No­var­tis con­tin­ues its blitz on NASH deals, grab­bing an ex­clu­sive tie-up in race to de­vel­op cock­tails

Vas­ant Narasimhan, No­var­tis

Five months ago No­var­tis $NVS rocked Cona­tus’ world with a col­lab­o­ra­tion deal for its NASH drug em­ri­c­as­an. The biotech’s stock quadru­pled in val­ue. And it got an­oth­er boost to­day as the phar­ma gi­ant fol­lowed up with its an­nounce­ment that it is in­deed pick­ing up the ex­clu­sive world­wide op­tion for the drug, chip­ping in an ex­tra $7 mil­lion to seal the deal.

Cona­tus stock $CNAT is up 13% in pre-mar­ket trad­ing and the mi­cro biotech has seen its mar­ket cap break through the $200 mil­lion mark.

The San Diego-based biotech is now ful­ly al­lied with the phar­ma gi­ant, which is cov­er­ing half the cost of a new­ly launched Phase IIb tri­al of em­ri­c­as­an. The oral pan-cas­pase in­hibitor has scored pos­i­tive, ear­ly-stage bio­mark­er da­ta for in­flam­ma­tion and cell death. And No­var­tis wants to add it to its FXR ag­o­nist drugs in a com­bi­na­tion drug ap­proach for Phase III as its in­ves­ti­ga­tors ex­pand their port­fo­lio of NASH ther­a­pies.

No­var­tis is al­so plan­ning to test the drug as a monother­a­py as in­ves­ti­ga­tors map out a big late-stage as­sault on NASH and liv­er fi­bro­sis.

No­var­tis al­so signed up with Al­ler­gan just a few weeks ago, com­bin­ing an FXR ag­o­nist with Al­ler­gan’s ceni­crivi­roc — CVC — for the treat­ment of non-al­co­holic steato­hep­ati­tis. No­var­tis be­lieves that Al­ler­gan’s CVC — which tack­les CCR2 and CCR5, a pair of in­flam­ma­to­ry chemokine re­cep­tors — is the kind of drug that will fig­ure promi­nent­ly in new cock­tails for NASH, a ma­jor mar­ket op­por­tu­ni­ty that has at­tract­ed a line­up of ri­vals like Gilead, In­ter­cept and Shire.

In­ter­cept $ICPT un­der­scored the in­tense ri­val­ry in the field with its an­nounce­ment to­day that their late-stage NASH pro­gram achieved a big goal.

“In our NASH pro­gram, we achieved a ma­jor mile­stone with the com­ple­tion of en­roll­ment of our in­ter­im analy­sis co­hort in RE­GEN­ER­ATE, the first and largest Phase III tri­al in NASH,” said CEO Mark Pruzan­s­ki in a pre­pared state­ment. “As we look to the mid­dle of the year, we ex­pect to an­nounce top-line da­ta from two ad­di­tion­al Phase II tri­als of OCA: CON­TROL, as­sess­ing com­bi­na­tion statin ther­a­py in NASH pa­tients, and AE­SOP in pri­ma­ry scle­ros­ing cholan­gi­tis.”

But No­var­tis seems de­ter­mined to leapfrog the lead­ers.

“We are pleased to add an­oth­er im­por­tant med­i­cine to our liv­er port­fo­lio with em­ri­c­as­an, which has shown po­ten­tial in pa­tients with ad­vanced fi­bro­sis and cir­rho­sis,” said Vas Narasimhan, Glob­al Head, Drug De­vel­op­ment and Chief Med­ical Of­fi­cer, No­var­tis. “We look for­ward to ad­vanc­ing our broad port­fo­lio of NASH and chron­ic liv­er dis­ease pro­grams to ad­dress this grow­ing un­met need.”

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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Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took at 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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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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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 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.