Monday, May 2, 2016

[Brooklyn Cross-Post] Update From Martin Shkreli's Seven Felony Indictments Edition


Tomorrow, Mr. Shkreli has a largely routine call, for status and timelines, in Brooklyn -- related to the seven count felony criminal indictment.

Here's "what's good, Miley" -- and, here's what's new: Mr. Shkreli Has Just Waived His Challenges To An Earlier Ruling Setting Aside "Client-Attorney Privilege" -- In The Felony Criminal Matters, Out East

I know. I KNOW. I said I wouldn't -- "WOULD NOT" -- but I cannot resist:

So, it seems that Mr. Shkreli's criminal defense counsel just filed a one page letter, in Brooklyn's federal District courthouse, in anticipation of tomorrow's largely routine hearing on schedules & timelines, etc....

The one pager makes it clear that rather than fight about whether Messrs. Shkreli and Greebel have, by their respective courses of conduct, effectively waived attorney-client privilege, under the "crime/fraud" doctrine (as the very able Judge Weinstein has previously ruled, in Brooklyn), Mr. Shkreli will simply not dispute that such a waiver has occured.

In doing so, Mr. Shkreli then may introduce potentially all the Greebel communications he ever received -- all then to be made part of the record, or at the very least large, chunks thereof, as evidence. He will then (presumably) argue that he simply relied on Mr. Greebel's advice -- as he (at least arguably) inadvertently commited the crimes for which he has been indicted. Of course: he was an innocent, and just followed his lawyer's instructions. That's the gist of it.

Ahem. As a matter of criminal law, that defense will only hold water if a reasonably well-informed lay-person in Mr. Shkreli's shoes could not have known (with reasonable diligence, on his part) that the conduct was unlawful -- or criminal. [He hinted at this line of defense, in an earlier MSM interview, when he said essentially "no one can tell if they've broken the securities laws, as they are just so darn complex...." Lunacy, that. For years he's been telling the world what a sophisticate -- as to all affairs Wall Street -- he forever has been. . . .]

And as Mr. Shkreli argues this line of thought -- Mr. Greebel is highly-likely to counter-argue that Mr. Shkreli was the master-mind, and he (Mr. Greebel) was only trying to dampen Mr. Shkreili's otherwise allegedly bad intentions, by casting them in more legally-palatable gowns.

This could be a fire-fight for the ages -- between these two former compadres.

So I'll mention it -- and commemorate it -- with a graphic, above.

It also makes it at least marginally more likely that Mr. Greebel has in fact become a "cooperating witness," and is trying to cut a plea deal, to keep himself out of prison -- and pin it all on Mr. Shkreli. That is pure conjecture, however, on my part, given that from the facts thus far it is now clear that these two close (former) friends are plainly at odds, as to their interests, in describing the predicate events. Fascinating, no?

Having said all that, none of it is likely to materially change events inside the KaloBios Chapter 11, proper.

But now you know. Do go read that letter. It is only a one page PDF. Now I promise not to rubber-neck (too much) at the slow-motion trainwreck unfolding in Brooklyn, on these seven felony criminal charges. Can't stop. . . smiling. Truly.

FiercePharma: AbbVie's Q1 2016 Numbers Confirm Effect Of Merck's Hep C Price Cutting -- On Zepatier®


While I continue to believe that not all the volume and price erosion that Gilead, and now AbbVie, are witnessing will show up as incremental profit for Kenilworth (as I said here, last week), I do think Merck is gaining a toe-hold -- especially in the vast VA governmetnal spend.

In early March 2016, we reported on Merck's deep deep cuts on Zepatier®, to go after the Veterans Affairs (federal government payer -- VA Health Care) business -- and I do think Merck will show solid Q1 2016 sales volume in Zepatier, on Thursday morning's earnings call. However, it may well show far less margin (i.e., price performance), due to these steep discounts -- to win the business. Here is FiercePharma's reporting, of this morning:

. . . .As AbbVie CEO Richard Gonzalez acknowledged on Thursday, Merck has been "more aggressive than we anticipated from a pricing standpoint" -- a factor that’s led to both price and volume loss for AbbVie.

Merck’s list price on its med--$54,600--is well below the $83,319 charged by the Illinois pharma for its Viekira Pak before discounts, or the $94,500 charged by Gilead for its combo med Harvoni. And AbbVie interpreted Merck's pricing move "as a strategy that would go after medical exceptions," since those "historically are in at more of a list price point." On that front, Merck has been “somewhat successful” in picking up those medical exceptions, Gonzalez said.

