Today, Lilly Ended Evacetrapib — Its CETP Inhibitor Program — What Then, To Make Of Merck’s Anacetrapib?

October 12, 2015 - Leave a Response

While Roche and Merck continue to move forward with CETP inhibitor R&D programs — I think it worth taking a moment to look at the less than wonderful data Lilly just saw, on its Phase III CETP candidate, evacetrapib.

As we have written before, this class of meds has been written off, only to be revived — several times, over the last half-decade. Here is the Lilly tidbit, leaving me with no answers — only more questions (though net-net, I would be surprised if it turned out to be class wide):

. . . .Lilly said it has ended late-stage development of evacetrapib, which was part of a costly study involving 12,095 patients at 540 sites in 37 countries. The therapy was in Phase 3 development — the final stage before a drug can be submitted to the Food and Drug Administration for approval.

The failure to bring the drug to the market reflects a significant setback for Lilly, which saw shares fall more than 10% to $77 in pre-market trading before regaining some ground.

An independent data monitoring committee “suggested there was a low probability the study would achieve its primary endpoint based on results to date,” Lilly said in a statement.

The drug, which was supposed to treat people at a high-risk of atherosclerotic cardiovascular disease, displayed “insufficient efficacy” the company said.

The company emphasized that the study was not halted because of safety problems. . . .

I am not enough of a chemist to say whether we should expect to see a similar CETP class-wide underperformance in Merck’s program. But I guarantee that several of the generally great chemists at Merck, and Roche are efforting that careful conjecture, right now. Onward — ever smiling!

Scottish Nurse’s Contacts Offered Merck’s Experimental Ebola Vaccine

October 12, 2015 - Leave a Response

MRK-Ebola-Scotland10-12-15 As is often true with epidemiology — it is two steps forward, one back. At the end of last week, a Scotttish nurse who was last year infected with Ebola in Sierra Leone — but then later deemed cured (and returned to regular life, in her home town) — presented with a fever, and other signs, which might be associated with a resurgence of the virus, in her body.

In an exercise of entirely appropriate caution, she was transferred to an isolation unit at the [Scottish] Royal Free hospital. All of her family and close contacts have been alerted, and offered Merck’s experimental Ebola vaccine. Of the 40 people so notified, 25 have elected to take the vaccine, so far — even if (based on trial data thus far, roughly) one in four may develop a low grade fever, and some joint stiffness. I think that a wise move, even if one believes the risk of transmission is/was slight — the consequences of being wrong about that assessment would be. . . pretty high. And so, I applaud the vaccination decision. Here’s a bit from The Courier UK Edition:

. . . .A total of 58 close contacts have been confirmed, believed to be a mixture of healthcare workers and Ms Cafferkey’s friends, family and community contacts, and an expert group managing Ms Cafferkey’s case agreed that anybody who has had direct contact with any bodily fluids would be offered vaccination as a precautionary measure.

Forty of the 58 close contacts were offered the vaccine in line with criteria set out by the expert group, with 25 of them accepting the vaccine.

NHS Scotland said the other 15 had either declined the vaccine or were unable to receive it due to existing medical conditions.

A spokesperson said: “The rVSV-ZEBOV vaccine offered is currently being trialled in collaboration with the World Health Organisation and has been tested in over 7,000 people during the recent outbreak of Ebola virus infection in Guinea. . . .”

Onward — and. . . forward, with hope. Now, dare I chant it? Go Cubs GO! Arrieta’s stuff is likely to be. . . Card-suffocating.

Updated Opdivo® Vs. Keytruda®: BMS Should Still Lead, When Q3 2015 SEC Results Are Announced

October 10, 2015 - Leave a Response

There have been a series of approvals, and (non-US) cost-gatekeeper favorable opinions, for both BMS and Merck in the past two weeks. Sorting out the overall picture is what we pride ourselves on, here. And as we have for quite a while, now — we call the win for BMS (even if we jinxed the Cubbies last night — oops).

