Idenix Pharmaceuticals Is Now. . . A Merck Subsidiary; Gone From NASDAQ

August 5, 2014 - Leave a Response

It would seem that the Delaware Chancery Court has blessed the settlement we mentioned, here.

And so, with Hart Scott cleared, the tender offer closed this morning. Merck owns Idenix, and its stable of drug candidates. Thus, our attention will now turn to the patent position(s), vis-a-vis Gilead — which arguably reads on Sovaldi®‘s methods — and composition of matter. In the mean time, here is the tender offer closing announcement:

. . . .As of the tender offer expiration yesterday, 131,693,787 shares of common stock of Idenix were validly tendered and not withdrawn from the tender offer, representing approximately 82.5 percent of the outstanding common stock of Idenix on a fully diluted basis. All of such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck expects to promptly pay for all such shares.

Upon completion of the merger, all outstanding shares of common stock of Idenix, other than shares held by Idenix in treasury or shares held by Idenix’s stockholders who are entitled to and properly exercise appraisal rights under Delaware law, will be canceled and converted into the right to receive cash equal to the $24.50 offer price per share without interest, less any applicable withholding taxes.

In addition, upon completion of the merger, Idenix will become a wholly-owned subsidiary of Merck. . . .

So the 17 per cent or so that did not tender, will get cash appraisal rights, which may well come in under the $24.50 offered. Idenix has now ceased trading on the NASDAQ — as of this morning. Accordingly we will keep an eye on the pending patent litigation, in California’s Northern District — that will be. . . fascinating.

Via Pharmalot — We Learn That India May Look Into Glenmark-MSD Mediation Terms — On International Antitrust

August 4, 2014 - Leave a Response

Actually, it would be surprising if the Indian authorities did NOT look at the mediation settlement likely still being negotiated — on sitagliptin, in country. [Our July backgrounder is here.] Afterall, it was Merck (MSD India) that sought to settle here — which would imply that Merck is going to make payments to Glenmark, to keep the franchise either in restricted access, or at a price maintenance point. But we will wait to see the final terms, before we offer a concrete prediction as to the lawfulness of the same, under applicable in-India antitrust precepts.

Here is Ed’s fine piece, on it and other cases, like it, in India — and here is the original material (LiveMint) link:

. . . .The MSD-Glenmark talks to settle the patent infringement matter on diabetes drugs Januvia and Janumet (sitagliptin brands of MSD) were initiated by the US firm. Glenmark launched generic versions of these brands in India in 2013.

These companies have been fighting their respective patent infringement cases in the Indian courts. An out-of-court settlement could give both sides some respite from the prolonged judicial process involved in patent litigation. It may also impair access to affordable medicines, say legal and industry experts.

“They need to be examined on a case-to-case basis and the terms of the settlement need to be made public. This is because the factors such as an unusually high payout to the generic drug maker in question to stay away from the market may tip the scales in favour of a funding of anti-competitive behaviour,” said Shamnad Basheer, a patent law expert and former intellectual property chair at the National University of Juridical Sciences, Kolkata. . . .

We will keep you posted, here.

So — What Is On Tap, At The NON-Public (And Not Yet Announced?) Portions Of FDA’s Sept. 18 Advisory Committee Meeting? And Whither A Morning Session?

August 3, 2014 - Leave a Response

File this one under the header “Sometimes, What Is Not Said — Is More Meaningful Than What Is. . .”

So, it is possible (likely even) that in the very near future, at FDA’s public website on Advisory Committee calendars and materials — this Cellular, Tissue and Gene Therapies Advisory Committee meeting agenda will be extended — to a full day. At the moment, it is a 1 PM to 4 PM affair. Seems unusual to have all these fine folks gathered (many of them having traveled, overnight, the night before — and available first thing that morning — the 18th) for just a couple hour afternoon session, right? Right.

But in order for pembrolizumab to clear FDA by October 28, 2014, a committee meeting with a Mid-September date is needed. This one would serve nicely as an update on the rolling FDA submission from Merck, on pembrolizumab. So will that occur, at some point, at this meeting? Who knows? If it does, it is also possible (if not quite as likely) that the committee will take a look at the BMS nivolumab data sets thus far adduced.Only about two and a half hours of the day long meeting are open to the public. So, it would be natural to ask whether this meeting date is tied to the indicated October 28, 2014 FDA “breakthrough” decision date for Merck.

