We May Learn More — On Mediation Progress — By October 8, In Fosamax® Femur Fracture Cases

September 26, 2014 - Leave a Response

With motions to dismiss the largest bulk of these cases already pending, and mediation underway, the able Judge Joel Pisano, in the New Jersey federal District Courts of Trenton, has set an update conference, in person, for counsel, on the morning of October 8.

We may well learn about the progress — of the mediation — on that day. From the order then:

. . . .ATTENTION COUNSEL: An in-person status conference has been set for October 8, 2014 at 11:00 AM in Trenton – Courtroom 1, before Judge Joel A. Pisano.

The following parties are directed to be present: Steve Marshall, counsel for Merck, and Plaintiffs counsel who can speak to the mediation and Merck’s pending motion for an Order to Show Cause. . . . Matter has been confirmed. . . .

So it goes. Happy Friday, one and all! Enjoy the day’s sunshine — I know I will.

Come January 2015, Merck May See Declines In Remicade®/Simponi® Franchise Growth Rate: NICE Proposal

September 25, 2014 - Leave a Response

Between now and then, each local level UK reimbursement authority will continue to adhere to its own reimbursement policies regarding the pair. After the NICE proposal becomes final, though, the pressure on reimbursement will be locked in, in England, and spread across the channel, in all likelyhood — and ultimately lead to reimbursement levels more deeply curtailed – for the duo, across the EU. As goes the UK, so goes EU — quite commonly, in these matters. . . eventually.

Recall that Merck’s single largest retained geography on this franchise is the United Kingdom and the EU, after the settlement of the J&J arbitration (with the termination fight occasioned by the S-P reverse merger). We shall see, but it would seem that the past year’s impressive growth in the Simponi®/Remicade® revenue stream (driven largely by EU growth) may be drawing to a gradual close. Here is PM Live! on it all:

. . . .In draft guidance the Institute says [Merck's] Remicade (Infliximab) and Simponi (golimumab), and AbbVie’s Humira adalimumab) have not been proven to be more cost effective than current available treatments.[Ed. Note: Those being "biosimilars" (essentially generic biological agents) -- approved last summer -- and made by Celltrion, and Hospira.]

This is despite MSD agreeing a patient access scheme with the Department of Health to make a 100 mg dose of Simponi (which costs £1,525.94) available to the NHS at the same cost as the 50 mg dose (£762.97).

Including the patient access scheme and assuming the recommended dosage is followed, the cost of Simponi induction therapy is £2,289 and its monthly cost for maintenance therapy is £763.

Meanwhile, the cost of Remicade induction therapy at its recommended dose is £5,035 and the monthly cost of maintenance therapy is £210 and induction therapy with Humira costs £2,113 and it has a monthly cost for maintenance therapy of £704. . . .

Obviously, the EU biosimilar approvals of last year (see archive graphic, at right) are taking hold in the minds of the reimbursement crowd in the United Kingdom, and soon — the EU, I predict. Do stay tuned.

Good For Consumers; Good For Pharma: More Insurers; More Coverage — In 2015 Under Obamacare

September 24, 2014 - Leave a Response

Ahem. The facts. . . matter.

And the facts. . . include these: Obamacare has improved competition in the health insurance marketplace, in the United States. That helps consumers.

And the broader pool of insured people — nationwide — adds to the money pharma (big and small) may collect for their life saving wares. This is what those Tea Partiers so desperately feared: A potentially healthier America, at a lower overall system wide cost? Seriously. Dude. Seriously?!

Via the Gray Lady overnight, then– a bit (but do go read it all):

. . . .Consumers in much of the country will have a broader selection of health insurance plans next year, the Obama administration said Tuesday, as it predicted an increase of about 25 percent in the number of insurers that are expected to compete in federal and state marketplaces.

More competition will help hold down premiums, federal health officials said. The administration released preliminary data on insurers that have indicated they want to participate next year in the insurance exchanges, where the federal government subsidizes premiums for millions of people.
So far, it said, the number of insurers, also known as issuers, is up to 315 next year, from 252 this year. For the 36 states served by the federal marketplace, it said, the number is up almost 30 percent, to 248 next year, from 191 this year.

Fourteen states ran their own exchanges, and half have reported the number of insurers expected in 2015. The number in these states and the District of Columbia is expected to increase by about 10 percent, to 67, from 61, the administration said. . . .

We will keep you apprised, but this is — to the letter — as I’ve said all along, since 2010. [Slow Merck news week.]

Roger Pomerantz — What’s He Up To, These Days?

September 22, 2014 - Leave a Response

Tonight we update the readers — on yet another Ex-Merckie. This time, it is Roger Pomerantz. He now serves as a senior partner at a venture fund called Flagship Ventures. In that role, he also acts as chairman, president and CEO of Seres Health, a company in which Flagship has a stake. We just learned that Dr. Pomerantz has also added the chairmanship of the scientific advisory board of privately-held Novira Therapeutics — to his list of avocations, post-Whitehouse Station.

