Ab­b­Vie and Roche tout a pos­i­tive PhI­II com­bo study of Ven­clex­ta, Rit­ux­an in CLL — ahead of FDA pitch

Ab­b­Vie and Roche are get­ting a boost out of the news that their com­bi­na­tion of Ven­clex­ta and Rit­ux­an met their pri­ma­ry end­point on pro­gres­sion-free sur­vival, beat­ing out a com­bi­na­tion of chemother­a­py and Rit­ux­an for treat­ment-re­sis­tant cas­es of chron­ic lym­pho­cyt­ic leukemia.

Ab­b­Vie says they’ll be hus­tling along the da­ta — none of which was on dis­play to­day — to reg­u­la­tors af­ter pick­ing up a break­through drug des­ig­na­tion on the com­bo for CLL, which has at­tract­ed a num­ber of drugs.

Michael Sev­eri­no

The re­sults from the MU­RA­NO study have been await­ed by a cou­ple of the an­a­lysts cov­er­ing Ab­b­Vie to see how the com­pa­ny can fare this year in ex­pand­ing its prospects in on­col­o­gy. Its big can­cer drug dri­ver is Im­bru­vi­ca, with Hu­mi­ra pro­vid­ing the bulk of its rev­enue.

Leerink’s Ge­of­frey Porges counts him­self as a hap­py camper on the news. He not­ed:

 We an­tic­i­pate an ex­pe­dit­ed reg­u­la­to­ry fil­ing and ap­proval based on these da­ta, which will ex­pand the la­beled in­di­ca­tion for Ven­clex­ta from a nar­row sub­set of CLL pa­tients (17p dele­tion) to the broad­er R/R CLL pop­u­la­tion and will ac­cel­er­ate the Ven­clex­ta rev­enue op­por­tu­ni­ty by H2 2018. Ven­clex­ta’s cur­rent quar­ter­ly rev­enue run rate of $20-30mm (our es­ti­mate) should in­crease sig­nif­i­cant­ly with the la­bel ex­pan­sion that is like­ly to fol­low this re­sult.

Ex­pand­ing the num­ber of FDA OKs for this drug is cru­cial to Ab­b­Vie’s plan to ex­pand rev­enue from about $125 mil­lion this year to as much as $1.5 bil­lion to $2 bil­lion a year by the end of the decade. The drug was orig­i­nal­ly ap­proved for pa­tients with CLL with 17p dele­tion back in April of 2016.

Re­searchers are al­so stay­ing mum about the safe­ty re­sults from the study, say­ing they’re ex­am­in­ing ad­verse events reg­is­tered in the study.

CLL ac­counts for about a quar­ter of all the new leukemia cas­es di­ag­nosed every year.

“Ab­b­Vie is com­mit­ted to re­search­ing the full po­ten­tial of Ven­clex­ta both as monother­a­py and com­bi­na­tion ther­a­py in pa­tients with CLL and oth­er hema­to­log­ic ma­lig­nan­cies. The analy­sis of the MU­RA­NO tri­al showed that Ven­clex­ta in com­bi­na­tion with Rit­ux­an may of­fer an­oth­er op­tion for pa­tients with R/R CLL, po­ten­tial­ly pro­vid­ing them with a chemother­a­py-free ther­a­py,” said Michael Sev­eri­no, Ab­b­Vie’s chief sci­en­tif­ic of­fi­cer. “We are look­ing for­ward to work­ing with reg­u­la­to­ry au­thor­i­ties around the world to bring this ad­di­tion­al treat­ment reg­i­men to R/R CLL pa­tients.”

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

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.

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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.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three ma­jor buy­outs an­nounced: Take­da/Shire; Bris­tol-My­ers/Cel­gene and now Ab­b­Vie/Al­ler­gan. And with this lat­est deal it’s in­creas­ing­ly clear that the sharp fall from grace suf­fered by high-pro­file play­ers which have seen their share prices blast­ed has cre­at­ed an open­ing for the growth play­ers in big phar­ma to up their game — in sharp con­trast to the pop­u­lar bolt-on deals that have been dri­ving the growth strat­e­gy at No­var­tis, Mer­ck, Roche and oth­ers.

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The top 15 mega-deals in bio­phar­ma: Ab­b­Vie and Bris­tol-My­ers ac­qui­si­tions stir fresh de­bate over what's too big to buy

The debate over what’s too big to buy in biotech is back. A number of top analysts went right after AbbVie’s rationale for the Allergan deal today, just as Bristol-Myers Squibb stirred immediate debate over the worth and wisdom of acquiring Celgene.

To help provide some added context to this discussion, we asked DealForma chief Chris Dokomajilar to look over the past decade of major M&A in biopharma to decipher the top 15 plays.

The new numbers, unadjusted for inflation, harken back to the days of the Pfizer-Wyeth buyout and Merck’s decision to absorb Schering-Plough — both triggered in 2009. The heat over those acquisitions made the big pharma mega-deal highly unpopular for most everyone — except Pfizer — as industry leaders swore off almost all but the handy bolt-on acquisition.

Until recently.

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Suf­fer­ing No­var­tis part­ner Cona­tus grabs the ax and packs it in on NASH af­ter a se­ries of set­backs

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.