Each release of early approval and favorable opinion is very good news for each competitor — but BMS has kept both the timing lead, and the wider indications lead, to date. It is — in short — ahead, in the heaviest burden cancers.

So, I expect that when Q3 2015 financial results are reported at month’s end by both companies, we will see that Opdivo® is well-ahead, and extending its lead, measured by global revenues through the first nine months of 2015.

But fret not — Merck’s second place finish will not really be all that disappointing — there is certainly at least a substantial share of the emerging $10 billion a year cancer med pie which Kenilworth will garner, into 2017 and beyond. BMS will just get more of it — that’s all.

All smiles here. . . viewing a participatory Saturday. . . .

Final Pre-Trial Conference Set For February 26, 2016 — In Gilead v. Merck Hep C Drugs Patent Spat

October 9, 2015 - Leave a Response

This is just a slow news Friday filler — related to the northern California federal patent litigation surrounding Gilead’s Sovaldi® — which Merck claims impermissably reads on some older Merck patents.

The only news to report here is that this week, the Court Clerk noted the PACER electronic jacket with an updated final pre-trial conference date, for Februiary 26, 2016 — assuming the parties don’t settle in Delaware and/or Europe, prior to that date. I continue to expect a modest settlement.

And so — do have a safe and pleasurable weekend, now one and all — Confidential psst: Go Cubs, Go!

W.H.O.’s Good News — No New Ebola Cases, Across Africa — For A Solid 10 Days

October 8, 2015 - Leave a Response

Anti-Ebola8-10-2015 We have been following this international human tragedy for over 18 months. . . and some more good news now appears.

For the first time since March of 2014, the entire continent of Africa has passed a week without a single new Ebola case. Of course, monitoring the remaining contacts, and vaccinating those rings of contacts, remains a pressing urgency — in order to avoid any recurrent flare-ups. And so, just about 34 days until the entire continent might be declared Ebola free, by an official WHO monitoring measure. Here’s a bit — compiled form various new sources — related to the latest WHO Ebola Situation report:

. . . .There were no new cases of Ebola in West Africa last week for the first time since March 2014. . . . As the number of cases drops though, closely monitoring contacts and any potential cases becomes increasingly crucial, WHO’s Ebola response director Rick Brennan explained in a previous interview. . . .

Onward — with a bit of a spring in my step, now. . . grinning. When we put our minds to it — there are few limits to what we might accomplish.

Diabetes Patent Wars In India: Glenmark’s Copycat Enjoined; MSD Prevails

October 7, 2015 - Leave a Response

As we have repeatedly noted, MSD India (that’s Merck’s ex-US naming convention, for its in-country operating subsidiaries) had long ago (circa April 2011) struck a deal with Sun Pharma to eventually make an “authorized generic” of sitagliptin in India.

And so, even as Glenmark completes the sell-off of its existing inventory, Merck is unlikely to benefit much from the India High Court ruling, entered overnight, New York time. Most analysts estimate that Glenmark still has a month’s worth of inventory it is allowed to sell — and then the lower priced Sun authorized generic will take the lead, on low price alternatives to Januvia® and Janumet® in India.

From the Business Standard, in any event then — the operative bit:

. . . .According to reports, the Delhi High Court today, 7 October 2015, restrained Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs Zita and Zita-Met, saying it has infringed patent of US-based Merck Sharp and Dohme.

Justice A K Pathak reportedly said that in view of the finding returned on the issues, Glenmark Pharmaceuticals is restrained by decree of permanent injunction from making using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin phosphate monohydrate or any other salt of Sitagliptin in any form, alone, or in combination with any other drug, thereby infringing patent of plaintiff (Merck Sharp and Dohme). . . .

I should mention, in passing, that MSD sells its branded products in India for about one-fifth of the US price — and the generic will be about a third less than that, in country. [See our earlier pharma pricing discussions, in comments.] Onward, then — with so very much to be grateful about. So much — Happy Birthday, Tim & Pete!