That’s not all. Merck has also introduced steeper-than-expected discounts in public segments, particularly the Department of Veterans Affairs, AbbVie said. And in that arena, the company "ultimately made the decision that we were not going to compete with the lowest overall price in the VA," adjusting its price downward but not matching Merck’s. The resulting price and volume losses hurt AbbVie, which previously "had a fairly significant share of VA. . . ."


Again, I do see AbbVie ultimately running third, behind leader Gilead, and then Merck -- in this latest Hep C iteration of price-warring. Now you know -- as we wait for Thursday morning. Onward, with a smile.

Sunday, May 1, 2016

From The Recording Secretary Of USW Local #10-86. . . .


[UPDATED Monday Noon EDT -- I now see that the USW has put this letter, below, behind the firewall. If anyone from the USW requests in anonymous comments below, that I remove it -- I'll gladly do so. For my part, I aver that it was on the public side, as of last evening when I copied it -- I do not hold a USW membership card, or ID. Just let me know -- though based on my traffic stats, this morning, it is clear that many many people in Kenilworth have seen it, now. End, updated portion.]

Tonight, the recording secretary of Local #10-86 of the United Steel Workers has posted a portion of what he calls a "Lost Newsletter".

I will simply run it -- without additional intro or editing. I will hope that Mr. Frazier sees it by morning, on Monday (he is known to have read this space -- and pretty regularly). Here it is, then:

. . . ."The fool who persists in his folly will become wise."

-- William Blake

Foolishness

To our shareholders, stakeholders, and the men and women in the High Castle at Merck, these words are for you.

As you may be aware of by now the collective bargaining agreement at our West Point facility expired at midnight, April 30th. Contract discussions continue. Membership continues to work.

But before negotiations turn ugly there are few things need saying for the record. Because we have every reason to believe our concerns never go any further than the fourth floor of building 53 (Human Resources).

Management’s opening proposals to the Union were insulting. We know this to be typical of any negotiations. Companies ask Unions for their first born children, a blood sacrifice and work backwards from there. Sometimes they break the Union’s spirit. Occasionally they settle for less than what they desired. It all depends on who has leverage. But rarely does the Company “lose.”

That is, unless there is a strike.

West Point has had two major ones. One was in 1969. If memory serves, membership voted down the contract and walked out. The strike lasted for the summer. When it ended the Union won a wage increase called a cost-of-living adjustment (COLA). Thanks to inflation the COLA reached $3.15 an hour before it was capped. All in all that was a win for us.

The other big strike was in 1984. We were OCAW then. The Company proposed a two-tier wage system, an obvious Union-busting tactic. The offer was voted down by membership. We continued working under the old contract for about a month. And then we didn’t. We walked in June and returned in September. We lost that one.

Everyone did. Every single vial and pill made by unskilled labor was trashed. The plant site was a mess. The strike was covered in the local press and nationally by papers like the New York Times. West Point suffered a black eye. Merck’s reputation was tarnished as well. Friendships were destroyed. Some wounds never healed.

There were people back who said it was inevitable. That once in a while an environment becomes so hostile you just have to “bleed” the poison out. As if such a process was a cyclical thing. The way a forest fire destroys dead wood and underbrush in order for new trees to grow.

Such thinking is foolish, and dumb.

More history: in 2004 new plant management arrived. They made no bones about their intent – they would break the Union. The contract of 2007 gave the Company the ability to be more flexible. Flex flow, polling and other workplace changes made it easier to run the business. So we were told. Management made a mess of it. To undermine the Union the Company shot itself in the foot.

In 2010 the Union gave away 144 “positions” of non-core work. By far, it was the worst decision by membership in the history of this Local. For a fat bonus check we sold away the livelihoods of our co-workers. It also allowed contractors the opportunity to get their foot in the door. Carpetbaggers, ignorant and arrogant enough to believe they could find cheap replacements for a highly skilled and educated Union workforce.

2013’s contract gave us an opportunity to fix what was wrong with the previous two. The Company turned around and abused the remedies we had hoped to implement. In fact, management used new drafting language to lay off over 100 bargaining unit members. Despite the fact that production work was plentiful and drafting was rampant. Good people were sacrificed on the altar of Target 2015 to the gods of Wall St.

Not too long ago a senior site leader told us they had a plan. They would remove an entire level of managerial redundancy. At the same time they would create dozens of Working Leader positions. The question we were asked, “Is the Union willing to step up and run the site?” The answer was and is YES. Yet management, like a dysfunctional parent, undermines us at every turn. It’s as if they feel threatened by our potential to succeed at self-direction.