In addition (to further butress my guess at right), I think I highlighted this fine writeup, from the OBR Blog, back in June — on what most experts see in the PD-1 melanoma races:

. . . .Although Merck’s submission might allow pembrolizumab to beat nivolumab to market in the relapsed/refractory setting, nivolumab still might ultimately prevail as it is being examined in two Phase III trials in newly diagnosed and relapsed/refractory settings. If one or both of these trials are successful, nivolumab could enjoy strong utilization in frontline and, as a consequence, keep pembrolizumab confined to later lines of therapy. Recognizing the drawbacks of potential confinement to later lines of therapy, Merck decided to challenge Yervoy by initiating a Phase III trial (NCT01866319) in September 2013 that will evaluate two dosing schedules of pembrolizumab (10 mg IV, either once every two weeks or once every three weeks) versus Yervoy in 645 Yervoy-naïve patients with unresectable or metastatic melanoma. This study includes patients who will receive first- or second-line treatment, with PFS and OS as co-primary endpoints. While going head-to-head with Yervoy is a good strategy, the combination trial of nivolumab and Yervoy currently poses the main threat for pembrolizumab. Data reported at ASCO 2014 showed an unprecedented two-year survival rate of 79% for the combination (as well as 43% ORR with 17% CR), which appears superior to pembrolizumab. . . .

Of course, each candidate is busily amassing solid data in other cancer types — lung cancer being chief among these. Do stay tuned. We will update you right here, if/when FDA offers additional translucency on the September 18, 2014 Advisory Committee agenda. And now it’s. . . bike and beach time!

Beginning Monday, Merck’s Januvia® Faces A[nother] New Competitor In The US

August 2, 2014 - Leave a Response

While the drug branded as Jardiance® (empagliflozin) in the US has already been on market in the EU for a bit, this is new — and the US market for diabetes treatments, and thus, for Januvia® (sitagliptin) is probably Merck’s most important franchise — at the moment. Significantly, Merck has a couple year’s head start, here.

Even so, it will be interesting to see if Indianapolis-based Lilly will be able to snag some of Merck’s share, here — as Jardiance is cut from “just about the same cloth” as sitagliptin. Will price competition in the US become a dominant form of garnering share? Who knows. Here is a bit — from yesterday’s Indy Star:

. . . .The drug is designed to be taken once a day to reduce a patient’s blood sugar levels by blocking glucose reabsorption in the kidneys and removing excess glucose through urine. Unlike other diabetes treatments, it does not depend on a patient’s insulin levels to be effective.

European Union regulators had already approved the drug, also labeled empagliflozin, in May.

Earlier this year, Lilly and Boehringer said the FDA didn’t approve the drug because of concerns about the Boehringer factory in Germany where it will be made. But a Lilly spokeswoman said Friday those concerns have been resolved.

Boehringer developed the drug, and Lilly will help co-promote it. . . .

We will keep a weather eye on the horizon — for this emerging battle. Off to see “Guardians of the Galaxy“, now (middle son’s call). Fingers crossed. Literally — heh!

A Narrow NuvaRing® MDL Litigation PSA — Non-Settling Plaintiffs: August 1, 2014

August 2, 2014 - Leave a Response

We mentioned this day was coming, early last week. Now. . . it has arrived.

IF you have filed a lawsuit alleging injuries from Merck’s NuvaRing® intervaginal birth control delivery device, and your name (and case number) is DULCE GOMEZ MORIN (4:13 CV 2627), GABRIELA LOZA (4:14 CV 467), CATHERINE LOEHR (4:14 CV 466), KATHRYN REEVES (4:08 CV 2001), JENNIFER SPENCE (4:09 CV 325), TIFFANY SMART (4:09 CV 718), LAKESHA SIMONS (4:09 CV 1214), JOANN MERCHANT (4:09 CV 1484), AOIFE CONNOLLY (4:09 CV 1504), BRANDY TAYLOR (4:09 CV 1606), MELISSA PLASENCIA (4:10 CV 62), MELLISSA HJELMSTAD (4:10 CV 395), ELTRACIE SINCLAIR (4:10 CV 680), ELIZABETH DELANEY (4:10 CV 767), COURTNEY THOMAS-MALAGARIE (4:10 CV 984), KIM ROSS (4:10 CV 990), BETTY STENHOUSE (4:10 CV 998), JOLYNCIA HINES (4:10 CV 1285), DANIELLE BACOTE (4:10 CV 1292), SAMIEKA BABERS (4:10 CV 1469), PATRICIA GUADARRAMA (4:10 CV 1726), ELIZABETH ELEDGE (4:10 CV 2258), PORSHA BOYD (4:11 CV 32), LISA TRIBE (4:11 CV 36), CAROL-ANN LUNDY (4:11 CV 448), EMILY GIES (4:11 CV 1239), JENNIFER NEVILLE (4:11 CV 1992), ROSALIE RIVERA (4:11 CV 2074), CHRISTINA GAGE (4:11 CV 2144), RONALD and SANDRA WESTBROOK (4:11 CV 2146), JAMIE OAKLEY (4:12 CV 662), WHITNEY GAINES (4:12 CV 870), SHEILA FONTANEZ (4:12 CV 1682), FACHON HAZEL (4:13 CV 511), BRANDY COOK (4:13 CV 641), MELISSA JARVIS (4:13 CV 988), AMY WILTSEY (4:13 CV 1524), AMADO and ADELITA PEREZ (4:13 CV 1620), PAULA WEST (4:13 CV 1808), MARY SNORTON (4:13 CV 1812), MICHELLE GRAY (4:13 CV 1942), VANESSA MURRAY (4:13 CV 1967), CHRISTINA PAOLI (4:13 CV 1967), KRYSTLE TANNER (4:13 CV 1967), KELLY CAROLLO-WEBER (4:13 CV 2040), ANDREA HEEBSH (4:13 CV 2041), SHEA WALTER (4:13 CV 2095), STACY BORKHOLDER (4:13 CV 2593), TIANA SPENCER (4:13 CV 2604), RACHEL FALIS (4:14 CV 11), SHEILA PATRICK (4:14 CV 1224), SHARELL WILSON (4:14 CV 127), REBECCA WATKINS (4:14 CV 532), KRISTINA KESTERSON (4:14 CV 218), SAMANTHA VINES (4:14 CV 326), TASHA ZACHODNI (4:14 CV 339), TRACY WELLS (4:14 CV 368), AMY STINNETT (4:14 CV 414), ERICA PATEL (4:14 CV 513), BARBARA LEE (4:14 CV 520) LACY JENSEN (4:14 CV 620), WHITNEY PURVIS (4:14 CV 638) or CATALINA CASTRO (4:14 CV 1329). . .

