Roche just her­ald­ed a great set of place­bo com­par­isons for their new flu drug — too bad it flopped against gener­ic Tam­i­flu

Genen­tech just rolled out some of the hard da­ta around its Phase III CAP­STONE-2 tri­al for their new flu med­i­cine balox­avir mar­box­il, and it doesn’t look good.

Once you dig through the bon­ny re­marks and keep go­ing on to the sta­tis­ti­cal­ly sig­nif­i­cant place­bo com­par­isons, the phar­ma gi­ant throws in a ma­jor sna­fu. Their flu drug failed to prove sig­nif­i­cant­ly bet­ter than Tam­i­flu in a head-to-head com­par­i­son on the time it took to re­duce symp­toms of the flu. And that’s the mon­ey shot.

The me­di­an time to im­prove­ment of symp­toms for balox­avir was 73.2 hours. The Tam­i­flu com­para­tor arm: 81 hours for an aw­ful p val­ue of 0.8347. Roche op­ti­misti­cal­ly called this out­come “nu­mer­i­cal­ly su­pe­ri­or,” but a pay­er would say the rel­a­tive­ly mod­est dif­fer­ence could have been due en­tire­ly to chance.

That’s not the sort of thing pay­ers like to pay for, es­pe­cial­ly as cheap copies of Tam­i­flu abound, eras­ing a fran­chise Roche had hoped to keep. Dur­ing epi­demics, Tam­i­flu had achieved multi­bil­lion dol­lar sales fig­ures. Now it looks to re­main an oc­ca­sion­al best­seller, at a frac­tion of the cost.

The fly in the flu da­ta helps ex­plain why peak sales fore­casts for this drug have tend­ed to vary dra­mat­i­cal­ly. 

There is a wide range of da­ta to il­lus­trate how this drug does bet­ter than a place­bo, but balox­avir won’t be com­pet­ing against a sug­ar pill. In the mean­time, Roche has a Christ­mas eve PDU­FA date with the FDA and strong odds they’ll get an OK for a record-break­ing year at the agency.

Roche got rights to this drug from Sh­iono­gi, which sells it in Japan.

On the bright side, Roche did have some good news for a sub­pop­u­la­tion, with their drug beat­ing Tam­i­flu in the in­fluen­za sub­type B cat­e­go­ry, with a me­di­an time to im­prove­ment of 74.6 hours com­pared to Tam­i­flu’s 101.6 hours (p<0.05). Their drug al­so re­duced “the time that the virus con­tin­ued to be re­leased from the body (vi­ral shed­ding; me­di­an time of 48.0 hours for balox­avir mar­box­il ver­sus 96.0 hours for both place­bo and os­eltamivir; p<0.0001).”

How about ad­verse re­ac­tions? There again, there was no sig­nif­i­cant dif­fer­ence, with balox­avir at 25.1% and Tam­i­flu at 28%. That too is weak, with the phar­ma gi­ant falling back to its ar­gu­ment of nu­mer­i­cal su­pe­ri­or­i­ty.

Roche’s Genen­tech had re­peat­ed­ly boast­ed that balox­avir was the biggest new thing to come along in the flu-fight­ing are­na in 20 years. And they’re still say­ing it.

“This study adds to the grow­ing body of ev­i­dence sup­port­ing balox­avir mar­box­il as a po­ten­tial first-in-class an­tivi­ral flu treat­ment, and we plan to dis­cuss these da­ta with health au­thor­i­ties around the world,” San­dra Horn­ing, Genen­tech’s chief med­ical of­fi­cer and head of Glob­al Prod­uct De­vel­op­ment.

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.