Merck Animal Health Quietly Acquires Privately-Held Harrisvaccines — Terms Withheld

November 13, 2015 - Leave a Response

I think this latest news may be safely read as more consolidation among newer franchises, in the AH space, broadly — and as a deal that gives Merck access to some newer vaccine tech and product candidates — more narrowly, as it looks for an edge, in competing with the 2013 era Pfizer AH spinoff, Zoetis.

The purchase price will be completely immaterial to Kenilworth, as 45 employees would imply low- to mid- double digits of millions price, as a pure guess. However, in the longer run, the fold in to animal vaccines may well-position the group — as additional consolidating deals among global animal health manufacturers are quite likely, in my view. Here’s the relevant bit, courtesy the overnight Des Moines Register:

. . . .Joel Harris, a vice president with Harrisvaccines, said the 10-year old company has been openly considering offers in the last year in order to help it enhance its ability to grow.

He said the vaccine manufacturer would benefit from Merck’s resources to expand its technology into other areas such as foot-and-mouth-disease in cattle and canine influenza in dogs.

The companies did not disclose the terms of the deal, including the purchase price. Harrisvaccines, which currently employs about 45 full-time people, does not expect any job cuts.

Harrisvaccines was the first company to get approval in 2014 for a vaccine to help protect piglets from the porcine epidemic diarrhea virus that killed millions of pigs in more than 30 states, including Iowa, the country’s largest pork producer. And last month it announced it was awarded a $6 million contract to provide 48 million doses of its bird flu vaccine to the USDA. . . .

We will keep an eye on this, but it ought to close before year end, as there are no Hart-Scott filings, or issues. Enjoying a weekend visit with a nephew, out on a college recruiting trip. . . so, keep it spinning in good karma, one and all!

Excellent News! Pauline Cafferkey Has Recovered — Again!

November 12, 2015 - Leave a Response

With the latest Ebola Situation Report confirming that there are no new cases this week in Guinea, this is a week of almost exclusively good news — globally, on the topic.

Overnight in London, the Scottish nurse who had last month been critically ill for a second time, with a form of menigitis caused by her prior Ebola bout — has been released from hospital, apparently with the help of an experimental Gilead candidate. This is very encouraging, indeed. Our backgrounder is here — and the Gray Lady, on it all:

. . . .The nurse, Pauline Cafferkey, contracted Ebola last year while doing charity work in Sierra Leone and recovered for the first time in January. Last month, she again fell critically ill from the virus.

She was discharged on Wednesday from the Royal Free Hospital in London, which has Britain’s only high-level isolation ward for the treatment of infectious diseases, the hospital announced on Thursday. She was transferred for additional care to Queen Elizabeth University Hospital in Glasgow.

Ms. Cafferkey was the second person found to have Ebola in Britain. . . .

Gilead’s response last month does typify the new pull-quote on my masthead. Kudos to all involved — Merck earlier, throughout Africa, and Gilead these past few weeks! Onward, on a blustery Thursday walk in. . . . 

Boulder’s míRagen® Therapeutics Secures $41 Million Equity Round, From Merck-Affiliated Venture Fund

November 10, 2015 - Leave a Response

míRagen is a Colorado based developmental stage entity — the therapeutic candidates of which are designed to target microRNAs, a class of small RNA molecules that regulate gene expression, and that can serve as potential indicators of disease. Were I betting, I might bet that MRL Ventures is interested in the potential to marry some future míRagen developed therapeutic (or test-marker), to Merck’s Keytruda® — and help treat/predict how cancer patients might be able to benefit most-robustly, from that new therapy. . . . We shall see.

I could certainly be mistaken, though — about that above guess. In any event (complete with a nice Flatirons underlay image), is a graphic, and the story — out of the Denver Post, this morning:

. . . .MíRagen Therapeutics Inc., a Boulder-based biopharma specializing in developing drugs targeting small ribonucleic acid molecules, landed $41 million in financing to bring two of its drug candidates into clinical development. . . .

MíRagen officials on Tuesday announced that the preferred stock financing led in part by a Merck venture fund would advance programs in the areas of hematological malignancies and pathological fibrosis. The drug targets miRagen intends to bring through clinical development are MRG-106 and MRG-201.. . .

