and Lupin included, could sell the "genericized" version -- at any price they choose. [Here is some of the much earlier 2013 background, on it all.]

So it is with great interest, that I note that The Times of India is reporting overnight that Merck's Indian affiliate has agreed to mediate the patent spat on Januvia® in India. It is likely to lead to a settled set of payments -- from Glenmark, to Merck -- a sort of small commission, on sales of generic sitagliptin phospate polymorphs. Note that the story itself recites the Glenmark's price is only 30 per cent cheaper than Merck's -- and the WHO estimates that the price of most life saving medicines need to be 99 per cent cheaper than US retail, to be affordable to the vast swath of diabetes sufferers, in India. Here's a bit -- do go read it all:

. . . .In the long-winding patent battle on a widely-prescribed diabetes drug, Januvia (sitagliptin), multinational company Merck (MSD) has sought a settlement to end the dispute with generic company, Glenmark on the blockbuster drug. Last year, US-based Merck's subsidiary in India dragged Glenmark to court, seeking a stop on the sale of a more affordable version of its diabetes drug, Januvia, joining the list of MNCs engaged in turf wars with generic companies in the country.

The MNC firm had earlier sought an injunction against Glenmark marketing the generic version of its diabetes drug. Glenmark priced its diabetes drug last year around 30% cheaper than Merck's Januvia, where the savings to patients could be nearly Rs 5000 a year. . . .

Also recall that Merck has agreed with Sun Pharmaceuticals in India -- to the effect that the latter shall be allowed to make an "authorized" generic version of Januvia for local in-country markets. I will try to discern whether Merck still intends to help Sun undercut the Glenmark offering in India -- as the mediation progresses. But I now think, since Merck itself volunteered to mediate the dispute -- Merck had made a calculated assessment that it was likely to lose the patent fight, in the Inidan courts -- or win, and seek the India Health Ministry grant a TRIPS "compulsary license" to the drug in India.

I suppose this also signals Mr. Frazier's disagreement with Pfizer's chairman -- as the latter is the PhRMA chair at the moment as well: Ian favors a "get tough" policy with INdia -- while Merck is now clearly being conciliatory. So it goes, over my coffee & banana, on a warm gray Saturday morning.

Friday, July 11, 2014

Live, Growing Smallpox Sample Vials Found In Forgotten US Lab-Storage Bins

Well -- this ought to "shiver our collective timbers"!

While not exclusively applicable as a Merck story (it is a vaccines story certainly, though), the idea that there might be likely lethal, but casually-stored 1950s era live virus vials floating around old labs. . . is deeply unsettling. From CNN online then:

. . . .At least two of the vials employees at the National Institutes of Health found in an unused storage room earlier this month contain viable samples of the deadly smallpox virus, the Centers for Disease Control and Prevention said Friday. Employees found six forgotten vials when they were preparing to move a lab from the Food and Drug Administration’s Bethesda, Maryland, campus to a different location. The laboratory had been used by the NIH but was transferred to the FDA in 1972.

When the scientists found the vials, they immediately put them in a containment lab and on July 1 notified the branch of the government that deals with toxic substances, called the Division of Select Agents and Toxins. . . .

Smallpox, known also by its scientific name as variola, was the deadly virus that was the scourge of civilization for centuries. It's been considered an eradicated disease since 1980, following successful worldwide vaccination programs. The last known outbreak in the U.S. was in 1947 in New York. . . .

This sort of thing is a scientist's worst fear: a disease we eradicated almost four decades ago -- springing back into the wild -- because some samples were forgotten, and not incinerated or irradiated. Good sci fi -- very scary Andromeda Strain style reality scenario. Have safe weekends, one and all -- and get, or stay. . . healthy!

Merck's Divestitures Of Consumer Health And Other Businesses to Bayer Clear Hart Scott: Federal Register

I'll have more in a few minutes, but Merck was granted early termination of the so-called HSR waiting period here in the US, overnight, just before the long holiday weekend break.

So this $14.2 billion deal is very likely to close in Q3 2014. From 79 FR 39392 of the Federal Register, reprinted as a feed at Insurance News Net, then:

. . . .Section 7A of the Clayton Act, 15 U.S.C. 18a, as added by Title II of the Hart-Scott-Rodin Antitrust Improvements Act of 1976, requires persons contemplating certain mergers or acquisitions to give the Federal Trade Commission and the Assistant Attorney General advance notice and to wait designated periods before consummation of such plans. Section 7A(b)(2) of the Act permits the agencies, in individual cases, to terminate this waiting period prior to its expiration and requires that notice of this action be published in the Federal Register .

The following transactions were granted early termination--on the dates indicated--of the waiting period provided by law and the premerger notification rules. The listing for each transaction includes the transaction number and the parties to the transaction. . . .

[06.30.2014] 20141051 G Bayer AG; Merck & Co., Inc.; Bayer AG. 20141052 G Merck & Co., Inc.; Bayer AG; Merck & Co., Inc. . . .

Not surprising, given the lack of US overlap in the involved businesses -- between each of Bayer AG and Whitehouse Station. Now the European Competition Commission is on deck -- to clear the deal -- do stay tuned. And have a glorious sun-drenched Friday!

Thursday, July 10, 2014

For Second Time In 30 Days, Chairman & CEO Lightens Holdings Slightly, Via Pre-Arranged Plan Sales

At the end of the day yesterday, Mr. Frazier disclosed another near 10,000 share sale, bringing his total sales to close to 20,000 shares since June 10, 2014. Each of these were via cashless exercises of options, in each case options granted and vested many years ago -- they were relatively close to expiry date, in any event.

