Where Te­va failed, Eli Lil­ly gained — mi­graine drug Em­gal­i­ty wins US ap­proval for episod­ic clus­ter headaches

It may be trail­ing be­hind its ri­vals in mi­graine sales, but Lil­ly’s Em­gal­i­ty has se­cured the FDA nod for episod­ic clus­ter headaches.

Em­gal­i­ty was the last in­jectable to win ap­proval for mi­graine pre­ven­tion last Sep­tem­ber, months af­ter Aimovig from Am­gen $AMGN  and No­var­tis $NVS, and Te­va’s {$TE­VA] Ajovy. All three form part of a fam­i­ly of drugs de­vel­oped to block cal­ci­tonin gene-re­lat­ed pep­tide (CGRP), a pro­tein as­so­ci­at­ed with the on­set of mi­graine pain. Each has demon­strat­ed a sig­nif­i­cant re­duc­tion in mi­graine fre­quen­cy in about half of pa­tients when test­ed in clin­i­cal stud­ies and is priced at $6,900 a year, or $575 per month. Tiny Alder’s $AL­DR CGRP is un­der FDA re­view.

In March, Em­gal­i­ty was grant­ed pri­or­i­ty re­view by the FDA for pre­ven­tion of episod­ic clus­ter headache in adults. The fol­low­ing month, Te­va aban­doned a late-stage tri­al test­ing Ajovy for episod­ic clus­ter headaches af­ter the drug failed to clear a fu­til­i­ty test, af­ter giv­ing up on a chron­ic clus­ter headache study last sum­mer. The Is­raeli drug­mak­er is still test­ing the drug for post-trau­mat­ic headaches.

Em­gal­i­ty was ap­proved on the ba­sis of da­ta from a 106-pa­tient place­bo-con­trolled study. In the tri­al, pa­tients on Em­gal­i­ty ex­pe­ri­enced an av­er­age of 8.7 few­er week­ly clus­ter headache at­tacks be­tween weeks 1 to 3 ver­sus 5.2 few­er week­ly at­tacks for pa­tients on place­bo (p=0.036). With Em­gal­i­ty, 71.4% of pa­tients had their week­ly clus­ter headache at­tacks cut in half or more from base­line at week 3 vs. 52.6% of pa­tients with place­bo (p=0.046).

“The op­por­tu­ni­ty in this pop­u­la­tion, which we es­ti­mate to be ~200,000 pa­tients in the US, could add to Lil­ly’s com­pet­i­tive ad­van­tage against Am­gen and Te­va,” Leerink an­a­lysts wrote in a note in April.

Af­flict­ed pa­tients ex­pe­ri­ence ex­cru­ci­at­ing headache at­tacks de­scribed some­times as “sui­cide headaches” be­tween 1-8 times per day, and these clus­ter cy­cles can last weeks or months and are usu­al­ly sep­a­rat­ed by headache-free re­mis­sion pe­ri­ods, which typ­i­cal­ly last months or years.

While the mi­graine dose is 120 mg, pa­tients pre­scribed Lil­ly’s $LLY Em­gal­i­ty for clus­ter headaches will be ad­min­is­tered a 300 mg dose at the on­set of a clus­ter pe­ri­od, fol­lowed by sub­cu­ta­neous in­jec­tions each month un­til the end of the pe­ri­od. The price per mg for Em­gal­i­ty re­mains the same, Lil­ly said.

In the first quar­ter of 2019, Aimovig gen­er­at­ed sales of $59 mil­lion, Ajovy brought in $20 mil­lion, while Em­gal­i­ty made $14 mil­lion.

The ap­proval comes as a wel­come re­lief for Lil­ly, which has suf­fered a string of set­backs in re­cent months — a late-stage fail­ure trig­gered the with­draw­al of its can­cer drug Lartru­vo, the US drug­mak­er rel­e­gat­ed two mid-stage drugs to the scrap heap, and Japan flagged safe­ty con­cerns as­so­ci­at­ed with its breast can­cer treat­ment, Verzenio.


Im­age: Kristof­fer Trip­plaar for SIPA AP

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,400+ biopharma pros reading Endpoints daily — and it's free.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.