Leapfrog­ging ri­vals, Roche's Tecen­triq plus chemo nabs PFS end­point in front­line lung can­cer seg­ment

Roche has nabbed the first shot at a front­line in­di­ca­tion for a sig­nif­i­cant share of the all-im­por­tant lung can­cer mar­ket with to­day’s news that their check­point Tecen­triq hit the pri­ma­ry end­point on pro­gres­sion-free sur­vival for squa­mous non-small cell lung can­cer. Some an­a­lysts say that in­di­ca­tion could be worth more than a bil­lion dol­lars a year in added rev­enue.

San­dra Horn­ing

Re­searchers com­bined Tecen­triq with Abrax­ane-based chemo and com­pared it to chemo in first line pa­tients with ad­vanced NSCLC. At an in­ter­im point the com­bi­na­tion beat out chemo on PFS with a sta­tis­ti­cal­ly sig­nif­i­cant out­come but had yet to show an over­all sur­vival ben­e­fit. In­ves­ti­ga­tors will now keep on track­ing re­sults to see how OS mea­sures out.

There were no da­ta points in Roche’s state­ment. The pos­i­tive PFS re­sults, though, give Roche a chance to march ahead of a bevy of com­pe­ti­tion from Mer­ck, Bris­tol-My­ers Squibb and oth­ers in a key can­cer mar­ket where the com­pe­ti­tion has been in­tense. And they’ll like­ly get a help­ing hand from the FDA, which has been ea­ger to stamp these check­points from the ma­jor play­ers with ac­cel­er­at­ed ap­provals.

Jef­feries rushed out a note ear­ly Tues­day high­light­ing some block­buster po­ten­tial for Roche, which has been scram­bling to catch up with the lead­ers in check­point in­hi­bi­tion and looked to gain a first-to-mar­ket ad­van­tage here. They note:

IM­pow­er131 is an im­por­tant study for Roche. Squa­mous cell NSCLC, which ac­counts for c.25%-30% of NSCLC, is a more com­pli­cat­ed dis­ease than non-squa­mous NSCLC and there are few­er treat­ment op­tions. Roche has pre­vi­ous­ly not­ed that it could be first to mar­ket in the 1L squa­mous NSCLC set­ting if IM­pow­er131 pro­duced a su­pe­ri­or re­sult. We cur­rent­ly mod­el $1.1bn of peak sales for Tecen­triq in this 1L squa­mous set­ting and have pre­vi­ous­ly high­light­ed that a pos­i­tive re­sult from the tri­al could see 1%-3% up­side to EPS and val­u­a­tion.

Mer­ck and Bris­tol-My­ers have tak­en the lead role in the over­all lung can­cer mar­ket, but none of the com­pe­ti­tion is ced­ing con­trol. IM­pow­er131 is one of five Phase III read­outs that Roche has for lung can­cer this year. And three more are in the clin­ic. Dur­ing their Q4 re­view last month, Roche phar­ma chief Daniel O’Day sound­ed bull­ish on Roche’s chances of carv­ing out a big piece of the mar­ket for it­self.

Their on­go­ing stud­ies, he said, “will di­men­sion­al­ize the first-line lung can­cer space in 2018.”

“I’m con­vinced there will be mul­ti­ple op­tions for dif­fer­ent pa­tient types in this set­ting which ac­counts for around 45% of the lung can­cer set­ting. I’m al­so con­vinced that we’ll play a very im­por­tant role there.”

That won’t come easy, though. Roche’s lat­est win in Phase III is its third in a mat­ter of months, but with 5 check­points on the mar­ket, every­one is promis­ing to play hard to beat the com­pe­ti­tion. And be­ing first may be an ad­van­tage, but it’s no guar­an­tee of mar­ket suc­cess. Mer­ck is al­so ex­pect­ed to pro­vide a read out in the same can­cer seg­ment soon from KEYNOTE-407.

“Squa­mous non-small cell lung can­cer is dif­fi­cult to treat and there have been lim­it­ed new treat­ment op­tions over the last few decades,” said San­dra Horn­ing, Roche’s chief med­ical of­fi­cer and head of glob­al prod­uct de­vel­op­ment. “We will share the IM­pow­er131 re­sults with glob­al health au­thor­i­ties and we look for­ward to see­ing more ma­ture over­all sur­vival da­ta.”

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.