Alan Armstrong, Almac Group CEO

Al­mac com­mits to $65M ex­pan­sion for its Penn­syl­va­nia HQ amid wider in­vest­ments

A North­ern Irish con­tract man­u­fac­tur­er is mak­ing some big moves in the Key­stone State.

The Al­mac Group, a glob­al con­tract­ing and man­u­fac­tur­ing com­pa­ny for APIs and phar­ma­ceu­ti­cals is ex­pand­ing its North Amer­i­can head­quar­ters in the town of Soud­er­ton, PA, north­west of Philadel­phia.

The com­pa­ny is look­ing to in­vest $65 mil­lion in­to the fa­cil­i­ty with the plan be­ing to in­crease the clin­i­cal ca­pac­i­ty at the fa­cil­i­ty by 60%. Al­mac is al­so look­ing to add ad­di­tion­al cold and ul­tra-low stor­age as well as just-in-time pro­cess­ing ca­pa­bil­i­ties which Al­mac pre­dicts will be to sup­port the in­dus­try trend to­ward bi­o­log­ics and ad­vanced ther­a­peu­tic med­i­c­i­nal prod­ucts (ATMPs).

The Soud­er­ton ex­pan­sion is ex­pect­ed to break ground some­time in ear­ly 2023, and once com­plete it will bring the com­pa­ny’s North Amer­i­can head­quar­ters to a to­tal of 340,000 square feet.

Robert Dun­lop

“Drug de­vel­op­ment and clin­i­cal tri­als con­tin­ue to evolve across the world, with spon­sors ex­pand­ing their pipelines to fo­cus on bi­o­log­ics, vac­cines and ad­vanced ther­a­py med­i­c­i­nal prod­ucts. Al­mac is at the fore­front of build­ing sup­ply chain ex­per­tise and ca­pac­i­ty for this evo­lu­tion,” said Robert Dun­lop, pres­i­dent of Al­mac Clin­i­cal Ser­vices said in a state­ment.

How­ev­er, this is not the on­ly in­vest­ment that Al­mac is look­ing to make. The com­pa­ny is al­so up­grad­ing its two oth­er Mont­gomery Coun­ty sites bring­ing the com­pa­ny’s to­tal in­vest­ment in Penn­syl­va­nia to $93.5 mil­lion. The com­pa­ny is al­so look­ing to add 355 jobs to the state over the next three years.

How­ev­er, to tack­le this ex­pan­sion the com­pa­ny has re­ceived mon­e­tary help from the state. The com­pa­ny re­ceived a fund­ing pro­pos­al from the Penn­syl­va­nia De­part­ment of Com­mu­ni­ty and Eco­nom­ic De­vel­op­ment of $1.8 mil­lion as well as a Penn­syl­va­nia First grant and a $250,000 work­force de­vel­op­ment grant. The com­pa­ny has al­so been en­cour­aged to ap­ply for a man­u­fac­tur­ing tax cred­it and a re­search and de­vel­op­ment tax cred­it pro­gram.

This is not the first ma­jor in­vest­ment the com­pa­ny has made in Penn­syl­va­nia. In 2016, the com­pa­ny com­mit­ted to leas­ing out 26,000 square feet of of­fice space in Lans­dale, PA, and in­vest­ing around $24.4 mil­lion in an ex­pan­sion project that saw the com­pa­ny add more ma­chine lines and cold stor­age as well as cre­ate 312 jobs.

While the Key­stone state is cer­tain­ly on the com­pa­ny’s mind, it has not ne­glect­ed its home in North­ern Ire­land, where last year it an­nounced that it was ex­pand­ing its Ar­magh lo­ca­tion by 42,000 square feet.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Andrew Phillips, Nexo Therapeutics CEO

Scoop: Ver­sant, NEA launch new biotech helmed by ex-CEO of pro­tein de­grad­er C4 Ther­a­peu­tics

Long-time biotech venture firms Versant and New Enterprise Associates are backing a new startup run by former C4 Therapeutics chief executive Andrew Phillips.

The fledgling biotech has raised at least $30 million so far, according to paperwork filed with the SEC this week. The round could balloon to $60 million.

Phillips, who left protein degradation startup C4 in 2020 to be a managing director at Cormorant Asset Management, is running the show of the new venture as president, the SEC filing outlines. He also served as interim CEO of Cormorant-backed and Hansoh Pharmaceutical-partnered Blossom Bioscience last year.

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Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.