Smallish Temodar® Recall — Cracks In The Childproof Bottle Caps

August 18, 2015 - Leave a Response

This is a long standing Schering- Plough/Merck legacy product (now as an authorized generic) — and the smallish issue has to do with the cap remaining childproof — not anything to do with purity or safety of the medicine inside the bottle.

Even so, we will note it. Just for a complete record — from a wire-service press release:

. . . .Merck believes that approximately 1,100 bottles out of an estimated 276,000 distributed bottles of TEMODAR and Temozolomide capsules (generic) could potentially have cracked caps. . . .

Onward — some of my Temodar background here — do use the search box to find more, going back seven years, if you are curious.

Like BMS Before It, Merck Announces A Slowed FDA Timeline In One Anti PD-1 Melanoma Indication, And Acceleration, In Another

August 18, 2015 - Leave a Response

About a week ago, BMS announced that its targeted complete response date from FDA had been pushed into November 2015 on an Opdivo® label expansion into other melanoma indications. This morning Merck has done much the same, and this time, in first line melanoma treatments.

Also like BMS, FDA has accepted for priority review Merck’s submission in melanoma with differing treatment precursors. Sort of a good news, and delay news — as a two for one — echoing BMS of a few weeks past. Here’s the bit from StreetInsider:

. . . .The FDA granted Priority Review with a PDUFA, or target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015. . . .

I might suggest, without looking into it too deeply, that FDA suspects BMS will have better efficacy here in the delayed indication — thus the November 2015 date for Opdivo, compared to a December date for Keytruda. I’ll trust the readership to correct me if I am mistaken about that. Smile. . .

My overall assessment is unchanged. BMS has a clear timing lead. Having said that, the overall market opportunity is so vast, that Merck will generate multiple billions in new reveue here, as well, going into mid-2017 (even as the payers seek limits on price). So, onward — out into a hot likely rain soaked August workaday world — but it is teeming with possibilities, as well. . .

Exclusive — Propecia® MDL Update: Rule To Show Cause Hearing For Dr. Imperato-McGinley: September 2, 2015

August 13, 2015 - Leave a Response

Apparently, Dr. Imperato McGinley did not turn over the voluminous set of documents associated with her finasteride studies, to the plaintiffs — as she promised she would. I would not have predicted/expected this outcome. [My May 2015 backgrounder.]

Apparently, she is being — or has been — represented by one of the in-house lawyers at the New York Presbyterian/Weill Cornell Medical Center. Also apparently, that in-house counsel has responded that the institution — not the doctor — controls custody of the 16 to 40 boxes of clinical trial records thus far pulled from storage. After some wrangling, the in-house counsel has also apparently said that she won’t accept service of a subpoena for the boxes, as a representative of either the doctor, or the institution.

And so, a rule to show cause hearing is now set for September 2, 2015 — in the Eastern District of New York. This will be a hearing as to why the doctor or the institution ought not be held in contempt of court — for allegedly evading the lawful discovery by subpoena process under the federal rules of civil procedure. I understand that there is a lot to look through, but it will be embarrassing if either of these parties is ultimately held in contempt for failure to go through the boxes, and provide relevant documents. The plaintiffs have even offered to cover the cost of that effort. This ought to be entertaining. From the full pleading (a 6 page PDF file), then — a bit:

. . . .The only document furnished by Dr. Imperato-McGinley was a two-page “bibliography.” Moreover, Dr. Imperato-McGinley’s responses strongly suggest, consistent with her counsel’s initial representation that there were at least sixteen boxes’ worth of documents, that numerous responsive documents do exist, but Dr. Imperato-McGinley is claiming not to have “possession, custody, or control” of those documents. Indeed, Dr. Imperato-McGinley is careful to assert, in each of her responses, that she has no responsive documents in her “possession”. . . .

Dr. Imperato-McGinley is, according to Merck, one of the most important individuals in the development of Finasteride, and the development of Finasteride in turn appears to be a major component of her life’s work. It is simply implausible – in fact, it is utterly unbelievable –- that Dr. Imperato-McGinley has no “right, authority or practical ability” to obtain and produce the relevant documents within the sixteen to forty boxes’ worth of documents at issue. Indeed, the fact that these boxes were apparently obtained by the attorney who represents her, reviewed with the assistance of a clerk at the undersigned’s expense, and then simply withheld on the eve of the date set for production conclusively demonstrates that numerous responsive documents were and remain within Dr. Imperato-McGinley’s “possession, custody, or control,” or at a bare minimum in the “possession, custody, or control” of her “representatives. . . .”

