Run­ning be­hind Bris­tol My­ers and J&J, Bay­er inch­es for­ward in the next-gen blood thin­ner race

Over the week­end, Bay­er took an in­ter­me­di­ate step in its quest to chase down Bris­tol My­ers Squibb and J&J in the next-gen­er­a­tion blood thin­ner race.

In a Lancet pa­per pub­lished Sun­day de­tail­ing a Phase II safe­ty and dose-find­ing study, Bay­er’s ex­per­i­men­tal drug asun­dex­i­an re­duced the num­ber of bleed­ing events by 67% com­pared to Eliquis, a stan­dard of care. Bay­er’s next steps are to wrap up an­oth­er Phase II, fi­nal­ize the dose and push it in­to a Phase III study, like­ly by the end of this year, lead au­thor Manesh Pa­tel told End­points News.

“We feel good about the dos­ing, and we ac­tu­al­ly feel good about the fact that the high­er dose al­so has sim­i­lar rates of bleed­ing,” Pa­tel, a pro­fes­sor at Duke Uni­ver­si­ty, said. “It’s en­cour­ag­ing that it’s small num­bers, and you don’t want to over­in­ter­pret.”

When pa­tients use blood thin­ners, some­times the an­ti­co­ag­u­la­to­ry as­pects of the med­i­cine don’t just re­duce ex­cess clot­ting, but nor­mal clot­ting as well, Pa­tel said. This study aimed to ex­am­ine how asun­dex­i­an af­fect­ed the rates of such events.

It did not, Pa­tel and the pa­per stressed, look at the ef­fi­ca­cy of the drug in dif­fer­en­ti­at­ing be­tween rates of clot­ting events com­pared to stan­dard of care, which will like­ly be the fo­cus of the up­com­ing piv­otal study. Pa­tel al­so not­ed that the to­tal num­ber of bleed­ing events in the Phase II tri­al was low­er than ex­pect­ed.

Bay­er ran­dom­ized 755 pa­tients about even­ly in­to three sep­a­rate arms: a 20 mg asun­dex­i­an dos­ing arm, a 50 mg asun­dex­i­an dose co­hort and the Eliquis con­trol arm. Al­most all pa­tients, 753, were evalu­able at the end.

Pool­ing the two asun­dex­i­an arms to­geth­er, Bay­er ob­served four bleed­ing events across the 503 pa­tients, com­pared to six bleed­ing events in the 250 in­di­vid­u­als tak­ing Eliquis. As such, the com­pa­ny was able to de­ter­mine a 67% re­duc­tion in bleed­ing events be­tween the two drugs.

The study en­rolled pa­tients old­er than 45 with atri­al fib­ril­la­tion, though the av­er­age age of par­tic­i­pants was 73.7 years old. Near­ly 3 in 10 pa­tients al­so had chron­ic kid­ney dis­ease.

Asun­dex­i­an is a Fac­tor XIa in­hibitor, part of the same drug class as Bris­tol My­ers and J&J’s next-gen can­di­date, mil­vex­i­an. The part­ners here have a leg up on Bay­er in at least one area, hav­ing com­plet­ed a Phase II study ob­serv­ing a low­er rate of ve­nous throm­boem­bolism af­ter knee surgery with­out in­creas­ing risk of bleed­ing.

Fac­tor Xa in­hibitors, such as Eliquis and Xarel­to, can come with a fa­tal risk of bleed­ing, hence the push to­ward Fac­tor XIa. BMS and J&J are al­so aim­ing to launch their Phase III study for post-knee surgery VTE some­time this year.

#BIO22: Fire­side Chat with John Car­roll & Stéphane Ban­cel; 'No­body needs the type of wealth that we have'

 

During the big BIO conference in San Diego last month, Endpoints News editor John Carroll sat down with Moderna CEO Stéphane Bancel to discuss the pandemic, Moderna’s $19.3 billion in financial reserves, what prompted him to donate a portion of his own fortune and more. Here’s their conversation:

John Carroll:

Well, good morning, everybody. I’m John Carroll from Endpoints News. I’m really happy to introduce our fireside guest here today, Stéphane Bancel, the CEO of Moderna.

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Texas drug man­u­fac­tur­er smacked with FDA warn­ing let­ter over mul­ti­ple vi­o­la­tions

A Texas drug manufacturing facility has drawn the FDA’s ire over missing records, inadequate processes and faulty controls on a laundry list of infractions outlined in an agency warning letter.