Foolish.

Despite all this nonsense our Company netted $6 billion last year. A good portion was generated here at West Point, the largest medicine manufacturing facility in the world. Vaccines produced by Union hands and Made in America. Citizens for Tax Justice noted in 2015 that Merck has another $60 billion in offshore profits stashed overseas.

And yet we are being asked to make concessions. If Merck was bleeding red from debt we would give back. Whenever this Company has asked Union leadership to work with them we have. We care about being successful. Our President presented language on day one for training and safety. We know these proposals will make us a better business. They were handed back with changes and emphasis on the Company having final say, which means our suggestions were ignored.

In their book Re-engineering the Corporation – a Manifesto for Business Revolution authors Michael Hammer and James Chamby point out that management analyzes the shop floor. But the workers understand it.

So how about this. Give us the next few years to come up with cost saving solutions. Let us use our knowledge, experience and training to implement a robust safety program. Let Union leadership engage the shop floor and convince them they really do have skin in the game. That they can have some say about their futures.

The Company had numerous chances to elevate our game. What does it have to show for it? A grievance system backlogged once again and enough waste and discards to build that idiot’s wall between us and Mexico. To continue down the path you are leading us is simply foolish. You can keep getting it wrong or give us all a chance to get it right.

We are not na├»ve enough to believe you would hand us the keys to the kingdom. Frankly, we don’t want them. All we ask is you check your egos at the gate. Give us a chance to do things just a little bit better. Let’s see how profitable that can be.

We might surprise you.

Paul Mercurio/Recording Secretary USW Local 10-00086. . . .


Good night, and Good-speed, to all of good will. Tomorrow is another day.

Bloomberg Is Updating My Story Of Last Month -- On Merck Vs. Gilead Sovaldi®/Harvoni® Patent Spats, Over The Weekend. . .


The very able USDC Judge Beth Labson-Freeman, sitting in San Jose, California is again quoted -- and the date is now set for argument -- on whether there will be remittitur of the verdict amount, now that both side's briefs are on file.

When she rules, we will cover it right here. In the mean time, I'll simply let the readership know that there is no real news in this Bloomberg piece, if the readership has been paying attention to our coverage -- we had all of this a full month ago (April 2, 2016).

. . . .At trial, Gilead and Merck each tried to show the other was claiming credit for scientific advances that wasn’t due. Over two weeks, a parade of doctors and scientists for Gilead, Pharmasset and Merck and its partner Ionis Pharmaceuticals Inc. testified about their roles in the patent process. . . .

Gilead contends that in 2004, at a point when Merck was exploring a take-over of Pharmasset, [a Merck scientist] participated in a phone call in which the secret details of Pharmasset’s compound were discussed. In a pretrial deposition he gave “unequivocal testimony” that he wasn’t on the call, Gilead said. He went on to recant his statement in court when he told the jury he "forgot" he was on the phone call and he had "overconcluded. . . ."


So now you know -- -- though I'd not be at all surprised to see the parties settle, confidentially, for far less than $200 million. And onward, driving north on a perfect Sunday afternoon with college age folks in tow. Smile. . . .

Saturday, April 30, 2016

USW Local #10-86 Will Stay On Job, As Talks With Merck's West Point Management Continue. . . .


It seems that the USW will stay on the job without a formal contract, in about an ninety minutes' time -- thus repeating the same narrative history, of exactly three years ago -- from back on May 1, 2013.

It also seems that contract talks continue -- and that is a hopeful sign. [I simply changed the date -- on my graphic at right, from back then.] We will keep you posted, but do check the Local's website.

. . . .Continue to work. We continue to talk. And If necessary, prepare to walk.

Stay tuned. . .

President Dan Bangert

Your 2016 Negotiating Committee. . . .


This is just how it all unfolded -- three years ago, tonight. Now you know -- as we wish the workers' families the best. So. . . sleep well, you buckaroos, and buckarettes. . . .

Friday, April 29, 2016

Kudos: Merck Set To Deliver Over 300,000 Ebola Vaccine Courses -- To Africa -- Within Weeks


Just as it did a generation ago with the river blindness initiative, it seems Kenilworth has really stepped up -- in combating the latest Ebola flare ups (also in Africa).

This news of 300,000 vaccine vials headed there, and within weeks -- may well mean the end of this horrific epidemic -- when used in a "contacts' ring" fashion. I am humbled by the magnitude of this effort. And to be sure, it is based on fundamental Canadian science, and NewLinks Genetics' development work. Well done -- Merck, NewLinks and HealthCanada.

