Roche/Ex­elix­is' Cotel­lic fiz­zles in piv­otal melanoma study

To lit­tle sur­prise, Ex­elix­is’ Cotel­lic — known chem­i­cal­ly as co­bime­tinib — in com­bi­na­tion with Roche’s Tecen­triq, has failed a late-stage study as a front­line treat­ment for pa­tients with a form of ad­vanced melanoma.

The Alame­da, Cal­i­for­nia-based com­pa­ny’s $EX­EL ki­nase in­hibitor — out-li­censed to Roche — was ap­proved in 2015 in com­bi­na­tion with the Swiss drug­mak­er’s Zelb­o­raf (ve­mu­rafenib) for pa­tients with BRAF V600E or V600K mu­ta­tion-pos­i­tive un­re­sectable or metasta­t­ic melanoma. Cotel­lic gen­er­at­ed rough­ly $61 mil­lion in glob­al sales last year.

Re­sults of the IM­spire170 study were dis­closed in a fil­ing on Thurs­day. Ex­elix­is said that Genen­tech (Roche), which spon­sored the study, had found that co­bime­tinib + Tecen­triq (ate­zolizum­ab) did not re­duce the risk of dis­ease pro­gres­sion or death com­pared to stan­dard-of-care Keytru­da, Mer­ck’s flag­ship PD-1 im­munother­a­py, in treat­ment-naïve pa­tients with BRAF V600 wild-type ad­vanced melanoma.

Last year, in the Phase III IM­blaze370 study, co­bime­tinib + Roche’s PD-L1 Tecen­triq failed to sig­nif­i­cant­ly help pa­tients with col­orec­tal can­cer live longer.

The like­li­hood of co­bime­tinib en­hanc­ing the im­pact of check­point in­hibitor ther­a­py in this melanoma tu­mor type (and oth­ers) was great­ly di­min­ished fol­low­ing last year’s dis­clo­sure of IM­blaze370 da­ta, Stifel’s Stephen Wil­ley wrote in a note. “We don’t view this news as the­sis-chang­ing (i.e. co­bime­tinib is not part of our, or any­one’s, near- or longer-term EX­EL the­sis) and con­tin­ue to view the dis­place­ment of 1L im­munother­a­py in this set­ting as un­like­ly.”

BMO Cap­i­tal Mar­ket’s George Farmer said the da­ta were in­con­se­quen­tial to his over­all Ex­elix­is in­vest­ment the­sis. “Phase 3 suc­cess (in the IM­spire170 study) would on­ly pro­vide up­side to ex­ist­ing co­bi sales, which was not fac­tored in­to our mod­el.”

An­oth­er co­bime­tinib late-stage tri­al, called IM­spire150 TRIL­O­GY, is ex­pect­ed to read out be­fore the end of this year. The study is eval­u­at­ing a triplet com­bi­na­tion of ve­mu­rafenib/co­bime­tinib/ate­zolizum­ab ver­sus the dou­blet com­bi­na­tion of ve­mu­rafenib/co­bime­tinib in pa­tients with first­line BRAF mu­tant ad­vanced melanoma. “(T)his triplet vs. dou­blet tri­al as more of a ‘check the box’ vs. an ‘ex­pand the mar­ket’ ex­er­cise and, like IM­spire170, don’t view IM­spire150 topline re­sults as a key cat­a­lyst for the stock,” Wil­ley wrote.

“We al­so be­lieve the on­go­ing eval­u­a­tion of oth­er triple-ther­a­py com­bi­na­tions (BRAF/MEK/PD-1) in 1L BRAF-mu­tant melanoma by oth­er, more-en­trenched com­peti­tors would like­ly keep any en­thu­si­asm re­lat­ed to a po­ten­tial TRIL­O­GY win ap­pro­pri­ate­ly mut­ed.”

Ex­elix­is’ for­tunes large­ly rest on the po­ten­tial of its TKI Cabome­tyx (cabozan­ti­nib) in the treat­ment of re­nal cell and he­pa­to­cel­lu­lar car­ci­no­ma. Top-line re­sults from the Check­mate-9ER tri­al, eval­u­at­ing cabozan­ti­nib plus Bris­tol-My­er’s $BMY PD-1 Op­di­vo, ver­sus Pfiz­er’s $PFE suni­tinib, are ex­pect­ed in the first half of 2020.

But com­pe­ti­tion is fierce. Mer­ck’s $MRK Keytru­da has been ap­proved in com­bi­na­tion with Pfiz­er’s TKI In­ly­ta for RCC pa­tients, as has Ger­man Mer­ck’s check­point in­hibitor, Baven­cio, (in com­bi­na­tion with In­ly­ta) for the pa­tient pop­u­la­tion.

So­cial im­age: Shut­ter­stock

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
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:

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