Here’s the bit — from local Philly.com sources:

. . . .Novira Therapeutics Inc., Doylestown, a privately held biopharmaceutical company developing novel therapies for curative treatment of chronic hepatitis B virus infection, has named Roger J. Pomerantz chair of its scientific advisory board. In this role, he also will function as a senior adviser to the company. Pomerantz is president, chief executive officer, and chairman of Seres Health and was senior vice president and worldwide head of licensing and acquisitions at Merck & Co. Inc., where he oversaw all licensing and acquisitions at Merck Research Laboratories. . . .

So it goes — he’s a very talented guy.

Also Last Week: Plaque Psoriasis Phase III Development License, With Sun Pharma

September 22, 2014 - Leave a Response

You (regular readers) will likely recall that Sun is Merck’s partner of choice in India, at least to make authorized generic versions of sitagliptin (since April 2013 — you know it as Januvia®/Janumet®). So, it makes sense that Whitehouse Station would partner up — on this smallish local India market license candidate, called tildrakizumab. Plaque Psoriasis is a reasonably large global market opportunity. Nothing like the “big burden” cancers — but a good market. SO it goes, whilst I was off the grid.

From the Economic Times (London — but India section), then:

. . . .Tildrakizumab is being evaluated in Phase III registration trials for the treatment of chronic plaque psoriasis, a skin ailment.

“Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product,” it added.

Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties ranging from mid-single digit through “teen percentage” rates on sales, the joint statement said. . . .

Beyond those very wide guardrails, there wasn’t any more granularity on the economic terms. Stay tuned.

No “Source Documents” For The Moment: Incretin Mimetics MDL — In Federal Dist. Ct., Southern California

September 21, 2014 - Leave a Response

My apologies. I’ve been away — for reasons. . . immaterial to the readership.

But I’m back. And while I was out last week, the very able Judge Anthony J. Battaglia, in the federal trial level courthouse, sitting in the Southern District of California, ruled that the so-called adverse event report “source documents” need not be disclosed to the plaintiffs, at this stage of the pleadings. Here is the most recent backgrounder we’ve written on it all. And, below is the salient portion of an order dated September 10, 2014– filed a few days later.

. . . .Further, the Court finds Defendants’ responses are sufficient given the limited scope of discovery previously set by the Court, and in particular the over broad scope of Interrogatory 26. . . .

So it goes. A more fullsome backgrounder is here, from about a month ago.

Sign Of The Times: Merck Ought To Take Heed — Low Cost Producer Licensing In India

September 16, 2014 - One Response

With the extremely high burden of Hep C as a disease in India, it seemed only a matter of time before — either through the mechanism of the DOHA Declaration (in international proceedings), the Indian patent courts, the Ministries of Health in country or otherwise, a life saving drug like Sovaldi® would be made more affordably in India. It will now appear in low cost authorized generic form, in over 90 countries around the globe. It is already there, in Egypt (March 2014). [This development will dampen only marginally the patent fights' income potential, however. That vast trove of money is generated in the post industrial Western world primarily.]

This has as much to do with the high price of it — as it does to do with the fact that it is effectively a cure for Hep C. And more people in India suffer from Hep C than in any single country on the planet. Even so, the price is unlikely to fall to the under $90 per regiment price that WHO experts estimate would put it in the hands of most of the world’s poorest Hep C patients. From the Irish Times then:

. . . .Gilead Sciences will allow seven large Indian generic drug producers to make and sell its blockbuster hepatitis C drug Sovaldi in more than 90 developing countries, in a move it says will ensure affordable access to the potentially life-saving treatment.

The deal with companies including Cipla and Ranbaxy Laboratories follows months of fierce debate over the price of Sovaldi, which has been hailed as the biggest breakthrough in treatment for hepatitis C since the virus was discovered in 1989. . . .

The object lesson here is glaringly obvious: Merck should be prepared for similar pressures in India, as Keytruda® becomes available for more strains of cancers. India’s cancer burden is unimaginably vast. So, India ministers will feel strong pressure to license, even on a compulsory basis, a bio-similar at some point. Stay tuned. The same applies to BMS — and nivolumab. Just my $0.02. [Should be yours, too -- heh.]

Additional FDA Filing Date Delays, For Merck’s Odanacatib — As Safety Signals Seem To Appear

September 15, 2014 - Leave a Response

Once again, the next gen Merck osteoporosis candidate has been run aground, and run aground — hard. Now a mid 2015 FDA filing may be a stretch — and peak sales may come in under $300 million a year. Ouch.

here is our February 2013 background piece on the program.

John Carroll is chief among the smart folks over at FierceBiotech — and he has a nice, pithy analysis of the data, and consequent additional delays up:

. . . .[T]here was also evidence of a troubling side effect profile that could well damage Merck’s prospects. There was a slight increase in the risk of atrial fibrillation as well as more strokes in the odanacatib crowd. A total of 109 patients (1.4%) had a stroke in the drug arm, compared to 89 (1.1%) in the placebo arm.

