Trump nukes bio­phar­ma, and the fall­out is ra­dioac­tive

End­points as­sess­es the big bio­phar­ma sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

The cheap shot heard around the bio­phar­ma world

Make no mis­take, Don­ald Trump dropped a nuke on JP Mor­gan in more ways than one when he sud­den­ly went off on an un­script­ed tan­gent in his press con­fer­ence and slimed the bio­phar­ma in­dus­try for its mur­der­ous pric­ing prac­tices.

We’ve heard some snip­pets be­fore from Trump as he stoked pop­ulist anger over drug prices. There were sug­ges­tions about Medicare ne­go­ti­a­tions and he clear­ly promised Time that as pres­i­dent he will rein in prices. Es­sen­tial­ly promis­ing to use the full force of the fed­er­al gov­ern­ment to ac­com­plish that, though, was the night­mare sce­nario that the in­dus­try feared was com­ing.

Can nasty tweets di­rect­ed at in­di­vid­ual drug prices be far be­hind?

And JP Mor­gan was go­ing so well…

I’ve been a reg­u­lar at JP Mor­gan long enough to know the drill. It’s a great way to start the year with a lift — no mat­ter what. If trends are aw­ful, you’ll get plen­ty of hype of bet­ter times to come. If they’re great, the news flow will con­vince you that good times will not be end­ing soon.

Sure, there are plen­ty of com­plaints. But Amer­i­cans com­plain the most when we’re win­ning. And few an­a­lysts would de­ny that most of the ba­sics in bio­phar­ma have been great — nu­mer­ous caveats and in­di­vid­ual de­feats aside.

This year was dis­tinct­ly dif­fer­ent, and that was ap­par­ent even be­fore Trump dumped all over the in­dus­try.

Busi­ness as usu­al is over in bio­phar­ma, and we all know it. I had a chance to dis­cuss this with a pan­el that in­clud­ed Brent Saun­ders, Richard Pops, Joaquin Du­a­to, Steven Pear­son and Stephen Ubl. I even snagged Bob Hug­in at the West­in for a few min­utes. And the pri­ma­ry top­ic was about change and how to man­age it.

The in­dus­try has a nar­row open­ing left to reg­u­late it­self in ways that will pro­tect the need for ag­gres­sive pric­ing on new drugs. I think we would all be hap­py to see the price gougers (Tur­ing, Valeant, My­lan) lined up against a wall and fig­u­ra­tive­ly shot for in­cit­ing on­line ri­ot­ing over drug prices. Port­fo­lio price hikes on patent­ed ther­a­pies will now be reined in, with much thanks to Saun­ders for lay­ing out the guide­lines.

Look over the price hikes you’ve seen over the past two weeks and you’ll see that Saun­ders’ pledge push has proven enor­mous­ly in­flu­en­tial.

Now the in­dus­try has to fol­low up with an un­apolo­getic, please-look-at-the-da­ta ap­proach on new drug prices. If there’s a land­mark event in drug de­vel­op­ment, you can and should ex­pect a steep price. That’s pay­ing for the in­dus­try’s R&D bill. The in­dus­try, though, has to do a much, much bet­ter job of ex­plain­ing why re­al ad­vances are worth pay­ing for. Gilead pro­vid­ed a clas­sic ex­am­ple of how not to do that when it rolled out So­val­di with its Death Star PR team at the fore­front.

The hid­den side to all of this is that once you strip away the re­mark­able an­nu­al port­fo­lio price hikes, the in­dus­try will be left to re­ly on in­no­va­tion for its fu­ture suc­cess. And can any­one doubt that some of the biggest com­pa­nies are the least pre­pared for what’s to come?

JPM kicks off with plen­ty of deals, prim­ing the pump for 2017

This time a year ago we all ex­pect­ed that 2016 would be a great year for M&A. I know I did. That proved to be flat wrong, but the con­sen­sus now is that 2017 has to be big for M&A. And the first round of deals an­nounced in and around JP Mor­gan in­di­cates that pre­mi­ums are still over the top.

Like a num­ber of play­ers, Ipsen has a new CEO in­ter­est­ed in mak­ing a rep for the com­pa­ny. So he start­ed by buy­ing out a Mer­ri­mack drug that has un­der­per­formed since launch. That $1 bil­lion deal sets the stage for what will be a busy year in ac­qui­si­tions, as Take­da proved with Ari­ad (pay­ing a 74% pre­mi­um). And we all know that Pfiz­er plans to be ac­tive.

Sanofi, Gilead, Bio­gen and many oth­ers are all but re­quired to per­form this year, if they want to get a pack of un­hap­py an­a­lysts off their backs.

Mer­ck sur­pris­es us all once again, in a good way

Once again the amaz­ing im­muno-on­col­o­gy team at Mer­ck is break­ing new ground and com­plete­ly wreck­ing all the ex­pec­ta­tions of their ri­vals and an­a­lysts. This week the wreck­ing ball came in the form of a swift FDA em­brace of their ap­pli­ca­tion for Mer­ck’s com­bo ther­a­py for lung can­cer.

Mer­ck has con­sis­tent­ly been shoved in­to sec­ond place with Keytru­da, and Roger Perl­mut­ter’s crew has con­sis­tent­ly proven that they won’t ac­cept that.

Up­set­ting ex­pec­ta­tions in R&D has be­come a habit for a Big Phar­ma out­fit that was once so mori­bund that it could nev­er fig­ure out how to jump off the tracks ahead of a fast-ap­proach­ing train. They’re on a roll now, and this time no one will un­der­es­ti­mate what the Keytru­da group can ac­com­plish.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

 

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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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.

Dave Barrett, Brian Chee, Amir Nashat, Amy Schulman. Polaris

Bob Langer's first port of call — Po­laris Part­ners — maps $400M for ninth fund

Health and tech ven­ture group Po­laris Part­ners, which counts Alec­tor, Al­ny­lam and Ed­i­tas Med­i­cine as part of its port­fo­lio, is set­ting up its ninth fund, rough­ly two years af­ter it closed Po­laris VI­II with $435 mil­lion in the bank, sur­pass­ing its tar­get by $35 mil­lion.

The Boston-based firm, in an SEC fil­ing, said it in­tends to raise $400 mil­lion for the fund. Po­laris — which rou­tine­ly backs com­pa­nies mold­ed out of the work done in the lab of pro­lif­ic sci­en­tist Bob Langer of MIT  — typ­i­cal­ly in­vests ear­ly, and sticks around till com­pa­nies are in the green. Like its peers at Flag­ship and Third Rock, Po­laris is all about cham­pi­oning the lo­cal biotech scene with a steady flow of start­up cash.

Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

Af­ter watch­ing its share price soar on a Bloomberg re­port and heat­ed ru­mors, Bio­haven stock takes a bil­lion-dol­lar bath

Back in April, Biohaven Pharmaceutical became one hot biotech stock $BHVN based on a report in Bloomberg that some “potential bidders” had been kicking the tires at the biotech, which has a lead drug for migraines. Then the rumor mill really started to smoke when execs canceled a presentation at an investor conference a little more than a week ago.

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Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.