Al­ny­lam kicks off #JPM18 with a re­struc­tured Sanofi deal, grab­bing glob­al rights to patisir­an

Four years ago Al­ny­lam $AL­NY jazzed the start of the JP­Mor­gan con­fer­ence with news that Sanofi had stepped up to pay $700 mil­lion for a chunk of its stock and the right to ex­pand its com­mer­cial rights to the biotech’s lead drug, patisir­an. But with patisir­an on the verge of win­ning like­ly reg­u­la­to­ry ap­proval this year, the com­pa­nies have once again re­struc­tured their deal in a way that gives Al­ny­lam glob­al con­trol over its fu­ture.

John Maraganore

Al­ny­lam will now han­dle the glob­al mar­ket­ing for patisir­an and ALN-TTRsc02, with the ex­pect­ed launch com­ing for AT­TR amy­loi­do­sis. In re­turn, Sanofi is land­ing glob­al rights to fi­tusir­an for he­mo­phil­ia A and B.

The rest of the deal terms re­main in place, with the two col­lab­o­ra­tors ex­chang­ing roy­al­ties on sales.

The move un­der­scores Al­ny­lam CEO John Maraganore’s con­fi­dence that the biotech can score big on patisir­an, which is head­ed in­to a com­mer­cial ri­val with Io­n­is $IONS, which has al­so racked up pos­i­tive da­ta for its hAT­TR amy­loi­do­sis drug. Most an­a­lysts, though, give Al­ny­lam a dis­tinct edge af­ter re­view­ing the piv­otal da­ta be­ing hus­tled to the FDA and EMA.

Al­ny­lam says it ex­pects to land an OK from the FDA in mid-2018, with a green light from the EMA fol­low­ing soon af­ter.

The new deal comes just weeks af­ter reg­u­la­tors lift­ed a clin­i­cal hold on fi­tusir­an, which was put in place fol­low­ing the death of a pa­tient due to a blood clot. Sanofi had paid $100 mil­lion to opt in on fi­tusir­an 10 months be­fore the hold was clamped down on the late-stage study.

Notes Leerink’s Paul Mat­teis:

Un­der the new agree­ment, AL­NY gains ROW com­mer­cial­iza­tion rights for patisir­an while re­tain­ing their rights to the US, Cana­da, and west­ern EU. SNY now stands to re­ceive tiered roy­al­ties of up to 25% on ROW sales for patisir­an, with the caveat that in Japan, SNY will re­ceive a flat roy­al­ty rate (not tiered) of 25%. AL­NY gain­ing ROW rights to patisir­an in ex­change for the roy­al­ty is like­ly to have a more mod­est im­pact on our mod­el. More im­pact­ful, the new agree­ment gives AL­NY full glob­al de­vel­op­ment and com­mer­cial rights to their fol­low-on TTR prod­uct ALN-TTRsc02 and AL­NY will pay SNY tiered roy­al­ties of 15%-30% on glob­al net sales. Fi­nal­ly, SNY will ob­tain full glob­al de­vel­op­ment and com­mer­cial­iza­tion rights to fi­tusir­an (he­mo­phil­ia). Per the agree­ment, AL­NY stands to re­ceive tiered roy­al­ties of 15%-30% on glob­al net sales of fi­tusir­an.

“This strate­gic re­struc­tur­ing en­ables stream­lined de­vel­op­ment and an op­ti­mized ap­proach to bring­ing in­no­v­a­tive med­i­cines to pa­tients with AT­TR amy­loi­do­sis and he­mo­phil­ia around the world, max­i­miz­ing the com­mer­cial op­por­tu­ni­ties for these pro­grams,” said Maraganore. “For Al­ny­lam, this pro­vides strate­gic clar­i­ty and op­er­a­tional align­ment with re­gard to the de­vel­op­ment and com­mer­cial­iza­tion of patisir­an and ALN-TTRsc02. This will al­low us to de­vel­op both prod­ucts in a com­pre­hen­sive man­ner, po­ten­tial­ly ad­dress­ing the full spec­trum of transthyretin-me­di­at­ed amy­loi­do­sis dis­ease treat­ment and pre­ven­tion. At the same time, we will con­tin­ue to sup­port and ben­e­fit – via roy­al­ties – from the fi­tusir­an op­por­tu­ni­ty through Sanofi’s sig­nif­i­cant de­vel­op­ment and com­mer­cial lead­er­ship.”

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Pascal Soriot (AP Images)

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

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The flu virus (CDC)

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