Astra-Zeneca Snags Merck’s Overall Business Leader — In China — A Coup!

June 16, 2015 - Leave a Response

While almost all multi-national pharma concerns have experienced their fair share of bumps in the road, in China — most often related to procurement, and contracting — and several are still under DoJ investigation (for alleged FCPA irregularities) here state-side, Ms. Cheng had kept Merck’s nose quite clean, in that regard. So I expect it will take more than a minute to fine a worthy successor, to report in to Kenilworth, from Beijing or Shanghai. In time, Mr. Frazier will find the right person — but it will take some time. So, this is a coup for AZ.

From Pharmacy Times, then — a bit:

. . . .AstraZeneca today announced that Pam P. Cheng has joined the Company as Executive Vice President, Operations and IT. Pam will succeed David Smith, who is retiring after nearly ten years with AstraZeneca. Pam will be responsible for manufacturing operations and supply chain, procurement and information technology globally. In the role she will oversee continued progress in driving efficiency and delivering excellence in these areas. . . .

Ms. Cheng was a 17-year veteran of Merck & Co., most recently serving as President of MSD China, covering a wide functional scope which included commercial, R&D, manufacturing and various business support organizations. Prior to serving as President of MSD China, Ms. Cheng served as Senior Vice President, Global Supply Chain Management for Merck in New Jersey, with overall end-to-end supply chain oversight for its human health, vaccines, and consumer care businesses globally. . . .

Just now recovering in full, from a late Blackhawks festivities night. . . but onward, we go. I’ll have a note up later today, about an update on one of the potential buyers (a for profit business) for Whitehouse Station. So, stay tuned, buckaroos.

Slightly O/T — Monday “History Of The Law”: The Great Seal And Writ Turns 800 Today

June 15, 2015 - Leave a Response

To be sure, the bulk of the Magna Carta is about preserving the property rights of the nobles, then at odds with the Crown. Even so, you need not join U. of C. law professor Tom Ginsburg in vilifying the Writ. Why? Because more than any proclamation or coherent set of ideas before — especially at Sections 38 through 40, and 44 to 45, of that aged sheet of vellum — are the beginnings of our nation — ruled by, and of laws — not men. In sum, Tom is simply. . . wrong.1

From those three to five sections (quoted below, in blue) comes eventually the right to trial by an impartial jury of peers, the right to confront ones’ accusers in open court and. . . most importantly, what we now call “due process of law” — what the English called then a “right of justice“. [Prior to Magna Carta, it was something the Crown could sell, and then refuse to enforce, at its whim. But today, that same Crown will celebrate this 800th birthday.]

. . . .No bailiff for the future shall, upon his own unsupported complaint, put anyone to his “law”, without credible witnesses brought for this purposes. . . .

No freemen shall be taken or imprisoned or disseised or exiled or in any way destroyed, nor will we go upon him nor send upon him, except by the lawful judgment of his peers or by the law of the land. . . .

To no one will we sell, to no one will we refuse or delay, right or justice. . . .

Men who dwell without the forest need not henceforth come before our justiciaries of the forest upon a general summons, unless they are in plea, or sureties of one or more, who are attached for the forest. . . .

We will appoint as justices, constables, sheriffs, or bailiffs only such as know the law of the realm and mean to observe it well. . . .

So — despite all her flaws (including perniciously singling out “the Jews” for onerous treatment), the grander ideas embedded in Magna Carta — and carried to the New World, via her ancient DNA, flow through to the birth this nation’s rights and privileges, down to this very day. Without these starts at the lofty ideas of Magna Carta, there would have been no Bill of Rights, no Civil Rights Act of 1964, and no Voting Rights Act of 1965, as just three examples. Onward — and. . . now, go Hawks!


1. Tom also points out that women couldn’t testify in certain trials, under the writ. What that fails to acknowledge, is that women COULD, after the writ, at least testify in trials about the death of their husbands. Prior thereto, there was no guarantee that any woman’s word would be accepted into evidence at trial — in any matter. So, yes — the law was flawed, and primitive in 1200. But this was a halting step. . . forward. Under Section 8, a woman could not be thrown off the land simply because her husband had died — and she would not be required to remarry, in order to keep their lands. That too was a step forward. So, I think Tom is wrong to vilify Magna Carta, with his benefit of hindsight.

Space Science “Sunday Fare”: Rosetta’s Comet Lander, Philae, Is. . . AWAKE!

