Sam­sung Bi­o­log­ics takes on man­u­fac­tur­ing du­ties for Green­Light's Covid-19 vac­cine

Sam­sung Bi­o­log­ics has en­tered an agree­ment with biotech Green­Light Bio­Sciences to man­u­fac­ture its mR­NA Covid-19 vac­cine at com­mer­cial scale, the two com­pa­nies an­nounced.

Sam­sung Bi­o­log­ics, one of the fastest grow­ing man­u­fac­tur­ers in the world right now, will use its vac­cine man­u­fac­tur­ing ex­per­tise to help pa­tients in low­er-in­come coun­tries, CEO John Rim said in a press re­lease. This will help ex­pand their ca­pa­bil­i­ties from drug sub­stance to asep­tic fill-fin­ish and all the way to com­mer­cial re­lease from one site.

“At this time of ur­gent glob­al de­mand, we will strive for seam­less ser­vice across our bio­man­u­fac­tur­ing net­work to fight the COVID pan­dem­ic and in turn, help make progress to­wards Ko­rea’s vac­cine hub goal,” he said in a press re­lease.

Sam­sung’s Song­do fa­cil­i­ty will be ready for cGMP op­er­a­tions in ear­ly 2022, the com­pa­ny said. It added drug sub­stance ca­pa­bil­i­ties to the site ear­li­er this year, in an at­tempt to be proac­tive in ac­com­mo­dat­ing clients’ needs.

In Au­gust, Green­light re­verse-merged its way on­to the Nas­daq, land­ing a $1.5 bil­lion val­u­a­tion af­ter merg­ing with the SPAC En­vi­ron­men­tal Im­pact Ac­qui­si­tion Corp., which is backed by Canac­cord Ge­nu­ity Group and Hud­son Bay Cap­i­tal Man­age­ment. That merg­er land­ed the com­pa­ny $207 mil­lion and $105 mil­lion in PIPE fi­nanc­ing.

The com­pa­ny was found­ed in 2008 to use its mR­NA tech­nol­o­gy to pro­tect both hu­mans and agri­cul­ture, in­clud­ing hon­ey­bees and crops. It was vir­tu­al­ly un­known be­fore the merg­er. Now, the com­pa­ny is look­ing to set up a blue­print for vac­ci­nat­ing the world from Covid-19, and hopes to do so through im­proved mR­NA man­u­fac­tur­ing ca­pa­bil­i­ties. It’s been work­ing on sea­son­al flu and sick­le cell dis­ease vac­cines as well, but it got its start while try­ing to shake up the pes­ti­cides mar­ket for in­dus­tri­al agri­cul­ture.

“There is an ur­gent need to de­vel­op vac­cines for the whole world,” Green­Light CEO An­drey Zarur said in a press re­lease. “Our vac­cine tri­al will open the way to make vac­cines that are avail­able to every­body, not just cit­i­zens of de­vel­oped coun­tries.”

There are cur­rent­ly three plants at the Sam­sung Song­do cam­pus. A fourth is on the way, and the CD­MO just got ap­proved to build a fifth in No­vem­ber.

Sam­sung will fin­ish the $259 mil­lion site on 32,808-square-feet of land in the city, which comes on the heels of its newest cell line, which launched in Au­gust 2020. It’s al­so in talks to ac­quire more land to de­vel­op a sec­ond bio com­plex. This, and all of Sam­sung’s oth­er ex­pan­sions, come on the heels of a 64% in­crease in sales from last year to $375 mil­lion, large­ly thanks to an in­creased de­mand for CD­MO ser­vices.

A pre­vi­ous ver­sion of this sto­ry stat­ed that Green­Light was based in South Ko­rea. It is based out of Boston, MA.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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More than half a bil­lion Covid vac­cine dos­es wast­ed af­ter Emer­gen­t's Bal­ti­more fi­as­co

New congressional committee findings released Thursday show that 135 million more coronavirus vaccine doses manufactured at Emergent BioSolutions’ Baltimore-based facility for Johnson & Johnson were designated for destruction due to quality deficiencies — bringing the total number of doses wasted due to the contractor’s failures to more than 525 million.

The new findings follow a committee report last May that uncovered damning new info on Emergent’s facility, which at one time was supposed to make hundreds of millions of doses for both J&J and AstraZeneca, and its interactions with the FDA.

Stephen Saad, Aspen Pharmacare CEO

De­mand-con­strained Covid vac­cine mar­ket may push South Africa's As­pen to change its di­rec­tion

Last year, South African manufacturer Aspen Pharmacare was in a good position, as the company opened new manufacturing lines and started to pump out J&J’s single-dose Covid-19 vaccine — even hitching its wagon to making its own version of the vaccine to sell to African markets.

But this year the company is facing the heat as it has not received a single order for the Covid vaccine, a New York Times report showed. And now, a report from Reuters points to more bad news for the company.

House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.