As Bio­haven Phar­ma comes off a roller­coast­er pipeline year, its CEO will take on more re­spon­si­bil­i­ty in a full C-suite makeover.
Vlad Coric was unan­i­mous­ly elect­ed to the role of chair­man of the board of di­rec­tors, af­ter De­clan Doogan’s re­tire­ment. Matthew Buten will take over the role of CFO af­ter James En­gel­hart’s re­tire­ment, and di­rec­tor Michael Hef­fer­nan has been ap­point­ed lead in­de­pen­dent di­rec­tor. All of the ap­point­ments are ef­fec­tive im­me­di­ate­ly, a com­pa­ny press re­lease said.
“The re­tire­ments de­scribed in this an­nounce­ment were not re­lat­ed to any dis­agree­ment with the com­pa­ny on any mat­ter re­lat­ing to the com­pa­ny’s op­er­a­tions, poli­cies or prac­tices,” per the re­lease.
The news comes on the same day that Bio­haven an­nounced that it will sub­mit a new drug ap­pli­ca­tion for in­tranasal za­veg­epant, a pain re­lief drug to treat mi­graines. That an­nounce­ment fol­lows the pos­i­tive re­sults from the sec­ond Phase III clin­i­cal tri­al, re­liev­ing par­tic­i­pants of the most both­er­some pain at the two-hour mark.
Pa­tients saw re­lief re­turn them to nor­mal func­tion as soon as 30 min­utes af­ter tak­ing za­veg­epant, Bio­haven not­ed at the time, and the pain-sus­pen­sion fac­tors last­ed be­tween two and 24 hours. If ap­proved, za­veg­epant will be the first in­tranasal cal­ci­tonin gene-re­lat­ed pep­tide avail­able to treat mi­graines in adults.
“The tri­al re­sults clear­ly show that the per­for­mance of this for­mu­la­tion ex­ceed­ed ex­pec­ta­tions by demon­strat­ing su­pe­ri­or­i­ty over place­bo on pain re­lief at 15 min­utes and re­turn to nor­mal func­tion by 30 min­utes,” Coric said in a state­ment. “The im­pres­sive ef­fi­ca­cy, safe­ty and tol­er­a­bil­i­ty pro­file shown in this tri­al high­lights the po­ten­tial of za­veg­epant to ush­er in a new era of non-oral CGRP tar­get­ing mi­graine ther­a­pies.”
Za­veg­epant beat place­bo in the end­point of pain free­dom 24% to 15%, and free­dom from the most both­er­some sys­tem by 40% vs 31%. Ab­nor­mal taste was the most com­mon side ef­fect, with 21% of tri­al par­tic­i­pants ex­pe­ri­enc­ing this, com­pared with 5% of those who were giv­en the place­bo.
Bio­haven is look­ing to re­bound af­ter turn­ing out a dud in its at­tempt to tar­get mul­ti­ple sys­tem at­ro­phy (MSA), a rare and fa­tal neu­rode­gen­er­a­tive dis­or­der. Its drug, verdiper­stat, failed to out­per­form the place­bo and whiffed on the pri­ma­ry ef­fi­ca­cy end­point, mark­ing the lat­est step in a tough year for the com­pa­ny af­ter it watched its Alzheimer’s study for glu­ta­mate mod­u­la­tor tro­r­ilu­zole crum­ble.
Last Jan­u­ary, it rolled out da­ta for tro­r­ilu­zole, a drug be­ing de­vel­oped for neu­rode­gen­er­a­tive dis­or­ders, that showed the can­di­date did not “sta­tis­ti­cal­ly dif­fer­en­ti­ate” it­self from a place­bo on the Alzheimer’s Dis­ease As­sess­ment Scale-Cog­ni­tive Sub­scale 11 (ADAS-cog) and the Clin­i­cal De­men­tia Rat­ing Scale Sum of Box­es (CDR-SB).
Even if Bio­haven gets za­veg­epant across the fin­ish line, it will face some com­pe­ti­tion. In May, Ab­b­Vie’s CGRP drug Ubrelvy got the go-ahead for acute treat­ment of mi­graine ahead of Bio­haven. Then in Sep­tem­ber, Ab­b­Vie’s oth­er oral CGRP re­cep­tor an­tag­o­nist Qulip­ta gained ap­proval.
As for Buten, he brings 20 years of ex­pe­ri­ence in health­care in­vest­ing to the team. He was pre­vi­ous­ly a port­fo­lio man­ag­er at Cat­a­pult/Mil­len­ni­um Part­ners and co-found­ed Sap­phire Cap­i­tal and Ar­gus Part­ners be­fore that.
Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.
Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.
Unlock this story instantly and join 125,100+ biopharma pros reading Endpoints daily — and it’s free.
Like hundreds of other virologists and epidemiologists, Benjamin tenOever’s Thanksgiving weekend was interrupted with emails about an emergency Omicron meeting.
But when he logged onto a WHO conference call 9 a.m. Monday morning, officials had a surprisingly upbeat spin on the little-understood variant that had already prompted leaders around the world, fearful the strain could evade vaccines, to close their borders to broad swaths of Southern Africa.
