J&J boasts im­proved car­dio safe­ty with SGLT2 fran­chise drug In­vokana

David Matthews, Steer­ing Com­mit­tee Co-Chair

J&J scored vi­tal­ly im­por­tant car­dio safe­ty da­ta for its SGLT2 di­a­betes drug In­vokana in a large Phase III out­comes study, which it hap­pi­ly shared with re­searchers at the an­nu­al Amer­i­can Di­a­betes As­so­ci­a­tion con­fer­ence in San Diego on Mon­day af­ter­noon.

The phar­ma gi­ant $JNJ spelled out a slate of pos­i­tive risk re­duc­tions on three key mea­sures, with a 14% re­duc­tion in risk for a com­pos­ite score on CV mor­tal­i­ty as well as non­fa­tal my­ocar­dial in­farc­tion and stroke, with each mea­sure con­tribut­ing to the pos­i­tive score.

In­ves­ti­ga­tors and pay­ers can now pour over the re­sults and start do­ing their com­par­isons with Jar­diance, the ri­val SGLT2 drug from Eli Lil­ly $LLY and Boehringer In­gel­heim which orig­i­nal­ly got this ball rolling two years ago. The big ques­tion now is whether this is a class ef­fect that will even­tu­al­ly ben­e­fit all play­ers, or pro­vide enough da­ta to start to sin­gle out one or two as bet­ter than the rest.

Class ef­fect may be the fa­vorite to­day, as J&J’s com­pos­ite 14% re­duc­tion in risk matched Lil­ly’s over­all num­ber per­fect­ly. Spe­cial­ists, though, will note that not all the end­points matched up, mak­ing cross tri­al com­par­isons tricky.

On the oth­er hand Jar­diance was more ef­fec­tive in cut­ting the risk of death (-38%) com­pared to a much more mod­est 13% re­duc­tion for In­vokana, which achieved more bal­anced ef­fects spread among end­points. And In­vokana was linked to a sig­nif­i­cant­ly high­er risk of am­pu­ta­tions, a safe­ty con­cern that has al­ready trig­gered a black box warn­ing.

Ad­di­tion­al analy­sis al­so demon­strat­ed that In­vokana (canagliflozin) low­ered the risk of HHF by 33% (HR: 0.67; 95% CI: 0.52 to 0.87) and pro­vid­ed sus­tained pos­i­tive ef­fects on glycemic and blood pres­sure con­trol, as well as weight re­duc­tion, with “wide-rang­ing dura­bil­i­ty,” J&J said in its state­ment. In ad­di­tion, the phar­ma gi­ant not­ed, their drug de­layed pro­gres­sion of al­bu­min­uria and re­duc­ing the risk of clin­i­cal­ly im­por­tant re­nal com­pos­ite out­comes (such as re­nal death, re­nal re­place­ment ther­a­py, and 40% re­duc­tion of eGFR) by 40%.

Mer­ck $MRK and Pfiz­er $PFE on­ly re­cent­ly out­lined their pos­i­tive Phase III da­ta for er­tugliflozin, look­ing for an ap­proval that will put them up against In­vokana, Jar­diance as well as As­traZeneca’s Farx­i­ga. Their car­dio out­comes da­ta, though, isn’t ex­pect­ed un­til 2019, giv­ing the lead­ers plen­ty of time to get fur­ther es­tab­lished first.

“Pa­tients with di­a­betes are two to four times more like­ly to suf­fer from as­so­ci­at­ed co­mor­bidi­ties, such as heart fail­ure and kid­ney dis­ease, and the CAN­VAS re­sults demon­strate the po­ten­tial of canagliflozin in re­duc­ing the risk for such con­di­tions in high-risk type 2 di­a­betes pa­tients,” said David Matthews, the tri­al’s steer­ing com­mit­tee co-chair and a pro­fes­sor of di­a­bet­ic med­i­cine at the Uni­ver­si­ty of Ox­ford. “These da­ta are promis­ing as they sug­gest canagliflozin may of­fer po­ten­tial ben­e­fits for pa­tients with type 2 di­a­betes, who are al­so fac­ing com­pli­ca­tions from, or are at risk for, hos­pi­tal­iza­tion for heart fail­ure or kid­ney dis­ease.”


Im­age: Shut­ter­stock

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

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.