UPDATING: North Wales Screening Facility Will Apparently Close, Afterall…

July 13, 2016 - Leave a Response

The total remains fixed (for now, in this local round, at least) at 300 to 360, but Merck’s spokesperson did confirm today that a part of the North Wales facility (one building at least) — a screening facility, will close, and those jobs will move to other facilities. [These facilities are separate from Upper Gwynedd and West Point.]

So it is that Derek had the correct “word on the street“, yesterday morning. Here’s a bit from the local Times Herald today:

. . . .Keller declined to give specific numbers, but said “less than 10 percent” of the company’s discovery, pre-clinical and early development employees would be affected. Multiple outside reports put that number at around 3,600 total employees, meaning 300 to 360 jobs could be cut.

According to Keller, Merck will close the North Wales screening facility, which is a separate and distinct facility from Upper Gwynedd and West Point Merck facilities, which are both located in Upper Gwynedd.

Along with the changes, Merck plans to increase investments in exploratory biology “in areas where biomedical research is converging,” specifically naming Cambridge, Mass., and the San Francisco area. . . .

Now you know — and onward, simply awash this evening,in the joys of a new generation — of perfect life. . . smile. G’night!

MRL To Shift About 350 Jobs Out Of NJ and PA — To San Francisco And Boston: Philly.com

July 12, 2016 - Leave a Response

Very early this morning, Derek Lowe had reported on the broad outlines, here (but he had heard that one or more of the facilities might be closed). We chose to wait for a confirmation from Kenilworth. I am now gratified that we did so.

About mid-afternoon, Eastern Daylight Time, Merck partially confirmed the rumblings Derek had heard, in an official fashion. [It also dispelled some of what he had heard, as well — in fairness.]

At one point, there were nearly 36,000 employees in New Jersey and Pennsylvania alone, prior to the absorption of legacy Schering-Plough, into Merck, in November 2009. After this latest set of cuts, there will be fewer than 12,300. Here’s Philly.com’s updated report:

. . . .Merck Research Laboratories is shifting jobs from its old manufacturing centers in Pennsylvania and New Jersey towards hotter biomedical research areas around Boston and San Francisco.

UPDATED 2:55 pm: Merck’s 3,600-staff Discovery, Pre-Clinical and Early Development group is cutting “less than 10 percent,” or between 300 and 360 jobs, from sites in North Wales, Montgomery County; Rahway, N.J.; and Kenilworth, N.J., near the company’s headquarters, says spokeswoman Lainie Keller. The sites will remain open.

Merck “is increasing our investment in exploratory biology in areas where biomedical research is converging, specifically in Cambridge, Massachusetts (home to Harvard University, where Merck has facilities). and the San Francisco Bay area,” said Keller. “Unfortunately, these changes will result in workforce reductions” at the company’s North Wales drug-screening facility and the New Jersey sites “as we shift resources and personnel.”

. . .Merck employs around 12,500 in central Montgomery County, mostly in Lower Gwynedd Township and West Point borough, where the company makes pills as well as developing drugs. . . .

Well it seems that “disease area biology, in Kenilworth” is not shutting down, entirely. And that is good news for all the families of these science and technical people. Now you know. Still beaming brightly, at the new life — and “the opinion of the Infinite that the Universe should go on. . . .”

One Impertinent Question: Is 35 Years Too Long, For A Broad — And Ferociously-Disputed — Basic Biotech Patent, To Live?

July 12, 2016 - Leave a Response

If not addressed, these long-simmering disputes might artificially inflate the prices of both Keytruda®, and Opdivo®, to patients and end-of-line payers — for these revolutionary immuno-oncology treatments. And they might artificially reduce the price of the Genentech/Roche offering branded as Tecentriq®.

But first — a small bit of the 35 year history, here: Genentech has claimed, over all these years, via various PTO interference proceedings, confidential settlements and complicated federal court maneuvers — including (allegedly) “buying off” other patentees — that its so-called Cabilly I, II and III patents cover “any method for producing any immunoglobulin molecule in any type of host cell.” And that is a breath-takingly broad claim.

And so, Kenilworth has decided to preempt yet another set of one-sided “negotiations“, with Genentech/Roche, over the amount of license royalties Merck must pay, under the newly issued continuation patent called Cabilly III, to Genenetech — in order to manufacture and sell pembrolizumab (branded as Keytruda).