So, September 2, 2015 should be an interesting morning in the federal courts in Brooklyn. Stay tuned.

BMO Capital Markets Bumps Merck Target To $70; “Outperform” Rating

August 13, 2015 - Leave a Response

Kenilworth saw one major Wall & Broad analyst firm make a material move, north — in its 12 month price target, this morning.

And the shares are reacting to it, on the NYSE today. $70 is a lofty goal. And we shall — as ever — wait to see, here. [Prior background from September 2014 here.] Here’s a bit from the street trade press outlets:

. . . .”Although we didn’t get the better entry point we were waiting for, we have become more optimistic on Merck’s pipeline and believe that the upcoming data readouts should also raise Street expectations and lead to multiple expansion,” analyst Alex Arfaei wrote.

Merck’s commercial and R&D execution were impressive. The company is expected to have “a good finish” in the back half of the year, Arfaei said, while adding that Merck appeared “on the verge of” five to six years of strong growth, driven by its higher margin specialty franchises, particularly Keytruda and Hep-C. . . .

In the report BMO Capital Markets noted, “After discussions with a number of experts at AAIC, we are more bullish on MK-8931, and now assign ~50% probability of approval in 1Q-2019 with risk-adjusted sales of $4.8B by 2024. We have low expectations for the Anacetrapib REVEAL interim look this year, and estimate 35% probability of success in 2017. . . .

So, a little give and take there, in the finer details — on Anacetrapib. But as indicated in that last link, that comes as no surprise to us — so, onward.

In The “Caught My Eye” Dept.: $8.2 Billion Written Off; 29,160 Jobs. . . Gone, Since 2010 — Legacy S-P

August 11, 2015 - Leave a Response

This is all as a direct result of the “yard sale” Fred Hassan (and his top six co-horts) made, out of what was legacy Schering-Plough.

Even so, the staggering $8.2 billion above doesn’t include the settlement of the various securities class actions that resulted from his mismanagement — which likely now push the all-in tally close to another $1 billion — or $9.2 billion, overall. [In addition, there were over 12,000 positions eliminated in the three years before Hassan sold S-P to Merck.] Merck’s recently filed SEC Form 10-Q (at pages 5 through 7) discloses what is pretty much the final tally, on the Merck side of the ledger — of the manifold Hassan & Co.’s miscue costs (per an industry-watching periodical):

. . . .Since 2010, Merck has recorded total pretax accumulated costs of approximately $8.2 billion and eliminated approximately 29,160 positions in connection with the post-Schering-Plough layoffs. . . .

Now you know — he truly was the “most heartless CEO” in corporate America — in his day. . . . Onward.

“Son Of Sunscreen Battle Royale” — Closing Out Legacy Lanham Act/Patent Litigation: Legacy S-P’s Sunscreen Brands

August 10, 2015 - Leave a Response

Since we have now fully entered the lazy Florida beach-sun drenched vacation days of August, I’ll close out the predictions I made in 2012, 2013 and early 2015 — that the parties would ultimately settle out of court. They have, as of June 15, 2015. So this is mostly about completing the record — for posterity.

I am quite tardy in posting this, because Merck sold these legacy assets to Bayer, last year. But this is the second large piece of patent infringement/Lanham Act litigation settled on the legacy sunscreen product lines, by Merck as successor to legacy Schering-Plough. Whatever the settlement payments, in either direction, provided for — the benefit (or payment) almost certainly went to (or came from) Bayer — since it now holds the brands. Here’s a bit of the order of dismissal/settlement:

. . . .Plaintiffs L’Oréal S.A. and L’Oréal USA, Inc. and Defendant MSD Consumer Care, Inc. (collectively the “Parties”) hereby stipulate, pursuant to Federal Rule of Civil Procedure 41(a), and subject to the approval of the Court, to the dismissal of all claims and counterclaims between them in this action with prejudice pursuant to a settlement agreement. Each party shall bear its own costs and attorneys’ fees. The Court shall retain jurisdiction to enforce the settlement agreement reached by the Parties. . . .

Yes. . . it is a slow Merck news day, here. More background, here. A lil’ more truthfully, I was just looking for an excuse to re-run that legacy graphic at right. Enjoy your August beach time, one and all — and stay. . . screened-up!

Ninth Circuit: Merck Unable To Force Five Non-Consenting CA State Court Plaintiffs Into Federal Court (Yet)

August 9, 2015 - Leave a Response

The federal civil procedural nuances are quite complicated here, but what the federal appellate courts sitting in California held, late this past week, is that if a plaintiff alleges injury, and chooses state court as the forum to bring the action, it is not automatically the right of the defendant (Merck) to remove the case to federal court (absent other considerations, like complete diversity of citizenship), and join it to a pending federal MDL. [Last year’s backgrounder, here.]