A Merck Nobel Prize — For River Blindness Cure; Pacific Trade Pact Reached

October 5, 2015 - Leave a Response

Delivered in round-up fashion — the bigger news first: Dr. William C. Campbell (depicted at right), during a 33 year Merck career as a bio-science researcher (since retired), along with two others, has won a Nobel Prize in Medicine — for work on Ivermectin, the drug largely responsible for nearly eliminating river blindness in sub-Saharan Africa. Kudos!

In addition, as we mentioned late on Friday, the Trans-Pacific Trade treaty has this morning been agreed by all involved nations. Now begins a 90 day waiting period in the US, while Congress studies the pact. Then (because Congress cannot prevent it), Mr. Obama will sign it.

Here is the bit on Dr. Campbell — via the Gray Lady:

. . . .William C. Campbell and Satoshi Omura won for developing a new drug, Avermectin. A derivative of that drug, Ivermectin, has nearly eradicated river blindness and radically reduced the incidence of filariasis, which causes the disfiguring swelling of the lymph system in the legs and lower body known as elephantiasis. . . .

So much is new — and to be hopeful for — just as though new life. . . is arriving. Onward!

More On Drug Price Increases — “The Rule, Not The Exception” — Unfortunately. [Now IMPROVED With. . . Tech Industry Analogy!]

October 4, 2015 - Leave a Response

At the outset, let us recall that Apple is NOT pharma. Apple has tended (for the last five or so years) to hold prices steady, even as it delivers vastly improved capabilities in each iteration of its newest product. Let us also recall that no one will die, if they don’t use the Apple specific product. They can “limp along” — with a Samsung or HTC. [Ironic content fully-intended.]

So, perhaps it is unfair to draw parallels between tech pricing, and pharma pricing. But each industry asserts that a vast R&D expense line is needed to stay competitive. I think we all agree that is true. What happens above that expense line (at the sales revenue/pricing line), is where they differ most significantly — for the purposes of this post.

That is to say. . . what strikes me most, here is not the randomly obscene Valeant and Turing price increases — but the idea that pharma wide, prices on mid-stream, and older drugs are rising — in double digit percentages, year after year. In many of these cases, patients will either grow very sick or die, without the now well-vetted drugs. And pharma raises prices. It does so until some generic competitor is able to get to market and undercut them, usually, all at once. But that “frictional” often three to five year price climb, at or very near the end of a drug’s patented life — is more the rule than the exception, as a pharma pricing strategy.

And so (with technology industry examples in mind), it is high time to ask — why should we as a nation of consumers tolerate that? Apple knows keeping the customer is the best profit inducer. So, keeping the patient “on med” ought to be the number one priority of pharma. To be clear, I don’t think government price control (via legislated price mandates) is the answer.

No, I think free market negotiatingBETWEEN the government, and the drug companies (i.e., repealing the Bush 43-era no-negotiating legislation stance) — on Medicaid, Tri-Care and the analogous program payers’ drug purchasing contracts, is the answer. Clearly private insurers and prescription benefit management companies are negotiating — and negotiating hard. [Which is why some argue pharma must be free to charge the government payers — without negotiations. I disagree. The math doesn’t bear it out.]

We often hear WSJ pundits extoll the free market mechanism. It is time to let it work — on drug pricing. Here’s the snippet of the NYT article that put me in mind of making this point, this morning — over hot coffee, fresh orange juice, yogurt and a banana:

. . . .[W]hile more conventional [drug] companies do not typically triple or quadruple prices overnight, they do often raise them year after year at a rate far faster than inflation. Big pharmaceutical companies like Pfizer and Merck raised list prices an average of 13 percent in 2014 and 8 percent so far this year, according to Deutsche Bank. . . .