Please contact your lawyer. Since you have elected to reject the $100 million settlement, the deadlines on your individual cases began to run again, as of yesterday morning. Prompt action may well be needed to preserve your rights, here.

For all the thousands of others, you should start to see payments in the fourth quarter of 2014, or perhaps a little earlier. I suppose since the above list purports to be all the claimants who opted out, and that is a small number (50-something or so) — compared to the more than 95 per cent of the class that did decide to participate. . . the settlement qualifies as a resounding success.

Now, go out and enjoy the summer — have an adventure! Do go see “Get On Up!” — the music will move you!

Merck’s Triple Damages Win Affirmed — Against Gnosis — In Second Circuit Folate Wars

August 1, 2014 - Leave a Response

A month ago, we reported on a small folate “no patent” win — in favor of Merck — against Gnosis SpA. Now, Gnosis has lost its appeal — in the Second Circuit.

Here’s a bit from some specialty law firm authors at Ackerman LLP — published in Lexology (an ACCA publication) — do go read it all — quite excellent analysis, and reporting:

. . . .On July 29, 2014, the Second Circuit decided a Lanham Act false advertising case that clarified the circuit’s jurisprudence on demonstrating consumer confusion and competitive injury. [T]he Court held that when literal falsity and deliberate deception have been demonstrated, it is appropriate for courts to apply a presumption of consumer confusion and a presumption of injury to the plaintiff, at least where the parties operate in the context of a two-player market or the economic equivalent.

Since 2002, Merck has sold a nutritional supplement under the name Metafolin. Metafolin is comprised of a naturally occurring version of folate and is considered to be a “pure isomer product.” In 2006, Gnosis S.P.A. began to sell a competing product called “Extrafolate.” Gnosis’ product was composed of a chemically mixed form of folate that was not naturally occurring. Because the Gnosis’ product was a mixed product, it sold for significantly less than Metafolin. . . . In 2007, Merck sued Gnosis for false advertising based on Gnosis’ use of the pure isomer product chemical name and properties in its marketing materials for Extrafolate. . . . The [Second Circuit panel] affirmed the damages award, as well as the other relief granted by the district court. The Court held that when the parties are direct competitors and where literal falsity and willful deception have been proven, the presumptions of injury and consumer confusion can be used for the purposes of awarding injunctive relief as well as monetary damages to a successful plaintiff. . . .

Smallish good news for Whitehouse Station. I doubt Gnosis will appeall to the Supremes — and even if it does, the Supremes are very unlikely to hear the matter. Not much new law to be made, there — in my opinion. Have a great weekend, one and all!

Merck Targets Upped — To $59; And $62 — At Two Wall Street Shops: Suggests Fully Valued, Here

August 1, 2014 - Leave a Response

Tonight, two firms have updated their outlooks — on Merck.

Both are only incrememntal bumps. Both suggest essentially neutral ratings, and both thus suggest that Merck is pretty fully valued at $58, or so. Links here, and here.

. . . .Merck’s stock had its “neutral” rating reaffirmed by Credit Suisse in a research note issued on Thursday. They currently have a $59.00 price target on the stock, up from their previous price target of $56.00. Credit Suisse’s price target suggests a potential upside of 1.58% from the company’s current price. . . .

