Am­gen pulls ahead in sprint to­wards CGRP ap­proval with promis­ing PhI­II mi­graine da­ta

The fron­trun­ner in the race to com­mer­cial­ize CGRP mi­graine med­ica­tions just picked up some added mo­men­tum. Am­gen $AMGN has pub­lished promis­ing Phase III da­ta that might lend to its ap­proval, keep­ing the com­pa­ny — and its part­ner No­var­tis — ahead of its many com­peti­tors in the crowd­ed space.

The drug, re­cent­ly coined Aimovig (erenum­ab), was stud­ied in 955 pa­tients over six months. The com­pa­ny says 50% of those pa­tients re­port­ed the high dose (140 mg) of Aimovig cut their mi­graine days by 50% or greater (com­pared to 26.6% with the place­bo). The drug met its pri­ma­ry and sec­ondary end­points. The da­ta were pub­lished in the New Eng­land Jour­nal of Med­i­cine.

This lat­est study, which the com­pa­ny calls STRIVE, is the lat­est in a string of tri­als test­ing the drug, in­clud­ing four Phase II and Phase III clin­i­cal stud­ies in­volv­ing more than 2,600 pa­tient.

Te­va, mean­while, came up with some im­pres­sive Phase III da­ta de­tails of its own for the ri­val fre­manezum­ab, with 41% of pa­tients on their CGRP drug see­ing their mi­graine days cut in half, com­pared to 18% on the place­bo. The dou­ble blast of da­ta un­der­scores the late-stage race to reg­u­la­tors as some big and small play­ers an­gle for a slice of the new mar­ket.

The FDA has al­ready ac­cept­ed Am­gen’s ap­pli­ca­tion for Aimovig — hand­ing the com­pa­ny a PDU­FA date of May 17 — giv­ing the com­pa­ny a lead on the com­pe­ti­tion. If ap­proved, Am­gen and its part­ner No­var­tis will co-com­mer­cial­ize the drug in the US, af­ter No­var­tis re­cent­ly bought in­to key US mar­ket­ing rights. Am­gen has ex­clu­sive rights in Japan, and No­var­tis has ex­clu­sive rights to com­mer­cial­ize the drug in the rest of the world.

The field is grow­ing hot, with a line­up of de­vel­op­ers po­si­tion­ing their own late-stage prod­ucts for the last leg of the race.

Ear­li­er this year, Eli Lil­ly $LLY cel­e­brat­ed its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. Then Te­va pub­lished pos­i­tive Phase III da­ta show­ing a 2.5-day re­duc­tion in mi­graines with its fre­manezum­ab. Lit­tle Alder $AL­DR is al­so plan­ning to join the com­mer­cial fight with their drug. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front.

Oh yes, then there’s Bio­haven $BHVN, which re­cent­ly in-li­censed a sim­i­lar drug from Bris­tol-My­ers Squibb and scored a very suc­cess­ful IPO ear­li­er this year.

The da­ta so far in­di­cate sev­er­al of these new drugs will look alike, and that means pay­ers will like­ly play them off against each oth­er.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,600+ biopharma pros reading Endpoints daily — and it's free.

Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,600+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,600+ biopharma pros reading Endpoints daily — and it's free.

Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.