Man­u­fac­tur­ing roundup: Phar­maron se­cures ac­qui­si­tion of a Rhode Is­land fa­cil­i­ty; GSK to open hub in South Amer­i­ca

A Chi­nese phar­ma com­pa­ny is grow­ing its pres­ence in the US with a new­ly ac­quired API man­u­fac­tur­ing site.

Phar­maron has en­tered in­to a de­fin­i­tive agree­ment to ac­quire a Coven­try, Rhode Is­land-based API man­u­fac­tur­ing site from drug man­u­fac­tur­er No­ram­co, which was pre­vi­ous­ly owned by John­son & John­son and now owned by the pri­vate eq­ui­ty firm SK Cap­i­tal.

Ac­cord­ing to Phar­maron, the site has an es­tab­lished his­to­ry of API man­u­fac­tur­ing from pi­lot kilo­gram to com­mer­cial met­ric ton scales. How­ev­er, ac­cord­ing to The Peo­ple’s Ra­dio, an NPR sta­tion cov­er­ing Rhode Is­land and parts of Mass­a­chu­setts, the fa­cil­i­ty was for­mer­ly owned by a sub­sidiary of Pur­due Phar­ma­ceu­ti­cals called Rhodes Tech­nolo­gies and was known for mak­ing opi­oid prod­ucts. Ac­cord­ing to that re­port, be­cause of Pur­due’s 2019 bank­rupt­cy fil­ing, the Coven­try fac­to­ry was sold to No­ram­co, an­oth­er opi­oid in­gre­di­ent man­u­fac­tur­er.

No­ram­co re­fused to make any com­ment to End­points News, and no de­tails on the pur­chase price were pro­vid­ed.

Ac­cord­ing to Phar­maron, the ac­qui­si­tion aims to ex­pand its chem­istry and man­u­fac­tur­ing ser­vices in the US. Along with its ex­ist­ing ser­vice ca­pa­bil­i­ties and ca­pac­i­ties in Chi­na and the UK, this site’s ad­di­tion will add to Phar­maron’s end-to-end CMC ser­vices.

“We are de­light­ed to have the Coven­try Site join the Phar­maron Group. Its proven reg­u­la­to­ry and com­mer­cial man­u­fac­tur­ing track record, com­bined with the high­ly ex­pe­ri­enced and sta­ble team, pro­vides a unique op­por­tu­ni­ty to rapid­ly ex­pand our chem­istry and man­u­fac­tur­ing ser­vices ca­pa­bil­i­ties in North Amer­i­ca and en­rich our glob­al net­work of ser­vices,” said Bo­liang Lou, Chair­man and CEO of Phar­maron, in a state­ment.

Phar­maron has been on an ac­qui­si­tion streak in the past year, al­so pur­chas­ing a Liv­er­pool man­u­fac­tur­ing fa­cil­i­ty from Ab­b­Vie as part of a $118.7 mil­lion sale.

South Ko­re­an chem­i­cal com­pa­ny look­ing to make head­way in a new CD­MO busi­ness

A South Ko­re­an sub­sidiary of the Han­mi Phar­ma­ceu­ti­cal Group is look­ing to ex­pand its ca­pa­bil­i­ties in the con­tract de­vel­op­ment and man­u­fac­tur­ing space.

Han­mi Fine Chem­i­cals, which spe­cial­izes in API de­vel­op­ment and man­u­fac­tur­ing, is now look­ing to ac­cel­er­ate in­to a new busi­ness sec­tor by ex­pand­ing its spe­cial­ties from on­go­ing APIs to ‘high-tech CD­MO’ ser­vices.

Ac­cord­ing to the com­pa­ny, the Covid-19 pan­dem­ic has brought an in­crease in the glob­al de­mand for high-lev­el, syn­thet­ic bio-phar­ma­ceu­ti­cal raw ma­te­ri­als. There­fore, Han­mi FC is look­ing to launch its ar­eas of the busi­ness to in­clude CD­MO projects in rel­e­vant fields.

