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

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $800 million.

En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months after Enhertu received twin breakthrough therapy designations, AstraZeneca and Daiichi Sankyo are one step closer to nabbing another approval for their potential blockbuster drug.

The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Sci­en­tists warn Amer­i­cans are ex­pect­ing too much from a coro­n­avirus vac­cine

The White House and many Americans have pinned their hopes for defeating the Covid-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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Once re­ject­ed, Kala's dry eye drug now gains en­try to a field where No­var­tis is groom­ing its own block­buster

When the FDA slapped a rejection on Kala Pharma’s dry eye drug last August, the biotech’s execs promised investors that a third Phase III study — they had already started at that point — would reverse their fortune.

Today they made good on that promise, clinching an approval for Eysuvis, an ocular corticosteroid being positioned as a first-line, short term treatment of dry eye disease.

Boasting a technology invented by Bob Langer out of MIT, Eysuvis is a corticosteroid, loteprednol etabonate, delivered by mucus-penetrating particles. It promises to enhance penetration into target tissue on the ocular surface, achieving an effect quicker than systemic corticosteroids and stronger than over-the-counter eye drops.

Ul­tragenyx slams the brakes on rare dis­ease study af­ter all 5 pa­tients are hit with a se­ri­ous set­back

Ultragenyx $RARE and its partners at GeneTx have been forced to halt early-stage study for a drug to treat rare cases of Angelman syndrome after all 5 of the patients being treated for the first time experienced a severe adverse event at the highest dose.

The patients in the study experienced “lower extremity weakness believed to be related to local inflammation due to GTX-102,” triggering a red light on dosing and enrollment.

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Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.