Last week, on Thursday, Merck asked a federal District Court judge sitting in Central California to declare the Cabilly III patent invalid — for double patenting, and laches — i.e., the 35 years Genenetech has already enjoyed. Alternatively, Merck asks the court to declare that Merck’s methods do not infringe these old patents — even if they are still valid.

Here is just a bit of the full 20 page complaint at law (a PDF file) — do take a look; it recites a very nicely-detailed history of these Cabilly I, II and III patents — and how they’ve been used as a bludgeon — against most of the important players in biotech, over these three decades:

. . . .Defendants [Genentech/Roche/City of Hope] have asserted that the Cabilly patents broadly cover the use of certain well-known, conventional recombinant methods to produce any antibody product in any type of host cell. Defendants have filed infringement claims under the Cabilly III patent against numerous companies who have made and sold antibody products that were produced using recombinant methods similar to the
recombinant methods used by Plaintiff [Merck] to make Keytruda® (pembrolizumab), and bezlotoxumab. . . .

Defendants have also previously initiated patent license negotiations with Plaintiff concerning the Cabilly patents with respect to Keytruda (pembrolizumab), bezlotoxumab and other Merck antibody products indevelopment. Given Defendants’ acts and statements, Plaintiff’s manufacture and sale of Keytruda (pembrolizumab) and Plaintiff’s manufacture and expected future sale of bezlotoxumab in the United States, a real, immediate, and substantial dispute exists between the parties concerning the Cabilly III patent for which Plaintiff now seeks declaratory relief. . . .

As ever, we will keep an eye on this potentially multi-billion dollar piece of patent litigation — as it could well have industry-wide implications. Earler versions, against other players, have been pending since 2015, brought offensively by Genenetech, in the same District Court, in California. Now you know. Smiling broadly, on a sweltering but joyful Tuesday early morning, here. . . Onward.

A Merck Services LLC Has Acquired Control Of Vestar’s StayWell

July 11, 2016 - Leave a Response

MRK-StayWell-2016 In what was likely less than a $10 million transaction, all in, the Healthcare Services & Solutions, LLC arm of Kenilworth has taken a controlling stake in a Vestar Capital Partners backed entity called StayWell (not to be confused with the other “Staywell“, a Florida-based WellCare health plan servicing company of the same name — this particular StayWell capitalizes its “W“!). . . .

More seriously, this is a nice coup for the Vestar private equity folks. A validation — and a suggestion that Merck intends to continue to build its relationships with payors and providers, via the LLC subsidiary. Here’s a bit, from the press release from StayWell:

. . . .StayWell will continue to operate as an independent entity after the transaction. Vestar will retain a significant minority stake in the Company. Terms of the transaction were not disclosed.

[Merck’s LLC subsidiary] HSS offers services and solutions that help patients, providers, and payors around the world achieve improved health care outcomes more efficiently and at a lower cost, through cutting-edge illness prevention and wellness programs and care management offerings. HSS operates as a separate business unit, independent from Merck’s pharmaceutical products business. Merck is known as MSD outside the United States and Canada. . . .

[Vestar representatives said] “StayWell also brings a large customer base, particularly in its domestic U.S. commercial footprint which includes hospitals, health care providers, health plans, major employers, and leading health advocacy organizations. Our shared emphasis on improving health outcomes, combined with our strong foundations in data, science, and evidence-based offerings, will provide new opportunities for both organizations as a result of this transaction. . . .

We will keep an eye on this one. And, it is — despite the masthead’s message — a day of encouraging signs here. And so, we are smiling, widely, Onward!

In My Opinion, What The FDA’s Priority Review Voucher Progam Was Supposed To Be About…

July 10, 2016 - Leave a Response

Strictly speaking, this is a tangent to the Merck review narrative — but even so, I did edit it a bit, and posted it to the KaloBios site as well — given its rather broad applicability to the PRV effort narrative, now underway at post-bankruptcy KaloBios.

In sum my intention is to highlight the stark differences between the effort to secure a KaloBios PRV (for Chagas), as compared to the Gilead effort — to secure a PRV for Ebola, related to the use of GS 5734 for acute cases (as imaged at right).

Quickly then (with more in-depth background available, here and here), at least two very acute (near death) cases of human Ebola viral infection were cured, at least in part, with the use of GS 5734 in an experimental, compassionate use role, last year.

