Am­gen, No­var­tis cel­e­brate promis­ing mi­graine da­ta, but Te­va and Alder are prepar­ing to crash the par­ty

Am­gen $AMGN post­ed some im­pres­sive re­sults for its Phase II study of a close­ly-watched mi­graine drug, but the big biotech may still be forced to ac­cept a shrink­ing share of what is shap­ing up as a high­ly com­pet­i­tive mar­ket as ri­vals crowd the same sec­tor.

Ge­of­frey Porges, Leerink

The key da­ta on erenum­ab: 40 per­cent and 41 per­cent of the pa­tients in the two dose arms (70 mg and 140 mg dos­es) ex­pe­ri­enced a re­duc­tion of 50% or more in the num­ber of mi­graine days record­ed at week 12, com­pared to about one in 4 (24%) of those tak­ing a place­bo.

In ad­di­tion, Am­gen’s in­ves­ti­ga­tors say the safe­ty pro­file for their drug looked quite sim­i­lar to a place­bo.

If those num­bers hold up in the soon-to-be-com­plet­ed Phase III, Am­gen and its part­ners at No­var­tis $NVS — which holds ex-US rights — should be look­ing at an ap­proval.

This drug tar­gets the cal­ci­tonin-gene-re­lat­ed-pep­tide (CGRP) re­cep­tor. And there­in lies the rub for Am­gen and No­var­tis. The gi­ants have a drug that does some­thing sim­i­lar to what a pair of ri­vals from Alder $AL­DR and Te­va $TE­VA does. And they may well have to wind up split­ting the mar­ket among drugs that look re­mark­ably sim­i­lar.

Leerink’s Ge­of­frey Porges took a look at the da­ta and fig­ures that Am­gen can still flirt with block­buster suc­cess with what it has, even though the drugs from Alder and Te­va bind di­rect­ly to the lig­and while Am­gen/No­var­tis’ drug tar­gets the re­cep­tor. But he’s cut­ting his peak rev­enue fore­cast.

Am­gen, notes Porges:

(F)ailed to dif­fer­en­ti­ate erenum­ab from com­pet­ing pro­grams from Alder (AL­DR, [OP]) and Te­va (TE­VA, [OP]) – al­though the re­sults con­tin­ue to val­i­date the class of CGRP tar­gets for the treat­ment of mi­graines. Cur­rent­ly we an­tic­i­pate first rev­enues for erenum­ab in 2018 to­tal­ing $85mm, in­creas­ing to $991mm by 2023, re­flect­ing a prob­a­bil­i­ty of suc­cess weight­ed ad­just­ment of 65%, and an ini­tial mar­ket share of 50% de­clin­ing to 23% as com­pet­ing prod­ucts en­ter the mar­ket. Our fore­cast is be­low re­cent con­sen­sus, which pre­dicts 2018 rev­enues of $161mm ex­pand­ing to $1.3bn in 2023. We are main­tain­ing our fore­cast while await­ing greater dis­clo­sures from Am­gen, in­clud­ing da­ta from the more clin­i­cal­ly mean­ing­ful end­points of 75% and 100% re­duc­tion in mi­graine days and the phase 3 erenum­ab tri­al re­sults for both episod­ic and chron­ic mi­graine.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.