Inflation is barely two per cent, as experienced by consumers overall this year, and less if we fully load the decrease in gasoline prices into current estimates. Compare that to 13 per cent increases on drugs, on average. So — as I wrote last weekend, over my coffee — smaller versions of the Shkreli scenario are the rule, not the exception. And as I wrote, both he and Saunders learned these tricks from Fred Hassan. It is the rule — not the exception. And only a free negotiating market will curb it effectively. Legislation cannot. Here endeth the sermon.

A Shortfall In US Public Funding Is Not Co-Terminous With “Pharma” Prevention Of Life Saving Drugs. Period.

October 3, 2015 - Leave a Response

I don’t want to overly belabor the point, but this very well-educated Upshot editorial commenter waits until paragraph 14 of his 16 paragraph essay to acknowledge that perhaps — just perhaps — not-for-profit, public-funded, or academic basic science programs should bring unpatentable (i.e., unprofitable) medicines and drug candidates to market — with yes, public assistance.

[Shareholders of for profit companies, on the other hand, expect. . . (gasp!). . . profits. And pharma profits flow from. . . patents. This is a point not mentioned by the commenter.]

While pharma could always donate more to such efforts, and pharma is very profitable, it is largely nonsensical to suggest that the companies “prevent” unpatentable tech from reaching market. And it is near-lunacy (in my estimation) to suggest that for profit companies be given patent like monopoly periods on such basic, obvious drug candidates, solely to hasten them to market. [Witness Mr. Shkreli’s various exploits, here.] So, the entire essay needs rethinking in my view — but here is the bit where he starts his slide. . . sideways:

. . . .By granting temporary monopolies to innovators, the patent system is widely credited with protecting and promoting innovation. But when it comes to pharmaceuticals, it may be preventing valuable therapies from coming to market. . . .

Now you know: granting pharma ever more profit opportunities by monopolies at law (even shortish ones), isn’t the right answer to a shortfall in basic public investment in public science — even obvious science. [There are, of course, other cases — where pharma arguably delays or prevents life saving medicines from reaching market — but these are not those cases.] Onward, on a gray Saturday here. . . but smiling just the same. In short, Prof. Outterson is right.

A Breath Of New Life — For A Possible Trans-Pacific Trade Accord? Could Be Good For Pharma. . .

October 2, 2015 - Leave a Response

Back in July of 2015 — and earlier, in June — we offered our perspective here on what such a pact might mean for US drug companies that compete in the Pacific Rim. Do read those. This is a complicated topic, with policy puts and takes, on all sides — and it covers everything from autos to technology goods. But pharma/biologics have long presented a particularly vexing set of trade issues.

And so, by late July, the talks had ended without an accord — or even a framework, for reaching one — in no small part due to the pharma/bio related issues. Chief among the sticking points was the US’s insistence on a 12 year biologics IP protection/exclusivity period. Well, tonight we read (courtesy of the New York Times) that there may be an eight year compromise afoot. It is my view that US multi-national drug companies would fare better, in the main, under an eight year compromise on biologics IP exclusivity, than to leave 2015 without an accord, at all. [With 2016 ushering in a full-on presidential election cycle, with protectionism looming as a key issue (on all sides), I think 2015 is the last best opportunity for several years.] I suspect BiO and PhRMA see it that way too — and will end up agreeing — after some gnashing and wailing. Still, a deal is far from certain, but this is a rather hopeful moment (again quoting The Gray Lady):

. . . .[Mr. Obama’s U.S. Trade Representative Michael] Froman was particularly embroiled on Friday in trying to settle the pharmaceutical drug issues. The most vexing question was how long drug companies can have exclusive rights to data related to their development of so-called biologic drugs (products made from living organisms and considered promising for cancer treatments) before they must share the information with generic manufacturers.

The United States, which had insisted on 12 years to ensure drug manufacturers have incentives to innovate, recently proposed an eight-year provision as a compromise. It would give companies five years of exclusive rights followed by a three-year period of limited market sharing. . . .

And so. . . “Hope is a good thing. In fact, it may be the best of all things.” Hope — of new life. Smile. G’night.


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