June 14, 2015 - Leave a Response

We all (goofy amateurs who follow matters of space science, generally) optimistically expected that — as the comet drew closer in, toward a distance about equal to the orbit of Mars, and began to warm up, more and more of the ice would melt, and my little buddie Philae’s solar panels would get some sunlight. We hoped it might get more than just some. And, that has in fact occurred!

You may recall the European Space Agency’s mission scientists thought, back in November of 2014, that little Philae ended up stuck under an icy crevice, tipped to one side, and thus was suffering from shadows obscuring all sunlight, for most of the “days” — on that comet’s surface. And so. . . its batteries died. But this morning, it phoned (radioed) up to Rosetta — and Rosetta just relayed the call home. Per ESA, then:

. . . .For 85 seconds Philae “spoke” with its team on ground, via Rosetta, in the first contact since going into hibernation in November.

When analysing the status data it became clear that Philae also must have been awake earlier: “We have also received historical data – so far, however, the lander had not been able to contact us earlier.”

Now the scientists are waiting for the next contact. There are still more than 8000 data packets in Philae’s mass memory which will give the DLR team information on what happened to the lander in the past few days on Comet 67P/Churyumov-Gerasimenko.

Philae shut down on 15 November 2014 at 1:15 CET after being in operation on the comet for about 60 hours. Since 12 March 2015 the communication unit on orbiter Rosetta was turned on to listen out for the lander. . . .

Now, mission scientists will adjust Rosetta’s orbit around the comet, to get more “talk time” — with my lil’ buddie, on the surface. It will be an exciting science summer, through to October of 2015, at least. Excellent; and Onward!

Propecia® MDL UPDATE: Dr. Imperato-McGinley Agrees To Deliver Requested Finasteride Clinical Trials Documents

June 13, 2015 - Leave a Response

UPDATED | 06.13.2015 @ 8 PM EDT: In response to Mr. I — here is the letter/order mentioned below, as a PDF file. I obtained all of this from the US Courts’ PACER electronic filing desk — you need to sign up at the PACER virtual window, and pay ten cents a page for each download, via a valid credit card. As to putting the narrative together, it helps a lot to know what to look for — and how to read the context, into what turns up. Note that the PDF contains the case file number at the top of each page, in blue. That’s how you track a case’s progress — remotely. Now you know. As to the substance, I actually suspect not much new will turn up, in the good doctor’s files — at least not anything the plaintiffs’ lawyers haven’t already sourced from Merck directly, in all likelihood. Now. . . GO Hawks! End, Updated portion.

The June 19, 2015 previously-scheduled conference (and potential contempt of court hearing) in the US District courthouse, for the Eastern District of New York (Brooklyn) is now postponed — to August, by agreed order.

The good doctor has agreed to turn over her documents. And the parties are speedily resolving their other production differences, we are told. There may still be some motion and briefing practice, as to a handful of of the issues remaining, but we will learn about that at the August 2015 conference. So, all as I predicted: no open fights, in Brooklyn in the near term.

. . . .An agreement has been reached with Dr. Imperato-McGinley, on the delivery of documents. . . .

So it goes. Onward. [Jurassic World was good fun, quite late last night.]

The Latest Delaware Federal District Court Challenge — To Gilead’s Win, At The USPTO On Interference — Is Likely To Be Summarily Dismissed

June 13, 2015 - Leave a Response

Still remaining are  several other suits — on the broader IP issues here — but this most recent one (just filed in May 2015) looks like a loser, for Merck (via its purchase of Idenix).

Gilead’s lawyers just filed a motion to dismiss this latest suit — for lack of subject matter jurisdiction. And it looks to me like a clear winner. In fact, Merck’s lawyers indicate (via footnote) that they do not oppose this motion. A very recent appellate case has found the interference challenge arguments of Idenix, and therefore, Merck — to be out of bounds, here. A case called Biogen (involving that company) has established this pretty firmly. So now you know:

. . . .On May 7, 2015, the United States Court of Appeals for the Federal Circuit affirmed the district court’s holding in Biogen and held unequivocally that “the AIA eliminated district courts’ subject matter jurisdiction under pre-AIA 35 U.S.C. § 146 to review decisions in interference proceedings declared after September 15, 2012.” Biogen, 2015 WL 2109812, at *10.

