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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Val­neva's chikun­gun­ya vac­cine on track for FDA nod af­ter long-term an­ti­body da­ta

The chikungunya virus met its match in Valneva’s vaccine candidate, VLA1553, according to data from an antibody persistence trial released today.

The trial found that 99% of 363 participants retained neutralizing antibodies 12 months after a single dose of vaccine in the company’s earlier, larger Phase III trial, called VLA1553-301. The participants from the long-term study will continue to be monitored for at least five years.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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