The com­pa­ny will be look­ing to in­vest about 10 bil­lion KRW ($7.9 mil­lion) to build fa­cil­i­ties for its new CD­MO fo­cus. Last year, Han­mi FC was se­lect­ed to con­duct the Ko­re­an gov­ern­ment’s project for ex­pand­ing pro­duc­tion fa­cil­i­ties for Covid-19 vac­cines and raw ma­te­ri­als and re­ceived 1.6 bil­lion KRW ($1.2 mil­lion) in sup­port of such ef­forts. Fur­ther­more, the com­pa­ny plans to up­grade these fa­cil­i­ties even more by sup­ple­ment­ing 8 bil­lion KRW ($6.3 mil­lion) from its funds.

Han­mi Fine Chem­i­cals has pre­vi­ous­ly worked on Han­mi Phar­ma­ceu­ti­cal’s bi­o­log­ics and an­ti­cancer drugs, as well as the de­vel­op­ment and pro­duc­tion of raw ma­te­ri­als.

The com­pa­ny is al­so con­duct­ing pre­clin­i­cal and clin­i­cal CD­MO projects with 10 do­mes­tic and for­eign com­pa­nies, and it is ex­pect­ed to form part­ner­ships with even more com­pa­nies in the sec­ond half of 2022.

GSK to open a new dis­tri­b­u­tion hub in South Amer­i­ca

Al­though GSK has de­cid­ed to short­en its name, it has cer­tain­ly not short­ened its in­ter­na­tion­al pres­ence.

Ac­cord­ing to the South Amer­i­can news agency Mer­co­Press, over the next two months, GSK will open one of its three new re­gion­al vac­cine dis­tri­b­u­tion cen­ters in the cap­i­tal of Mon­te­v­ideo. The cen­ter will seek to han­dle more than 12 mil­lion dos­es an­nu­al­ly in six South Amer­i­can coun­tries — Ar­genti­na, Bo­livia, Brazil, Chile, Paraguay and Uruguay.

The op­er­a­tions will be based at Mon­te­v­ideo’s Car­ras­co Air­port, specif­i­cal­ly at the Latin Amer­i­ca Car­go City fa­cil­i­ties, which serve as an air­port du­ty-free zone. The com­pa­ny aims to op­ti­mize costs and re­duce de­liv­ery times through a hub where it will con­cen­trate the prod­ucts man­u­fac­tured in its dif­fer­ent plants in Eu­rope.

Ac­cord­ing to Mer­co­Press, the de­ci­sion to set up shop in Mon­te­v­ideo has been con­veyed to Uruguayan au­thor­i­ties in De­cem­ber of 2021, but GSK but col­lab­o­ra­tions be­tween the British phar­ma and Uruguay start­ed back in 2017 when both par­ties en­tered in­to a co­op­er­a­tion agree­ment for the joint fi­nanc­ing of re­search projects.

Ac­cord­ing to a state­ment from the Uruguayan gov­ern­ment to Mer­co­Press, the com­pa­ny plans to dis­trib­ute drugs for the treat­ment of asth­ma, COPD, al­ler­gic rhini­tis, epilep­sy, and HIV, among oth­ers.

Swiss biotech ad­vances fur­ther in­to IVD and vac­cine space

Biosynth Car­bosynth, a sup­pli­er of ma­te­ri­als to the life sci­ence in­dus­try, has ac­quired Irish-based Aal­to Bio Reagents. The com­pa­ny is a de­vel­op­er and provider of bi­o­log­i­cal ma­te­ri­als to the in-vit­ro di­ag­nos­tic (IVD) and vac­cine de­vel­op­ment in­dus­try.

The ac­qui­si­tion, ac­cord­ing to Biosynth, will look to broad­en its ca­pa­bil­i­ties and of­fer­ings in the IVD space. Aal­to’s prod­uct port­fo­lio in­cludes an ex­ten­sive range of pro­teins, anti­gens, an­ti­bod­ies, dis­ease state hu­man plas­ma and biospec­i­mens used by di­ag­nos­tics and vac­cine de­vel­op­ment com­pa­nies glob­al­ly.

“This ac­qui­si­tion marks the next phase of our am­bi­tious jour­ney to be­come a lead­ing glob­al sup­pli­er and part­ner to the bio­phar­ma and di­ag­nos­tics in­dus­tries. It al­lows us to of­fer an ex­pand­ed range of prod­ucts to our IVD cus­tomers in­clud­ing com­plex bio­chem­i­cals, pep­tides and bi­o­log­i­cal ma­te­ri­als” said Urs Spitz, CEO and pres­i­dent of Biosynth.

The terms of the deal were not dis­closed.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.