Despite that ruling, two weeks later, on May 21, Idenix filed its complaint in this case, seeking review of the PTAB’s decisions in the ’981 interference pursuant to 35 U.S.C. § 146. Idenix acknowledged the Federal Circuit’s Biogen opinion, but disagreed with its holding and stated that it filed its complaint “to exercise and preserve [its] right to pursue a Section 146 action.” (D.I. 1, at Footnote 1.) Idenix also informed this Court that it would be simultaneously appealing this same interference to the Federal Circuit under § 141. (Id.) Indeed, the next day, Idenix filed a second “Notice of Appeal” seeking review of the same rulings in the same interference in the United States Court of Appeals for the Federal Circuit pursuant to 35 U.S.C. § 141. . . .

We will keep you updated — on all the other facets of this potentially multi-billion-dollar series of claims and counterclaims, in litigation, which now sprawl across courtrooms in most of the developed world. But that’s for another day — as it is truly lovely out — and, off I go.

Saturday Musings: Who Is Entitled To The Couple’s Jointly-Created DNA? Who Is Responsible? 21st Century Law Reflections — When Couples Split

June 13, 2015 - Leave a Response

I’ve seen a flurry of articles — mostly about lawsuits — on what happens when modern couples split — but have DNA stored, jointly. So I’ve decided (over coffee and a banana, and fresh OJ) this fits with Merck’s legacy Schering-Plough/Organon reproductive medicines and family planning lines of business (or. . . it is at least as good an excuse as any, to write on the topic).

Let’s start with the basics: while every state presumes that married male-female couples are both considered the parents of any child born into the marriage, every state now allows any outsider to the marriage (upon competent evidence) to file a suit and present that evidence — to establish that the child is “made up of/from the DNA” of that stranger to the marriage. Absent a donor agreement (which would nullify these parental rights), or surrogacy contract — any person’s DNA — found to be present in a child, to 95 per cent probability of parenthood, would be enough to allow visitation, and would correlatively allow the married couple to seek support payments, and perhaps even allow the stranger to enforce joint custody arrangements (in every state in the Union, if memory serves). This is true, regardless of whether there is a separate, conflicting, contemporaneous marriage. That’s the boring, straight black letter law, here. [And so, many traditionalists will need to expand their views of what makes a collectively shared DNA group. . . a blendedfamily“, in my opinion.] Now let’s take a look at a few of the variations, all of rather recent vintage:

In a high profile Arizona case, two WNBA players (apparently using a sperm donor, and a written donor agreement) to get pregnant — while married — are splitting, at the insistence of the non-pregnant spouse. The non-pregnant soon to be ex-spouse wants to avoid the implications of having a child jointly, by annulling the marriage. The pregnant spouse intends to carry to term, and seek support. This is so, even though the spouse she will seek support from has no DNA in common with the baby-to-be, nor any adoption papers, nor any agreement to jointly raise the donor’s DNA. That one will make new law, for certain.

In another case, a female MD who, while fighting cancer, along with her then-boyfriend, long ago banked fully fertilized eggs, in cryo-storage (i.e., DNA from both of them — an embryo), in the hope she’d survive the cancer — and upon her return to health, wanted to have a surrogate carry that embryo to term. Her efforts were held in limbo, until yesterday, when a judge ruled in her favor — basing his ruling on the fact that a written agreement exists, which to allows her to proceed, in his view. The ex-boyfriend had sued in Chicago — to keep her from using their three fertilized eggs — for just the purpose described in the agreement. He says the storage facility agreed in writing not to do anything with the embryos without both of the “parents'” consent. And he’s not. . . consenting. But of course, the storage facility’s written agreement meant only that it could not sell the embryos — to a third party stranger.

Finally, a female actor/model wants to prevent her ex-fiancé’s attempt to create a jointly-shared DNA life, from an embryo they banked, while together — and so, she has waged a long-running legal battle to prevent him from implanting the joint DNA into a surrogate, post the relationship. So, onward it goes.

From the Gray Lady’s coverage of the WNBA case, then — a bit:

. . . .In a petition for annulment filed June 5, Ms. Griner, a center for the Women’s National Basketball Association’s Phoenix Mercury, said their marriage of less than a month was “void based on fraud and duress. . . .” Ms. Johnson, the court papers said, pressured Ms. Griner into marrying her with “threatening statements. . . .”

Ms. Griner’s divorce filing in Maricopa County Superior Court in Phoenix came the day after Ms. Johnson announced on Instagram that she was pregnant — with a photo of a cake shaped like a bun going into an oven. . . .

And, from the actor/model’s case:

. . . .Two people fall in love and want to have children. For whatever reason, they try in vitro fertilization, which successfully results in embryos ready to be brought to term at their discretion. But they fall out of love. One person still wants those embryos to become children, and the other person does not.

