Re­gen­eron, Al­ny­lam spell out a re­search al­liance that could run be­yond a decade, with bil­lions built in for suc­cess

Re­gen­eron $REGN and Al­ny­lam $AL­NY have laid a foun­da­tion for an en­dur­ing R&D al­liance that could go out well past a decade, with bil­lions of dol­lars on the line if they’re suc­cess­ful.

We al­ready know that Re­gen­eron is pay­ing $800 mil­lion for the up­front and eq­ui­ty stake, with an­oth­er $200 mil­lion for proof-of-prin­ci­ple mile­stones — which we’ve not­ed makes it one of the top plat­form deals in in­dus­try his­to­ry. 

In an SEC fil­ing Wednes­day, Re­gen­eron went deep­er in­to the num­bers and terms. These added deal terms are par­tic­u­lar­ly im­por­tant as they cre­ate a bond that rep­re­sents a whole new gen­er­a­tion of drug de­vel­op­ment work for two of the most im­por­tant biotechs in the in­dus­try. And it ar­rives as each are turn­ing from col­lab­o­ra­tions with Sanofi and de­sign­ing a new fu­ture for them­selves.

There’s an au­to­mat­ic ex­ten­sion built in­to the deal that could ex­tend this pact by 7 years. And Re­gen­eron holds an op­tion to add 5 years that would be worth any­where from $200 mil­lion to $400 mil­lion for Al­ny­lam. The ac­tu­al amount will be based on ac­cep­tance of their INDs, with the part­ners plan­ning on 6 new tar­gets each year.

Re­gen­eron, as we al­ready know, is tak­ing the lead on the eye, where it’s look­ing to Al­ny­lam to help es­tab­lish a durable de­fen­sive bar­ri­er around the fran­chise it’s built for Eylea. Then they’ll al­ter­nate lead roles for CNS dis­eases and liv­er pro­grams, with a shot at co-col­lab­o­ra­tions where they’ll split the prof­its.

That lead role won’t come cheap. The lead will pay the part­ner up to $150 mil­lion in mile­stones, plus roy­al­ties, on each pro­gram.

Then there’s a $325 mil­lion mile­stone con­sid­er­a­tion that’s be­ing built in­to a spe­cial al­liance for their two C5 pro­grams, com­ing to­geth­er as a com­bi­na­tion ther­a­py to take on Alex­ion’s cash cow Soliris and the suc­ces­sor drug that just hit the mar­ket.

Al­ny­lam CEO John Maraganore al­so built in some safe­guards against see­ing Re­gen­eron go hos­tile in a takeover at­tempt af­ter it’s bought in­to the com­pa­ny. Re­gen­eron agreed to lim­it any eq­ui­ty pur­chas­es of Al­ny­lam stock to 30% of the com­pa­ny dur­ing the length of the col­lab­o­ra­tion. 

And Re­gen­eron can ter­mi­nate the al­liance with 90 days no­tice, in case the ex­ecs aren’t hap­py.

If they’re suc­cess­ful, they can both en­joy big­ger pipelines and more com­mer­cial roll­outs. Fail­ure in­cin­er­ates the fi­nan­cials that are baked in now.

Im­age source: AP

Roger Perlmutter Merck Investor Day 1

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

Eli Casdin, Casdin Capital

Eli Cas­din backs Codex­is' plat­form tech with $50M eq­ui­ty buy

About a month af­ter Codex­is notched a deal with No­var­tis $NVS, the Cal­i­for­nia com­pa­ny $CDXS on Thurs­day said long-time in­vestor Cas­din Cap­i­tal is putting up $50 mil­lion in a pri­vate place­ment, which puts the New York-based in­vest­ment firm in con­trol of more than 5% of the pro­tein en­gi­neer­ing play­er’s stock.

Eli Cas­din start­ed his epony­mous in­vest­ment firm in 2012 and dates his re­la­tion­ship with Codex­is back to at least a decade. About three years ago, Cas­din Cap­i­tal be­gan in­vest­ing in the in­dus­tri­al biotech com­pa­ny, af­ter it piv­ot­ed its fo­cus to the life sci­ences — un­der the aus­pices of new chief John Nicols — away from the en­er­gy in­dus­try.

In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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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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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

In­vestors pony up $476M for the lat­est round of biotech IPOs to hit the Street

Three biotechs — and a genome se­quenc­ing play­er — have caught the lat­est tide to the Gold Coast of IPOs, round­ing out the first half of 2019 with 23 new drug de­vel­op­ers mak­ing it on Nas­daq.

Most of these com­pa­nies filed their IPOs al­most si­mul­ta­ne­ous­ly, though we’re still wait­ing on word of fel­low class­mate Bridge­Bio’s pric­ing af­ter CEO Neil Ku­mar set the terms at $14 to $16 a share on Mon­day in search of a $240 mil­lion (or so) wind­fall. If he’s suc­cess­ful, that would take the one-week haul past the $700 mil­lion mark, a fresh sign that in­vestors’ en­thu­si­asm for new­ly coined pub­lic biotechs hasn’t cooled.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.