Oc­u­lar Ther­a­peu­tix's last-minute gam­bit fails to sal­vage its sec­ond FDA ap­pli­ca­tion, shares plunge

An 11th hour bid by Oc­u­lar Ther­a­peu­tix to sal­vage its FDA ap­pli­ca­tion for their drug/de­vice eye treat­ment Dex­ten­za got shot down in a hur­ry on Tues­day.

A year af­ter Oc­u­lar re­ceived its first re­jec­tion of the eye ther­a­py based on man­u­fac­tur­ing is­sues, the Bed­ford, MA-based com­pa­ny was hand­ed its sec­ond com­plete re­sponse let­ter af­ter in­spec­tors flagged is­sues dur­ing a pre-NDA in­spec­tion a cou­ple of months ago.

Oc­u­lar shares $OCUL took a nose dive on the news, drop­ping more than 30%.

Oc­u­lar ex­ecs tried to win a re­prieve by fil­ing a re­sponse to the FDA’s man­u­fac­tur­ing con­cerns on Mon­day, the day ahead of the PDU­FA date. They want­ed reg­u­la­tors to flag the re­sponse as a ma­jor amend­ment to their ap­pli­ca­tion and ex­tend the dead­line, but the FDA stiff-armed the biotech with­out even tak­ing a look — ac­cord­ing to Oc­u­lar’s ver­sion of events.

Amar Sawh­ney

Dex­ten­za has had a mixed Phase III record in the clin­ic, suc­ceed­ing with its hy­dro­gel plug in de­liv­er­ing dex­am­etha­sone over an ex­tend­ed pe­ri­od in re­duc­ing post-sur­gi­cal pain, but fail­ing at sig­nif­i­cant­ly re­duc­ing oc­u­lar itch­ing for al­ler­gic con­junc­tivi­tis. An­a­lysts have al­so been scratch­ing their heads over the com­mer­cial prospects of a ther­a­py avail­able in cheap eye drops.

None of that gets an­swered, though, be­fore the com­pa­ny wins a reg­u­la­to­ry green light. And now the biotech, which is part­nered with Re­gen­eron on an ex­tend­ed dos­ing ap­proach for Eylea, will once again have to go back to the draw­ing board over its man­u­fac­tur­ing woes as it preps for a third shot at an OK.

Said Oc­u­lar Ther­a­peu­tix CEO Amar Sawh­ney:

Im­por­tant­ly, there were no clin­i­cal is­sues iden­ti­fied in the CRL per­tain­ing to ef­fi­ca­cy or safe­ty re­lat­ed to the post-sur­gi­cal pain in­di­ca­tion. We be­lieve that DEX­TEN­ZA can be ap­proved once these open man­u­fac­tur­ing items are re­solved.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.