Were we to look back in time an additional year, we would see that Gilead’s science team — as the Ebola epidemic was flaring-up in western Africa — began trying their library of experimental proteins against the virus (in primate models), with the help of US governmental labs. They came to learn that an older portion of an anti-HCV agent, spliced onto the top of an HIV fighting agent, led to pretty solid animal model results. [That clipped HCV portion, in the 2D model at upper right, is shown in a green hue.]

And, though Gilead will never be able to sell this very expensive “nuc” (pronounced “nuke“) for a profit, it is without a doubt, a vitally-needed tool, as the two known cures in humans would suggest. And so, right now Gilead is studying it in the remaining non-acute cases in Liberia, Sierra Leone and Guinea, with the idea of ultimately filing to seek FDA approval — for an ebola indication — for GS 5734.

The central motivator here is to alleviate death and suffering — from future ebola outbreaks, and to protect against a wide-ranging pandemic in the US or Western Europe. [Merck’s vaccine candidate would likely be the first line deployed there — should an outbreak of size appear in the US or Europe.]

So, Gilead is now eligible for a priority review voucher from FDA related to the tropical disease called… ebola.

And that makes eminent good public health sense.

Okay, contrast the deaths of nearly 11,300 people (and over 28,000 gravely ill) in sub-Saharan Africa in 2014-16 (ebola) with perhaps seven to ten acute cases of Chagas in the US, since the 1960snone of which were fatal.

While I agree it would be optimal — and wise — to have a stable supply of an FDA approved agent (benznidazole) to use against Chagas here in the US, it is a very pale effort, and threat — compared to those presently underway at Gilead and Merck — in many ways working hand in glove, to combat the scourge that is ebola.

In short, some efforts are more deserving than others. That’s my opinion.

Now you know. Grinning ear to ear, at the miracle that is new life. . . . truly amazing.

And, Speaking Of Bonuses… Merck’s USW Local 10-86 Members Should Already Have Theirs…

July 10, 2016 - Leave a Response

As part of the signing of the new collective bargaining agreement at West Point, Pennsylvania a couple of months back (early May, actually), Merck agreed to pay signing bonuses, upon ratification.

The ratification had long-since occurred, and so — as of last Friday, July 1, 2016all members should have seen a deposit advice for their signing bonus, thus:

. . . .Finally (not that anyone has been asking), we’ve been told the signing bonus SHOULD be in this Friday’s (July 1st) paycheck. It will arrive as a second deposit/check in your account. . . .

Now you know — and G’mornin’ — on a Sunday completely bubbling with perfect new baby life, and so much more. . . we are truly blessed — lucky to be alive here and now. . . smiling widely.

When Will Pauline Cafferkey Receive Her £4,000 “Ebola Service” Bonus?

July 9, 2016 - Leave a Response

Many, many other brave UK health care workers have long since been paid the £4,000 bonus the British health ministries authorized for those who deployed to Africa — to remediate the 2014-2016 Ebola epidemic.

Pauline Cafferkey is among others who have yet to receive theirs. At one point, an under-minister for public health had indicated that — because she was once transported (entirely inside the UK) in a manner considered “unsafe” — apparently while she had a fever, in a relapse of her viral conditions — his agency might take disciplinary action against her. We are hopeful that this is not the form of discipline that minister had in mind.

To my understanding, others who are not on staff of Public Health England have received their bonuses, but it may be that the under-minister ruled her ineligible on the basis that she isn’t PHE staff. But the UK’s Mirror news-outlet, and The Guardian, have been asking after it — since at least July 1. Here’s a bit:

. . . .Ebola nurse Pauline Cafferkey, who nearly died after contracting the virus while treating patients in Sierra Leone, has not been given a £4,000 bonus many of her colleagues have received, Parliament has heard.

[UK Prime Minister] David Cameron described the Scottish nurse as “one of the bravest people” he had ever met and pledged to look into the issue after it was raised in Prime Minster’s Questions.

The nurse, form South Lanarkshire, has twice had to be treated at a specialist infectious diseases unit at the Royal Free Hospital in London after coming down with the virus. . . .

“We took the decision to help partner with that country, to deal with Ebola, and it is now Ebola free. . . .”

His remarks came after the SNP ’s Ms. Ferrier (Rutherglen and Hamilton West) said NHS volunteers had missed out on the payments given to Public Health England staff.

She said: “The Prime Minister will no doubt be aware of my constituent Pauline Cafferkey, a nurse who contracted Ebola in Sierra Leone in 2014 when she was there as part of the DFID organised response to the outbreak. She and around 200 NHS volunteers through UK Med have not received an equivalent bonus of £4,000 that was awarded to 250 Public Health England staff. . . .”

