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

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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Richard Pazdur (via AACR)

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News.