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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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