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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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As TRIPS coun­cil meets, the IP waiv­er for vac­cines is on life sup­port ahead of a De­cem­ber dead­line

The WTO’s TRIPS Council is meeting today and tomorrow to discuss a Covid-19 vaccine IP waiver that remains divisive and unlikely to be adopted thanks to European opposition, but which proponents still think could unlock more vaccine doses for low and middle-income countries.

Following the meetings this week, it’s expected there will be a better sense if some kind of waiver can be agreed to by December, Tahir Amin, an IP lawyer and co-executive director of I-Mak, told Endpoints News.