From the online version of New Scientist, then, tonight -- we learn:

. . . .In March this year, 10 people in Guinea got Ebola after a man who had recovered from it 15 months earlier infected his wife via semen.

The outbreak was contained, partly because 1600 people who came into contact with these 10 received an experimental Ebola vaccine. The drug firm Merck says it will soon have 300,000 doses of this vaccine to help manage such flare-ups. . . .


And so. . . I am hopeful that both sides in the USW Local 10-86 labor dispute will remember that they are stewards to the legacy of ending river blindness. Stewards to science, and sometimes, to science even before maximum profits. So, I am now smiling -- and smiling widely. Let the luminous but clear dawn of bio-science push back -- against the night of disease. . . Very proud -- even as I ask Mr. Frazier to honor this legacy, and settle the contract with the USW.

Merck Labor Relations Update: With No Real Progress To Report In USW 10-86 Contract Talks, Sunday Looms Large


We had honestly expected to read of some real progress, by this point -- on Friday morning, before the collective bargaining agreement expires on the stroke of midnight, as this Saturday becomes. . . Sunday. But that -- thus far -- has not come to pass.

Here then, is the latest, from the USW Local 10-86 website:

. . . .Due to a lack of progress in talks with the Company over contract negotiations we have some very important information for membership:

Once or if a work stoppage or lockout is initiated, PLEASE FOLLOW THESE INSTRUCTIONS: DO NOT report to your Picket Duty assignment. Report to work on your normal shift at your regular start time. Go to the gate you normally use to enter the plant. There will be a Picket Duty Captain waiting to give you further instruction. . . .

In the event of the above situation, our off-site Union Office will be our center for communications. . . .


For our part, we continue to hope for an agreed solution -- for the sake of the employees' families.

And, as I mentioned before -- if any union members (or non-members) wish, anonymously, to inform us about how things are going on the ground, we will preserve your anonymity. That's a promise -- in our comment box.

Onward now, to a fun family filled weekend, here in the City of Big Shoulders. . . .

Thursday, April 28, 2016

Gilead's Q1 2016 Results Show The Stress-Effects Of Merck's Hep C Pricing Move. . . .


After market close today, Gilead reported Q1 2016 results -- and its flagship Hep C cure franchise showed the corrosive effects (on reported -- i.e., post discounted sales revenue) that the entry of a low-priced competitor -- like Merck (as of January 2016) engenders. [Backgrounder, here.]

Were I a betting man, I wouldn't expect that all of Gilead's loss will become Merck's gain. That is not how price cutting in the pharmaceuticals markets works out. Merck too is likely discounting off of its list price, and so too palinly is AbbVie. All of them could see some flagging -- due to the move. But in truth, a price cut was Kenilworth's only real play to get some form of toe-hold, in what had been Gilead's pretty much air-tight space, for at least six quarters running. Here's The Wall Street Journal reporting tonight, on it all:

. . . .In the first quarter, Gilead said sales of Harvoni, its newer treatment, fell 16% to $3.02 billion. Analysts were looking for $3.15 billion, according to FactSet. Meanwhile, Sovaldi sales jumped 31%, to $1.27 billion, but the increase fell short of expectations amid soft European markets. Analysts had projected a 34% rise in Sovaldi sales to $1.30 billion.

Gilead is facing growing competition in the booming hepatitis space. During the quarter, pharmaceutical giant Merck & Co. launched a new treatment that costs 30% less than rival drugs and comes in the form of a once-daily pill. Meanwhile, AbbVie Inc. markets Viekira Pak, a competing and similarly costly treatment it launched in late 2014. Gilead has managed to protect much of its market share, but analysts have cautioned that pressure is heating up. "People are worried about the hepatitis C market," said RBC analyst Michael Yoon. "Prices have gone down [and] there’s increased competition," he said. . . .


As ever, we will let you know whether this Gilead overall revenue miss was "a canary in the coal mine," as to Merck's Q1 2016, at least in the in Hep C space -- as well. But Merck should show pretty robust growth in the immuno-oncology space -- even as it trails BMS, in second, there. That is still a huge pile of reveune, rolling in. As are all of these franchises, in truth. And so. . . Onward.

Smith, et al. v. Merck -- We Mention This Solely To Complete The Record. . . .


Ed Silverman, that fine gent long writing Pharmalot, now over at the Boston Globe's STAT, first reported early this morning on this item. Nice scoop!

