WHY Leerink Swann Reduced Its Merck Target To $62.50, From $66 — Fernandez’s Latest Opdivo® Analysis

March 16, 2015 - Leave a Response

In a word — BMS’s Opdivo®.

It seems Seamus Fernadez agrees with us: Merck’s Keytruda® fortunes are at least marginally worse (albeit in a slightly material fashion), post the news of eleven days ago. Here is a bit, from the Leerink key take-aways, at that firm’s 2015 conference on global healthcare. Do go read it all:

. . . .Off-label reimbursement [for BMS’s Opdivo] has been challenging to date, but the KOL believes that lung cancer approval in one setting paired with the available scientific publications and abstracts should drive reimbursement across multiple lines of therapy or histologies. Both physicians believe that 2nd line approval of PD1/ PDL1 could change the progression from 1st to 2nd line therapy such that the discontinuation rate between 1st and 2nd line treatment could be much less than the frequently cited 50%.

In addition, it was suggested that savvy physicians could employ a “fast-fail” strategy with chemotherapy in order to more quickly start patients on these life-saving drugs. One KOL noted a similar strategy with Zytiga (abiraterone) which broadened use earlier than most expected. . . .

Opdivo [is] expected to quickly replace Afinitor in 2nd line kidney cancer; assumes success of BMY’s -025 study. The genitourinary specialist (prostate, kidney) was confident that BMY’s Opdivo would best Afinitor in the head-to-head 025 study largely because Afinitor is such a poor treatment standard. He predicted that once available, Opdivo will quickly replace 100% of Afinitor use in kidney cancer. He noted, however, the need for combination therapy to demonstrate improved overall survival vs. 1st line VEGF TKIs.. . .

Sleep well, now one and all!

The Week That Was: Jefferies Still See-Sawing On Merck

March 15, 2015 - Leave a Response

I suspect this slight down-beat was due to BMS’s Opdivo® receiving an FDA lung cancer (NSCLC) nod, during the past ten days. It marginally erodes Merck’s market cap potential. But only marginally.

Jefferies’ Seamus Fernandez is unlikely to alter his views very much on Merck, or BMS (or J&J, for that matter) in the near term. He has bounced it around, quite a bit, from $65 to $60 — with one stop north of there, only — in the last 24 months. Here’s a bit, from a reprint of an earlier time:

. . . .Jefferies Group has also taken action a number of other healthcare stocks recently. The firm lowered its price target on shares of Merck & Co., Inc. from $63.00 to $62.00. They have a hold rating on that stock. Also, Jefferies Group raised its price target on shares of Johnson & Johnson from $108.00 to $110.00. They have a hold rating on that stock. . . .

So — really no news at all. And so, we waited until Sunday morning to note it, casually, over coffee, juice and a banana.

O/T, But Only Once A Century — Epic Pi Day 3.141592653!

March 14, 2015 - 4 Responses

mrk-ALT-pi-21415-9-26 Well, I suppose it belongs here — because of its importance to all of the life sciences, generally. And — as someone told me yesterday — I’m a goof for it. True — but my adoration of it is. . . shameless.

From The New York Times opinion page, this afternoon, then:

. . . .Early mathematicians realized pi’s usefulness in calculating areas, which is why they spent so much effort trying to dig its digits out. Archimedes used 96-sided polygons to painstakingly approximate the circle and showed that pi lay between 223/71 and 22/7. By the time Madhava (in India, around 1400) calculated pi to over 10 decimal places using his groundbreaking infinite series (which regrettably bears Leibniz’s name), it was already more than accurate enough to address all practical applications. Pursuing pi further had essentially become a mathematical challenge. . . .

I just had a big slice of warm pecan pie, literally swimming in dollops of whipped cream. . . so my celebration and observance is. . . complete! Have you. . . had yours?

I Hate Being Right About This Kind Of Stuff: Bridion® — No St. Paddy’s Gift — At FDA

March 13, 2015 - Leave a Response

Buried on a Friday afternoon before St. Patrick’s. . . .

I’ll have more in a few minutes, but this former Fast Fred “Star” just cannot catch a break. The review at an Advisory Committee of FDA next week was just. . . scrubbed. Pulled. Dumped. From Kenilworth’s presser, then:

. . .The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101). The Agency has indicated it plans to conduct these additional inspections prior to an Advisory Committee meeting and completion of their review. Due to the timing of the additional inspections, Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015. Merck will continue to work with the FDA as it completes its review. . . .

Alas — no luck of the Irish there. We had mentioned this scheduled FDA Advisory Committee meeting at the beginning of the month. Oh well. What a tortured path this operating suite drug candidate has endured — largely due to legacy Schering mismanagement of the studies, and miscalculations in the FDA filing strategy, in that legacy law department. So it goes. Maybe 2016 will be its year. It feels a lil’ like my. . . Cubs. Smile.

