Re­silience shells out $110M for blue­bird bio site, kick­start­ing new col­lab­o­ra­tion

Just a lit­tle more than two years af­ter blue­bird bio pur­chased a man­u­fac­tur­ing fa­cil­i­ty and spent an­oth­er $80 mil­lion on up­grades, the com­pa­ny has spun around and sold it.

Re­silience has ac­quired blue­bird’s North Car­oli­na lentivi­ral vec­tor man­u­fac­tur­ing fa­cil­i­ty for $110 mil­lion. The 125,000-square-foot site in Durham, NC, in­cludes drug sub­stance and drug prod­uct pro­duc­tion suites, qual­i­ty con­trol labs and ware­house space. There’s al­so room for fu­ture ex­pan­sion.

All of more than 100 em­ploy­ees will be re­tained at the site. In the press re­lease, blue­bird pitched the deal as a col­lab­o­ra­tive project with Re­silience more so than an ac­qui­si­tion with agree­ments to es­tab­lish ex­pense- and rev­enue-shar­ing part­ner pro­grams and es­tab­lish a “next-gen­er­a­tion man­u­fac­tur­ing R&D col­lab­o­ra­tion” al­so in the works.

As a part of the agree­ment, blue­bird and spin­off 2sev­en­ty will still have ac­cess to the LVV man­u­fac­tur­ing for the pipeline pro­grams. The drug­mak­ers is in the process of break­ing in­to two sep­a­rate rare dis­ease and on­col­o­gy units. Re­silience and 2sev­en­ty will col­lab­o­rate on its emerg­ing pipeline.

“As we con­tin­ue to piv­ot to­ward the planned sep­a­ra­tion of blue­bird and 2sev­en­ty, this strate­gic part­ner­ship al­lows us to share risk, stream­line our busi­ness op­er­a­tions, pro­vide ad­di­tion­al cap­i­tal and im­por­tant­ly en­sures un­in­ter­rupt­ed ac­cess to vec­tor sup­ply as we de­vel­op ad­di­tion­al trans­for­ma­tive treat­ments,” blue­bird CEO Nick Leschly said in a press re­lease.

When an­nounced, the plan was for the site to pro­duce lentivi­ral vec­tors for in­ves­ti­ga­tion­al gene and cell ther­a­pies, in­clud­ing bb2121 and bb212217 for treat­ment of mul­ti­ple myelo­ma and pos­si­ble Lenti­Glo­bin to treat trans­fu­sion-de­pen­dent tha­lassemia and sick­le cell dis­ease.

The ac­qui­si­tion of the site gives Re­silience an “im­por­tant strate­gic pres­ence” in North Car­oli­na’s Re­search Tri­an­gle, and a site with the lat­est tech. This will mark the com­pa­ny’s 10th site in North Amer­i­ca.

“This al­liance sup­ports our vi­sion of in­no­v­a­tive prod­uct par­tic­i­pa­tion busi­ness mod­els and blue­bird’s demon­strat­ed lead­er­ship and ex­per­tise in the field of gene and cell ther­a­py makes them an ide­al part­ner for this next phase of growth,” Re­silience CEO Rahul Singhvi said in the press re­lease.

Bob Nelsen’s lat­est project hit the ground run­ning in 2021 and caught the eye of the Cana­di­an Strate­gic In­no­va­tion Fund, which an­nounced ear­li­er this year that it will spend $163 mil­lion to mod­ern­ize and ex­pand pro­duc­tion ca­pac­i­ty for new tech­nolo­gies such as mR­NA, the key com­po­nent of Pfiz­er/BioN­Tech and Mod­er­na’s vac­cine, at a Re­silience site. That will add 205 new jobs in Mis­sis­sauga, On­tario, at a 136,000-square-foot fa­cil­i­ty that cur­rent­ly pro­vides fill-fin­ish man­u­fac­tur­ing.

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.

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.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.