The federal District Court sitting in New Jersey has allowed the Smith FMLA opt-in case to proceed, on a conditional certification of class status basis, in an 18 page opinion, overnight. From Ed's item, then:

. . . .The lawsuit, which seeks [at least] $250 million in damages, alleges the drug maker systematically discriminated by paying the reps less than their male counterparts, denying them promotions, and subjecting them to sexual harassment. The lawsuit also claims pregnant employees were often pressured to leave. . . .


That is the allegation, anyway. We first mentioned this almost exactly three years ago. So, this will help keep the record here current. We will (once again) return to quietly monitoring this lititgation. Onward, with a son due in town shortly. . . smile. . . .

Merck Union Woes? With No Deal In Sight, First Seven Days Of Pickets Scheduled -- USW Local #10-86 West Point, PA Facilities


Late on Wednesday evening, the USW Local 10-86 web site was down for a bit of updating; when it came back online, the first week's picket duty rosters (starting Sunday, May 1) were set forth -- in a 42 page PDF file. [Last backgrounder here.]

There was a rally again yesterday, but it appears that no overall deal for a new collective bargaining agreement yet exists. So the first seven days of picket-line assignments are now posted.

And that is unfortunate for all concerned parties -- but especially for the families that depend on Merck facility wages and benefits.

I'll keep a good thought, here -- and hope that calmer heads prevail, a strike is averted (and talks continue), and that work continues, even without that contract finalized -- at the facility.

Now you are right up to date -- g'night to all of good will. . . .

Wednesday, April 27, 2016

Wellcome Trust/Merck Venture Now Enters Phase II With Heat-Stable Rotavirus Vaccine Candidate


It is hard to overstate the importance of having a vaccine that is heat-stable and lyophilized (in a powdered form, for transport), in the developing world. Getting sterile water to re-constitute the vaccine -- on the ground, at point of delivery, is far easier than perserving refrigeration for finished dosing vials -- in these mostly remote and often tropical climates.

As the WHO map at right indicates, rotovirus is a vast burden (especially among toddlers) in India, and Africa. One of the chief barriers to safe and effective administration of the current vaccine stock is the need to refrigerate the vaccine -- all the way to delivery. As many a prior viral epidemic has taught us, maintaining refrigeration of a liquid vaccine stock, in Sub-Saharan Africa, or in southern India -- all the way to point of delivery -- is a highly daunting endeavor. This portends a game-changing moment, then.

This Hilleman Labs venture, with MSD (that's "our" Merck's non-North American arm) and the Brits' Wellcome Trust -- is potentially a huge leap ahead, in preventing rotavirus in the developing world. Still a fair stretch to go yet -- but here is a bit from the press release, overnight:

". . . .Since beginning our collaboration with Hilleman Laboratories, we have been closely monitoring the development of both the rotavirus and cholera vaccines. We are now thrilled to get an opportunity to translate research into preventable treatment. . . ."

Lauding the Indian government’s efforts to reduce child mortality by including rotavirus vaccines under the Universal Immunisation Programme, Dr. Gill added, "This is a welcome step taken by the government of India. However, high dependence on cold-chain for vaccine preservation, is a major gap in the delivery system. With our heat-stable rotavirus vaccine, we aim to further support the government’s efforts of expanding coverage and reducing child mortality. . . ."

Rotavirus is the leading cause of severe diarrhea and death among children less than 5 years of age, 90 per cent of these deaths occur in developing countries. According to the ministry of health and family welfare, nearly 80,000 to 100,000 children in India die annually due to rotavirus diarrhea while nearly 900,000 children are admitted to hospitals with severe diarrhea. . . .


And so, as I write this morning, I have upper-most in my mind these children -- millions of them -- who will live on, if and when this new vaccine becomes available, globally -- at an affordable price point. And that is the goal of this venture. Kudos, anew -- to Kenilworth. And I am. . . smiling.

Tuesday, April 26, 2016

Several New (Improved) Features In KaloBios' Chapter 11 Exit Plan -- DiP Financing Auction Tomorrow In NYC


[This is cross posted (with minor edits) from the KaloBios bankruptcy site.] Overnight, KaloBios filed a major amendment to the Plan and the related Disclosure Statement (that's a link to the red-lined amended statement, a  1 MB PDF -- hefty; not for tight, small bandwidth connections).