These amounts (anything under $100 million) are clearly rounding errors, to Kenilworth, but may lead to a significant new product class, or a test for one. So, the bet is a good one (plus it leads to ski weekends, on the ensuing update/diligendce trips). Onward — on a flawless Tuesday — hunting for good soup. . . . Smile!

Will Bridion® (sugammadex) FINALLY Win Approval (On Fourth Try: 12.19.2015) — At FDA?

November 9, 2015 - Leave a Response

We have covered, for at least seven years, the intrepid path of sugammadex, one of former Schering-Plough CEO Fred Hassan‘s 2007-2008 “Five Stars.” Back then he was touting a likely 2009 approval. If he’s lucky, it might — just might — make approval in the US before the end of 2015. And even then, the concerns with rather rare, but troubling, allergic reactions in the Operating Room Suites seem to continue — in Europe, where it has been approved for over three years, now. This is clearly going to be an immaterial US franchise for Kenilworth, if approved, but it is some good news, nonetheless.

Here is a bit from BioPharmaDive, on it:

. . . .Seven months ago, Bridion was rejected by the FDA’s reviewing panel for the third time. The concern was ‘hypersensitivity’ to the drug, and because the drug had already been used in the E.U. for some time, there were numerous case reports to attest to this risk. . . .

The FDA is not bound by the committee’s guidance but takes its advice into consideration when reviewing investigational medicines. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review of Bridion is December 19, 2015. . . .

It is (in my opinion) probable that the US label-copy will contain strong warnings — about watching for patients’ allergic reactions while under heavy sedation, in the OR. Onward, we go, in any event — on a perfect fall Monday afternoon!

“These are not the droids you are looking for” — Gilead Channels Obi-Wan — In Photo-Tube Flap, Over Solvaldi® (sofosbuvir) Patents

November 7, 2015 - Leave a Response

About twelve days ago, I highlighted some unusual Saturday federal court filings by Merck’s lawyers, in this truly massive, sprawling (globe spanning, actually) patent battle — which if ultimately decided on the merits — could generate (or cost) literally billions in revenue — on sofosbuvir, for the two parties in interest: Gilead and Merck. Late on Friday, Gilead’s answer appeared in the electronic patent dockets, to Merck’s motion to compel.

In sum, you got the wrong guy, man — is the answer. Or, as December 18 looms, brightly — “These are not the droids you are looking for. . .”

[Please forgive the dated reference, there. Smile. Updated PG-13 parody clip, below.] In any event, here is the full 26 page PDF of Gilead’s Response — and a bit:

. . . .Merck’s request is rooted in a demonstrably wrong assertion — that the material in one of the Photographed Tubes is PSI-6130. Merck makes that assertion in the face of overwhelming evidence that PSI-6130 did not exist in October of 2002 and based solely on the unremarkable fact that one of the tubes contains material with a molecular weight identical to PSI-6130’s weight of 259.2. However, Merck is already in possession of information clearly identifying the compound in question as PSI-0194 — a compound having a distinctly different structure from PSI-6130, but sharing its molecular weight. Merck had this information before filing its October 23, 2015 Motion to Compel Plaintiff and Dr. Seeger to Comply with Discovery Requests and Subpoena (the “Motion”). Additionally, after Merck filed its Motion, Gilead provided additional evidence unambiguously identifying the material in the Photographed Tubes as including PSI-0194, and excluding PSI-6130.

Nonetheless, despite Gilead’s requests, Merck has refused to withdraw its Motion, unreasonably forcing Gilead to incur the costs of opposing Merck’s meritless demands. . . .

If you are so inclined, do go read it all — but that is the sum and substance — mistaken identity. So, Merck has no new leg up, here. Off — to enjoy a flawless, SoFA glass sculptures filled Saturday, now. . . photos on insta, later. Smile.

Small Civil Dulera® Pricing Investigation Disclosed In Latest Form 10-Q

November 6, 2015 - Leave a Response

Rather late last evening, Kenilworth filed its Q3 SEC Form 10-Q — and at page 22 we find a new government investigation. There is no indication as to when the US Attorney from the Eastern District of Pennsylvania came knocking with this CID, but I’ll bet a dollar that it wasn’t long after Martin Shkreli’s antics became public fodder. I say this because it looks to be very recent — and Lilly received one, as well.

