In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

That’s the bot­tom line from a new sto­ry in to­day’s Wall Street Jour­nal, which quotes sources say­ing that the phar­ma gi­ant will spell out this ap­proach in its up­com­ing in­vestors’ day on Thurs­day — the first in 5 years.

Roger Perl­mut­ter Mer­ck

An­a­lysts have been quick to cheer on Mer­ck’s R&D chief Roger Perl­mut­ter, whose ar­rival at the gi­ant op­er­a­tion 6 years ago co­in­cid­ed with the rise of Keytru­da as it be­gan a clin­i­cal march to­ward its cur­rent po­si­tion as the lead drug in its field. For ri­val Bris­tol-My­ers Squibb, drop­ping in­to sec­ond place meant chang­ing gears and go­ing af­ter Cel­gene. But Mer­ck’s suc­cess led to a long, large­ly dor­mant po­si­tion on the M&A front.

No more.

Mer­ck has oth­er drugs to boast about, in­clud­ing a ri­val to Pfiz­er’s best­selling Pre­vnar 13 that is in late-stage de­vel­op­ment on the vac­cine’s side of the busi­ness. But it’s not near­ly enough to sat­is­fy an­a­lysts that Mer­ck is po­si­tioned to sur­vive a sub­stan­tial hit in I/O, where Keytru­da rev­enue has swelled to a re­mark­able $7 bil­lion.

Ken Fra­zier Mer­ck

Be­hind Keytru­da and Bris­tol-My­ers Squibb’s Op­di­vo are 4 oth­er ap­proved PD-1/L1s in the US, along with a tsuna­mi of pro­grams in Chi­na and among oth­er bio­phar­mas. Both Am­gen and No­var­tis have their own PD-1s in the pipeline, large­ly so they can con­trol their own com­bo pro­grams. BeiGene is field­ing one that they be­lieve has best-in-class po­ten­tial. And a host of com­pa­nies are turn­ing out me-toos with re­mark­able con­sis­ten­cy.

All that could com­modi­tize Mer­ck’s mar­ket in a short pe­ri­od of time.

Perl­mut­ter was nev­er big on bold, risky ac­qui­si­tions. At Am­gen, be­fore Ken Fra­zier brought him back to Mer­ck, Perl­mut­ter was well known for se­lec­tive­ly tar­get­ing biotechs which he open­ly ad­mired for their sci­ence and lead­er­ship. Pick­ing up the pace now may not come nat­u­ral­ly for some­one like the R&D chief, not much of a wheel­er-deal­er, but with decades of ex­pe­ri­ence and a glob­al BD team with un­com­mon reach, it shouldn’t prove im­pos­si­ble.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. The idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.

Ver­tex deal for Scot­land — no deal for Eng­land

Cystic fibrosis (CF) drug maker Vertex Pharmaceuticals — which is still locked in negotiation with NHS England to endorse the use of its medicines — has successfully negotiated a deal with Scottish authorities.

A month ago, the Scottish Medicines Consortium spurned two of the company’s medicines — Orkambi and Symkevi — citing uncertainty over their long-term efficacy in relation to their cost.

Tony Kulesa, Brian Baynes. Petri

Star founders, in­ves­ti­ga­tors hud­dle around new Boston ac­cel­er­a­tor spot­light­ing young en­tre­pre­neurs

As a widely recognized biotech hub, Boston is undoubtedly one of the best places to start a new company at the frontier of biology and engineering. With a dense network of incubators, venture capitalists and talent, seasoned company founders can have their pick of partners and models launching their latest startups.

But for young, aspiring entrepreneurs, it’s a very different scene.

Big VC firms might hire you to work on their ideas instead of yours, and accelerators may not offer the kind of deep technical expertise and guidance needed to make it in the field.

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From part­ner to knight in shin­ing ar­mor: Cas­tle Creek to buy Fi­bro­cell

In April, Castle Creek swooped in to partner with the embattled gene and cell therapy Fibrocell to shepherd its lead gene therapy for a type of “butterfly” disease into late-stage development. Now, the New Jersey-based dermatology company is acquiring its partner in a deal worth $63.3 million.

Pennsylvania-based Fibrocell last year initiated a review of strategic alternatives, including a sale.