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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Nurses star in J&J's campaign centered on the importance of nurses who are increasingly stressed, burnt out and quitting the profession (via Johnson & Johnson)

Thank­ful for nurs­es: J&J's new cam­paign aims to re­set pan­dem­ic clock back to grat­i­tude

In the early days of the pandemic, people cheered for nurses – delivering food, writing thank you notes and ringing bells nightly to show their appreciation. But something shifted this summer, and now Johnson & Johnson wants to remind people of the gratitude that nurses still deserve.

Call it politics or pandemic weariness or the result of almost two years of a deadly pandemic, but nurses today face threats and mistreatment from patients and their angry family members. And nurses are leaving the profession in record numbers.

Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Drug­mak­ers cut prices on av­er­age by more than 60% to get on Chi­na's 2022 NDRL list — re­port

China’s National Reimbursement Drug List (NRDL) is a crystal clear example of the country’s bargaining power in the biotech and pharma market, as more firms have reportedly agreed to cut their prices for 67 new medicines to be included in its national medical insurance coverage starting in January.

Being on the list is lucrative. Essentially, if a biotech or pharma company gets on this list, they’re covered by the biggest insurance network in the country. Given China’s vast population, the Chinese government has significant leverage to decide which medicines can make a profit. While domestic drugmakers are quite willing to play that game, cutting prices significantly in exchange for getting on the list, international companies don’t do it as often.