Catal­ent pledges to in­crease pro­duc­tion of Mod­er­na vac­cine at its In­di­ana fill-fin­ish plant

One of the big con­tract part­ners in the Covid-19 ef­fort, Catal­ent has signed deals with most of the ma­jor vac­cine play­ers to help ramp up sup­ply. Now, the New Jer­sey firm will ex­pand its deal with Mod­er­na in hopes of churn­ing out dou­ble the amount of fin­ished vials in time for sum­mer.

The CD­MO will in­crease its pro­duc­tion ca­pac­i­ty of the vac­cine in its Bloom­ing­ton, IN bi­o­log­ics fa­cil­i­ty through its new high-speed vial fill­ing line, Catal­ent an­nounced Tues­day. Sources close to the mat­ter told The Wall Street Jour­nal that agree­ment will in­crease the vac­cine out­put in April to 400 vials a minute.

New dos­es will be ready for ship­ment in May, and the plant’s up­grades will al­low for an ad­di­tion­al 80 mil­lion vials a year, the WSJ re­port­ed. This will help with Pres­i­dent Joe Biden’s push to pro­vide enough shots to vac­ci­nate every Amer­i­can adult by late May, and comes at a cru­cial time as talks of ex­pand­ing vac­cine avail­abil­i­ty to chil­dren have tak­en shape in re­cent weeks.

The ex­pand­ed deal fol­lows a March 17 an­nounce­ment that Catal­ent would sig­nif­i­cant­ly in­crease its man­u­fac­tur­ing ca­pac­i­ty for com­mer­cial sup­ply of the J&J vac­cine in Anag­ni, Italy, through late 2022.

Mod­er­na will now have a ded­i­cat­ed fill­ing line at Catal­ent’s In­di­ana fa­cil­i­ty through 2023, where, for now, it will man­u­fac­ture the Covid-19 vac­cine. On March 29, Mod­er­na an­nounced that it had pro­duced its 100 mil­lionth dose of that vac­cine.

Juan An­dres

Catal­ent an­nounced in Sep­tem­ber that it would spend $50 mil­lion to ex­pand the Bloom­ing­ton fa­cil­i­ty. The project, which the com­pa­ny said nor­mal­ly takes around 18 months to com­plete, was fin­ished in 10.

“We ap­pre­ci­ate this ex­pand­ed col­lab­o­ra­tion with Catal­ent and the ded­i­ca­tion of their team,” Mod­er­na CTO Juan An­dres said in a state­ment. “This ad­di­tion­al fill-fin­ish ca­pac­i­ty will be im­por­tant for not on­ly our COVID-19 vac­cine, but al­so po­ten­tial­ly for oth­er pro­grams in our clin­i­cal de­vel­op­ment pipeline.”

Catal­ent’s fa­cil­i­ty in Italy made head­lines at the end of March, when Ital­ian po­lice of­fi­cers raid­ed its Anag­ni plant amidst com­plaints that As­traZeneca was stock­pil­ing dos­es of its vac­cine. That vac­cine was made out­side of the EU and brought to An­gani to be filled in­to vials, a state­ment from As­traZeneca said, and it was “in­cor­rect to de­scribe this as a stock­pile.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

GSK is continuing to build out its Barnard Castle site in the UK.

According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.

The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.

The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.

invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.