Mallinck­rodt's woes per­sist as re­for­mu­lat­ed opi­oid painkiller fails to pass FDA muster

The FDA’s re­luc­tance with pre­scrip­tion painkillers at a time the Unit­ed States is swept by a tsuna­mi of opi­oid abuse, over­dose and ad­dic­tion was on full dis­play on Wednes­day, when the reg­u­la­tor re­ject­ed Mallinck­rodt’s $MNK abuse-de­ter­rent opi­oid painkiller, so­lic­it­ing more da­ta from the UK drug­mak­er.

The drug un­der scruti­ny was a tweaked ver­sion of Rox­i­codone, an im­me­di­ate-re­lease for­mu­la­tion of the com­mon­ly abused opi­oid oxy­codone that was ap­proved by the FDA in 2000. This re­for­mu­la­tion was de­signed to de­ter abuse via snort­ing or in­ject­ing. In its CRL, the agency “pro­vid­ed guid­ance re­gard­ing ar­eas of fur­ther eval­u­a­tion nec­es­sary to re­sub­mit the NDA for fur­ther re­view,” Mallinck­rodt said.

Shares of the Staines-up­on-Thames-based com­pa­ny, which said it would spin off its spe­cial­ty busi­ness last week, were down about 9% pre-mar­ket. The an­nounce­ment fol­lows an­oth­er set­back: one of two late-stage drugs Mallinck­rodt won as part of its $1.2 bil­lion ac­qui­si­tion of Su­cam­po failed a piv­otal study in No­vem­ber.

The CRL for the painkiller does not come as a com­plete sur­prise. In a re­view last month, FDA staff point­ed out that the agency had not made any de­fin­i­tive con­clu­sions re­gard­ing whether the drug could be ma­nip­u­lat­ed for in­tra­venous abuse, as Mallinck­rodt had not yet sub­mit­ted da­ta from sev­er­al key stud­ies as part of its NDA. A pan­el of in­de­pen­dent ex­perts re­view­ing the drug a few days lat­er con­curred, sug­gest­ing the drug be la­beled as an abuse de­ter­rent on­ly via the nasal route.

This could cul­mi­nate in a sim­i­lar sit­u­a­tion to that of En­do’s $ENDP Opana, which was with­drawn from the mar­ket last year at the be­hest of the FDA, af­ter post-mar­ket da­ta showed the re­for­mu­lat­ed opi­oid painkiller was be­ing abused in­tra­venous­ly at a high­er rate, even as rates of nasal abuse fell.

But Mallinck­rodt is plan­ning to plough ahead. The com­pa­ny in­tends to re­quest a meet­ing in the com­ing weeks with the reg­u­la­tor to dis­cuss its next steps, it said on Wednes­day.

On av­er­age, opi­oid over­dos­es kill 115 Amer­i­cans per day, and the eco­nom­ic bur­den of pre­scrip­tion opi­oid mis­use alone is a hefty $78.5 bil­lion each year, in­clud­ing the health­care costs, lost pro­duc­tiv­i­ty, and crim­i­nal jus­tice in­volve­ment, ac­cord­ing to the CDC. As the num­ber of opi­oid-re­lat­ed deaths mount, the FDA has large­ly changed its tune on the oft’ mis­used class of drugs by amend­ing its pre­scrib­ing rec­om­men­da­tions,track­ing the num­ber of pre­scrip­tions, tight­en­ing scruti­ny and re­quir­ing man­u­fac­tur­ers to de­vel­op abuse-de­ter­rent for­mu­la­tions.

How­ev­er, the agency is not quite im­pos­ing a blan­ket ban on all things opi­oid. Last month, it ap­proved Acel­Rx Phar­ma­ceu­ti­cals $ACRX painkiller Dsu­via, a drug 10-times more po­tent than fen­tanyl, which in turn is a syn­thet­ic opi­oid pain re­liev­er that is 50 to 100 times more po­tent than mor­phine. The con­tro­ver­sial ap­proval was sanc­tioned de­spite height­en­ing con­cern and fiery crit­i­cism (from a host of crit­ics in­clud­ing a hand­ful of US sen­a­tors) on the grounds that the drug — which was de­vel­oped in col­lab­o­ra­tion with the De­part­ment of De­fense — is a sub­lin­gual for­mu­la­tion, mak­ing it ide­al for mil­i­tary use, not­ed FDA Com­mis­sion­er Scott Got­tlieb.

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.