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.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.