NICE re­jects No­var­tis' mi­graine drug Aimovig, months af­ter de­clin­ing to en­dorse pricey Kym­ri­ah for adult use

No­var­tis $NVS is will­ing to play ball with UK’s cost-ef­fec­tive­ness watch­dog NICE, who re­ject­ed their mi­graine pre­ven­tion drug in a draft guid­ance on Thurs­day, months af­ter de­clin­ing to en­dorse the Swiss drug­mak­er’s cell ther­a­py Kym­ri­ah in adult lym­phoma pa­tients.

The drug, erenum­ab, is sold as Aimovig in the Unit­ed States by No­var­tis and part­ner Am­gen $AMGN. It forms part of a new crop of bi­o­log­ics tar­get­ing the CGRP pro­tein that trans­mits pain sig­nals in­to the brain, and is con­sid­ered in­stru­men­tal in gen­er­at­ing and main­tain­ing headaches as­so­ci­at­ed with mi­graine. Erenum­ab costs around £5,000 (about $6368) per year, ex­clud­ing a con­fi­den­tial dis­count that would have been grant­ed to Eng­land’s na­tion­al health ser­vice (NHS) had NICE rec­om­mend­ed the drug.

In its re­port, NICE ac­knowl­edged that al­though the drug is a clin­i­cal­ly ef­fec­tive treat­ment, the to­tal­i­ty of the da­ta sup­port­ing the med­i­cine did not in­clude all “rel­e­vant” com­par­isons against ex­ist­ing drugs and out­comes, which prompt­ed its re­jec­tion for NHS use.

Mein­dert Boy­sen

“There was not enough ev­i­dence to sug­gest that it (erenum­ab) is more ef­fec­tive than bot­u­linum tox­in type A (Al­ler­gan’s Botox) for peo­ple with chron­ic mi­graine, which NICE al­ready rec­om­mends. And for both the chron­ic and episod­ic mi­graine pop­u­la­tions there was no ev­i­dence to show that erenum­ab is ef­fec­tive in the long-term in peo­ple for whom 3 pre­vi­ous pre­ven­tive treat­ments had failed,” said NICE’s di­rec­tor of the cen­tre for health tech­nol­o­gy eval­u­a­tion Mein­dert Boy­sen in a state­ment.

No­var­tis pledged to work with NICE to ad­dress the agency’s ques­tions, but sug­gest­ed the watch­dog had not cap­tured the broad­er so­ci­etal im­pact of its med­i­cine.

“NICE does not con­sid­er the im­pact of dis­eases on broad­er so­ci­ety when eval­u­at­ing the cost-ef­fec­tive­ness of med­i­cines. We be­lieve this fails to cap­ture the true val­ue of med­i­cines like Aimovig. As mi­graine pre­dom­i­nant­ly af­fects peo­ple of work­ing age, it costs the UK econ­o­my £8.8 bil­lion per year in lost pro­duc­tiv­i­ty alone,” the drug­mak­er said in a state­ment, un­der­scor­ing that the UK al­ready “lags sig­nif­i­cant­ly be­hind” its oth­er Eu­ro­pean coun­ter­parts in en­sur­ing ac­cess to new med­i­cines.

It is es­ti­mat­ed there are 190,000 mi­graine at­tacks ex­pe­ri­enced every day in Eng­land, ac­cord­ing to NICE. The agency con­ced­ed that ex­ist­ing mi­graine treat­ments in­clud­ing be­ta-block­ers, an­ti­de­pres­sants and epilep­sy med­i­cines can have sig­nif­i­cant side-ef­fects and don’t work for some pa­tients, but for those with chron­ic mi­graine for whom at least 3 pre­vi­ous pre­ven­tive oral treat­ments have failed, Botox re­mains an op­tion.

The pro­vi­sion­al de­ci­sion on erenum­ab comes af­ter the agency re­fused to en­dorse No­var­tis’ CAR-T drug Kym­ri­ah in adults, say­ing it was too ex­pen­sive, in Sep­tem­ber, al­though it did rec­om­mend the treat­ment’s use in pe­di­atric pa­tients in a pre­vi­ous rul­ing.

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.