Amarin gets a boost from the FDA as reg­u­la­tors promise speedy Vas­cepa de­ci­sion — but what about that pan­el re­view?

There’s plen­ty of buzz to­day about Amarin $AM­RN and its quest to get car­dio out­comes da­ta added to the la­bel for Vas­cepa, its ther­a­peu­tic strength ver­sion of fish oil.

John Thero Amarin Cor­po­ra­tion

The FDA has giv­en their sN­DA pri­or­i­ty re­view sta­tus, leav­ing a de­ci­sion on open­ing up the mar­ket for this ther­a­py just 4 short months away on Sep­tem­ber 28. The move lops months off the reg­u­la­to­ry process and moves a po­ten­tial ap­proval in­to Q3 of this year — one of the biggest cat­a­lysts on the H2 cal­en­dar.

That’s a very big deal for Amarin, which man­aged to wow just about every­one with its 25% re­duc­tion in the risk for the first oc­cur­rence of a ma­jor car­dio event in their tar­get pop­u­la­tion, the pri­ma­ry end­point that has sparked buzz about a po­ten­tial takeover — though one has yet to ma­te­ri­al­ize.

As an ex­cit­ed Michael Yee at Jef­feries not­ed to­day, Amarin CEO John Thero is stay­ing con­ser­v­a­tive in an­tic­i­pat­ing a pan­el re­view. But as Am­gen got a pass on PC­SK9 CV out­comes, he’s 50% to 60% cer­tain there won’t be a pan­el — which would be the fi­nal de-risk­ing event that would pave a like­ly ap­proval here.

Here’s the biotech’s rather dry sum­ma­ry:

Amarin pre­vi­ous­ly ex­pressed that it be­lieves an Ad­Com meet­ing or­ga­nized by the FDA in con­junc­tion with its re­view of the ex­pand­ed la­bel for Vas­cepa is like­ly, as this will be the first ever drug ap­proved for the large pa­tient pop­u­la­tion stud­ied in the RE­DUCE-IT tri­al.  It is not un­com­mon for the FDA to pro­vide clar­i­fi­ca­tion lat­er in the process on whether an Ad­Com will be held.

Set­ting aside some of the wilder pro­jec­tions, the new peak sales es­ti­mates for Vas­cepa are now in block­buster ter­rain, which is why so many in­vestors have bet on a buy­out. On the oth­er hand, this is a tough mar­ket to cap­i­tal­ize on, as Am­gen and Re­gen­eron learned the hard way with PC­SK9. And that could give buy­ers cold feet in any ne­go­ti­a­tions tied to big sums in a sell­er’s mar­ket when it comes to late-stage and ap­proved drugs.

In­vestors liked the sounds of progress to­day, though, bid­ding up shares by 5% while bet­ting on the like­li­hood of an ap­proval. And Yee is al­so count­ing the mon­ey as they wait on the FDA. He notes:

The scripts con­tin­ue to go high­er each week de­spite any la­bel ex­pan­sion yet. We be­lieve this is a tes­ta­ment to the strong CVOT da­ta pub­licly pre­sent­ed and pub­lished al­ready, and the de­mand by pa­tients and docs and ease in re­im­burse­ment – per our nu­mer­ous doc checks. We think Q2 is like­ly to be a strong quar­ter (in­to the $90M+ and up from $77M in Q1) and this strong tra­jec­to­ry would put them pos­si­bly on track to beat 2019 guid­ance of $350M this year.


Im­age: An­drew Harnik AP

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

Jan van de Winkel, Genmab CEO

Seat­tle Ge­net­ics, Gen­mab turn on TV for a high­light reel in cer­vi­cal can­cer — but a ri­val biotech promis­es a bet­ter show

Seattle Genetics $SGEN and their partners at Genmab $GMAB polished up some positive Phase II numbers for their antibody drug conjugate tisotumab vedotin — you can call it TV — for recurrent cervical cancer. And while they mapped out a shortcut to a potential quick approval, the big challenge for this team is being presented by a rival biotech which muscled its way into the spotlight for the same indication a year ago.

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