FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, en­thu­si­asm for Amarin’s fish-oil pill Vas­cepa bur­geoned when the FDA signed off on ex­pand­ing the cho­les­terol fight­er’s la­bel to in­clude the drug’s ben­e­fi­cial im­pact on car­dio­vas­cu­lar risk, but months lat­er the ex­u­ber­ance for the block­buster-to-be took a big hit when a judge in­val­i­dat­ed key patents pro­tect­ing Vas­cepa.

De­spite Amarin’s $AM­RN pledge to ap­peal — a process that could take months — the rul­ing opened the door for gener­ic com­pe­ti­tion. Hik­ma Phar­ma­ceu­ti­cals, one of three chal­lengers in the Neva­da suit, on Fri­day said that its gener­ic copy of pure EPA, the omega-3 fat­ty acid that con­sti­tutes Vas­cepa, has been ap­proved by the FDA.

An­a­lysts sug­gest­ed that there was a low prob­a­bil­i­ty of a Hik­ma launch any­time soon.

“Giv­en AM­RN’s on­go­ing ap­peal of the dis­trict court’s rul­ing in­val­i­dat­ing Vas­cepa’s patents on ob­vi­ous­ness and the fact the tri­al has been ex­pe­dit­ed by the court, we think it is un­like­ly Hik­ma will launch at-risk and risk po­ten­tial tre­ble dam­ages if AM­RN were to pre­vail on the ap­peal,” Stifel an­a­lysts wrote in a note.

At the mo­ment, Amarin does not have an in­junc­tion in place to stop any po­ten­tial at-risk launch, al­though the com­pa­ny could file one now, Jef­feries’ an­a­lysts said.

“Amarin strong­ly dis­agrees with the rul­ing and will vig­or­ous­ly pur­sue all avail­able reme­dies, in­clud­ing an ap­peal of the Court’s de­ci­sion and a pre­lim­i­nary in­junc­tion pend­ing ap­peal to…pre­vent launch of gener­ic ver­sions of Vas­cepa in the Unit­ed States,” com­pa­ny chief John Thero said in a March press re­lease.

Amarin man­age­ment has al­so in­di­cat­ed that with an ex­pe­dit­ed ap­peal a new rul­ing could po­ten­tial­ly come by the end of 2020 or ear­ly 2021.

“It’s hard to de­fin­i­tive­ly know whether Hik­ma will launch in the near-term and there is al­ways the pos­si­bil­i­ty of the oth­er gener­ic fil­er — Dr. Red­dy’s — al­so re­ceiv­ing ap­proval for their gener­ic Vas­cepa and po­ten­tial­ly launch­ing at-risk. The next ma­jor up­date in the ap­peal will be around 6/16 when the gener­ics file their re­sponse briefs,” Stifel an­a­lysts added.

End­points News has con­tact­ed Hik­ma for com­ment on its launch plans and reached out to Amarin in­quir­ing about whether it in­tends to file an in­junc­tion block­ing the Hik­ma launch.

Amarin’s Vas­cepa, known chem­i­cal­ly as icos­apent eth­yl and an omega-3 fat­ty acid de­rived from fish oil com­posed sole­ly of EPA, was orig­i­nal­ly en­dorsed by the US reg­u­la­tor as a treat­ment for el­e­vat­ed triglyc­erides. How­ev­er, in De­cem­ber the FDA sanc­tioned its use in a much broad­er pa­tient pop­u­la­tion af­ter a land­mark tri­al — RE­DUCE-IT — which showed the pill trig­gered a 25% re­duc­tion in the risk for the first oc­cur­rence of a ma­jor car­dio event, and a 26% re­duc­tion for 3-point MACE, a com­pos­ite of car­dio­vas­cu­lar death, non­fa­tal heart at­tack and non­fa­tal stroke. An­a­lysts pre­dict­ed the new la­bel could sky­rock­et sales to the $2 bil­lion peak mark.

But a stun­ning set­back in late March seem­ing­ly re­versed Amarin’s for­tunes, when gener­ic chal­lengers in­clud­ing Hik­ma and Dr. Red­dy’s won a suit chal­leng­ing five of Amarin’s patents that were set to ex­pire by 2030. Te­va, an­oth­er chal­lenger, signed a set­tle­ment with Amarin to de­lay its gener­ic launch un­til 2029.

Jef­feries Michael Yee has pre­vi­ous­ly sug­gest­ed that gener­ic chal­lengers still face a sig­nif­i­cant hur­dle to bring their wares to the mar­ket, in­clud­ing de­vel­op­ing man­u­fac­tur­ing plants to pro­duce pure EPA. Amarin cur­rent­ly has three such fa­cil­i­ties, it is un­clear whether the gener­ic chal­lengers have ac­cess to one, he added.

As for Amarin, man­age­ment sug­gest­ed an EU fil­ing for Vas­cepa is in the works and is slat­ed for the end of the year. The com­pa­ny has been look­ing for a part­ner for the drug in Eu­rope, but Cowen’s Ken Cac­cia­tore as­sert­ed that sell­ing the EU rights would be the most pru­dent route.

“We con­tin­ue to be­lieve the most wealth-cre­at­ing de­ci­sion would be to sell, as op­posed to li­cense. And we be­lieve a CVR could be es­tab­lished to re­al­ize the po­ten­tial op­tion­al­i­ty of a U.S. ap­peal re­ver­sal,” he wrote. “Giv­en that the work­ing as­sump­tion must be that an ap­peal in the U.S. will not be suc­cess­ful, a li­cense agree­ment for the re­main­ing ex-U.S. rights could set up a sit­u­a­tion where Amarin is sim­ply a pub­licly-trad­ed roy­al­ty com­pa­ny.”

So­cial im­age: John Thero, pres­i­dent and chief ex­ec­u­tive of­fi­cer of Amarin Corp., smiles dur­ing an in­ter­view in New York, U.S., on Wednes­day, Aug. 28, 2019. Thero dis­cussed the com­pa­ny’s plans for its car­dio­vas­cu­lar drug Vas­cepa. Pho­tog­ra­ph­er: Christo­pher Good­ney/Bloomberg via Get­ty Im­ages

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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In­cyte’s PD-(L)1 in­hibitor head­ed for an ODAC show­down next month

The FDA’s Oncologic Drugs Advisory Committee will spend a half day on June 24 reviewing Incyte’s PD-(L)1 inhibitor retifanlimab as a treatment for locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) for those who have progressed on or who are intolerant of platinum-based chemotherapy.

The eighth PD-(L)1 entrant in January nabbed a priority review and an orphan designation from the FDA, which sets the agency’s final decision date as July 25.

Third time’s the charm as Heron wins FDA nod for non-opi­oid anes­thet­ic Zyn­relef

With an aim to reduce the use of opioids in the post-op setting, Heron Therapeutics on Thursday announced that it finally won FDA approval — after two prior CRLs — for its long-lasting local anesthetic, which is a combination of bupivacaine and the NSAID meloxicam.

Heron will price the drug, known commercially as Zynrelef, somewhere between 22% and 28% less than its direct competitor, Pacira Biosciences’ Exparel (bupivacaine liposome injectable suspension), Heron CEO Barry Quart told Endpoints News in an interview.