Onward, on a quiet, contemplative Saturday morning. Smiling once again, just the same. And wishing only joy for all the workers who risked their lives for the good people of Sierra Leone, Guinea and Liberia. Onward.

O/T, But Not Really: It Is Hard To Know What To Say, This Friday…

July 8, 2016 - Leave a Response

I do feel compelled to say. . . something. Whew. There are five dead police officers in Dallas, this morning — and seven more (two of them civilians), still struggling for their lives.

Yet — and in no way to condone the snipers’ actions in Dallas — there has been an undeniably thunderous drum-beat of very recent live videoed encounters in which (mostly) black men, mostly un-armed, and mostly for what-were-originally-fairly-trivial alleged offenses, end up dead — by police gunfire.

Each is an abomination. Each is a tragedy. Each life is valuable — police officer, and citizen. But we need to accept that race is an unhealed wound, in America.

It will serve no useful purpose (and is illogical) to reflexively blame these murders in Dallas on our leaders who note these facts, about very disparate policing outcomes (but some nut-job right wing bloggers are doing just that). The Governor of Minnesota spoke the truth. Our 44th President simply spoke the truth — that all Americans should be troubled by these needlessly deadly police encounters.

And all Americans should condemn the killers of the Dallas police officers — at least one video of a suspect the Dallas police forces sought (and is now dead) is shown “open carrying” a AR-15 semi-automatic rifle (apparently lawful in Dallas). Moreover, it cannot be a sane answer to read OUT of the Second Amendment, the words “well-regulated” which appear ahead of “militia”. Yes, the NRA too must answer for Dallas.

Prior to actual gunfire (in the odiously wrong view of the NRA), the Dallas police on scene for the protest could not lawfully stop the would-be suspect/protester, even though he was strapped with an semi-automatic AR-15 sniper style rifle. Thanks to the NRA — that is what it claims passes as a constitutional right (against law enforcement), now in Texas. Assault rifles being used to kill police, in the protester(s) hands, in the open — unchallenged in Dallas, until actual shooting starts.

To be clear, the above is not to blame the Dallas police. They have to live with the laws the Texas legislature has passed. That is however, to blame the legislators “captured” by the NRA. The five officers’ blood is on the legislators’ hands.

And the bloodshed caused by police over-reaction in Louisiana and Minnesota, this week — the equally senseless killing of black men — is on the hands of those who chant to the crowds (and the police) that all brown people are to be suspects, first and foremost — and I mean Donald Trump, here.

This is a profoundly sad and shameful moment in America — but one that has been fairly easy to see coming. One largely fed by the wildly self-absorbed and thus irresponsible would-be “Muslim deporting“, and “wall-building” politician the GOP plans to nominate for President. Shameful. [And all of this is not entirely off-topic, since the CDC has suggested treating gun violence like an infectious epidemic. That seems apt (if entirely too pale) — flare ups in Louisiana and Minnesota inevitably lead to. . . even larger infections — in Dallas.]

And now — to provide at least one Merck related trivial update — the appeal of the $200 million wipe out will have to wait, since post trial motions — including the fee motion — are not completed yet, per the federal Circuit, yesterday:

. . . .On consideration of the notice of appeal filed on July 5, 2016, a motion of the type enumerated in Fed. R. App. P. 4(a)(4) has been filed in the United States District Court for the Northern District of California rendering the notice of appeal ineffective, it is ORDERED that the appeal be, and it hereby is, DEACTIVATED.

The appeal will be reactivated upon entry of the order disposing of the last such outstanding motion. . . .

FOR FOR THE COURT

July 7, 2016

Peter R. Marksteiner

Clerk of Court. . . .

In addition, AstraZeneca, and all other pre-bankruptcy R&D partners of BIND Therapeutics, were granted protection of their IP rights, in a Delaware bankruptcy court ruling entered yesterday. That’s it, for the trivial.

Now, in an effort to bend the arc of the narrative toward the positive — our family is expecting the next generation of sweet new baby-girl life, this very weekend. So, as they say — “a baby is the Infinite’s opinion that the Universe should. . . continue.

I agree. I agree. Amen, and Namaste. . . take good care of all you love, they are precious human lives — young, and old, new and not so — one and all. Whoosh.

BIND Therapeutics Chapter 11: Shouldn’t Merck File A “Limited Objection”, Too?

