Eli Lil­ly, Pfiz­er cel­e­brate a PhI­II suc­cess for their block­buster pain drug con­tender tanezum­ab -- but ques­tions linger

Five years af­ter Eli Lil­ly stepped up with a $1.8 bil­lion deal to bring Pfiz­er’s an­ti-NGF pain drug tanezum­ab back from lim­bo, the phar­ma gi­ants are re­port­ing that they suc­cess­ful­ly nav­i­gat­ed a ma­jor Phase III study for the non-opi­oid ther­a­py among pa­tients suf­fer­ing from os­teoarthri­tis.

Christi Shaw

Re­searchers say that their drug hit three pri­ma­ry end­points for pain, phys­i­cal func­tion and the pa­tients’ over­all as­sess­ment of their OA. Tapped by Pfiz­er as one of the lead­ing late-stage drugs in their pipeline, the in­ves­ti­ga­tors al­so not­ed that “rapid­ly pro­gres­sive os­teoarthri­tis was ob­served in tanezum­ab-treat­ed pa­tients at a fre­quen­cy of less than 1.5%, and was not ob­served in the place­bo arm.”

That kind of safe­ty sig­nal, though, could come back to haunt them. 

Ever­core ISI’s Umer Raf­fat ze­roed right in on it, telegraph­ing:

What we re­al­ly need is a break­down of RPOA1 vs RPOA 2 (much more se­vere form).  Press re­lease did NOT have this in­fo and Pfiz­er is not dis­clos­ing cur­rent­ly.

–       With that said, Pfiz­er does seem en­cour­aged by the da­ta, but like­ly needs longer fol­low up be­fore be­ing more de­fin­i­tive about its view on safe­ty.

–       As a re­minder, press re­lease notes 1.5% RPO rate … even if ALL these RPOs are Type 1, there is still that po­ten­tial for con­ver­sion from Type 1 to Type 2 – es­pe­cial­ly since the tri­al re­port­ed to­day was 16 wk.

–       A 3000 pt 52-wk tri­al is re­port­ing this fall – that will be KEY.

There were no cas­es of os­teonecro­sis and no new safe­ty sig­nals to re­port.

The da­ta are be­ing held in re­serve for a sci­en­tif­ic con­fer­ence. Mean­while the part­ners have the drug in on­go­ing stud­ies for sev­er­al dif­fer­ent con­di­tions.

This is one of sev­er­al pow­er­ful painkillers that were in the clin­ic 8 years ago, then sud­den­ly shelved for some years as de­vel­op­ers grap­pled with un­ex­pect­ed safe­ty is­sues. And with the opi­oid cri­sis grab­bing head­lines around the world, ex­pec­ta­tions are still run­ning high.

Back in 2010 tanezum­ab was wide­ly con­sid­ered one of the top prospects in the in­dus­try’s late-stage pipeline. The en­tire class of an­ti-NGF drugs was es­ti­mat­ed by some an­a­lysts to be worth a po­ten­tial $11 bil­lion. Then the stud­ies for the drug — as well as ther­a­pies at oth­er ma­jor de­vel­op­ers — were shelved af­ter it be­came ap­par­ent that a group of pa­tients were blow­ing out joints that then need­ed to be re­placed.

Christi Shaw, se­nior vice pres­i­dent, Eli Lil­ly and Com­pa­ny and pres­i­dent, Lil­ly Bio-Med­i­cines, not­ed: 

“We look for­ward to con­tin­u­ing to ad­vance tanezum­ab in our on­go­ing glob­al Phase III de­vel­op­ment pro­gram, which in­cludes six stud­ies in ap­prox­i­mate­ly 7,000 pa­tients with os­teoarthri­tis, chron­ic low back pain and can­cer pain.”

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.