Unlock this story instantly and join 125,100+ biopharma pros reading Endpoints daily — and it’s free.
KEY POINTS
Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.
Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.
Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio.
The first substantial evidence for how mRNA vaccines will hold up against the new Omicron variant was released Tuesday night from scientists in South Africa.
The study, conducted by mixing sera from vaccinated individuals with live Omicron virus, showed that the variant could largely — but not entirely — dodge antibodies elicited by the Pfizer-BioNTech vaccine.
The result suggests that the vaccines will be less effective at preventing infection by Omicron. But because many antibodies do still bind to the virus, experts say, boosters should help stem the decline. And efficacy will likely hold up against the most important metric for vaccines: preventing severe disease.
Since leaving the FDA’s top post last January, Steve Hahn has been busy, jumping between multiple industry positions thanks to Flagship Pioneering, and most recently taking the helm at a startup focused on the detection of early cancer with a simple blood test.
Hahn’s new company, known as Harbinger Health, will receive $50 million from Flagship to use a proprietary platform combining AI and machine learning to potentially create an entirely new paradigm for cancer diagnosis, enabling early therapeutic interventions or prevention. Hahn’s prior work as chief medical executive of the University of Texas MD Anderson Cancer Center will likely inform his new role, where he’s serving as a Flagship CEO-partner as well as CEO of Harbinger.
Unlock this story instantly and join 125,100+ biopharma pros reading Endpoints daily — and it’s free.
The team at OncoMyx is trying to leverage one therapeutic to treat several forms of cancer, using the Myxoma virus. Wednesday, it announced the closing of a $50 million Series B financing to take it a step closer to that goal.
The round was co-led by Lumira Ventures and B Capital Group with participation from LYZZ Capital and its Series A investors Boehringer Ingelheim Venture Fund, Delos Capital, Xeraya Capital, Korea Investment Partners, City Hill Ventures, and Madison Partners. Beni Rovinski, the managing director at Lumira Ventures, and Widya Mulyasasmita, the senior principal of healthcare at B Capital Group, will join the companies board of directors.
When prominent biotech founder David Sabatini was ousted by the Whitehead Institute and the Howard Hughes Medical Institute this summer over sexual harassment allegations, he fought back with a lawsuit claiming he was falsely accused.
On Monday, a main defendant in that case — one of Sabatini’s accusers — filed a counterclaim maintaining that Sabatini condoned a “toxic and sexually charged lab environment,” and that he coerced her into a non-consenual sexual relationship.
The Federal Trade Commission and seven states on Tuesday announced a new order under which the states will recoup $40 million from pharma badboy Martin Shkreli, who’s currently in prison for securities fraud, and who spiked the price of an old, cheap toxoplasmosis drug Daraprim by 4,000% overnight.
The order follows a January 2020 complaint against Shkreli, his associate Kevin Mulleady, who’s banned from working in for pharma for 7 years, their company Vyera Pharmaceuticals and its parent company Phoenixus AG. The complaint alleged that Shkreli and Mulleady not only hiked the price of Daraprim but used restrictive distribution and supply agreements, as well as data secrecy, to illegally block cheaper generic versions of the drug.
Nomic is trying to develop the world’s highest throughput proteomic platform. It will now do so with another $17 million in tow.
The Montreal-based company announced the closing of its Series A financing round Wednesday that was led by Lux Capital, SR One  and Casdin Capital. The funds will be used to help build the nELISA, a scalable form of ELISA — the decades-old technique for detecting proteins in a sample — that uses advances in DNA nanotechnology, an imaging technique called spectral multiplexing, and automation to bring a scalable and generalizable approach to multiplexed protein quantification.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas<!–
2029 Becker Drive,
(785) 813-1733 –>
© Endpoints Company 2021
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.
ENDPOINTS NEWSby John Carroll & team — all the news at 11:30am ET
EARLY EDITIONby Arsalan Arif — news and links at 7:15am ET
ENDPOINTS MANUFACTURINGWeekly biopharma manufacturing report, Thursdays at 2pm ET
ENDPOINTS WEEKLYRecaps the most important developments on Saturday 6am ET
ENDPOINTS FDA+Regulatory news and analysis for drug developers, Wednesday 2pm ET
ENDPOINTS MARKETING RXCovers advertising and the multibillion-dollar drug commercialization world, Tuesday 2pm ET
Join over 125,100 biopharma colleagues who rely on Endpoints News every business day for the latest developments in drug discovery, development, and commercialization.
ENDPOINTS NEWSdaily at 12 PM ET sample issue
EARLY EDITIONdaily at 7:15 AM ET sample issue
ENDPOINTS WEEKLYSaturday at 6 AM ET
ENDPOINTS MANUFACTURING Thursday at 2 PM ET sample issue
ENDPOINTS FDA+ Wednesday at 2 PM ET sample issue
ENDPOINTS MARKETING RX Tuesday at 2 PM ET sample issue

source