Well — Apple Moves At Lightning Speed, It Seems: UPDATED “Informed Consent” Guidelines For Stanford Med App

March 12, 2015 - Leave a Response

Barely eight hours ago, we wrote about the “brave new world” of clinical trial recruiting. . . via an ingeniously simple and elegant iPhone App — released just Monday. Tonight, AppleInsider is reporting that Apple has already tightened its developer guidelines to address the patient confidentiality and informed consent concerns that FDA and other regulators around the globe might justifiably articulate.

From those just-revised Apple Developer Guidelines, then:

. . .27. HealthKit and Human Subject Research

27.1 Apps using the HealthKit framework or conducting human subject research for health purposes, such as through the use of ResearchKit, must comply with applicable law for each Territory in which the App is made available, as well as Sections 3.3.28 and 3.3.39 of the iOS Developer Program License Agreement

27.2 Apps that write false or inaccurate data into HealthKit will be rejected

27.3 Apps using the HealthKit framework that store users’ health information in iCloud will be rejected

27.4 Apps may not use or disclose to third parties user data gathered from the HealthKit API or from health-related human subject research for advertising or other use-based data mining purposes other than improving health, or for the purpose of health research

27.5 Apps that share user data acquired via the HealthKit API with third parties without user consent will be rejected

27.6 Apps using the HealthKit framework must indicate integration with the Health app in their marketing text and must clearly identify the HealthKit functionality in the app’s user interface

27.7 Apps using the HealthKit framework or conducting human subject research must provide a privacy policy or they will be rejected

27.8 Apps that provide diagnoses, treatment advice, or control hardware designed to diagnose or treat medical conditions that do not provide written regulatory approval upon request will be rejected

27.9 Apps conducting health-related human subject research must obtain consent from participants or, in the case of minors, their parent or guardian. Such consent must include the (a) nature, purpose, and duration of the research; (b) procedures, risks, and benefits to the participant; (c) information about confidentiality and handling of data (including any sharing with third parties); (d) a point of contact for participant questions; and (e) the withdrawal process. . . .

Oh my — it isn’t often that I get caught completely slack-jawed by the advancing pace of tech, but tonight I confess — I am agape. Maybe I’m just getting old, but it sure seems that the world moves so quickly these days. [Not entirely rhetorically — I wonder whether both Stanford and Apple received calls from FDA staffers today, post the Bloomberg story and the AppleInsider note, earlier in the week.] Sleep well, one and all!

Drug Discovery — In Entirely New Places? Merck Take Heed.

March 12, 2015 - Leave a Response

Well, it is truly a brave new world. How so?

I see this morning that the Stanford University Medical Research iPhone App garnered 10,000 patient volunteers in its first two nights of availability in the App Store (to conduct large cardiovascular studies).

In the old world, to get 10,000 patients enrolled in a CV study, one would expect that it would take over a year — and well north of $2 million, in expenses — just to get a CRO to find that many, and sign them to required informed consent forms. . . before even beginning a study. So, even if we may quibble about how perfect a match these 10,000 iPhone users will be — compared to the overall populations involved — that it was accomplished essentially for freeand in 48 hours – is positively mind-bending.

As if that weren’t enough, I just read that my favorite lil’ genome-mapping-by-spit company, 23andMe (the Google non-affiliated-affiliate!) has just signed a Genentech executive to begin. . . drug discovery efforts, using the vast database of genomic information the company now holds. I’ll note that he must have gotten a release under his non-compete from Genentech, because 23andMe already has agreed to collaborate with Roche (the parent), through Genentech — using the 23andMe database for. . . you guessed it — drug discovery. In fact, this same executive apparently spear-headed that deal. Small world.

This is entirely fascinating — from Bloomberg – more later this afternoon:

. . . .23andMe Inc., the Google Inc.-backed genetic-testing startup that popularized a $99 DNA spit test, will expand from screening people for diseases to inventing new medicine to cure them.

The Silicon Valley company has recruited a top biotechnology executive to help. Richard Scheller spent almost 15 years at Genentech, heading research and early development at the company that invented pioneering cancer drugs Herceptin and Avastin. He’ll lead 23andMe’s new therapeutics group.

It’s the latest evolution for 23andMe, which went from a seller of novelty ancestry kits to one of the world’s biggest repositories of genetic data, doing business with major pharmaceutical companies like Pfizer Inc. and Genentech. . . .

We will of course keep the readership posted. Much more shortly above now, but this is. . . a potential game changer.

Keytruda® Early Access In UK For Melanoma; Derek Lowe On R&D Shakeouts (Cubist Version)

March 11, 2015 - Leave a Response

Kenilworth this morning announced — and the gent Ed Silverman duly noted — that Keytruda® is the first candidate in the United Kingdom to receive an MHPRA pre-clearance “early access” to therapy (likely at small or no price) nod, for patients with advanced melanoma only. That is smallish good news, for Merck — at least in comparison to BMS’s news.

Separately, Derek Lowe at Corante has been lamenting of late the R&D cuts we’ve all been reading about — including the Cubist Lexington, Massachusetts ones.

