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.”

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.