Sam­sung con­struct­ing new $2B 'Su­per Plan­t' rough­ly the size of Amer­i­ca's largest malls

Sam­sung Bi­o­log­ics is plan­ning to con­struct a new ‘Su­per Plant’ about the size of the biggest shop­ping malls in the US.

Last month, the com­pa­ny an­nounced that it is ex­pect­ing to break ground on the man­u­fac­tur­ing plant, its fourth over­all, some­time be­fore the end of the year. The build­ing, which will cost rough­ly $2 bil­lion, is ex­pect­ed to en­com­pass 238,000 square me­ters, or about 2.5 mil­lion square feet. That’s the size of all three of its cur­rent plants com­bined and about 90% the area of Min­neso­ta’s Mall of Amer­i­ca and Philadel­phia’s King of Prus­sia mall, the coun­try’s two biggest, ful­ly-open malls.

Tae Han Kim

“With the pro­duc­tion of Plant 4, our ‘Su­per Plant,’ Sam­sung Bi­o­log­ics is in­vest­ing in a to­tal line re­fine­ment and ad­di­tion of new mid- and small-scale fa­cil­i­ties to en­sure pro­duc­tion ef­fi­cien­cy and pro­vide top-notch ser­vices to raise the bar even fur­ther to es­tab­lish our­selves as the lead­ing glob­al stan­dard,” CEO Tae Han Kim said in a state­ment.

Sam­sung ex­pects to be­gin man­u­fac­tur­ing ac­tiv­i­ties in the sec­ond half of 2022.

The new plant will add 256KL to Sam­sung’s over­all man­u­fac­tur­ing ca­pac­i­ty, bring­ing the com­pa­ny’s to­tal to 620KL. Sam­sung is hop­ing to cap­i­tal­ize on the surge in de­mand for out­sourced man­u­fac­tur­ing due to the Covid-19 pan­dem­ic, say­ing it has signed deals worth 2.5 times its 2019 rev­enue in the first half of this year alone.

Orig­i­nal­ly, this new plant was sup­posed to be far small­er, Kim told the Wall Street Jour­nal this week. But see­ing how the pan­dem­ic cre­at­ed a new prod­uct cat­e­go­ry in Covid-19 treat­ments, he pushed for a larg­er ex­pan­sion as the com­pa­ny is reach­ing max­i­mum ca­pac­i­ty at its cur­rent three plants.

Re­cent­ly, Sam­sung en­tered in­to a $231 mil­lion con­tract with GSK to help pro­duce the British drug­mak­er’s spe­cial­ty care drugs, such as the lu­pus drug Benlysta. The com­pa­ny al­so makes drugs for Bris­tol My­ers Squibb and the Roche group.

Found­ed in 2011, Sam­sung Bi­o­log­ics is a rel­a­tive­ly re­cent ven­ture for the con­glom­er­ate known main­ly for its smart­phones. Over the last sev­er­al years, it’s been mired in an ac­count­ing scan­dal as the com­pa­ny al­leged­ly in­flat­ed its val­ue ahead of its 2016 pub­lic list­ing.

Three ex­ecs were jailed last De­cem­ber for de­stroy­ing ev­i­dence re­lat­ed to the probe af­ter South Ko­re­an reg­u­la­tors raid­ed an of­fice build­ing and found con­cealed lap­tops, com­put­er servers and USB dri­vers un­der­neath a meet­ing room floor. Ac­cord­ing to the Jour­nal, Kim was one of 11 cur­rent and for­mer high­er-ups in­dict­ed on Tues­day for var­i­ous fraud and mar­ket-vi­o­la­tion counts. Sam­sung has de­nied all wrong­do­ing in the case.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.

Med­ic­aid com­mis­sion to Con­gress: In­crease re­bates for ac­cel­er­at­ed ap­proval drugs

As the FDA continues to approve more new drugs under its accelerated approval pathway, the non-partisan Medicaid and CHIP Payment and Access Commission (MACPAC) is telling Congress to increase the statutory Medicaid rebates for such drugs until their clinical benefits have been verified.

Higher rebates for drugs with accelerated approvals, a move opposed by the biopharma industry, would mean lower net prices, lessening their financial burden on the health care system while incentivizing the companies to speed the verification of the drugs’ clinical benefits in confirmatory trials. Once those benefits are confirmed, the companies would return to the lower rebates when the accelerated approval is converted into a full approval, MACPAC suggests.