Mil­li­pore­Sig­ma looks to keep up with the com­pe­ti­tion in new Wis­con­sin ex­pan­sion

As Mer­ck KGaA con­tin­ues to boost its man­u­fac­tur­ing pres­ence in Eu­rope, most re­cent­ly in Ire­land and France, the com­pa­ny’s US branch is not shy­ing away from state­side ex­pan­sion.

On Thurs­day, Mil­li­pore­Sig­ma’s pro­duc­tion fa­cil­i­ty in Verona, WI, near the state capi­tol of Madi­son, opened a new ex­pan­sion on an ex­ist­ing site to pro­duce high­ly po­tent APIs (HPA­PIs). The new $65 mil­lion, 70,000 square-foot ad­di­tion will look to bring 50 new jobs to the area, on top of the 350 that are em­ployed al­ready at the site.

The ex­pan­sion has now dou­bled the square footage of the site, round­ing out at 140,000 square feet, and in­cludes six new labs that can han­dle sin­gle-dig­it nanogram ma­te­r­i­al.

Ac­cord­ing to the Wis­con­sin Eco­nom­ic De­vel­op­ment Cor­po­ra­tion (WEDC), it au­tho­rized $200,000 in state in­come tax cred­its over the next three years, with the of­fer con­tin­gent up­on the num­ber of ac­tu­al jobs cre­at­ed.

Matthias Bucerius

Matthias Bucerius, head of ac­tives and for­mu­la­tion at Mil­li­pore­Sig­ma, said the lo­ca­tion has been man­u­fac­tur­ing and de­vel­op­ing com­pounds for over 30 years, and re­cent­ly the com­pa­ny is look­ing for a greater op­por­tu­ni­ty with pro­duc­ing HPA­PIs pri­mar­i­ly for their us­age in tar­get­ed ther­a­pies.

These com­pounds have cell-killing abil­i­ties at low dos­es and can re­sult in re­duced side ef­fects for pa­tients. They are used in nov­el can­cer ther­a­pies, in­clud­ing an­ti­body-drug con­ju­gates (AD­Cs), which are chang­ing the land­scape of can­cer treat­ments.

“There is an in­creas­ing de­mand for HPA­PIs due to their ef­fec­tive­ness against can­cer at low­er dos­es and the trend to­wards more tar­get­ed ther­a­peu­tics. Low­er dos­es of these ther­a­pies re­duce the neg­a­tive side ef­fects for pa­tients who are tak­ing on this crit­i­cal fight,” said Dirk Lange, head of the life sci­ence ser­vices at Mer­ck KGaA, in a state­ment.

Dirk Lange

But Mil­li­pore­Sig­ma’s ex­pan­sion comes at a time when Verona and the greater area are re­ceiv­ing greater at­ten­tion from the man­u­fac­tur­ing world.

In May, Ar­row­head Phar­ma­ceu­ti­cals an­nounced it is con­struct­ing a new drug man­u­fac­tur­ing fa­cil­i­ty in Verona that will have 125,000 square-foot lab­o­ra­to­ries and of­fices, as well as 160,000 square feet of man­u­fac­tur­ing space, which al­so has $2.5 mil­lion in back­ing from the WEDC. And in 2021, Alde­vron com­plet­ed a ren­o­va­tion and ex­pan­sion project in Madi­son as well. And with com­pa­nies such as Catal­ent and Mallinck­rodt near­by, Mil­li­pore is ex­pand­ing amongst a grow­ing pond.

How­ev­er, Bucerius be­lieves the com­pa­ny has sev­er­al ways to sep­a­rate it­self from the pack. This in­cludes em­bed­ding it­self in the com­mu­ni­ty through lo­cal vol­un­teer­ing pro­grams and en­gage­ment op­por­tu­ni­ties. But Bucerius al­so said that with the com­pa­ny be­ing a ful­ly-fledged CD­MO, it can have a mul­ti­fac­eted ap­proach with sev­er­al av­enues such as mR­NA pro­duc­tion to syn­thet­ic lipids that can keep the com­pa­ny above the lo­cal com­pe­ti­tion.

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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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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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.

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.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.