Cardiovascular side effects are going to attract careful regulatory attention. More morphea-like skin lesions and atypical femoral shaft fractures were also reported for 5 patients in the odanacatib group with none in the placebo group. And Merck–which had been expected to file before the end of this year—says it will now delay its FDA submission until next year after it gathers more data.. . .

We will keep the readership posted.

Tough breaks — rather literally.

Why “Adverse Event” Source Documents Matter, In Discovery Of Incretin Mimetics Litigation

September 15, 2014 - Leave a Response

Incretin mimetics, like Merck’s Januvia® (sitagliptin), and those made and sold by several other manufacturers, are the subject of some consolidated federal MDL action in Southern California.

We’ve begun tracking this narrative, as of relatively recently. [Backgrounder of two weeks ago, there.]

The plaintiffs are angling to get the origial source documents (AERs), or copies of them — of the hundreds of adverse event reports — from Merck and the others. The plaintiffs need them they say to establish causation, as to their claims (increased risk of pancreatitis and possibly, risks of some kinds of cancers). Put succinctly, a summary of the document may look ordinary, while the source itself may reveal patterns not apparent in the very same summaries. So, here is a bit of the plaintiffs’ latest motion, and argument — for discovery and production of the source files:

. . . .Source files are important for many reasons. They show what actually happened with an adverse event. It is not uncommon for MedWatch summaries to mischaracterize or misstate important aspects of an event. For instance, a manufacturer’s MedWatch summary may say an event was not causally related to its drug, when the source documents (e.g., medical records) show the doctors felt the event was caused by the drug. The only way to tell if the MedWatch forms given to the FDA accurately characterize an adverse event is to review the source files for that event. . . .

Source files also show whether pancreatic cancers were properly reported to the FDA. There are reasons to believe such cancers were not correctly reported, and were underreported. . . .

These questions can only be answered by reviewing the source documents for each pancreatic cancer adverse event. . . .

Source files can also show whether “safety signals” have been generated. FDA guidance notes that even one “well-documented” adverse event can be a safety signal. Source files can provide the detailed documentation for those signals. . . . Signal detection leads directly to the assessment of causal association. . . .

Finally, source documents are also necessarily part of Defendants’ preemption defense. To establish that defense, Defendants must prove by “clear evidence” that the FDA would reject any [additional warnings] that fully explained the basis for the proposed warning. . . .

We will keep you posted, but remember, these are the plaintiffs’ arguments. Merck would say all the info the plaintiffs need is already available in a summarized fashion, at MedWatch. Have a peaceful and productive start to the week!

Q.: Is A 10 Per Cent Max. “Sales” Bonus Opportunity Going To Be Adequate — To Sell Keytruda® — In Melanoma?

September 14, 2014 - Leave a Response

At the outset, I’ll suggest that this sales compensation incentive plan decision may well have been driven in large part — by the compliance folks at Merck — being appropriately conservative. [More on that, in the final paragraph after the pull-quote.] To the story, then:

One of our erstwhile anonymous commenters below asks an excellent question — and I will take it as being an accurate characterization of Merck’s current sales incentive plan, as the very same predicate facts have been discussed over at CafePharma during the last 60 or so hours.

Our commenter reports that Merck is only offering a maximum of 110 per cent normal sales bonus opportunity to the oncology reps selling Keytruda® — at least on this initial narrow “non-responder” melanoma patient FDA approval, in the US. As my graphic would suggest, I think the monoclonal antibody largely sells itself (just lay out the clinical trial results to date). Moreover, it is (until BMS’s Opdivo® [nivolumab] clears, here in the US) a monopoly product. Yep — as a breakthrough — hard to see how the biologic won’t sell itself. And then I’d note that perhaps only 1,500 patients meet the current indicated protocol. No need to “beat the bushes” to find them. Their doctors will find Merck, and pronto. The are all facing very dire prognoses without Keytruda.

. . . .Anonymous said. . .

So the sales plan incentives for the program were announced internally today. The top of the heap 10% in sales max out at 110% of target. It looks like management is convinced this one will sell itself.

Another huge mistake.

September 12, 2014 at 10:53 PM. . . .

It may be — I guess we shall see, when BMS prices and rolls out its incentives plan, relative to its Opdivo® (nivolumab) melanoma launch, here in the US, later this year. [Does anyone know how BMS has handled this -- as it launched -- in Japan, back in mid-summer 2014?]

In closing, I will observe that the LAST thing Whitehouse Station wants to deal with, in relation to its single best hope for a “turnaround” drug/biologic francheise, in oncology. . . is an enforcement proceeding/cease and desist order from FDA/DoJ/FTC. The compliance folks likely argued that — a too generous maximum initial bonus opportunity might encourage the Merck reps in the field to actively promote to oncologist/prescribers “off-label“. I think that mindset explains about 60 per cent of the “why” behind this initial sales compensation plan. Just my $0.02. Have a peaceful, sunny and joy-filled Sunday — to one and all, of good will.

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