Oys­ter Point in­vestors bet $93M on a PhI­II study aimed at dis­rupt­ing a ma­jor con­sumer mar­ket and top­pling Al­ler­gan


Every­one who ever felt the tears well up in their eyes as they bit in­to a red hot chili pep­per should be able to quick­ly gain a ba­sic un­der­stand­ing of what Oys­ter Point Phar­ma is try­ing to do. The team there be­lieves they’re on to a new and bet­ter way to treat dry eye dis­ease. And they now have a whop­ping $93 mil­lion round from some so­phis­ti­cat­ed in­vestors will­ing to back a Phase III to give it a fi­nal push — hope­ful­ly to­ward reg­u­la­tors.

The con­cept is sim­ple: use an in­tranasal ther­a­py to stim­u­late the trigem­i­nal parasym­pa­thet­ic path­way to kick up nat­ur­al tear pro­duc­tion. And they have a re­for­mu­la­tion of Chan­tix — OC-01 — which com­ple­ments an in-house NCE — OC-02 — to pick from for the piv­otal. There’s some mixed but most­ly pos­i­tive mid-stage da­ta on dis­play — some of which reg­u­la­tors ev­i­dent­ly be­lieve are good enough to stand in as a well-con­trolled tri­al need­ed to back up their Phase III.

Sound easy? Any­thing but.

Ste­fan Vi­torovic

While a whole host of biotech star­tups are go­ing af­ter rare dis­eases or can­cer nich­es to keep stud­ies small and com­mer­cial prospects man­age­able, Oys­ter Point staffers — all 8 of them — are go­ing af­ter a com­mon ail­ment suf­fered by tens of mil­lions. In biotech land, it’s ab­solute­ly es­sen­tial that you make a con­vinc­ing case that you can man­age com­mer­cial­iza­tion work on your own; you may even claim that that is your strat­e­gy. 

Part­ners and po­ten­tial buy­ers are put on alert that they don’t have to take any of­fer on the ta­ble. And you have to be able to con­trol your own des­tiny.

Gulp.

Sure, the big com­mer­cial out­fit at Brent Saun­ders’ Al­ler­gan now dom­i­nates the space with Resta­sis — which faces cheap gener­ic com­pe­ti­tion, says Oys­ter Point. But on­ly a frac­tion of pa­tients are be­ing treat­ed prop­er­ly, and Resta­sis and the oth­er prod­ucts are de­liv­ered via eye drops. This new path­way is bet­ter.

That’s Oys­ter Point’s sto­ry, and they’re stick­ing to it as they set out to prove their case.

“Com­pa­nies like us have to plan to take it all the way to the goal line,” Oys­ter Point CEO Jef­frey Nau tells me. Maybe some­body would buy the com­pa­ny, he adds in re­sponse to my ob­vi­ous query, but ei­ther route “is vi­able.”

An IPO could work as well to fund a launch.

Set­ting aside the fea­si­bil­i­ty of a tiny biotech field­ing a con­sumer prod­uct for dry eye dis­ease, Nau’s clear­ly pumped by the $93 mil­lion B round, which does give him a clear shot at tak­ing one of his drugs through a large Phase III study with about 600 or so pa­tients and on to an NDA. The CEO ex­pects to kick that study off at the mid-point of this year, with a read­out in ear­ly 2020.

Nau says his syn­di­cate is back­ing what he be­lieves is the largest sin­gle round ever as­sem­bled for an oph­thal­mol­o­gy up­start. The mon­ey is com­ing from two new lead in­vestors, In­vus Op­por­tu­ni­ties and Fly­ing L Part­ners al­lied with Fal­con Vi­sion. NEA and Ver­sant, which launched the com­pa­ny, are back, joined by Vi­da Ven­tures, where co-founder Ste­fan Vi­torovic has cham­pi­oned their strat­e­gy.

Their mon­ey will al­low the com­pa­ny to quadru­ple its staff in the near-term. And they can even think in terms of the com­mer­cial plan. Which they can han­dle. On their own. If needs be.

Let the Phase III be­gin.


Im­age: Jef­frey Nau. OYS­TER POINT

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.

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.

Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Merck waved off a looming forced retirement for Ken Frazier last September, the board cited flexibility in CEO transition as a key factor in the decision. Having Frazier — who’s also chairman of the company — around beyond his 65th birthday in 2019 would ensure they install the best person at the best time, they said.

The board has evidently begun that process with a clear preference for internal candidates, sources told Bloomberg. CFO Robert Davis, chief marketing officer Michael Nally, and chief commercial officer Frank Clyburn are all in the running, according to an insider.

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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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Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

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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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.

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.

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.