As we said then, however, since these are simply pre-set trading plan sales -- they do not reflect a view of any kind -- about Merck's current operations or prospects. As with all high executives at Merck, he is now likely over-invested (from a diversification standpoint) in Merck -- it is his career as well as his single largest investment (by asset class), in all likelihood. So this small diversification should not concern the market. Afterall, Mr. Frazier still owns over 341,000 Merck common shares outright (and holds the right to acquire several hundred thousand more, via options) -- after these transactions.

In fact, after the cashless exercises of a day or so ago (and the related partial sales) -- his net position has increased slightly -- by about 3,000 shares since June 10, 2014. He's up -- not down -- in total beneficial ownership of Merck stock. Trust that.

Longer Term (8 to 12 Months Out), ISI Group's Schoenebaum (Like Almost All On Wall Street) Expects Opdivo® (Nivolumab) To Best Merck's Pembrolizumab In US And Be Oncology Front Line "Standard Of Care"

So -- while the potential October 28 date at FDA for Merck's immuno-Anti PD-1 candidate remains in place (and likely ahead of BMS's timeline in the US -- for melanoma), BMS is swiftly pivoting toward approvals in the US for lung cancer -- the bigger market opportunity, by far -- and is very likely to garner the first US FDA approval, for that mammoth indication. To speak more plainly, that will render Merck's candidate quite clearly. . . a second-class citizen, in the most important market, I'm afraid.

This bears much more close watching -- but it seems the horse race is now BMS's to lose. It has the most important lead, here. From Investors' Business Daily, then:

. . . .Nivolumab, now branded Opdivo, is Bristol's lead drug in the much-anticipated anti-PD-1 class of cancer fighters and has achieved outstanding results in clinical trials against melanoma when combined with Bristol's already-launched drug Yervoy. . . . [ISI's Mark] Schoenebaum added that the combo will probably become the standard of care and overtake Merck's anti-PD-1 pembrolizumab, which is in process for a melanoma approval perhaps eight months ahead of Opdivo's. Opdivo is also already on the FDA's agenda as a treatment for squamous-cell lung cancer and was approved for melanoma three days ago in Japan. . . .

So -- if Merck reaches US FDA approval in melanoma first (though as of this morning, there isn't even an Advisory Committee date on the FDA's official calendar -- for immuno-oncology candidates) -- it will likely only be by a few months, as I've long held. The bulk of this perhaps $35 billion market opportunity will go to BMS. Just my guess. Do stay tuned.

Wednesday, July 9, 2014

Dutch Court: Mylan To Pay Merck Damages -- For Sales In EU Of Generic Version Of Propecia®?

This patent litigation has raged hot and cold -- including some country by country settlements -- since early 2012. In October of this year, the central patent expires on finasteride. [Two of my many older backgrounders -- more generally, on the Merck hair loss drug's travails, here; and here.]

So -- Mylan may well end up (at some distant future date) paying infringement royalties to Merck for the 2012 to date sales, at least in the Netherlands. I am sure Mylan will appeal. If it does, it will have to post a bond for at least a portion of the awarded damages. So I expect settlement talks are underway, now. Here is the item -- and a bit (do go read it all):

. . . .[The patent] has been the subject of legal proceedings in various countries, with different outcomes:

▲ In the United Kingdom, the Court of Appeal held the patent to be valid.

▲ The German Federal Patent Court invalidated the patent for lack of novelty. On appeal, MSD and Mylan settled the case.

▲ In France, EP 724.444 B1 was held invalid by the first-instance court; the case is now on appeal.

▲ The Spanish first-instance court and the court of appeal invalidated EP 724.444 B1 for lack of inventive step.

▲ In Italy, EP 724.444 B1 was held valid at first instance, and MSD and Mylan settled on appeal. . . .

Do stay tuned. . . we will too. Have an excellent birthday -- if today is your special day!

Tuesday, July 8, 2014

Merck's Chief HR Officer Nets Over $5 Million In Open Market Sale -- Cashless Option Exercise On Monday

Again (as was true with Mr. Deese last week), this HR EVP's sale was all dictated by a so called 10b5-1 trading plan, so this doesn't say much about the executive's view on Merck's fortunes or operations.

It just says that she has diversified her holdings -- to the tune of $5.2 million. She still has over $5.5 million in Merck equity of various sorts. So, she is still keenly focused, I'd argue.

This automated robo-press-writing algorithm quotes a gross figure, not the net proceeds (and even then, the $5 million is pre-tax):
. . . .Mirian M. Graddick Weir sold 180,047 shares of the company’s stock on the open market in a transaction that occurred on Monday, July 7th. The stock was sold at an average price of $59.16, for a total value of $10,651,580.52. Following the transaction, the insider now directly owns 93,564 shares in the company, valued at approximately $5,535,246. . . .

Nice work -- if you can get it.

Leerink Swann Had Merck At $57 Since February 2014 -- Now. . . Target Is $60 (But CIti Targets Merck At $57)

Well, I think the overall message here -- as a consensus -- is that Merck is pretty nearly "fully valued".

As the headline indicates, Seamus Fernandez's firm has a new 12 month target of $60 on Whitehouse Station's common stock. That's up only five per cent from the last target -- and only a percent or two above today's NYSE opening price. Significantly, Citi has a 12 month target below today's price -- at $57, though that too was an increase, for Citi.

Last week, during the holiday lull, Barclays (the optimist of the bunch, at the moment!) set $61 as its new 12 month target. [Recall that Barclays inherited the Lehman Bros. analysts -- when the latter firm imploded in 2008.] Still not very much over the current NYSE MRK trading ranges. So it goes.

[BTW, I love that Matt Herper was able to pin Merck down -- on the record -- on the Italian Zetia MD ham-handing. Sometimes, at least, the little guys get. . . heard.]