Eli Lil­ly touts some mixed PhI­II re­sults for clus­ter headaches as Am­gen, No­var­tis prep a mar­ket-bust­ing move in mi­graine

With Am­gen and No­var­tis ea­ger­ly await­ing their PDU­FA date for the lead­ing CGRP mi­graine drug Aimovig lat­er this week, Eli Lil­ly is step­ping up with some mixed Phase III re­sults for its own con­tender in the field.

Christi Shaw

In a hit and a miss, Lil­ly re­searchers say that gal­canezum­ab scored on the pri­ma­ry end­point in a Phase III study of pa­tients suf­fer­ing from episod­ic, week­ly clus­ter headaches. Placed up against a place­bo, their drug achieved a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in clus­ter at­tacks — though the p val­ue of 0.036 was a long way from a stand­out grade. 

Lil­ly al­so not­ed that an­oth­er Phase III for chron­ic clus­ter headaches failed — though you can be sure the phar­ma gi­ant was far more ea­ger to high­light the pos­i­tive re­sults in its re­lease. And now Lil­ly ex­ecs are set­ting up talks with reg­u­la­tors about the way for­ward to the mar­ket.

Lil­ly has al­ready post­ed its pos­i­tive late-stage da­ta for this drug in suc­cess­ful­ly re­duc­ing mi­graines. CGRP drugs are wide­ly viewed as the up­com­ing stan­dard of care for this cat­e­go­ry of dis­ease, and Am­gen and No­var­tis aim to push hard to cap­i­tal­ize on their fron­trun­ner sta­tus — pro­vid­ed the FDA comes through as ex­pect­ed with an ap­proval with­in a cou­ple of days.

An­a­lysts have of­fered a $1.2 bil­lion peak sales es­ti­mate for Aimovig — mak­ing it a top-12 drug for this year — which il­lus­trates just how im­por­tant a ground­break­ing po­si­tion can be in drug de­vel­op­ment.

Lil­ly is in a fa­mil­iar po­si­tion fur­ther back in the field, as it awaits an FDA de­ci­sion some­time in the third quar­ter. But they should be next in line be­hind the Am­gen/No­var­tis team. Te­va’s ri­val fre­manezum­ab had been in line for a June de­ci­sion, then ear­li­er this month con­ced­ed that man­u­fac­tur­ing prob­lems would tem­porar­i­ly de­rail its pro­gram and push any ap­proval and mar­ket­ing launch fur­ther back in the year. And in March lit­tle Alder, which al­so has a con­tender in the mix, oust­ed its CEO and be­gan to re­struc­ture af­ter falling be­hind the lead­ers.

Eli Lil­ly has been scram­bling to beef up its on­col­o­gy pipeline with bolt-on deals this year. The phar­ma gi­ant has gained a num­ber of new ap­provals in re­cent years, but was se­ri­ous­ly de­layed on baric­i­tinib last year, be­fore the FDA abrupt­ly de­cid­ed to al­low their mar­ket­ing pitch to move through a re­view with­out a re­quired safe­ty tri­al.

“Clus­ter headache can be dif­fi­cult to eval­u­ate in clin­i­cal stud­ies, which has con­tributed to few avail­able treat­ment op­tions for clus­ter headache, of­ten con­sid­ered the most se­vere pain one can ex­pe­ri­ence,” said Christi Shaw, pres­i­dent of Lil­ly Bio-Med­i­cines. “The pos­i­tive re­sults in episod­ic clus­ter headache are tru­ly a land­mark mo­ment—both for peo­ple liv­ing with clus­ter headache and for our re­searchers at Lil­ly, many of whom have spent more than two decades re­search­ing and de­vel­op­ing in­no­v­a­tive, non-opi­oid treat­ment op­tions for dis­eases like mi­graine and clus­ter headache.”

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Nadim Ahmed (Bristol Myers Squibb)

Bris­tol My­er­s' top hema­tol­ogy ex­ec is on his way out — right on the heels of a $6B CVR im­plo­sion

Fourteen days after the $6.3 billion CVR tied to the approval of liso-cel went up in smoke, one of the top execs in charge of the work at Bristol Myers Squibb is preparing to step out of his job.

Mizuho analyst Salim Syed, who’s been following every twist and turn in the CVR saga, told investors on Thursday morning that Nadim Ahmed is on his way out. Syed’s note:

Recall, Ahmed is EVP and President of Hematology at BMY (i.e. JCAR017 and bb2121 are both hematological drugs). He’s still listed on the BMY management page. This is true — he’s still technically there. However, I have confirmed w/ BMY that his last day is tomorrow, Friday 1/15. To my best knowledge, Ahmed does not have another job lined up post his departure tomorrow.

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With KRAS break­through on the hori­zon, Am­gen's David Reese re­flects on so­tora­si­b's loom­ing re­view date and murky fu­ture

After decades of failures laid waste to R&D outfits looking to solve the KRAS G12C puzzle, Amgen is as close as anyone ever has been to an approval with sotorasib. For Amgen R&D head David Reese, the drug’s looming review date is a point of reflection for his own career and a big milestone for Amgen’s blooming — if controversial — next-gen oncology pipeline.

Amgen filed its FDA application for sotorasib in December to treat metastatic non-small cell lung cancer with the KRAS mutation — once thought to be “undruggable” — months after the agency offered its breakthrough designation based on pivotal Phase I data showing previously unheard of response rates.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.