I'll have much more, on other aspects of the re-negotiated exit plan in future posts (over there), but the PIPE group has struck an enhanced preliminary deal, in negotiations with KaloBios and the DiP lender group, likely in order to secure a favorable vote (as to the Chapter 11 exit plan, from the so-called Class 4 claimants -- a/k/a the PIPE-ers), thus:

. . . .If Class 4 Accepts the Plan, then the PIPE Claim of each Holder of a PIPE Claim that has Accepted the Plan will be Allowed and, on account of and in full and final satisfaction of such Allowed PIPE Claim, such Holder will: (i) retain the Existing Common Stock purchased by such Holder in the PIPE Transaction; (ii) receive (a) its pro rata share of [277,608] shares of Remaining New Common Stock [and (b) reimbursement of reasonable, documented attorneys’ fees incurred in connection with the PIPE Litigation up to $250,000 in the aggregate among all Holders of PIPE Claims that have accepted the Plan]. The number of shares of Remaining New Common Stock allocated to each Holder of an Allowed PIPE Claim shall be in a 1:1 ratio of the number of shares purchased by the Holder of such Allowed PIPE Claim in the PIPE Transaction. . . .


So, the PIPE group, should they support the plan, will get to keep all the original December 2015 shares bought, plus split up to an additional 277,608 shares (that used to be around 163,000 shares -- or, a 70 per cent increase over last offer), upon exit. And tomorrow at Noon EDT is the auction, for DiP Secondary Plan financiers, at Hogan Lovells' offices in New York City.

Do go see the latest filings at Prime Clerk. More later today -- much more (at the KaloBios Chapter 11 site). Onward, into a gray Tuesday -- with only the Predators still in the Stanley Cup hunt. . . but smiling, just the same. . . .

Monday, April 25, 2016

Updating The Status Of The Keytruda® Vs. Opdivo® Dueling Federal Patent Suits


It has been over a year since last we mentioned these series of federal suits over whether any of Merck's pembrolizumb manufacturing and marketing violates patents held by BMS. About ten days ago, Merck filed another suit, this time in the federal District Courts in New Jersey, to have the BMS patents declared invalid, or non-infringed, by Kenilworth's pembrolizumab. Here is that suit, as a PDF file. So, onward it rolls. . . as ever.

As to the older suits, here is the latest discovery minute entry, in the Delaware federal cases -- these are not likely to reach a trial date before early 2017, in my estimation, now:

. . . .Minute Entry for proceedings held before Judge Gregory M. Sleet -- Discovery Telephone Conference (#1) held on 4/18/2016.

Discussion on the issues presented in counsels' joint letter agenda.

(Court Reporter Kevin Maurer.) Associated Cases: 1:14-cv-01131-GMS, 1:15-cv-00560-GMS, 1:15-cv-00572-GMS(mdb). . . .


At the end of last year, in the UK, the BMS patents were held valid -- but the wrangling contiues there, and in much of the EU. Now you know -- and. . . Go Blackhawks: 2-2! Post scriptum: Hawks are. . . Toast. Congrats to St. Louis. . . .

Pfizer Was Paying Lobbyists -- On Anti-Trust Issues Specific To The Allergan Redomicile Proposal (Now Abandoned) -- In Q1 2016


As I said before, due largely to the 2016 US Presidential election cycle, lobby spend is up quite a bit in this first quarter reporting, at most large pharma concerns -- Pfizer plainly included.

I am highlighting the Pfizer Q1 spend here primarily to mention the company's focus (through lobby firm Brownstein Hyatt Farber Schreck, LLP) on anti-trust lobbying specifically targeted at the now scuttled "Pfilergan" merger/redomicile transaction. I long suspected (and last-speculated, in December of 2015) that antitrust issues were likely to be pretty daunting in the US, on that proposed deal. That now seems plainly true, with the benefit of actual lobby-spend disclosure hindsight. Of course, the second reason I write on this topic, is simply to mention that as is almost always true, Pfizer outspent Kenilworth on lobbying in DC. Now you know -- here is a bit of the detail from Pfizer's Q1 2016 spending reports, now on file with the US Senate disclosure office:

. . . .Patent Troll Legislation. . . . 21st Century Cures Initiative; Senate Innovation Project; Drug Pricing; Biosimilars Reimbursement Policy. . . .

Medicare Rebates/Medicare Part D; Non-Interference; Medicare Part B Reimbursement; Medicare Part B Demonstration Proposal; Medicare Part B CMMI Demo. . . .

Deferral; Comprehensive Tax Reform; Territorial Systems; Patent Innovation Box; Cadillac Tax; Inversions. . . .

International tax policy, including inversions; Trans Pacific Partnership (TPP) negotiations - Executive Branch action re this issue; Miscellaneous tariff bill; Customs reauthorization conference report - HR 644, Trade Facilitation and Trade Enforcement Act of 2015. . . .

