Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

An­oth­er $65 mil­lion is mu­sic to the ears of the team at Au­gust Bioser­vices, a con­tract man­u­fac­tur­er in Nashville.

The com­pa­ny an­nounced the Se­ries B round last week, which will fund equip­ment in a new build­ing ex­pect­ed to open in 2023, ac­cord­ing to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led Au­gust’s Se­ries A round in Ju­ly 2020.

Jenn Adams

Au­gust Bioser­vices, a pro­duc­er of ma­te­ri­als such as pre­filled sy­ringes, IV bags and vials, was formed back in 2020 af­ter the ac­qui­si­tion of PMI Bio­Phar­ma So­lu­tions, al­so based in Nashville. Adams said the goal was to build a busi­ness that could “ad­dress the scarci­ty of sup­ply rel­a­tive to ster­ile in­jectable man­u­fac­tur­ing based in the US” and pro­vide a broad range of man­u­fac­tur­ing ser­vices.

The ini­tial cap­i­tal that came along with the ac­qui­si­tion was used to ren­o­vate Au­gust’s fa­cil­i­ty and plan for the con­struc­tion of an­oth­er build­ing. Con­struc­tion is now un­der­way, and Au­gust or­dered equip­ment for the first fill­ing suite a year and a half ago. That suite and the new build­ing are ex­pect­ed to open in 2023.

Af­ter much analy­sis over the last six months, Au­gust pur­sued the Se­ries B for an ad­di­tion­al fill­ing suite that can ac­com­mo­date a “high-speed, high-vol­ume liq­uid vial fill­ing line,” and can al­so au­to­mate its down­stream process­es, ac­cord­ing to Adams. Au­gust is fi­nal­iz­ing the plans to pro­cure equip­ment and an­tic­i­pates that pro­duc­tion will start in that suite in ear­ly 2025.

Adams added that Au­gust has plans to grow its head­count. The com­pa­ny cur­rent­ly has around 120 em­ploy­ees and plans to bring on more by the end of the year, even­tu­al­ly reach­ing 250 by 2026.

As Au­gust is in a pe­ri­od of growth, Adams not­ed that its team and ex­per­tise set it apart from the pack.

She said:

Ster­ile in­jectable man­u­fac­tur­ing … just the na­ture of it is com­plex. And the equip­ment and fa­cil­i­ties re­quire­ments are spe­cif­ic, and I think, some­times an un­der­rec­og­nized re­quire­ment of ster­ile in­jectable man­u­fac­tur­ing is the tech­ni­cal ex­per­tise of the team. So, we’ve fo­cused a lot of at­ten­tion and made sig­nif­i­cant in­vest­ments and it’s not just the num­ber of in­cre­men­tal jobs that we’re cre­at­ing, but it’s the tech­ni­cal ex­per­tise of the em­ploy­ees that we’re hir­ing. We view that as a dif­fer­en­tia­tor for us.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.