John Thero, Amarin CEO (Christopher Goodney/Bloomberg via Getty Images)

Amarin los­es patent ap­peal and their brief grip on a car­dio­vas­cu­lar, fish oil em­pire

Amarin’s briefly-held fish oil em­pire has slipped from its grasp, and now ap­pears gone for good.

A US fed­er­al ap­peals court re­fused on Thurs­day to over­turn a March rul­ing that stripped the Irish drug­mak­er of its patents on the fish oil-based heart drug Vas­cepa, open­ing the door for gener­ic al­ter­na­tives to hit the mar­ket. The rul­ing means that Amarin’s chance of turn­ing an ex­pand­ed ap­proval from last De­cem­ber in­to block­buster rev­enues has es­sen­tial­ly van­ished.

In­vestors re­spond­ed ac­cord­ing­ly, with the stock falling 7% from $5.04 to $4.67. The drop-off like­ly would have been steep­er, but high odds of a patent loss had al­ready been baked in­to the stock’s price, with Wall Street be­gin­ning to sig­nal its skep­ti­cism in the win­ter and the stock drop­ping 70% when the first patent rul­ing came down on March 30. Vas­cepa is their on­ly prod­uct.

The an­nounce­ment yes­ter­day of the judges that would serve on the ap­peal pan­el pro­vid­ed the fi­nal nail. An­a­lysts con­sid­ered the judges col­lec­tive­ly un­fa­vor­able to­ward Amarin, and the stock sold off 30%.

In a state­ment, Amarin CEO John Thero said it will “vig­or­ous­ly pur­sue avail­able reme­dies,” which could in­clude one last form of ap­peal, but an­a­lysts have large­ly moved on. In a note, Stifel’s Derek Archi­la said the ques­tions that Amarin now face cen­ter on Eu­rope, where Vas­cepa re­mains un­der patent pro­tec­tion. He es­ti­mat­ed $650 mil­lion in peak sales there, but not­ed that the drug still has to be ap­proved and the com­pa­ny still has to se­cure re­im­burse­ment.

“So we don’t think 2021 sales of Vas­cepa in the EU are like­ly to be mean­ing­ful,” Archi­la said. “We think the fact AM­RN was not able to part­ner the EU rights for Vas­cepa for a mean­ing­ful sum and chose to go-it-alone could mean part­ners viewed this op­por­tu­ni­ty to be a more mod­est one or chal­leng­ing to ex­e­cute on, thus, we are con­ser­v­a­tive with our peak sales es­ti­mates and sales ramp in the EU.”

Still, there are ques­tions about how much mar­ket Vas­cepa could still grab in the US. Archi­la not­ed that Vas­cepa is com­plex to make, po­ten­tial­ly lim­it­ing how much gener­ic com­pe­ti­tion emerges. And Amarin said in a state­ment that giv­en how cur­rent com­peti­tors may like­ly have lim­it­ed sup­ply, they will for now main­tain their sales and pro­mo­tion­al in­fra­struc­ture.

Archi­la cau­tioned, though, that cut­ting in the US soon­er might be “pru­dent” to pre­pare for the costs of launch­ing in the EU. While say­ing they will con­tin­ue to fight in the states, Thero em­pha­sized the op­por­tu­ni­ties else­where. “We are par­tic­u­lar­ly ex­cit­ed about the an­tic­i­pat­ed com­mer­cial­iza­tion op­por­tu­ni­ties for Vas­cepa in Eu­rope as we pre­pare for ex­pect­ed ap­proval and launch in ear­ly 2021,” he said, al­so not­ing mar­kets in Chi­na and the Mid­dle East.

The court rul­ing caps a rol­lick­ing two years for Amarin. In Sep­tem­ber 2018, the spe­cial­ty phar­ma out­let first an­nounced pos­i­tive da­ta from a Phase III tri­al show­ing its omega-3 fat­ty acid prod­uct had re­duced the risk of a car­dio­vas­cu­lar event — such as a heart at­tack — in a large group of at-risk pa­tients. That sent the stock soar­ing 288% as an­a­lysts talked about a $2 bil­lion mar­ket op­por­tu­ni­ty.

As more de­tailed da­ta came back, the stock stayed high and buzz start­ed form­ing around a pos­si­ble buy­out from a larg­er com­pa­ny. Amarin de­cid­ed to go it alone, per­haps in part be­cause ques­tions around the com­pa­ny’s in­tel­lec­tu­al prop­er­ty hov­ered over its suc­cess. On De­cem­ber 12, the FDA hand­ed a block­buster ex­pand­ed ap­proval. The patent suit, which pit­ted Amarin against gener­ic drug­mak­er Dr. Red­dy’s and Hik­ma Phar­ma­ceu­ti­cals, start­ed a month lat­er.

A judge de­cid­ed against Amarin, rul­ing that claims in its patents that Dr. Red­dy’s and Hik­ma in­fringed on were “ob­vi­ous.” The ap­peal court did not hand down a for­mal opin­ion.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.