Al­ler­gan set to make head­way in crowd­ed CGRP mi­graine mar­ket, as the bat­tle for for­mu­la­ry cov­er­age be­gins

Mil­lions of mi­graine suf­fer­ers could soon get their hands on an oral CGRP drug de­signed to be used as-need­ed, as Al­ler­gan $AGN on Wednes­day said it was on track to file for FDA ap­proval for ubro­gepant in the first quar­ter of next year. The mul­ti-bil­lion dol­lar mi­graine mar­ket is al­ready re­plete with in­jectable med­ica­tions from Te­va $TE­VA, Eli Lil­ly $LLY, and one from Am­gen $AMGN and No­var­tis $NVS, which are all de­signed to be used as pre­ven­ta­tive treat­ments and are cu­ri­ous­ly priced iden­ti­cal­ly.

Last month, Lil­ly se­cured FDA ap­proval for its in­jec­tion Em­gal­i­ty, af­ter the agency grant­ed sim­i­lar ap­provals to Aimovig from Am­gen Inc and No­var­tis, and Te­va’s Ajovy. All three drugs large­ly work in a sim­i­lar man­ner and have demon­strat­ed a sig­nif­i­cant re­duc­tion in mi­graine fre­quen­cy in about half of pa­tients when test­ed in clin­i­cal stud­ies. In­ter­est­ing­ly, each drug­mak­er has al­so priced their of­fer­ings at a list price of $6,900 a year, or $575 per month.

But ear­li­er on Wednes­day, Reuters re­port­ed that the hefty US phar­ma­cy ben­e­fit man­ag­er Ex­press Scripts $ES­RX had de­cid­ed to cov­er new mi­graine drugs from Lil­ly and Am­gen as part of its for­mu­la­ry and ex­clude Te­va, fol­low­ing ne­go­ti­a­tions with all three man­u­fac­tur­ers.

“This puts more pres­sure on Te­va to score for­mu­la­ry wins in the oth­er larg­er plans, which at this point may still be up for grabs. We es­ti­mate peak share of 20% for Ajovy but ac­knowl­edge it will be im­per­a­tive for it to get 1-2 ma­jor wins to get there,” Leerink an­a­lysts wrote in a note.

Te­va shares are down 5%.

A spokesper­son from Al­ler­gan told End­points News that it was pre­ma­ture to com­ment on ubro­gepant’s pric­ing and pay­er dis­cus­sions as the com­pa­ny has not yet filed its mar­ket­ing ap­pli­ca­tion, and that it could not com­ment on its plans for an EMA fil­ing at this time.

Ac­cord­ing to the Mi­graine Re­search Foun­da­tion, mi­graine is the third most preva­lent ill­ness in the world, af­fect­ing about 39 mil­lion in the Unit­ed States and some 1 bil­lion world­wide. The mar­ket for mi­graine drugs is ex­pect­ed to hit $8.7 bil­lion by 2026, ac­cord­ing to Glob­al­da­ta.  Be­fore the slate of ap­provals this year, pa­tients were large­ly treat­ed with a host of drugs in­clud­ing an­ti-de­pres­sants, hy­per­ten­sion med­i­cines and a class of drugs called trip­tans. This new class of bi­o­log­ics, known as CGRP (cal­ci­tonin gene-re­lat­ed pep­tide) in­hibitors, tar­get the CGRP pro­tein that trans­mits pain sig­nals in­to the brain, and is be­lieved to be in­stru­men­tal in gen­er­at­ing and main­tain­ing headaches as­so­ci­at­ed with mi­graine.

For those pa­tients who still ex­pe­ri­ence mi­graine at­tacks while on pre­ven­ta­tive an­ti-CGRP ther­a­py, acute, as-need­ed treat­ments will still be re­quired, which is where Al­ler­gen’s ubro­gepant, which the com­pa­ny ac­quired from Mer­ck $MRK in 2015, could come handy.

If ap­proved, ubro­gepant could po­ten­tial­ly be used in com­bi­na­tion with its an­ti-CGRP in­jectable ri­vals and/or Al­ler­gan’s own ver­sa­tile Botox in­jec­tion, which has been ap­proved for mi­graine pre­ven­tion since 2010.

Al­ler­gan has al­ready re­port­ed pos­i­tive Phase III da­ta on ubro­gepant from two stud­ies ear­li­er this year, and on Wednes­day said that two oth­er stud­ies fur­ther eval­u­at­ing the drug’s safe­ty and tol­er­a­bil­i­ty, in­clud­ing one which eval­u­at­ed the po­ten­tial of he­pat­ic tox­i­c­i­ty in healthy pa­tients, meant that it was on track to file in Q1, 2019. Mi­graine drug de­vel­op­er, Bio­haven $BHVN, how­ev­er is do­ing their safe­ty study in mi­graine pa­tients, as Ever­core’s Umer Raf­fat points out.

Both Bio­haven and Alder $AL­DR are poised to sub­mit their mi­graine drugs for mar­ket­ing ap­proval next year.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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