Less than a year af­ter Rho­pres­sa launch, Aerie scores new glau­co­ma drug ap­proval

Just over a year af­ter se­cur­ing ap­proval for its glau­co­ma drug, Rho­pres­sa, Aerie Phar­ma­ceu­ti­cals has fol­lowed up with an ap­proval for its sec­ond such treat­ment en­gi­neered to tack­le hard-to-treat cas­es of the com­mon eye dis­ease that if un­treat­ed typ­i­cal­ly cul­mi­nates in blind­ness.

The new ap­proval, grant­ed by the FDA on Tues­day, is for Rock­la­tan — a once dai­ly eye drop com­pris­ing the wide­ly used gener­ic la­tanoprost and ne­tar­sudil, the ac­tive in­gre­di­ent in Rho­pres­sa. 

Glau­co­ma is char­ac­ter­ized by dam­age to the op­tic nerve, usu­al­ly caused by flu­id build­ing up in the front part of the eye, which in­creas­es pres­sure in­side the eye. This leads to the pro­gres­sive de­gen­er­a­tion of reti­nal cells, re­sult­ing in vi­sion loss and even­tu­al­ly blind­ness. Ac­cord­ing to es­ti­mates by the Glau­co­ma Re­search Foun­da­tion, over 3 mil­lion Amer­i­cans have glau­co­ma but on­ly half of those know they have it.

Rho­pres­sa works by restor­ing out­flow through the tra­bec­u­lar mesh­work — the eye’s pri­ma­ry flu­id drain and the dis­eased tis­sue re­spon­si­ble for el­e­vat­ed in­traoc­u­lar pres­sure (IOP) in glau­co­ma — while la­tanoprost in­creas­es flu­id out­flow through a sec­ondary mech­a­nism known as the uveoscle­r­al path­way, Aerie said.

Rock­la­tan’s ap­proval was based on two late-stage stud­ies: MER­CURY 1 and MER­CURY 2, in which the drug demon­strat­ed sta­tis­ti­cal­ly su­pe­ri­or IOP re­duc­tion over la­tanoprost or ne­tar­sudil alone at every mea­sured time point. It is al­so be­ing eval­u­at­ed in the MER­CURY 3 piv­otal study for Eu­ro­pean reg­u­la­tors.

El­e­mer Piros

“Rock­la­tan has the abil­i­ty to ad­dress high­er pres­sures and more-dif­fi­cult-to-ad­dress glau­co­ma cas­es, giv­en the drug con­tains la­tanoprost. La­tanoprost is an added prostaglandin that could be used to in­crease drainage out­flow. From the MER­CURY stud­ies, >60% of pa­tients tak­ing Rock­la­tan achieved IOP re­duc­tions of >30% (2x greater than what was seen by pa­tients tak­ing la­tanoprost alone). By 2021, we ex­pect Rock­la­tan to have the same mar­ket share as Rho­pres­sa, which we be­lieve could be sur­passed start­ing in 2022,” Can­tor Fitzger­ald’s El­e­mer Piros wrote in a note.

In the lead up to the de­ci­sion for Rho­pres­sa, FDA staff had high­light­ed that the drug did not work as well as the com­para­tor ther­a­py (tim­o­lol oph­thalmic so­lu­tion) in the more se­vere­ly af­flict­ed pa­tients (with IOP ≥ 25 mmHg) in­clud­ed in their Phase III stud­ies. Giv­en that Rock­la­tan is de­signed to tap in­to the spec­trum of IOP-low­er­ing mech­a­nisms, it could be suit­ed for pa­tients with such ad­vanced dis­ease. 

Rho­pres­sa was launched last April, and made about $24.2 mil­lion over the course of the year. Rock­la­tan, ex­pect­ed to hit the mar­ket in the sec­ond quar­ter of 2019, is al­ready un­der re­view for re­im­burse­ment by ma­jor play­ers, the com­pa­ny said. 

Difei Yang

“(I)nsurance cov­er­age pick­up could be faster as con­tracts with pay­ers will al­ready be in place (from Rho­pres­sa),” Mizuho an­a­lyst Difei Yang wrote in a note.

In a sep­a­rate re­lease, Aerie man­age­ment pro­ject­ed full-year 2019 rev­enue in the range of $110 mil­lion to $120 mil­lion for Rho­pres­sa and Rock­la­tan com­bined. “We see this guid­ance as con­ser­v­a­tive and we be­lieve there is a rea­son­able chance for Aerie to out­per­form in 2019,” Yang added.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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Eli Lil­ly re-ups di­ver­si­ty pledge, pitch­ing in $30M to ven­ture fund for mi­nor­i­ty-owned health­care firms

The fight against racial injustice spurred by a series of high-profile shootings of Black men by police earlier this year put Big Pharma and healthcare — industries targeted for their lack of diversity — in the hot seat. Eli Lilly made an early pledge to change its ways and put more back into the community, and now it’s continuing to make good on that commitment.

Lilly will infuse $30 million into the Unseen Capital Health Fund, a venture fund looking to invest in early-stage minority-owned healthcare companies that have been historically “unseen” by the investment community, the pharma said Friday.

CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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UP­DAT­ED: Am­gen tops cost watch­dog's price gougers list based on 'un­sup­port­ed' in­creas­es for En­brel with­out mean­ing­ful da­ta

In a top 10 ranking of the most egregious price gougers from 2019, Amgen’s Enbrel topped US cost watchdog ICER’s naughty list with “unsupported” markups that added as much as $403 million to the nation’s drug spend during that time.

Price increases for some of pharma’s most popular drugs have long been a focus of consumer ire, but the industry has argued those increases are routine and meant to cover the cost of R&D innovation. Without meaningful guidance at the state or federal level, ICER looked to connect how much a drug had progressed in the clinic compared with its increase in both wholesale and net price in 2019.

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Albert Bourla, Pfizer CEO (AP Images)

#JPM21: Al­bert Bourla pre­pares Pfiz­er to set­tle in to next phase post-Up­john, but that does­n't mean he's rul­ing out deals

One of the iconic brands in biopharma, Pfizer took a big gamble on the strength of its in-house science when it decided to offload its flagging Upjohn generics business last year. Now, a more agile Pfizer is looking to cement its identity for the future, but one thing will stay the same: M&A is still very much a part of the game plan.

With its Upjohn generics business off the books, Pfizer is looking to double down on its branded medicines with the goal of hitting 6% annual growth each year — previously unheard-of at old Pfizer — while continuing to develop its blockbuster pipeline, CEO Albert Bourla said at a JP Morgan fireside chat Tuesday.

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Stefan Oelrich (Bayer)

What can a 157-year-old phar­ma gi­ant bring to the ta­ble of cell and gene ther­a­pies? Quite a bit, Bay­er says

By now, Bayer has sketched out in bold strokes some grand plans for cell and gene therapy, cemented by big-dollar acquisitions of platform companies.

But just how do you stitch together a new unit bursting with the newest ideas within a storied pharma?

Stefan Oelrich, the head of Bayer’s pharma division, briefly lifted the curtain and spotlighted three key factors as he took the stage on a virtual media day, flanked by Emile Nuwaysir and Sheila Mikhail, the chiefs of BlueRock and AskBio, who each introduced their work in a way you’d expect from a biotech CEO.