Am­gen scores pos­i­tive PhI­II car­dio out­comes for its PC­SK9 fran­chise drug Repatha

Sean Harp­er, Ex­ec­u­tive Vice Pres­i­dent, Re­search and De­vel­op­ment

Am­gen got an­oth­er round of good news for its PC­SK9 fran­chise drug Repatha. Hot on the heels of a ma­jor patent fight vic­to­ry over Sanofi and Re­gen­eron, the big phar­ma com­pa­ny says in­ves­ti­ga­tors gar­nered pos­i­tive top-line car­dio out­comes da­ta from their crit­i­cal FOURI­ER tri­al.

There’s no da­ta avail­able yet, but the com­pa­ny re­ports that Repatha proved to sig­nif­i­cant­ly re­duce the risk of car­dio events in pa­tients with clin­i­cal­ly ev­i­dent ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease. The drug al­so hit on an end­point for cog­ni­tive func­tion.

Am­gen shares surged 3.4% in af­ter-mar­ket trad­ing.

Am­gen has had high hopes for Repatha, but sales have lagged well be­hind ini­tial ex­pec­ta­tions — Q3 2016 sales were on­ly $40 mil­lion — as pay­ers proved re­luc­tant to cov­er the drug with­out some clear ev­i­dence of a car­dio ben­e­fit. The ques­tion now is whether Am­gen can trans­late its da­ta, what­ev­er they are, in­to greater cov­er­age.

The lev­el of ben­e­fits that Am­gen was look­ing to achieve in Fouri­er, though “are rel­a­tive­ly mod­est, and thus, im­pact on sales may not be ‘trans­for­ma­tion­al,’” Baird’s Bri­an Sko­r­ney re­cent­ly not­ed. An­a­lysts will get a look at the de­tails in March, dur­ing the Amer­i­can Col­lege of Car­di­ol­o­gy an­nu­al meet­ing.

Not­ed Leerink’s Ge­of­frey Porges:

In­vestors will con­tin­ue to pon­der the im­pact of mod­est ben­e­fit (ie 15-20% risk re­duc­tion), com­pared to what con­sen­sus con­sid­ers a more sig­nif­i­cant ben­e­fit (20-25%) re­duc­tion, and the pos­si­bil­i­ty that the com­pa­ny achieved a ma­te­ri­al­ly bet­ter than con­sen­sus out­comes ben­e­fit (>25% risk re­duc­tion).

Am­gen re­cruit­ed 27,500 pa­tients for this study, an in­di­ca­tion of what they’re will­ing to in­vest to make this drug a block­buster. The pri­ma­ry end­point was the time to car­dio­vas­cu­lar death, my­ocar­dial in­farc­tion, stroke, hos­pi­tal­iza­tion for un­sta­ble angi­na, or coro­nary revas­cu­lar­iza­tion. The key sec­ondary end­point was the time to car­dio­vas­cu­lar death, my­ocar­dial in­farc­tion or stroke.

Just a few weeks ago Am­gen scored a stun­ning court­room win over Sanofi and Re­gen­eron when a fed­er­al judge banned sales of the ri­val PC­SK9 drug Pralu­ent. The rul­ing, now be­ing ap­pealed, said that Am­gen would suf­fer “ir­repara­ble harm” if the com­pe­ti­tion was al­lowed to con­tin­ue af­ter the two com­pa­nies vi­o­lat­ed the patents used to pro­tect Repatha.

Sanofi and Re­gen­eron have their own out­comes study un­der­way, with da­ta due to­ward the end of the year.

“In the GLAGOV study, we demon­strat­ed that Repatha has an ef­fect on ath­er­o­scle­ro­sis, the un­der­ly­ing cause of car­dio­vas­cu­lar dis­ease. These FOURI­ER re­sults show un­equiv­o­cal­ly the con­nec­tion be­tween low­er­ing LDL cho­les­terol with Repatha and car­dio­vas­cu­lar risk re­duc­tion, even in a pop­u­la­tion al­ready treat­ed with op­ti­mized statin ther­a­py,” said Sean E. Harp­er, M.D., ex­ec­u­tive vice pres­i­dent of Re­search and De­vel­op­ment at Am­gen. “Car­dio­vas­cu­lar dis­ease re­mains the num­ber one health bur­den in the world, and we look for­ward to shar­ing these out­comes da­ta with the sci­en­tif­ic com­mu­ni­ty at the ACC 66th An­nu­al Sci­en­tif­ic Ses­sion.”

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Paul Hudson, Sanofi CEO (Getty Images)

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

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About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

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Roger Perlmutter, Merck R&D chief (YouTube)

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David Hoey (Vaxxas)

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

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AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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