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.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.

Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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