But this morning, he offers us the flip-side — the quite correct view that this is a very exciting time for science — and scientists — cancer researchers, in particular. And he is right, vast, market disrupting advances will inexorably lead to frictional dislocation of resources. . . including human capital. Here is a bit of Derek Lowe’s fine analysis — do go read it all:

. . . .That’s just one therapeutic area, although it’s a big one. There are others advancing as well. That’s the frustrating part, in a way – coming into this field de novo, you’d look around and see so many opportunities that you wouldn’t know where to start. But many of the existing businesses (and in some cases, existing business models) are having a heck of a time fitting in. Running an organization the size of a Merck or a Pfizer, with those expenses and those legacy commitments and that overhead, really is a beastly job. But no business is owed some sort of right to always exist in its present form. Business-wise, this is an ugly period. Scientifically, it’s really quite good. Bridging those two, now – that’s where all the clanging noises are coming from. . . .

Our thoughts are with the affected scientists’ families — but we do agree, we will collectively likely look back a decade or two from now, and say. . . this was the turning point, on cancer. That’s heady stuff. So. . . onward.

Barclays To Host Merck’s Rob Davis Tomorrow — In Miami

March 10, 2015 - Leave a Response

Well, at least the weather will be nicer than. . . Boston.

He’s not likely to make any real news in Miami tomorrow, but we’ll likely listen in just the same. [I suppose he might comment on the NSCLC FDA approval for BMS’s Opdivo® — and, perhaps, Merck’s catch-up plans.] We may liveblog any real news:

. . . .Merck announced today that Robert Davis, executive vice president and chief financial officer, Merck, is scheduled to present at the Barclays Global Healthcare Conference in Miami on March 11, 2015 at 8:00 a.m. EDT. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation. . . .

We will — as ever — keep the readership posted. [Housekeeping note: Now that the UN Conference on “Every Woman; Every Child” has concluded, I’ve removed the post that linked directly to that streaming video feed. For future reference, it is http://www.webtv.un.org.]

Undercutting Even The Laudable PATH Initiative, Bharat Offers India A $1/Dose Version Of Merck’s RotaTec®

March 10, 2015 - Leave a Response

Almost exactly four years ago today, I featured a story about Merck introducing the RotaTec® rotavirus vaccine into India — at an affordable price (in local Rupees) — and suggested Mr. Frazier was a visionary for doing so.

It seems that, four years on — much as we saw yesterday, in the Sovaldi®/Bangladesh story — local commerce has vaulted well ahead. . . of charity. And that’s a good thing, globally.

From FiercePharma‘s fine story, this morning, then:

. . . .Back in 2011, Indian company Bharat Biotech pledged to offer its rotavirus prospect at a price that undercut even discounted vaccines from GlaxoSmithKline and Merck. Now, it’s ready to make good on its promise.

The [company] has rolled out Bharat’s three-dose vaccine, Rotavac, at a rate of around 60 rupees–or just under one U.S. dollar. . . .

[I]t’s Bharat’s new manufacturing process that consumers can thank for Rotavac’s low price. The biotech has spent about $20 million to construct new facilities and supporting infrastructure at its Genome Valley plant, which boasts a capacity of 300 million doses per year, it said in a release. . . .

My March 2011 backgrounder may be found here. Onward, on a foggy but temperate Tuesday.

More Granularity, On What BMS’s NSCLC FDA Opdivo® Nod Might Mean In 2015 Through 2017

March 9, 2015 - Leave a Response

An erstwhile anonymous commenter remarked last week that perhaps the FDA nod to Opdivo® would not mean too, too much to Merck’s Keytruda® in NSCLC, longer term. I suppose it may be that the world is changing underfoot (wouldn’t be the first time that’s happened to me!), but it had always been my perception that — in oncology at least — it tends to be “winner take all“. The below reiterates that view.

Of course, I do think there will be perhaps $5 to $7 billion in Keytruda market proceeds for Merck (per year), working into 2018 and beyond. However, I do think in the near term, BMS has scored a vast win, here — by nailing an inroad to NSCLC first — by as much as 9 to 12 months, over Kenilworth.

And I do think — as the below Bloomberg article intones, oncology is. . . different. Both as to price points — and as to prescribing patterns — where (as here) there is a clear survival benefit. A bit, then — from the Bloomberg story of this afternoon:

. . . .That’s because the FDA’s practice of approving drugs by each cancer type and stage of disease. So even if two cancer drugs are similar on paper, they may still not compete directly because they are approved for slightly different uses.

Another factor that helps keeps pricing up is that cancer doctors tend to exclusively prescribe the drug that is perceived to have the most efficacy for each particular cancer type, even if the advantage is narrow.

In oncology, it tends to be winner take all,” Evans said. “Whoever has the best efficacy will get all the sales, and that really preserves the pricing power. . . .”

I still think the commenter has a fine longer term (circa 2018 and beyond) point. And, as much as I hate to say it, once Opdivo starts posting results in lung cancer, inside the oncology wards, day by day — those docs are reasonably likely to write off label for it — and second line vs. third line will become a blurred line, at best. In sum, I just think it is hard to overestimate the significance of Opdivo’s FDA NSCLC nod, last week. For what it is worth.

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