Again, these are still the early stage maneuvers, in the overall incretin mimetic MDL litigation, but these five cases, for now, will not be shoved onto the federal trial court docket in San Diego. Overall, it matters only slightly to Kenilworth, but here is the opinion (as a 31 page PDF file), and the court’s reasoning:

. . . .”[T]here is no indication that Congress’s purpose in enacting CAFA was to strip plaintiffs of their ordinary role as masters of their complaint and allow defendants to treat separately filed actions as one action regardless of plaintiffs’ choice.” Scimone, 720 F.3d at 885; see Tanoh, 561 F.3d at 953. . . .

“In this case, concluding that plaintiffs’ claims fall outside CAFA’s removal provisions is not absurd, but rather is consistent with. . . the well-established rule that plaintiffs, as masters of their complaint, may choose their forum by selecting state over federal court . . . .”

Incretin mimetics, like Merck’s Januvia® (sitagliptin phosphate), are suspected by some medical practitioners and researchers, of being associated with increased risks of pancreatitis — and perhaps even certain cancer risks. But “suspected” is the key word, there. As of the moment, there appears to be no gold standard, independently rigorous study linking the increased risk of cancer claimed by some, to any incretin mimetic regimen of any particular drug manufacturer. And, while it is true that judicial resources are often well-economized in federal MDL proceedings, there hasn’t yet been a binding determination that these cases (over 900 of them, according to page 22 of the just filed SEC Form 10-Q) are appropriately similar — to allow for an imposed MDL, on all plaintiffs.

All in all, a perfect post-workout Sunday — so. . . onward we go.

“Fast Fred” Hassan Joins Amgen Board — My Condolences, To Amgen Shareholders

August 8, 2015 - Leave a Response

I have ignored this tidbit of history (for legacy Schering-Plough folks, at least), long enough. [Sometimes — I just need to rant. Forgive me for that. I’ll try to be. . . restrained, here.]

At the end of last month, Fast Fred Hassan was added to the board of directors of Amgen — a fine (and storied) biotech company.

This led some in the MSM to speculate that Amgen may be a target — given Fred’s history.

I will make no comment on that score — or any other.

All I can offer is. . . my condolences — to the affected shareholders. Onward, now — to the northlands!

BMS’s Opdivo® Extends Its Immuno-Oncology Lead, In the United Kingdom, Over Keytruda®

August 7, 2015 - One Response

Now the U.K.’s NICE need only finally decide the level of reimbursement for NSCLC treatments (not likely to be known until early 2016, officially) — but as of this moment, BMS will be shipping in regular fashion (not early access/experimental fashion) throughout the UK. Lung cancer is a very high burden disease in England — and Merck may not come off of experimental “early access” protocols (i.e., low- to no- sales price) there, until late 2015 or early 2016. Thus — as we’ve long posited, the BMS lead is stretching to a year or more, in this perhaps $35 billion a year market, by 2018.

From PharmaTimes, then earlier this morning, a bit — but do go read it all:

. . . .Bristol-Myers Squibb’s Opdivo has launched for lung cancer in the UK, becoming the first immunotherapy available for the disease in the country. The launch follows EU approval for the indication earlier this month. . . .

This may therefore be troubling news to BMS’ main PD-1 rival Merck, whose Keytruda is still only available in the UK for melanoma, and then only through the Early Access to Medicines scheme. . . .

Onward — and I’m headed to the North Woods this weekend, so blogging may be skittish/interrupted. . .

Old Simcere (China) JV Returned To JV Partner In Q2 2015: Merck’s Just Filed SEC Form 10-Q

August 6, 2015 - Leave a Response

This is a rather smallish item, but as I review the SEC Form 10-Q just filed this evening, I thought I’d note it (so I don’t forget it!) — since we’ve covered the Simcere JV for five years. [Previous backgrounder here. Earlier stuff here.]

The JV will no longer be included in Kenilworth’s consolidated results — and a tiny charge was taken on the divestiture, per page 48 of the SEC filing:

. . . .In March 2015, Merck and Simcere Pharmaceutical Group (“Simcere”) executed a restructuring agreement in which Merck agreed to transfer its 51% ownership interest in the Simcere MSD Shanghai Pharmaceutical Co., Ltd. joint venture to Simcere. As a result, Merck deconsolidated the joint venture and recorded a net loss of $7 million in Other (income) expense, net in the first six months of 2015. . . .

Onward — and a torch still burns, brightly. . .


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