Fort Worth-based Monarch PCM, which makes pharmaceutical liquids, tablets, creams and lotions among other products, was inspected by the FDA from June through August last year. The new FDA warning letter dated June 10, 2022, listed the company’s methods, facilities and controls for a range of manufacturing and processing issues that did not conform to current good manufacturing practices (CGMP).

Justin Klee (L) and Josh Cohen (Amylyx)

In a twist, Amy­lyx's ALS drug will get a sec­ond crack at ad­comm en­dorse­ment af­ter FDA de­cides to re­con­vene ex­perts

After a close negative vote earlier this year, Amylyx Pharmaceuticals will get another attempt to persuade FDA advisors that its experimental ALS drug is effective.

US regulators will hold a second meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss Amylyx’s application, the biotech announced Tuesday morning. The hearing, which will take place Sept. 7, will come less than six months after the previous meeting ended in a 6-4 vote saying the company did not offer conclusive proof its drug worked.

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OIG re­port ac­cus­es FDA of not fol­low­ing poli­cies for for­eign drug in­spec­tions

A new report from the US Department of Health and Human Services’ Office of Inspector General accuses the FDA of not following its policies around foreign drug inspections, and recommends some improvements.

The OIG report, released on Thursday, found that the FDA has not always followed its policies and procedures for foreign for-cause drug inspections, and that the agency allegedly misplaced documents to prove its lead investigators completed their required training.

Huntington Mayor Steve Williams (L) and Attorney General Patrick Morrisey (AP Photo/Leah M. Willingham)

West Vir­ginia judge rules in fa­vor of drug dis­trib­u­tors in opi­oid suit

Three major drug distributors are off the hook for what may have been a $2.5 billion payment after a federal judge found them not liable for the opioid epidemic in parts of West Virginia, one of the hardest-hit areas of the country.

Despite distributing more than 51.3 million doses of oxycodone and hydrocodone to pharmacies in Cabell County and the city of Huntington over less than a decade, McKesson, AmerisourceBergen and Cardinal Health didn’t cause an oversupply of opioids in the area, Judge David Faber ruled on Monday.

#Can­nes­Lions2022: Rewind and re­view of the big win­ners in phar­ma, health and well­ness cat­e­gories

The bottom line story for the pharma industry coming out of the Cannes Lions show was fewer entries and fewer awards. And not only for Big Pharma brands, but across submissions and wins in the two categories.

Now the question for next year is, how will the downturn in interest in the seminal ad show impact creativity in the industry? After all, many ad agency creatives and executives consider nabbing a Cannes Lion a career-making achievement, and while not a day-to-day concern, most at least acknowledge the prestige of the prize.

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Reshma Kewalramani, Vertex CEO

FDA lifts hold on Ver­tex's di­a­betes stem cell ther­a­py af­ter just two months un­der the mi­cro­scope

Vertex Pharmaceuticals has received the FDA go-ahead to continue studies for its diabetes stem cell therapy.

The treatment, which Vertex has attempted to describe as a “cure,” had been on hold at the agency since May, when regulators expressed concerns about a lack of information ahead of the dose escalation portions of the study. With the hold lifted, Vertex will begin enrolling patients again at the high dose level.

Joshua Brumm, Dyne Therapeutics CEO

An­oth­er Duchenne clin­i­cal hold gets lift­ed, this time at Dyne Ther­a­peu­tics

Clinical holds have hampered a host of trials testing treatments for Duchenne muscular dystrophy, but one biotech is getting the go-ahead to start its study five and a half months after the initial roadblock.

The FDA cleared Dyne Therapeutics’ first clinical trial in boys with a certain type of Duchenne muscular dystrophy, the Massachusetts biotech said Tuesday morning, sending shares $DYN up nearly 10% before the opening bell. The regulator had requested more clinical and non-clinical information back in January, but the biotech has been mum on details of what exactly the agency wanted to look at before signing off on the Phase I/II trial.

Franz-Werner Haas, CureVac CEO (AP Images)

Left be­hind at the Covid vac­cine start­ing line, Cure­Vac files suit against BioN­Tech over megablock­buster IP claims

BioNTech and their Big Pharma partners at Pfizer handily beat Germany’s CureVac to the market with a megablockbuster mRNA vaccine to fight Covid-19. But CureVac — still working on that front — says their German rival only got there after picking up some of its IP along the way.

And now they want a cut.

CureVac’s first entry in the race to develop an mRNA vaccine floundered in the clinic, missing the bar on efficacy after BioNTech’s rival was already deeply entrenched in the market. Now they say that while they won’t interfere with the sale or distribution of the BioNTech/Pfizer vaccine Comirnaty, they want “fair compensation” for the alleged infringement of a range of their patents.

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