This very personal battle has in recent weeks become public for the actor Sofia Vergara and her ex-fiance, Nick Loeb, as he claimed in tabloid newspapers that she wanted to destroy frozen embryos they had created. On Thursday, he brought this battle to the New York Times, which ran his editorial about why their two embryos “have a right to live. . . .”

I may offer more on this, as these — and other cases — progress. [Graphic/image, above right, derived from a Wiki-Commons photo of a sculpture. Fair use claimed.] Onward — to a cool, clear, fun Saturday!

An Intriguing Matt Herper Piece — In Forbes — With Merck’s “Three Times FDA JILTED” Candidate Bridion® — As Its Poster Boy

June 12, 2015 - 2 Responses

As we last noted around St. Paddy’s 2015 — sugammadex (a former 2008-09 “Fast Fred” Five Stars candidate) has been repeatedly left at the altar, by FDA staffers and the associated Advisory Committees. That is probably wise, in my estimation. [It is however approved — and on sale in a handful of countries around the world — as Bridion®.]

The latest? Today, Matt Herper re-ignited the engines — on calls to require companies to disclose precisely why FDA repeatedly bounces certain drug candidates. He offers great analysis of a new British Medical Journal study — one that lays bare how far off the mark most companies are, when describing the “why” behind repeated “complete response letters” (that’s the modern term for a rejection letter, at FDA). Here’s a bit — do go read all of Matt’s fine writing:

. . . .Current FDA regulation means that the agency does not publish its rejection letters, known as complete response letters. But FDA researchers led by Peter Lurie, the Associate Commissioner for Public Health Strategy and Analysis at the FDA and a former researcher at the consumer gadfly group Public Citizen, found a clever way around this restriction. They broke up the complete response letters, resulting press releases, and filings to the Securities and Exchange Commission into discrete statements. Then, they counted how often the statements in the press releases (or, in a separate analysis, the SEC filing) matched what was actually in the rejection letter.

Twenty one percent, or 13, of the press releases did not contain any of the details from the letters. Press release statements matched only 93, or 14%, of the 687 statements about reasons for rejection contained in the complete response letters. This increased to 101, or 15%, when the analysis of SEC filings was concluded. . . .

And so — the fate of Bridion may dribble now into 2016 — and that’s eight full years beyond Fred Hassan’s “most conservative” predictions. Maybe it is just not such a great drug, afterall, on the safety vs. efficacy/perceived OR benefit, as a co-plotted dimensional x-y chart. Onward — have a stellar weekend, one and all!

UPDATED: Plaintiff’s Answer Date Extended To June 25, 2015 — In “What Makes A Bully?” FMLA Post Trial Motion

June 12, 2015 - Leave a Response

Please take the poll at top left margin. As a reader, what do YOU think? Was this a bit of bullying/overreach, or prudent post trial motion practice — to seek return of what would putatively be the Merck shareholders’ $68,000 (which effort I’ve noted may cost well over $100,000 in additional legal fees — to ultimately recover the $68,000, from a. . . mom)? You may have your say. See at left.

I write a smallish update to this item, this morning, simply to indicate that the very able Judge Chesler has granted the plaintiff some additional time to answer Merck’s motion for taxation of costs, here.

And, as I said on Monday, the law plainly allows this sort of odious post trial motion practice behavior — I just find it. . . a little over the top, and immoral, truthfully.

As I said before, she is an individual, facing down a global public company with annual revenues of well over $40 billion a year.

And, as I said before, she made out a good faith case. The jury didn’t find her way, but it was clearly a good faith case (in my opinion — and federal District Court (NJ Dist.) Judge Chesler’s — based on his prior rulings).

. . . .So Ordered: Answer In Opposition Now Due June 25, 2015. . .

I will also note that in the wake of her loss, several members of Congress are again calling for new legislation to afford moms (like her) greater protections, at law. And that bastion of old line capitalism on Wall Street, Goldman Sachs & Co., just expanded its paid paternity/maternity leave policies on Tuesday — though I’d be cautious about drawing a direct connection to the outcome in this case — as to the Goldman movements. Previously, Virgin Atlantic had granted a full year, to its employees — as well.

Onward, then. Still not sure how to handle your disclosures — about potentially blended/entangled parenthood, here.

Merck’s 2014 Sirna/RNAi Divestiture Epilogue, Of Sorts: “The Merck 6″?!