Analysts at BMO Capital Markets raised their price objective on shares of Merck & Co. (NYSE:MRK) from $60.00 to $62.00 in a research report issued to clients and investors on Thursday [and continued their "market perform" rating]. . . .

So it goes.

Merck Vs. Pfizer Nanomedicines Efforts Featured, In New Story

July 31, 2014 - Leave a Response

Overall slow Whitehouse Station news day (these, being the dog days of summer) — so I’ll drop this one in. [My February 2014 backgrounder here.]

I think it is good, insofar as it goes. Sort of superficial, but accurate. Do go read it all, at Bidness.etc, online:

. . . .Pfizer:

Pfizer, the biggest drug maker in the world, signed a deal with BIND Therapeutics Inc. (BIND) last year, to collaborate on the development of nanoparticles, called Accurins. The particles are capable of highly selective targeted and programmable nano-based therapeutics effective for oncology, inflammatory diseases and cardiovascular disorders.

Both the companies will collaborate on the preclinical research of Accurins. The deal, which was signed on April 2013, made Bind eligible for an upfront payment of $50 million, while $160 million is tied to the regulatory and sales milestone.

Pfizer has been spending over $6 billion on R&D for over a decade, and had 279 R&D projects going on by the end of 2013. Among those, 20 were in phase 3, while all others were in earlier stages of testing.

Merck:

Merck is one of the biggest supporters of nanotechnology. Some of its major products with nanotechnology intervention include anti-nausea drug Emend, animal health product Panacur, and sunscreen line Coppertone [Ed. Note: that last one is being divested, to Bayer].

The company has signed partnership deals with Ablynx NV, Celgene Corporation and Qlight Nanotech Ltd. among others to build advanced nanomedical capabilities. This year, the company signed a deal with NanoBio Corporation, which gave it the rights to nanoemulsion (NE) adjuvant technology, which will be used in intranasal respiratory syncytial virus (RSV) and an intranasal seasonal influenza vaccine. . . .

So it goes — glorious day here, today. . . so do go be excellent to one another!

Pfizer Pays 2X Sales, For Baxter Vaccines Biz — Bulking Up To Compete With. . . Merck?

July 30, 2014 - Leave a Response

MRK-pfizer_Baxter-2014Prior to this deal’s announcement, Pfizer’s global vaccine biz was rolling out around $1.1 billion a year. Last year, Merck’s stood at over five times that — or, $5.2 billion.

I think Ian Read has some “Merck-jabs” envy there. Smile. [And I think Bob Parkinson (Baxter's chief) doesn't mind letting a smaller competitor to Merck in the space (Pfizer) pay just 2X sales -- to get access to his vaccines. Afterall, Merck just recently "stole away" Baxter's former CFO (and a guy who was, most recently, a leader many might have surmised would succeed Mr. Parkinson, as chief).] In any event, Pfizer seems to be looking to bulk up on vaccines, ex-US. And, that is another way to “naturally hedge off” some of the offshore revenue Pfizer earns as well (should it not renew its mostly hostile inversion bee-waggle dance — for AZ). I am certain this will close by year end — no real antitrust issues of note. From Reuters reporting then — do go read the rest:

. . . .The deal will give Pfizer access to Baxter’s meningitis vaccine, NeisVac-C, and its encephalitis vaccine, FSME-IMMUN.

Pfizer will also get access to a portion of Baxter’s facility in Austria where the vaccines are made.

The deal is expected to close by the end of the year. . . .

Who knows if this was a shot across the bow, at Mr. Frazier — for “poaching” Mr. Davis, from Deerfield, Illinois? Dunno. But it will be fun to watch; I’ll pop the popcorn.

More — On “Adult CEO Perspectives” — For US Corporate Tax Rate Policy Reform

July 29, 2014 - Leave a Response

In a second stark moment of contrast (compared to brother Pfizer) on a single morning, CEO Frazier made it clear that Merck would not be likely to pursue a deal of size, near term — and certainly not an inversion.

Recall that Ian Read pretty much whacked the proverbial hornets’ nest, on inversions, earlier this year, when his unwelcome, north of $100 billion advances, upon a British old line pharmaceutical house were. . . soundly rebuffed.

And do recall that Mr. Frazier was the voice of reason, then too. From Bloomberg reporting, a bit ago, then — do go read it all:

. . . .Merck is not interested in large scale purchases that are “very time consuming and distracting to what we’re here to do, which is invest in new medicines,” Ken Frazier, Merck’s chief executive officer said in an interview today. Merck also isn’t looking for a cross-border deal to lower its tax rate, he said.

Instead, “we’re trying to get Congress to look at how all U.S. firms are at a huge disadvantage” and encouraging tax reform, Frazier said by telephone. . . .

Yes — it is. . . refreshing to read some sober, balanced and mature analysis of US corporate income tax policy — from a public company CEO and Chairman. That much is certain.

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