With a full slate of in­jectable CGRP mi­graine drugs po­si­tion­ing them­selves at the fin­ish line for FDA ap­provals for chron­ic cas­es, Al­ler­gan $AGN to­day took an­oth­er big step for­ward with its pill for acute cas­es. The com­pa­ny hailed a Phase III win for its first late-stage test of ubro­gepant, one of the mi­graine drugs it ac­quired from Mer­ck a lit­tle more than two years ago.

Re­searchers say the drug hit both of the co-pri­ma­ry end­points for acute mi­graine, with a sta­tis­ti­cal­ly sig­nif­i­cant beat for a place­bo arm in be­ing pain free and free of most symp­toms of mi­graine two hours af­ter ini­tial treat­ment.

David Nichol­son, Al­ler­gan

Al­ler­gan plans to pub­lish more of the da­ta lat­er in the year, with the sec­ond Phase III read­out com­ing in the first half of 2018. Al­ler­gan ex­ecs in turn ex­pect that will set up an NDA for next year.

Mean­while, Am­gen and No­var­tis are in the lead on the in­jectable side of the CGRP race, with the FDA re­view­ing their drug, Aimovig. The drug will like­ly be chal­lenged by a group of com­peti­tors rang­ing from Eli Lil­ly $LLY to Te­va $TE­VA and Alder $AL­DR that have all demon­strat­ed broad­ly sig­nif­i­cant da­ta in cut­ting the num­ber of mi­graine days ex­pe­ri­enced by a chron­ic suf­fer­er.

Com­mit­ted to in­no­va­tion in #mi­graine treat­ments. @Al­ler­gan An­nounces Pos­i­tive Top Line Phase 3 Re­sults for Ubro­gepant – an Oral CGRP Re­cep­tor An­tag­o­nist for the Acute Treat­ment of Mi­graine https://t.co/ytP2W1CpW5

— Brent Saun­ders (@brentl­saun­ders) Feb­ru­ary 6, 2018

“We are pleased with the fa­vor­able re­sults of our ACHIEVE I study, which sup­port the ef­fi­ca­cy, safe­ty, and tol­er­a­bil­i­ty pro­file of ubro­gepant. We are con­fi­dent that ubro­gepant, an oral cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) re­cep­tor an­tag­o­nist will be an op­tion for the treat­ment of mi­graines in adults,” said David Nichol­son, Al­ler­gan’s head of R&D. “Al­ler­gan re­mains com­mit­ted to iden­ti­fy­ing, de­vel­op­ing and bring­ing to mar­ket ther­a­pies that ad­dress un­met need for pa­tients suf­fer­ing from this de­bil­i­tat­ing dis­ease.”

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).

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.