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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.