FDA quash­es block­buster dreams at Eli Lil­ly and In­cyte, of­fer­ing a se­vere­ly lim­it­ed ap­proval for Olu­mi­ant

Vi­sions of block­buster sales for the rheuma­toid arthri­tis drug baric­i­tinib were quashed by the FDA’s ap­proval to­day. Reg­u­la­tors came through with an OK for the low, 2 mg dose of the drug, to be mar­ket­ed as Olu­mi­ant, spurn­ing the 4 mg dose that they had been seek­ing and lim­it­ing the pa­tient pop­u­la­tion to TNF re­sis­tant cas­es.

The reg­u­la­to­ry OK al­so comes with a black box warn­ing for the drug’s side ef­fects, which in­cludes a star­tling sig­nal on throm­boem­bolism.

Once tapped as a top fran­chise play­er for Eli Lil­ly $LLY and its part­ners at In­cyte $IN­CY, the FDA hauled the drug back from lim­bo af­ter the ar­rival of Scott Got­tlieb as com­mis­sion­er at the FDA. The agency had ini­tial­ly re­ject­ed the drug, de­mand­ing a new study. But then reg­u­la­tors abrupt­ly re­versed them­selves — with­out ex­pla­na­tion — and let the mar­ket­ing ap­pli­ca­tion pro­ceed.

De­spite the com­mer­cial set­back, Lil­ly plans to come out swing­ing for as much mar­ket share as it can grab. The phar­ma gi­ant says it will of­fer Olu­mi­ant at a 60% dis­count to the price of the lead­ing TNF in­hibitor.

“We are pleased to pro­vide RA pa­tients in the U.S. an ef­fec­tive treat­ment op­tion with Olu­mi­ant, as peo­ple with RA who have had an in­ad­e­quate re­sponse to TNF in­hibitors are gen­er­al­ly con­sid­ered to be some of the most dif­fi­cult to treat RA pa­tients,” said Christi Shaw, pres­i­dent, Lil­ly Bio-Med­i­cines.

To­day’s de­ci­sion fol­lows an ex­pert pan­el vote which weighed heav­i­ly against the 4 mg dose af­ter agency ex­perts out­lined their con­cerns about the safe­ty pro­file. They al­so gave a thumbs up to the 2 mg dose, which is like­ly to be far less suc­cess­ful and not near­ly as com­mer­cial­ly vi­able as the 4 mg. Some an­a­lysts were al­so shak­ing their heads to­day at the re­stric­tion to pa­tients who were re­sis­tant to TNF in­hibitors.

“The Olu­mi­ant ap­proval was a bit worse than the pan­el’s rec­om­men­da­tion,” Mor­gan Stan­ley an­a­lyst David Risinger said, ac­cord­ing to a re­port from Reuters.

Elim­i­nat­ing the 4 mg dose, notes Leerink’s Ge­of­frey Porges, gives Pfiz­er’s Xel­janz a big edge with 6 years of safe­ty da­ta. He adds:

Ul­ti­mate­ly this la­bel means that Olu­mi­ant is like­ly to be re­strict­ed to sal­vage ther­a­py on­ly, and ex­pect fore­casts for the prod­uct to de­cline even fur­ther (Lil­ly con­sen­sus re­mains >$1bn). This doesn’t mean that Ab­b­Vie’s upadac­i­tinib and Gilead’s fil­go­tinib will au­to­mat­i­cal­ly get this la­belling. In fact, it is like­ly that one or both of them avoids the throm­bo­sis risk and gets mul­ti­ple dos­es ap­proved with su­pe­ri­or ef­fi­ca­cy. We be­lieve that the best of the JAKs is still fil­go­tinib, un­til proven oth­er­wise, but the class as a whole is like­ly to be sad­dled with much of the lan­guage in to­day’s Olu­mi­ant la­bel.

This marks the sec­ond big set­back for In­cyte this year, af­ter its IDO pro­gram foundered and scut­tled a whole line­up of com­bi­na­tion stud­ies with ma­jor in­dus­try play­ers.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.

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

Click on the image to see the full-sized version

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.

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

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 63,100+ biopharma pros reading Endpoints daily — and it's free.