Regular readers will recall that Dulera was a legacy Schering-Plough product, FDA approved in 2010. In late 2010, once it controlled Schering-Plough’s legacy products — Merck withdrew its application in the EU for approval of an aersolized fixed dose combo version, for a host of reasons. So it goes:

. . . .The Company has received a civil investigative demand from the U.S. Attorney’s Office, Eastern District of Pennsylvania which requests information relating to the Company’s contracting and pricing of Dulera Inhalation Aerosol with certain pharmacy benefit managers and Medicare Part D plans. The Company is cooperating with the investigation. . . .

Morning, one and all! Onward!

As Of Tomorrow, Sierra Leone Is… Ebola-Free

November 6, 2015 - Leave a Response

UPDATED: The Ebola epidemic in Sierra Leone has ended. That is very good news. And we should celebrate it — as we do whenever science and human life finds a way — over adversity.

But in the same moment, we must acknowledge that the life form called ebola (a virus). . . finds a way, too. During the past week, one active case in Guinea, a mother, died after child-birth — and her newborn replaced her, on the W.H.O. lists, as an infection case — so the total in the outlying Forecariah prefecture — and in Guinea — remains (in an unspeakably tragic way) steady, at three. Despite the pending good news in Sierra Leone, the story in the tiny rural village of Tana, in Forecariah Prefecture, Guinea is the front page of The New York Times, this morning:

. . . .The prime minister had arrived, and he was there to give this rural community a serious scolding.

“I demand the cooperation of the population,” said the prime minister, Mohamed Said Fofana, nearly hollering from his perch on a makeshift bamboo stage.

“Ebola is gone everywhere — except here,” Mr. Fofana told the nearly 300 people gathered around him. “The eyes of the world are on Tana village.”

This is the last known place on Earth with Ebola. . . .

Getting to zero — as the effort to finally stop the outbreak is known — has bedeviled governments and international health experts for months. Workers from aid groups have descended on the villages where the virus is still spreading, a promising experimental [Merck/NewLink] vaccine is being given to adults who have been in contact with a victim, and government officials, once reluctant to acknowledge the dangerous outbreak, are helping to wipe it out. . . .

We will certainly meditate — to keep all mothers, expecting and delivered — awash in golden hued good ju-ju, this weekend. Namaste. . . .

While We Wait For Pfizer To File Its Now (Allegedly) Quite Tardy Q3 2015 LD-2 Lobbying Disclosure. . .

November 5, 2015 - Leave a Response

Pfizer apparently occasionaly waits until February or March of the next ensuing calendar year to file its (prior year’s) Q3 LD-2 — lobby expen- diture/ disclosure form. It seems to file the first, second and fourth quarter ones generally on time — but about every second year, it waits past the New Year — to file its third quarter report. Odd. And it generally does so, by claiming an amendment. I am not a pure specialist in this arcane area of the law, but on a review, I see nothing that permits such a delay — in fact, the scheme contemplates robustly prompt filings (without any explicit authority for waivers)1.

The rules in fact further contemplate that a registrant like Pfizer at least file a notice that it is going to be late, and explain the reasons for the tardiness, as I read it. Even so, the tardy filing won’t be excused, without some additional (but apparently unspecified) liability. [Does it pay a fine? That seems. . . unclear.] As I say — odd.

[My weekend backgrounder here; but there will be another post (a right full and proper Part II), on the evolution of so-called inversion-regulation — related to the potential for a $100-plus billion Allergan deal — since we last visited the topic when Pfizer was attempting a semi-, evolving to fully- hostile maneuver to take over Astra-Zeneca, and then nominally re-incorporate in AZ’s home country, and reap vast US tax abatement windfalls, during 2014.]

3f684-mrk-az-2014However, while we wait — we do already know that the lobby-firm Williams and Jensen, PLLC lobbied for Pfizer during the third quarter of 2015 (as it timely filed with the US Senate office of disclosure — to the tune of an annualized $320,000 per year), on:

. . . .[Lobbied US Senate and US House of Representaives about. . .] Tax issues affecting the pharmaceutical industry including international tax. Revenue proposals on international tax. Comprehensive tax reform proposals. . . .

