Treve­na forges plan to take once-re­ject­ed opi­oid across fin­ish line, af­ter 'pro­duc­tive' FDA meet­ing

Tiny Treve­na may have a new lease on life for its con­tro­ver­sial opi­oid painkiller — re­ject­ed by the FDA last No­vem­ber cit­ing the dearth of drug safe­ty da­ta — fol­low­ing a scathing in­ter­nal staff cri­tique and lop­sided ex­pert pan­el re­view.

The com­pa­ny’s shares $TRVN swelled near­ly 120% on Mon­day af­ter Treve­na said the agency had agreed that the drug’s ex­ist­ing safe­ty data­base would suf­fice for a par­tic­u­lar dose of the drug — help­ing forge a path for­ward for the biotech to re­sub­mit its mar­ket­ing ap­pli­ca­tion.

The IV in­jec­tion, oliceri­dine, was de­vel­oped to help adult pa­tients man­age mod­er­ate to se­vere acute pain. It is de­signed to in­duce a sim­i­lar anal­gesic ef­fect as mor­phine, but work faster and re­duce the messy side ef­fects of se­da­tion, res­pi­ra­to­ry de­pres­sion and slow­ing gas­troin­testi­nal motil­i­ty. But mixed tri­al re­sults and gaps in safe­ty da­ta in­clud­ing QT in­ter­val da­ta — the time the heart mus­cle takes to recharge be­tween beats — prompt­ed the reg­u­la­tor to even­tu­al­ly re­ject the opi­oid in ear­ly No­vem­ber. At the time, the agency asked for a big­ger safe­ty data­base for the drug, as well as “cer­tain ad­di­tion­al non­clin­i­cal da­ta and val­i­da­tion re­ports”.

Car­rie Bour­dow

On Mon­day, Treve­na said its cur­rent safe­ty da­ta would sup­port la­bel­ing at a max­i­mum dai­ly dose of 27 mg, and that the FDA had agreed that the com­pa­ny con­duct a study (in­clud­ing place­bo- and pos­i­tive-con­trol arms) in healthy vol­un­teers to amass the re­quest­ed QT in­ter­val da­ta.

The Chester­brook, Penn­syl­va­nia-based drug de­vel­op­er in­tends to sub­mit a pro­to­col and analy­sis plan to the FDA short­ly and, up­on re­ceipt of reg­u­la­to­ry feed­back, ex­pects to ini­ti­ate the study in the first half of 2019. The com­pa­ny added it does not need any more ef­fi­ca­cy da­ta to re­sub­mit its mar­ket­ing ap­pli­ca­tion for the drug, but did not pro­vide any de­tails on when that re­sub­mis­sion could be ex­pect­ed.

CEO Car­rie Bour­dow said she was “en­cour­aged by the pro­duc­tive dis­cus­sion” with the FDA in a state­ment.

Max­ine Gowen

Back in 2016, un­der the be­hest of CEO Max­ine Gowen, Treve­na had sug­gest­ed an end-of-Phase II meet­ing with the FDA had cul­mi­nat­ed in a gen­er­al agree­ment about the Phase III de­sign for oliceri­dine, and that Gowen was “very pleased” with the dis­cus­sion. But it was on­ly last year that it was re­vealed that the FDA had in fact in­di­cat­ed oth­er­wise — the agency had dis­agreed with pro­posed dos­ing and the pri­ma­ry end­point in the late-stage pro­gram. This rev­e­la­tion prompt­ed at­tor­neys at Bern­stein Lieb­hard to ac­cuse Treve­na ex­ecs, par­tic­u­lar­ly for­mer CEO Max­ine Gowen, of mis­lead­ing in­vestors for rough­ly two years.

FDA pol­i­cy dic­tates it must not re­lease any in­for­ma­tion re­lat­ed to dis­cus­sions with drug spon­sors un­til a drug is up for re­view. Com­mis­sion­er Scott Got­tlieb had ini­tial­ly made promis­es to arm the agency to re­veal more in­for­ma­tion, for in­stance the reg­u­la­tor’s rea­son­ing be­hind is­sued CRLs, but that has not come to fruition.

Mean­while, the FDA’s ap­proval of an­oth­er opi­oid amidst a na­tion­al cri­sis of opi­oid abuse, mis­use and ad­dic­tion that kills about 130 Amer­i­cans each day will like­ly cause more fric­tion. Acel­Rx’s $ACRX ap­proval for its opi­oid Dsu­via last year sparked a flur­ry of in­tense crit­i­cism, even prompt­ing a mem­ber of the FDA’s own ex­pert pan­el to call out the agency’s at­ti­tude to­ward opi­oids as “will­ful blind­ness that bor­ders on the crim­i­nal.

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.

Is there a recipe for M&A suc­cess? The best and worst buy­out deals in the past decade of­fer some keys to suc­cess — and fail­ure

It’s not easy achieving a solid win in M&A in this industry. But if you follow a few simple guidelines, you may be able to increase your odds of success.
Geoffrey Porges and the team at SVB Leerink went about the “notoriously difficult” task of scoring the biopharma buyout of 2009 to 2019. Sizing up current and expected revenue from the products that were gained, they came up with the 5 winners:
Merck/Schering Plough
Bristol/Medarex
Gilead/Pharmasset
Sanofi/Genzyme
AstraZeneca/Acerta
It says a lot about the field that it’s much easier sorting out the 5 worst deals, though there’s also a lot more competition for that title, notes Porges. As picked by the analysts:
J&J/Actelion
Merck/Cubist
Alexion/Synageva
AbbVie/Stemcentrx
Gilead/Kite

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