Now a two-time los­er, As­traZeneca’s hopes for selume­tinib dwin­dle af­ter an­oth­er PhI­II flop

As­traZeneca’s one-time block­buster hope­ful selume­tinib is now a two-time los­er in late-stage de­vel­op­ment. The phar­ma gi­ant was forced to con­cede Tues­day morn­ing that the drug flopped in KRAS-pos­i­tive non-small cell lung can­cer. The drug whiffed on pro­gres­sion-free sur­vival and failed to score on over­all sur­vival as well.

As­traZeneca had to walk away from the first Phase III for selume­tinib last year af­ter the drug — in-li­censed from Ar­ray — failed for an eye can­cer called uveal melanoma.

The back-to-back fail­ures leave shrink­ing hope that the drug can ever live up to the block­buster fu­ture that CEO Pas­cal So­ri­ot had fore­cast for it sev­er­al years ago. The drug was a sig­nif­i­cant piece of As­traZeneca’s promise to build rev­enues to $45 bil­lion by 2023. Now it’s an­oth­er ex­am­ple of the hit-and-miss for­tunes of the phar­ma gi­ant since So­ri­ot took the helm.

As­traZeneca’s plans for the drug have dwin­dled down to thy­roid can­cer, where it won’t be giv­en good odds of suc­cess. As­traZeneca is known for stay­ing rigid­ly fo­cused on adding im­por­tant drugs to its port­fo­lio, a strat­e­gy that has led to the dis­count sales of trou­bled drugs like bro­dalum­ab and lesin­u­rad.

Shares of As­traZeneca slipped a lit­tle Tues­day morn­ing, while shares of Ar­ray $AR­RY cratered, drop­ping 18% in pre-mar­ket trad­ing.

As selume­tinib and oth­er drugs fad­ed, As­traZeneca’s suc­cess with Tagris­so loomed large as an ex­am­ple of what the can­cer drug side of the com­pa­ny could ac­com­plish. Those hopes ex­tend to the PD-L1 drug dur­val­um­ab, now in a big Phase III pro­gram as Bris­tol-My­ers, Mer­ck and Roche all divvy up the mar­ket with ap­proved drugs. But As­traZeneca has had oth­er set­backs on the can­cer front as well. Last spring, just weeks af­ter As­traZeneca ($AZN) re­port­ed a suc­cess for a com­bi­na­tion study of dur­val­um­ab and treme­li­mum­ab, the phar­ma gi­ant was forced to con­cede that the CT­LA-4 drug treme­li­mum­ab flunked a so­lo chal­lenge for mesothe­lioma.

Sean Bo­hen, As­traZeneca CMO

As­traZeneca CMO Sean Bo­hen was left to read the last rites over the lung can­cer study. And he didn’t sound hope­ful that this drug had much of a fu­ture in a pre­pared state­ment:

A ran­dom­ized Phase II tri­al showed promis­ing ac­tiv­i­ty of selume­tinib in com­bi­na­tion with do­c­etax­el in pa­tients with KRASmu­ta­tion-pos­i­tive lung can­cer. It is dis­ap­point­ing for pa­tients that these re­sults have not been con­firmed in Phase III. We ex­pect to present da­ta at a forth­com­ing med­ical meet­ing. We re­main com­mit­ted to fur­ther de­vel­op­ing treat­ments in the lung can­cer set­ting, such as our im­munother­a­py com­bi­na­tions and tar­get­ed EGFR treat­ments.

 

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

In an investor call later in the day, execs noted that they are not planning another study and stood by their intention, publicized in October to much surprise, to submit regulatory filings based on what they have.

“We don’t file willy nilly,” said Al Sandrock, head of R&D. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”

Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting.

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No­var­tis CEO Vas Narasimhan's R&D up­date spot­lights next wave of drug stars as well as late-stage fa­vorites

As one of the biggest spenders in biopharma R&D, Novartis execs love to tout the scope of its late-stage pipeline, spotlighting the winners most likely to create blockbuster revenue streams in the near future.

Building on the 5 drug approvals the pharma giant expects to end the year with, Novartis CEO Vas Narasimhan — who’s done a slate of acquisitions topped by the recent $9.7 billion MedCo buyout — tapped the top emerging drugs as:

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Jeff Jonas, Sage

UP­DAT­ED: Sage's star ex­per­i­men­tal de­pres­sion drug fails the cru­cial MOUN­TAIN study — shares crash

Sage Therapeutics’ crucial MOUNTAIN study for Sage-217 has failed, setting the stage for a quick and ugly investor backlash.

Widely viewed by analysts as the critical clinical study $SAGE needed to win on major depression, researchers say the drug failed to beat out a placebo at day 15, falling well short of the mark for statistical significance on the primary endpoint. And investors reacted with alacrity, fleeing the stock and gutting the price with a 60% instantaneous drop — erasing about $4.6 billion in market cap in an instant.

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Jasper Ther­a­peu­tics launch­es out of Stan­ford with new ap­proach to stem cell treat­ment

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take.  Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

→ Gastrointestinal disease-focused Phathom Pharmaceuticals has shaken up its leadership team. The company has tapped former Celgene exec Terrie Curran as CEO, succeeding David Socks, who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of Otezla for $13.4 billion to Amgen — and has held a previous stint at Merck. In addition to Curran, the company also welcomed former Omeros CMO Eckhard Leifke as CMO, ex-Celgene exec Joseph Hand as chief administrative officer, and former general counsel for Cyclerion Therapeutics Larry Miller as general counsel. They also replaced Chris Slavinsky on the board with Takeda exec Asit Parikh.

UCB buffs up in block­buster pso­ri­a­sis race as bimek­izum­ab beats Hu­mi­ra in head-to-head

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender Stelara in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug.

Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020.