July 7, 2016 - Leave a Response

As we mentioned over the long holiday weekend, Pfizer earlier made a $20 million “stalking horse” bid for the assets of BIND, in Chapter 11. Yesterday, AstraZeneca entered a limited objection to that proposed deal, in the Delaware federal Bankruptcy Courts. [That hearing will be underway shortly in Delaware, BTW.]

Simply stated, AZ wants to be sure that Pfizer doesn’t acquire (free and clear of its rights) the patents, patent applications and other intellectual property rights that AZ earlier obtained rights to — via its own previously-spent research collaboration money. Those IP rights, the argument runs, should not be lien-free when/if BIND departs bankruptcy, at least not in the hands of Pfizer, should it win the bidding. AZ simply asserts its rights to receive what it is due under the agreements it struck with old pre-bankruptcy BIND Therapeutics.

It occurs to me that a very similar situation likely applies to Merck — and its earlier (November 2014) R&D agreements with BIND — so I would expect that Merck’s lawyers will soon file a similar objection. After-all, neither of these multinationals wants to have to “ask” Ian C. Read to return their IP — IP they already bought and paid for. Here’s the AZ version of that bankruptcy objection, though — and a relevant bit:

. . . .Upon review of the Sale Motion, AstraZeneca believes that the proposed sale of the Purchased Assets pursuant to the Bidding Procedures may include patents, patent applications or other intellectual property that is or may be subject to the rights of AstraZeneca under the License Agreement. . . .

AstraZeneca does not object to the Bidding Procedures or oppose a sale by the Debtor of any of its patents, patent applications or other intellectual property that is subject to the rights of AstraZeneca under the License Agreement. However, to the extent that the Debtor seeks to sell the Purchased Assets free and clear of liens and interests, AstraZeneca files this Limited Objection to ensure that any and all sales of the Purchased Assets remain subject to the rights of AstraZeneca under the License Agreement, including, in the event of rejection, any applicable rights of AstraZeneca under section 365(n) of the Bankruptcy Code. . . .

We will see if/when Kenilworth’s lawyers make a similar filing. Onward, on a gorgeous mid-summer morning — springing out the door, expectantly!

Merck Appeals Obliteration Of Sofosbuvir Patent Infringement Jury Verdict, Just As Gilead Seeks $15 Million In Its Legal Fees

July 6, 2016 - Leave a Response

Back in mid-June, I guessed that Gilead’s attorneys’ fees might reach almost $18 million in this matter. My guess was just a little bit too rich.

It turns out that — in a motion filed yesterday, in the federal District Court in San Jose, California — Gilead is seeking just a bit over $15 million in legal fees, from Merck — due to alleged earlier “unclean hands” acts, and inequitable conduct.

At almost the same moment though, yesterday, Kenilworth’s own lawyers filed the previously-promised appeal, sending the case to the federal Circuit, in DC. That appeal cites as error (among other things) Judge Labson Freeman’s set aside of the jury’s earlier $200 million verdict, in Merck’s favor.

And now, while we wait for the replies and argument dates to arrive, I’ll mention in passing that Law.com is making some significant hay out of the fact that the same firm that allegedly gave Hillary Clinton “less than perfect” guidance — on her email difficulties at the State Department — is also the firm that allegedly advised Merck to wait until immediately before trial to disclose the “variances” in Dr. Durette’s testimony, over time. Of course, that “varying” testimony (in large part) led the very able Judge Labson Freeman to set aside the $200 million Merck thought it had earlier won, here. Here’s a bit from Gilead’s fee-recovery motion:

. . . .On June 6, 2016, this Court issued its Order Regarding Non-Jury Legal Issues, in which it found that “Merck’s patent attorney, responsible for prosecuting the patents-in-suit, was dishonest and duplicitous in his actions with Pharmasset, with Gilead and with this Court, thus crossing the line to egregious misconduct. Merck is guilty of unclea[n] hands and forfeits its right to prosecute this action against Gilead.” (ECF No. 422 at 65.)

The Court found that “numerous unconscionable acts” each compelled that finding of unclean hands: “lying to Pharmasset, misusing Pharmasset’s confidential information, breaching confidentiality and firewall agreements, and lying under oath at deposition and trial. . . .”

Ouch. For those keeping score at home, the law firm’s name is Williams & Connolly — a silk stocking/white shoe “Biglaw” firm out of DC. Onward, on a rainy, languid, pleasantly serene Wednesday morning, then — with a wry smile, as ever.

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