Antitrust issues associated with proposed merger between Pfizer and Allergan. . . .

Omnibus Appropriations Bill. . . .


Out for a bit -- to enjoy a perfect Spring midday walk now, will wander by NFL Draft HQ -- big fun, there. . . smile.

Friday, April 22, 2016

Update: After Three Days Of Merck/USW #10-86 Local West Point Contract Negotiations


There is still no agreement on several of the key issues, including 12 hour workdays, outsourcing and part-time workers, among others (just as our earlier anonymous commenters had suggested).

We will keep you posted, but here is the latest from the USW local's website, late this afternoon:

. . . .Local 10-00086 just completed three more days of negotiations, April the 19th, 20th and 21st. Conversations continue and are at times "passionate." We did reach two tentative agreements (TAs); one on Safety Committees and another on Inter-Plant Transfers.

However, major proposals, such as Outsourcing/Subcontracting, Premium Pay, 12 Hour Shifts, Part-time Workers and others still remain on the table. Next week we move into the final week of our collective bargaining agreement.

Remember, with the continued support of membership, we will bring home – A FAIR CONTRACT. . . .


Indeed. Sleep well, one and all!

Gilead Has Renewed Its Motion To Invalidate Merck's Patents On Sofosbuvir


No surprises here, but as post-trial motion practice, proper, wraps up in the Northern District of California's federal courthouse, before the very able Judge Labson-Freeman -- on the Sovaldi®/Harvoni® patent battles -- Gilead has renewed its post bench-trial motion for a ruling that (as a matter of law) Merck's patents are invalid as (i) merely derivative of other prior art, or (ii) due to prior invention by others.

It will be a bit yet before the briefs are all filed, but as I've long said -- it is very far from certain that Merck will ever see even a portion of the jury's earlier award, in this litigation. Here's the bit, from an overnight electronic filing available in PACER:

. . . .Gilead requests judgment that U.S. Patents Nos. 7,105,499 and 8,481,712 are invalid due to derivation under 35 U.S.C. § 102(f). Gilead further requests judgment that U.S. Patents Nos. 7,105,499 and 8,481,712 are invalid due to prior invention under 35 U.S.C. § 102(g). In the alternative, Gilead seeks a new trial on whether U.S. Patents Nos. 7,105,499 and 8,481,712 are invalid due to derivation and prior invention. . . .


As another work-week draws to a close, do go home, and be excellent to one another. Mountain family in town, so much fun ahead. . . smile.

Thursday, April 21, 2016

Federal Propecia® MDL Status Conference -- In About A Week's Time


Not much more additional detail is electronically available, but there will be a status update next week, on Wednesday.

I guess the update will cover (i) discovery progress, and (ii) how the 50 or so bellwether trial selection pool fact sheets are progressing. Those are now due by the first week of May. The initial case pool lists should be complete by May 27, 2016. Here's the minute entry, in full, from yesterday:

. . . .Set/Reset Scheduling Order Deadlines:

Status Conference set for April 27, 2016 -- 02:30 PM in Courtroom 322 North before Magistrate Judge Peggy Kuo. . . .


Onward. Sleep tight all of you -- still stunned and saddened, that Viator is traveling out of the Cosmos now (hoping that the salacious Fox News reports are untrue). . . As ever, tomorrow will be a better day.

Merck's Q1 2016 Lobbyist Spend More Than Doubles -- Over Q1 2015 [With Prince, Footnoted.]


As we generally have in the past, we keep a weather-eye here -- on what Kenilworth seeks from the halls of our Congress, and how much it spends, in doing it. Two caveats, by way of perspective, here: (i) it is a Presidential election year afterall, so much is in play (so much must be spent, at least arguably, to protect Merck's policy positions); and (ii) Pfizer will have spent over $4 million in the quarter, in all likelihood (as ever, not all of Mr. Read's filings are in at the Senate's electronic disclosure desk, yet).

Even so, this is a rather amazing leap in spending -- more than doubling compared to the last few regular quarters' spends -- by Merck. Here is some of the detail, just so you know:

. . . .340B (no specific bill), Hepatitis C (general education; no specific bill), general vaccine policies (no specific bill), antimicrobial resistance (general education and DISARM (H.R. 4187), biosimilars (no specific bill), 21st Century Cures (H.R.6), Senate Innovation Project (no bill number), value of medicines (no specific bill), general pharmaceutical issues. . . .

Comprehensive tax reform (no specific bill), international tax proposals (no specific bill), orphan drug legislation (S.1128), base erosion (no specific bill), territorial tax system (no specific bill), tax extenders bill. . . .