June 11, 2015 - Leave a Response

From my perspective, I’ll take the side of Dicerna — and trust that it did, in fact — as it says — appropriately investigate Alnylam’s concerns in January, and conclude that it had firewalls in place, to keep trade secrets of Alnylam (which were acquired by Alnylam, from Merck, in 2014) from being used inappropriately at Dicerna, by the so-called Merck Six.

I suppose (on balance) I fall on the side of freedom of contract — the freedom of scientists to find gainful employment, here in the US. I do also respect intellectual property rights, but saying that six former Merck scientists (who I’ll speculate were likely facing a downsizing after Merck essentially exited this area of research and development), are unable to work anywhere in their chosen field of endeavor. . . seems decidedly. . . un-American. Smile. Yes — that is tongue in cheek.

In any event, here is a bit of Dicerna’s response press release this morning. Do also go read Derek Lowe (at In The Pipeline) on the topic.

. . . .”Dicerna’s technology is built firmly on its own research and innovation” noted Douglas Fambrough Ph.D. chief executive officer of Dicerna “Dicerna focuses on serious life-threatening diseases involving the liver and genetically defined cancers for which patients have few or no treatment options available. Our RNAi-based therapeutics utilize our proprietary RNAi technologies and not prior Merck research. We stand behind these technologies and the company’s record and practices for respecting IP rights in order to develop and deliver life-changing therapies as efficiently as possible. . . .”

Earlier this year Alnylam indicated it was concerned about unspecified aspects of Dicerna’s GalNAc delivery technologies. Dicerna then conducted a thorough investigation and confirmed that there has been no use of Merck/Alnylam confidential information at the company. Dicerna communicated the results of its investigation to Alnylam (one of many facts omitted from the complaint). Likewise Dicerna communicated to Alnylam facts demonstrating that many of the insinuations in the Alnylam complaint are simply false and others are unfounded speculation. . . .

My prior background (circa March 2014) on the unwinding of Merck’s interest in RNAi tech, is here. Here was yesterday’s version of Alnylam’s original complaint in state court in Massachusetts. I will predict that unless this all settles very quickly, the suit will be removed to the federal courthouse in Boston, by Dicerna’s counsel. Both are Delaware companies, and both have executive offices in Massachusetts, but I still see that as being likely — if this is to go to trial. But we shall see. Onward. Missing your soft lips, miss. . . .

Is This Proof That The J&J Versus Merck Remicade® Arbitration Settled On Very UNFRIENDLY Terms? I Think So.

June 10, 2015 - Leave a Response

This morning, Kenilworth and a bio-similars development subsidiary of the Samsung Japanese entities announced some encouraging Phase III results (prior coverage of that relationship here). Among other things, they announced that the pair’s joint study of a bio-similar to infliximab, the agent branded as Remicade® around the world [and marketed by both J&J and Merck(!)], has shown good results — and will likely allow a filing with non-US, non-EU (i.e., “rest of world“) drug regulators later this year.

This is fascinating. Our readers will likely recall that — as a result of less than perfect lawyering, in the Schering-Plough reverse merger transaction — Merck was forced into an arbitration — against J&J — over the global rights to Remicade. That arbitration ultimately settled with J&J getting US rights, and Merck getting EU, Turkish and Russian rights to market the medicine. That left all the rest of the world as “open territory”. Now Merck is going to sell knockoffs of the stuff, wherever it is not prohibited by license from doing so. I suspect J&J is none too pleased about this development.

Why? It will eat into future market expansion plans of J&J, for the branded product — and (to my eye at least) this is Kenilworth effectively thumbing their collective noses — in the general direction of J&J. [Of course, as we’ve reported, Merck is presently suffering “generic” introductions in parts of the EU, which would lead me to now wonder aloud — whether J&J is quietly “helping out” with that competitive set of efforts.] Hilarious. From the presser then:

. . . .The portfolio includes biosimilar candidates in immunology, oncology and diabetes. There are five candidates in Phase 3 development [Merck partnered territories]:

· SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]

· SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]

· SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]

· SB3 Herceptin (trastuzumab) [worldwide]

· MK-1293 Lantus (insulin glargine) [worldwide]

Each of these five biosimilar candidates is expected to be filed with regulatory authorities around the world between 2015 and 2016. . . .

Do go read all of the FierceBiotech item on the studies, and regulatory filing plans too. Because of the manifold geography limitations, these deals may not turn out to be of much material import, overall — to Merck. Onward we trudge — or forge, depending on our mood. . . missing you. . .


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