Aerie bags an ear­ly OK for its self-de­scribed block­buster glau­co­ma drug Rho­pres­sa, re­cruit­ing 100 reps

The FDA has ap­proved Aerie’s $AERI glau­co­ma drug Rho­pres­sa, hit­ting the green light a full two months ahead of the PDU­FA date.

This wasn’t a big sur­prise. An ex­pert pan­el of­fered a lop­sided 9-to-1 vote in its fa­vor, hap­py to see a new drug would be a wel­come ad­di­tion to the phar­ma­copeia avail­able for the eye dis­ease.

That vote came on the heels of an in­sid­er FDA re­view that con­clud­ed the drug re­duced el­e­vat­ed in­traoc­u­lar pres­sure in the eye — the key task in the field. But the re­view al­so not­ed that the com­para­tor drug, the gener­ic tim­o­lol oph­thalmic so­lu­tion 0.5% twice dai­ly, was more ef­fec­tive for the more se­vere­ly af­flict­ed pa­tients.

Vi­cente Anido

About the last po­ten­tial threat to the drug ap­proval was erased in ear­ly No­vem­ber when the FDA cleared a new drug from Valeant in­tend­ed to be man­u­fac­tured in the same Bausch + Lomb fa­cil­i­ty in Tam­pa, FL that had been sanc­tioned twice for reg­u­la­to­ry short­com­ings. Once the fa­cil­i­ty got a stamp of ap­proval, Aerie’s drug looked like a lock.

It didn’t es­cape sev­er­al ob­servers’ at­ten­tion to­day that the ear­ly OK brought the FDA’s record on new ap­provals to 43 for the year, just two back from the 10-year high of 45 hit in 2015. New ap­provals are run­ning at twice the lev­el hit last year af­ter the in­dus­try saw a slump in NDAs.

A bull­ish Aerie CEO Vi­cente Anido has al­ready tout­ed Rho­pres­sa as a like­ly block­buster able to earn more than $1 bil­lion a year, even though the biotech had to get the FDA’s per­mis­sion to change the end­point for its sec­ond late-stage study of Rho­pres­sa in or­der to avoid back-to-back fail­ures.

Anido, not one to un­der­play a sen­ti­ment, called the ap­proval “the sin­gle great­est achieve­ment” so far for the com­pa­ny.

“We have been prepar­ing for com­mer­cial­iza­tion for well over a year, and our plans are clear,” he added in a state­ment. “We will hire our sales force of 100 sales rep­re­sen­ta­tives ear­ly in the first quar­ter of 2018, and plan to launch by mid-sec­ond quar­ter of 2018. As the 2018 year pro­gress­es, it is our goal to make strides in gain­ing for­mu­la­ry cov­er­age for com­mer­cial plans, which rep­re­sent ap­prox­i­mate­ly half of the U.S. mar­ket. The oth­er half of the U.S. mar­ket is cov­ered through Medicare Part D, and we ex­pect our for­mu­la­ry pres­ence for this mar­ket to com­mence in Jan­u­ary 2019.”

Next up: Aerie has a fol­lowup drug called Ro­cla­tan, a com­bo drug that com­bines the gener­ic la­tanoprost to its in-house drug Rho­pres­sa. That drug will be filed in Q2, says Anido.

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

In an investor call later in the day, execs noted that they are not planning another study and stood by their intention, publicized in October to much surprise, to submit regulatory filings based on what they have.

“We don’t file willy nilly,” said Al Sandrock, head of R&D. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”

Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting.

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Vas Narasimhan, Getty Images

No­var­tis CEO Vas Narasimhan's R&D up­date spot­lights next wave of drug stars as well as late-stage fa­vorites

As one of the biggest spenders in biopharma R&D, Novartis execs love to tout the scope of its late-stage pipeline, spotlighting the winners most likely to create blockbuster revenue streams in the near future.

Building on the 5 drug approvals the pharma giant expects to end the year with, Novartis CEO Vas Narasimhan — who’s done a slate of acquisitions topped by the recent $9.7 billion MedCo buyout — tapped the top emerging drugs as:

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Jeff Jonas, Sage

UP­DAT­ED: Sage's star ex­per­i­men­tal de­pres­sion drug fails the cru­cial MOUN­TAIN study — shares crash

Sage Therapeutics’ crucial MOUNTAIN study for Sage-217 has failed, setting the stage for a quick and ugly investor backlash.

Widely viewed by analysts as the critical clinical study $SAGE needed to win on major depression, researchers say the drug failed to beat out a placebo at day 15, falling well short of the mark for statistical significance on the primary endpoint. And investors reacted with alacrity, fleeing the stock and gutting the price with a 60% instantaneous drop — erasing about $4.6 billion in market cap in an instant.

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Jasper Ther­a­peu­tics launch­es out of Stan­ford with new ap­proach to stem cell treat­ment

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take.  Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

→ Gastrointestinal disease-focused Phathom Pharmaceuticals has shaken up its leadership team. The company has tapped former Celgene exec Terrie Curran as CEO, succeeding David Socks, who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of Otezla for $13.4 billion to Amgen — and has held a previous stint at Merck. In addition to Curran, the company also welcomed former Omeros CMO Eckhard Leifke as CMO, ex-Celgene exec Joseph Hand as chief administrative officer, and former general counsel for Cyclerion Therapeutics Larry Miller as general counsel. They also replaced Chris Slavinsky on the board with Takeda exec Asit Parikh.

UCB buffs up in block­buster pso­ri­a­sis race as bimek­izum­ab beats Hu­mi­ra in head-to-head

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender Stelara in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug.

Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020.