A new PC­SK9 play­er draws rave re­views for in­clisir­an. Can a mar­ket­ing war with Am­gen be far be­hind?

The Med­i­cines Com­pa­ny $MD­CO wad­ed di­rect­ly in­to the mid­dle of one of the most bit­ter­ly con­test­ed fields in bio­phar­ma to­day us­ing a de­tailed set of ef­fi­ca­cy and safe­ty da­ta from their Phase III study of in­clisir­an to build a case that their drug can whip 3 heavy­weight ri­vals deep in­to the trou­bled PC­SK9 game.

Just don’t ex­pect the new CEO run­ning things at the com­pa­ny to say much about that ri­val­ry.

Top-lined a few days ago, the ef­fi­ca­cy num­bers post­ed at the Eu­ro­pean So­ci­ety of Car­di­ol­o­gy’s ESC Con­gress in Paris line up where the an­a­lysts had hoped, with a 54% rel­a­tive re­duc­tion in LDL tied to the drug arm com­pared to place­bo — which ranks up there with the high 50s hit by Repatha (Am­gen) and Pralu­ent (Re­gen­eron and Sanofi). Just as im­por­tant­ly, the safe­ty da­ta on ex­hib­it Mon­day look pris­tine, with an ad­verse event pro­file that tends to mir­ror the con­trol arm along with no ev­i­dence of added tox­i­c­i­ty — a fea­ture that will en­cour­age every­one in RNAi to go deep­er in­to dis­eases with mas­sive pa­tient pop­u­la­tions af­ter es­tab­lish­ing them­selves in rare dis­eases.

There’s even some ex­plorato­ry car­dio da­ta — which will have to be con­firmed in a huge, on­go­ing out­comes study — to help back up their ex­pec­ta­tions for a com­pet­i­tive ben­e­fit on MACE and strokes that pay­ers will want to see proved be­yond a rea­son­able doubt.

The num­bers back up a good set of odds on a near-term OK for in­clisir­an in 2020, pro­vid­ed a nasty sur­prise isn’t in wait along the side­lines. If so, they’ll be ready­ing a roll­out now that will take aim against two of the most tout­ed drugs that ever fell far short of their mark.

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