Medicare Part D (general education, no specific bill), changes to low-income subsidy structure in Medicare Part D (general education, no specific bill), Medicare Part B (general education, no specific bill); Medicaid (no specific bill). . . .

Patent reform (H.R. 9, the Innovation Act; S.632, the STRONG Patents Act). . . .

General animal health issues. . . .

Issues relating to the further development of antibiotics and antimicrobials for serious and unmet medical needs; Issues relating to 340b Drug Pricing Program; Antibiotics/stewardship; Value of prescription drugs. . . .

Trans-Pacific Partnership, data exclusivity for biologics. . . .

Medicare reimbursement; Low-income subsidy in Part D; Part B reimbursement and coding. . . .


I do read that bolded bit as tantamount to a defense of the pricing policies Merck (and Pfizer) employ in the United States. To be fair, these companies are innovators, not knock-off artists -- like Valeant, Actavis and Turing (IMHO). So it goes -- as we wish Viator (a/k/a Prince a/k/a Prince Rogers Nelson) a peaceful ride out of the Universe this noon-time. Travel easy; travel light. . . Only 57 -- too young, was he. . . . Whoosh, and gone. Out for a breezy plaza lunch in the warm Spring sunshine here, now -- but still smiling. . . .

Wednesday, April 20, 2016

Merck -- West Point USW Local #10-86 Contract Rally Held Today


I am just dropping a lil' squib here, to serve official notice: if any union members (or non-members) wish, anonymously, to inform us about how things are going on the ground, we will preserve your anonymity. That's a promise -- in our comment box.

This will also serve as a "stay-tuned" reminder -- as this contract draws to a close -- in ten days' time.

So -- do expect to hear more, at this address, as more develops (as it always does), with the USW Local #10-86, and West Point Merck management.

Know also -- all you rank and file Merck workers -- that this outlet appreciates the dedicated, professional and tireless work you do -- to a person, we do. Onward -- in solidarity. . . smile.

Harmonizing Diagnostic Tests -- To Optimize Immuno-Oncology Patient Responses


Yesterday morning, I mentioned (largely by way of footnote) that there would likely be a very aggressive payer-push to use diagnostic testing -- on various cancer patients, to determine which cancers, and patients, would most likely respond favorably to the new class of immno-oncology agents -- Merck's Keytruda® and BMS's Opdivo®.

As an amplifying follow-up here, then -- I will note that Merck is helping drive exactly that discussion, with the so-called Blueprint PD-L1 Assay Comparison Project -- the results of which were shared at AACR last month. The idea is to calibrate diagnostic tests across both (i) the manufacturers of the tests, and (ii) the novel biological agents themselves, to confidently predict where a given therapy will do the most good. Because of the highly-daunting price point on these new therapies, that is a particularly important triage step. Here's a bit, from a Benzinga reprinted press release -- but do go read it all:

. . . .[Merck] is proud to be a part of the Blueprint PD-L1 Assay Comparison Project, an important initiative to compare several new diagnostic tests for the immune biomarker PD-L1 in non-small cell lung cancer (NSCLC). Merck believes strongly in the importance of PD-L1 testing in NSCLC, and is committed to supporting the Blueprint Project and overall efforts to use diagnostics to help physicians identify the best treatment approach for their patients with some cancers.

In oncology, testing is now common for numerous cancer biomarkers to enable physicians to better tailor treatment decisions for each patient. The data from a range of studies, including Merck's studies of KEYTRUDA® (pembrolizumab), demonstrate that PD-L1 testing can be a useful tool to help identify patients more likely to respond to treatment with an anti-PD-1/PD-L1 therapy in certain cancers, including NSCLC. . . .

Results from the Blueprint Project, a first-of-its kind collaboration, were presented at the American Association for Cancer Research 2016 Annual Meeting.

In March 2015, the AACR in partnership with the U.S. Food and Drug Administration and the American Society of Clinical Oncology held a one-day workshop to examine whether multiple companion diagnostics intended for the same class of therapeutics could be harmonized. During the workshop, a group of four pharmaceutical companies and two diagnostic companies released a blueprint proposal to analytically compare and characterize each of their IHC-based PD-1/PD-L1 companion diagnostics for non-small cell lung cancer in the pre-approval stage. The thought was that, upon approval of these tests, the information generated by this project could lay the groundwork for additional studies that will help inform patients, physicians, pathologists, and others on how best to use the test results to determine treatment decisions. . . .


Now you know. Onward, with a crinkle-eyed grin. . . . simply lovely here, this morning!