Lil­ly's ap­proved can­cer drug Lartru­vo fails con­fir­ma­to­ry study, set­ting the stage for with­draw­al of reg­u­la­to­ry en­dorse­ment

Back in 2016, Lil­ly won FDA ac­cel­er­at­ed ap­proval for its soft tis­sue drug olara­tum­ab on the ba­sis of en­cour­ag­ing da­ta from a small 133-pa­tient mid-stage study, but on Fri­day a larg­er, con­fir­ma­to­ry tri­al meant to ce­ment the ap­proval showed that the treat­ment failed to help pa­tients live longer, which means the US health reg­u­la­tor can re­scind its en­dorse­ment of the drug.

The drug, sold as Lartru­vo, had won the FDA nod in com­bi­na­tion with the chemother­a­py dox­oru­bicin as a first-line treat­ment for a sub­set of pa­tients with the dis­ease, which had seen no new ap­provals in decades. By the third quar­ter of 2018, Lil­ly had raked in $221.2 mil­lion in Lartru­vo sales last year.

The con­fir­ma­to­ry Phase III tri­al — AN­NOUNCE — test­ed Lartru­vo in com­bi­na­tion with dox­oru­bicin, ver­sus dox­oru­bicin monother­a­py in pa­tients with ad­vanced or metasta­t­ic soft tis­sue sar­co­ma. The study did not meet the main goal of im­prov­ing over­all sur­vival in the pa­tient pop­u­la­tion, in­clud­ing the sub­set of leiomyosar­co­ma pa­tients — there was no dif­fer­ence in sur­vival be­tween the study arms for ei­ther pop­u­la­tion, the com­pa­ny said.

Anne White

Da­ta from the pre­vi­ous, pos­i­tive Phase II tri­al had helped Lil­ly se­cure ac­cel­er­at­ed ap­proval in the Unit­ed States, and con­di­tion­al ap­proval in Eu­rope. But those ap­provals were con­tin­gent on fa­vor­able AN­NOUNCE re­sults con­firm­ing its ben­e­fit, and now the com­pa­ny will talk to reg­u­la­tors to de­ter­mine the next steps for the drug.

For now, the drug­mak­er has sus­pend­ed Lartru­vo pro­mo­tion, and ex­pects to in­cur a pre-tax charge in the range of $70 mil­lion to $90 mil­lion (or $0.10 per share, af­ter tax) in the first quar­ter of 2019.

“Lil­ly was sur­prised and dis­ap­point­ed that LARTRU­VO did not im­prove sur­vival for pa­tients with ad­vanced soft tis­sue sar­co­ma in this study,” said Anne White, pres­i­dent of Lil­ly On­col­o­gy in a state­ment. Lil­ly’s $LLY shares slipped about 3% pre-mar­ket.

The drug is cur­rent­ly al­so be­ing test­ed in com­bi­na­tion with gem­c­itabine and do­c­etax­el in a sep­a­rate Phase II tri­al in ad­vanced soft tis­sue sar­co­ma pa­tients.

The fail­ure fol­lows Lil­ly’s an­nounce­ment this month to swal­low Loxo On­col­o­gy for $8 bil­lion. Ac­cord­ing to a SEC fil­ing post­ed on Thurs­day, Lil­ly ex­ec­u­tives were look­ing for a swift deal when they sat down with Loxo CEO Josh Bilenker five days ahead of Christ­mas. They were will­ing to fork out $230 a share for the small­er com­pa­ny, in a hur­ry to get the deal done in time for the JP­Mor­gan ex­trav­a­gan­za. There were no oth­ers bid­ders for the com­pa­ny, but in or­der to has­ten the buy­out, Lil­ly agreed even­tu­al­ly to pay $235 per Loxo share, al­low­ing for the ac­qui­si­tion to be re­vealed on Jan­u­ary 7.

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan -- an­a­lysts turn thumbs down

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

AbbVie $ABBV has agreed to pay $188.24 a share — cash and stock — for the troubled Allergan, reflecting a 45% premium as investors bid up shares in anticipation of a much buzzed about company split. That price — with each share of Allergan worth 0.8660 AbbVie shares and $120.30 in cash — reflects a sharp fall from the $330 peak for Allergan and Saunders 4 years ago — but much better than anything shareholders had in mind for the near future.

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With 4 more biotech IPOs due to wrap up Q2, how is the class of 2019 far­ing?

With 22 biotech IPOs on the books and four more set to price in the last week of June, in­vest­ment ad­vis­er Re­nais­sance Cap­i­tal has tak­en the pulse of the re­cent rush.

By the IPO ex­perts’ count, 25 out of 32 health­care of­fer­ings this year have been from biotechs — dif­fer­ing slight­ly from Brad Lon­car’s tal­ly — and the over­all pic­ture is one of un­der­per­for­mance. While they av­er­aged a first-day re­turn of 9.0%, col­lec­tive­ly they have trad­ed down to a 5.9% re­turn. Turn­ing Point $TP­TX and Cor­texyme $CRTX emerged on top at the half-year mark, ris­ing 135% and 109% re­spec­tive­ly.

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:

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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.

Eye­ing a $500M peak sales pot, Almi­rall dou­bles down on le­brik­izum­ab as Der­mi­ra lines up PhI­II

With eyes on what it be­lieves is a $500 mil­lion peak rev­enue op­por­tu­ni­ty in Eu­rope, Barcelona-based Almi­rall has stepped up with $50 mil­lion in cash to take up the op­tion on Der­mi­ra’s IL-13 an­ti-in­flam­ma­to­ry drug le­brik­izum­ab just ahead of the start of Phase III. And there’s an­oth­er $30 mil­lion due as the late-stage pro­gram gets geared up.

That shouldn’t be long from now, as Der­mi­ra ex­pects to be­gin the late-stage tri­al work for atopic der­mati­tis be­fore the end of this year as it fol­lows a trail that ex­ecs in­sist leads to block­buster re­turns. Along the way, they’ll need to take on the 600-pound go­ril­la in atopic der­mati­tis: the IL-13/IL-4 drug Dupix­ent, from Re­gen­eron and Sanofi. Ri­vals al­so in­clude Leo Phar­ma, in its piv­otal with tralok­izum­ab, and Anap­tys­Bio in the hunt with a mid-stage pro­gram for etokimab, pre­vi­ous­ly re­ferred to as ANB020.

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.

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.

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.

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.