Amarin scores a big win for its car­dio out­comes study on Vas­cepa — stock races high­er as an­a­lysts ap­plaud

Amarin $AM­RN has staked its claim to the next big block­buster in the car­dio space, herald­ing a clear sta­tis­ti­cal win on the pri­ma­ry end­point for its 7-year clin­i­cal quest to prove that its in­dus­tri­al strength pu­ri­fied fish oil Vas­cepa can sig­nif­i­cant­ly re­duce ma­jor car­dio threats for a broad swath of pa­tients.

An ear­ly pre­view of the top-line da­ta rolled out at a bleary-eyed time in the morn­ing on Mon­day point­ed a di­rect ar­row at a rel­a­tive 25% drop in risk for ma­jor car­dio events — such as death, stroke and hos­pi­tal­iza­tion due to angi­na — hit­ting a high­ly sta­tis­ti­cal p=<0.001 for the pa­tients in the years-long RE­DUCE-IT study. And re­searchers al­so high-fived each oth­er for a clean safe­ty pro­file in the same head­line da­ta to make the state­ment.

The da­ta sup­port­ed “ro­bust” ev­i­dence of its ef­fect across mul­ti­ple sec­ondary end­points, ac­cord­ing to the com­pa­ny. We won’t see the par­tic­u­lars un­til lat­er, but the com­pa­ny is on track to file for ap­provals in ear­ly 2019.

An­a­lysts at Jef­feries have said that a suc­cess here could trans­form Vas­cepa in­to a $2 bil­lion-plus drug. And that num­ber res­onat­ed this morn­ing, as Amarin’s share prize zoomed up 288%. The stun­ning ad­vance fol­lowed fresh re­marks from Jef­feries about the rel­a­tive val­ue that Amarin un­der­scored this morn­ing rel­a­tive to oth­er drugs that have tried — and failed — to make much of an im­pres­sion.

The mag­ni­tude of MACE re­duc­tion is so far the great­est among all ther­a­pies on top of statins, far ex­ceed­ing the clin­i­cal­ly mean­ing­ful CV ben­e­fit ex­pec­ta­tion. Re­call two PC­SK9 in­hibitors (Repatha and Pralu­ent) and Ilaris all re­duced MACE risks by 15% in re­cent­ly com­plet­ed CVOTs (FOURI­ER, ODYSSEY, and CAN­TOS). The FDA has ex­pand­ed Repatha’s la­bel to in­clude cer­tain CV risk re­duc­tion and is cur­rent­ly re­view­ing sBLA of Pralu­ent in MACE re­duc­tion (PDU­FA on 4/28/19). Our doc sur­vey sug­gest­ed 10-15%+ risk re­duc­tion in MACE is con­sid­ered clin­i­cal­ly mean­ing­ful.

“We are de­light­ed with these topline study re­sults,” said John Thero, pres­i­dent and CEO of Amarin, in a state­ment. “Giv­en Vas­cepa is af­ford­ably priced, oral­ly ad­min­is­tered and has a fa­vor­able safe­ty pro­file, RE­DUCE-IT re­sults could lead to a new par­a­digm in treat­ment to fur­ther re­duce the sig­nif­i­cant car­dio­vas­cu­lar risk that re­mains in mil­lions of pa­tients with LDL-C con­trolled by statin ther­a­py, as stud­ied in RE­DUCE-IT.” 

None of this is go­ing to make it easy for the com­pa­ny, though, with a host of an­gry short in­vestors like­ly to try what­ev­er it takes to fo­ment a back­lash against the da­ta for the last big cat­a­lyst of Q3. Fur­ther com­pli­cat­ing their suc­cess, As­traZeneca has its own out­comes study for the ri­val Epano­va ready to read out next year, while GSK’s Lo­vaza went gener­ic sev­er­al years ago.

But as the morn­ing wore on, it be­came ap­par­ent that Amarin was hold­ing on to its big gains and sup­port­ers are swoon­ing.

Pa­tients en­rolled in RE­DUCE-IT had reg­is­tered an LDL-C lev­el be­tween 41-100 mg/dL (me­di­an base­line LDL-C 75 mg/dL) con­trolled by statin ther­a­py with a slate of car­dio­vas­cu­lar risk fac­tors in­clud­ing: per­sis­tent el­e­vat­ed triglyc­erides be­tween 150-499 mg/dL (me­di­an base­line 216 mg/dL) and ei­ther es­tab­lished car­dio­vas­cu­lar dis­ease or di­a­betes mel­li­tus and at least one oth­er CV risk fac­tor. 

That’s a big mar­ket.

This Phase III has been end­less­ly de­bat­ed as the time drew near for the read­out. Amarin’s Vas­cepa — ap­proved more than 4 years ago for hy­per­triglyc­eridemia — demon­strat­ed its abil­i­ty to sig­nif­i­cant­ly re­duce triglyc­erides in those pa­tients while in­flu­enc­ing bio­mark­ers on in­flam­ma­tion. But as we know from past big car­dio stud­ies, that cer­tain­ly doesn’t nec­es­sar­i­ly trans­late in­to the kind of hard and demon­stra­ble health ben­e­fits such that pay­ers are will­ing to cov­er much larg­er mass pop­u­la­tions of at-risk mem­bers.

RE­DUCE-IT set out to an­swer that ques­tion, with re­searchers en­rolling more than 8,000 pa­tients so they could com­pare it as an add-on to statins in re­duc­ing in­stances of ma­jor ad­verse car­dio­vas­cu­lar events (MACE) as com­pared to statin-treat­ed pa­tients plus place­bo.

We al­ready know from the re­cent AS­CEND study that pop­u­lar fish oil prod­ucts sold in every phar­ma­cy have no clear health ben­e­fits, and Amarin has been built on the no­tion that its high­ly-pu­ri­fied, omega-3 fat­ty acid prod­uct could dis­tin­guish it­self from the sup­ple­ment field. Com­pa­ny ex­ecs said that fish oil’s weak­ness would sim­ply make it eas­i­er to prove Vas­cepa’s val­ue, once the out­comes da­ta were in.

Is it good enough?

Even pos­i­tive car­dio da­ta don’t al­ways trans­late in­to com­mer­cial op­por­tu­ni­ty, and an­a­lysts now will see whether Amarin has come up with da­ta that are good enough to qual­i­fy as the prac­tice-chang­ing event that the com­pa­ny’s back­ers have in­sist­ed would now be in reach.

The dif­fer­ence amounts to a mar­ket with mil­lions of po­ten­tial pa­tients.

Sup­port­ive Jef­feries an­a­lysts who helped build sup­port for the drug’s suc­cess re­cent­ly not­ed:

Pos­i­tive RE­DUCE-IT will be prac­tice chang­ing as it will pro­vide POC that us­ing a high­ly pu­ri­fied Omega-3 drug (vas­cepa) in MD pa­tients on sta­ble statins and rel­a­tive­ly well-con­trolled LDL-C (<100mg/dL) con­tributes to a CV ben­e­fit. While LDL-C has de­creased over decades, TGs con­tin­ue to rise. The mar­ket needs this type of drug.

But for every ad­vo­cate, you could count two more who bet against the drug and any up­beat rise in the share price. The die hards won’t re­treat with­out putting up a fight, but their num­bers were def­i­nite­ly dwin­dling Mon­day.

Im­age: John Thero. AMARIN

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Doug Giordano might have some thoughts on how that could work out.

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