FDA hands a CRL to drug­mak­er Eton af­ter a de­layed in­spec­tion — but are Covid-19 trav­el re­stric­tions re­al­ly the is­sue?

For the sec­ond time in three years, Eton Phar­ma­ceu­ti­cals has re­ceived a com­plete re­sponse let­ter from the FDA, this time for its de­hy­drat­ed al­co­hol in­jec­tion to treat methanol poi­son­ing. The com­pa­ny blamed the de­lay on a miss­ing in­spec­tion but al­so point­ed to “oth­er ques­tions” from the agency.

On Fri­day, Eton dis­closed it had re­ceived a let­ter from the agency, ty­ing it to a pend­ing pre-ap­proval in­spec­tion of its Eu­ro­pean man­u­fac­tur­er due to Covid-re­lat­ed trav­el re­stric­tions. But it’s worth not­ing that the FDA doesn’t is­sue CRLs based sole­ly on in­spec­tion de­lays, an agency spokesman pre­vi­ous­ly told End­points News, in­di­cat­ing there may have been oth­er is­sues with Eton’s ap­pli­ca­tion.

“The com­pa­ny be­lieves all oth­er FDA ques­tions raised in the let­ter can be ful­ly ad­dressed in a re­sponse in the com­ing months,” the com­pa­ny said in a re­lease. A spokesman could not be reached at press time.

Wall Street re­spond­ed ac­cord­ing­ly to the news, send­ing Eton’s stock down as much as 14% short­ly af­ter the open­ing bell Fri­day.

In 2019, Eton’s plan to launch an over-the-counter treat­ment for an oc­u­lar itch of­ten found in chil­dren was al­so is­sued a CRL. The eye drop — now dubbed Al­away — set out to be the first preser­v­a­tive-free al­ler­gy eye drop in the US. A year lat­er, the drops cleared the FDA.

Eton cur­rent­ly re­ceives roy­al­ties from three FDA-ap­proved prod­ucts, in­clud­ing Al­away. Alkin­di Sprin­kle is a cor­ti­cos­teroid used for be­nign adreno­cor­ti­cal tu­mors in chil­dren. Eton ac­quired the Cana­di­an rights to Alkin­di Sprin­kle at the start of the year. Bior­phen, when ap­proved in 2019, be­came the first ready-to-use form of phenyle­phrine for the treat­ment of hy­poten­sion from anes­the­sia.

The com­pa­ny sold its neu­rol­o­gy port­fo­lio — which in­cludes epilep­sy seizure drug zon­isamide — to Azu­ri­ty Phar­ma­ceu­ti­cals in Feb­ru­ary for $15 mil­lion up­front, in a deal worth up to $45 mil­lion to­tal.

So­cial: Sean Bryn­jelsen, Eton CEO (file pho­to)

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.