That bit of text would plainly cover loosening of the newly tightened inversion rules — as part of the scheme of corporate taxation of multinationals inside the US. So, Ian Read has been a busy fella’, in the halls of Congress this year — but we may not know precisely just how busy — until early 2016. And by then, he may have won his Allergan inversion-fueled prize. Ugh. Now you know — and as ever, onward — on a perfect fall 70 degree day!


1 Viz., US Senate S1-Guidance PDF file (page 13 of 2008 edition) “…The Secretary and Clerk do not have the authority under the LDA to grant extensions to registrants.

The obligation to report under the LDA arises from active status as a registrant (i.e., a registration on file that has not been validly terminated). Section 5(a) of the LDA requires a registrant to file a report for the quarterly period in which it incurred its registration requirement, and for each quarterly period thereafter, through and including the reporting period encompassing the date of registration termination. A timely report using Form LD-2 is required even though the registration was in effect for only part of the reporting period….

Propecia® MDL Status: Newly-Revised Pre-Trial Conference Schedule [Updated]

November 3, 2015 - Leave a Response

This is just a smallish update — to the schedule laid out generally, here. A new Magistrate Judge has been assigned to the MDL — and the first pre-trial conference has been reset, to a new date, in turn (in blue below).

Even so, no actual trials on the merits, before a jury, are expected before September 2017. We will keep a weather eye on the horizon — for any sign of how the good doctor’s production hearing turned out — though I will note for the record that several people from her institution did visit repeatedly here, just yesterday. So that led me to this update — Thanks!

. . . .The Pretrial Conference originally scheduled before Magistrate Judge Viktor V. Pohorelsky has been rescheduled to 12/3/2015 02:00 PM in Courtroom 322 North before Magistrate Judge Peggy Kuo.

The MDL and all pending member cases have now been reassigned to Magistrate Judge Peggy Kuo Associated Cases: 1:12-md-02331-JG-PK et al. . . .

Now you know. Smiling widely — while looking back. . . with joy some three. . . and eighteen, and thirty six. . .

Keytruda® Gets New FDA Breakthrough Designation In Relatively Narrow Set Of Colorectal Cancers — Smallish Good News

November 2, 2015 - Leave a Response

This is clearly welcome news — for Kenilworth — but it covers only about a fifth (give or take), of all current colorectal oncology cases. And the underlying study, called “Keynote-164“, is still in Phase II.

But we note it — as more step by step evidence that Merck has an important new oncology product/candidate franchise here. [As ever, BMS is out ahead — but there will be multiple billions in annual revenue available to Merck, even as the “second place” overall finisher.] Here’s a bit of the morning’s press release:

. . . .Testing tumors for microsatellite instability can identify patients with defective DNA mismatch repair (MMR) systems. DNA MMR is a process that permits cells to recognize and repair genetic mismatches generated during DNA replication. A defective MMR system allows mismatch mutations to persist. The average tumor has dozens of mutations; however tumors with DNA MMR deficiency may harbor thousands, especially in regions of repetitive DNA known as microsatellites. Tumors that are found to have mutations in select microsatellite sequences, called microsatellite instability (MSI), are considered DNA MMR-deficient. These tumors are referred to as being “MSI high.” Overall, DNA MMR-deficiency is present in approximately 15-20 percent in Stage II disease, 10 percent in Stage III disease and approximately 5 percent or less in Stage IV disease. In colorectal cancers, MMR-deficiency is seen in approximately 15-20 percent of non-hereditary colorectal cancers and in most hereditary colorectal cancers associated with Lynch Syndrome.

Merck is conducting a Phase 2 registration study (KEYNOTE-164) to evaluate the efficacy and safety of KEYTRUDA based on microsatellite instability status in patients with previously treated advanced colorectal cancers, and is also planning a Phase 3 study (KEYNOTE-177) in a treatment naïve patient population. . . .

Now you know — and we will keep an eye on Keynotes-164 and -177. ‘Tis a perfectly sunny fall day here. . . so I am grinning, ear to ear!


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