Stéphane Bancel, Moderna CEO (Photo by FABRICE COFFRINI/AFP via Getty Images)

Span­ish PM: Mod­er­na to in­vest $523M in­to the coun­try to boost vac­cine pro­duc­tion

While some coun­tries are in the midst of on­go­ing ne­go­ti­a­tions with Covid-19 vac­cine sup­pli­ers now that the sup­ply of pan­dem­ic shots is start­ing to out­weigh de­mand, Mod­er­na is dou­bling down on pro­duc­tion in a Eu­ro­pean na­tion  — throw­ing more than half a bil­lion dol­lars to start things off.

Mod­er­na is in­vest­ing 500 mil­lion eu­ros in­to Spain with the biotech con­firm­ing af­ter Spain’s prime min­is­ter Pe­dro Sánchez tweet­ed out Tues­day.

In Eng­lish, it reads:

Great news. Spain will lead the pro­duc­tion of mR­NA vac­cines with a new lab­o­ra­to­ry and an in­vest­ment of more than €500 mil­lion. To­day I met with the Vice Pres­i­dent of@mod­er­na_tx Dan Stan­er, who has ex­plained to me the ex­pan­sion plans of the phar­ma­ceu­ti­cal com­pa­ny in our coun­try.

A Mod­er­na spokesper­son told End­points News in a state­ment that “Mod­er­na has a sig­nif­i­cant in­vest­ment in the coun­try through its man­u­fac­tur­ing part­ner­ship with ROVI and foot­print in Spain. In 2022, we ex­pect this in­vest­ment to be ap­prox­i­mate­ly $530 mil­lion.”

Mod­er­na had pre­vi­ous­ly an­nounced a 10-year deal with Span­ish CMO Rovi back in Feb­ru­ary to in­crease man­u­fac­tur­ing ca­pac­i­ty for Mod­er­na’s Covid-19 vac­cine Spike­vax, and po­ten­tial­ly uti­lize Rovi’s plat­form for fu­ture mR­NA vac­cine can­di­dates. Fi­nan­cials of that Feb­ru­ary deal were not dis­closed.

Be­yond that — and men­tioned by Sánchez — Mod­er­na is plan­ning on build­ing a qual­i­ty test­ing lab in the coun­try for mR­NA drugs. With­out pro­vid­ing more de­tails, a spokesper­son said that the fa­cil­i­ty “is ex­pect­ed to be op­er­a­tional by 2023.”

Mod­er­na has been busy else­where — un­veil­ing plans to in­vest $500 mil­lion in­to a man­u­fac­tur­ing plant in Africa last Oc­to­ber and hav­ing inked deals with CD­MOs such as Catal­ent and Lon­za. How­ev­er, these de­vel­op­ments will be worth keep­ing an eye on as Switzer­land just threw out more than 600,000 dos­es of Mod­er­na’s Spike­vax last month af­ter they ex­pired.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

Endpoints Premium

Premium subscription required

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

On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fujifilm’s spending spree into its CDMO arm is not slowing down.

The multinational announced on Wednesday that it will invest $1.6 billion to enhance and expand the cell culture manufacturing services of the CDMO arm of the Japanese conglomerate Fujifilm Diosynth.

The investment will enhance Fujifilm Diosynth Biotechnologies’ sites in Hillerød, Denmark, and College Station, TX. The investment is expected to create approximately 450 jobs across both facilities.

Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

Man­u­fac­tur­ing roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA opens plant for HPA­PI pro­duc­tion

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.