Hanns-Christian Mahler, ten23 health CEO

In quick turn, ten23 al­ready look­ing to ex­pand Visp fill-fin­ish site

Last Oc­to­ber, ten23 health ac­quired a Visp, Switzer­land, site from swiss­fil­lon, a lo­cal phar­ma known for its fill-fin­ish op­er­a­tions. On Mon­day, the CD­MO an­nounced that it will ex­pand the Visp man­u­fac­tur­ing site by adding an­oth­er 1,000-square-me­ters of clean room space for de­vice as­sem­bly and pack­ag­ing by the end of this year.

Cost was not dis­closed.

Ten23 picked up swiss­fil­lon just a month af­ter it launched. CEO Hanns-Chris­t­ian Mahler has been a phar­ma guy his whole life and worked at Lon­za as the head of drug prod­uct ser­vices from 2015 un­til his move over to ten23 in March. It’s his sec­ond go at the helm of a start­up, as he co-found­ed drug de­liv­ery com­pa­ny Kriyabio af­ter work­ing at Mer­ck for five years and be­fore that 10 years at Roche. The speed of the swiss­fil­lon pick­up was un­prece­dent­ed, even for Mahler.

“That was a lit­tle in­sane,” he said in a call with End­points News on Mon­day. “Now this is ba­si­cal­ly the first ex­pan­sion on the ac­quired com­pa­ny.”

Ex­pand­ing the site has been on the ten23 team’s radar from the day the ac­qui­si­tion hap­pened. Even as it ne­go­ti­at­ed the ac­qui­si­tion, ten23 was in talks with the build­ing’s land­lords, en­sur­ing that it could ex­pand ap­pro­pri­ate­ly, and add more em­ploy­ees at the site as well.

By ex­pand­ing in­to more com­plex dosage forms, with sy­ringes and car­tridges, the swiss­fil­lon ac­qui­si­tion al­lowed ten23 to pro­vide its cus­tomer base with more op­tions be­yond the stan­dard vial, though it need­ed more space to do so. So it added a flex-room where op­er­a­tors can put ma­chin­ery and hard­ware with a small­er foot­print. It bought an as­sem­bly ma­chine to put on a table­top first, but the space can be con­vert­ed for oth­er re­spon­si­bil­i­ties as well lat­er on.

Ten23 need­ed the space in part be­cause clients and part­ners were de­mand­ing dif­fer­ent vari­a­tions of fill­ing, but al­so be­cause drug de­liv­ery-de­vice com­pa­nies be­gan ap­proach­ing them as well.

“That flex room pro­vides us with a lot of op­por­tu­ni­ty to do a lot of vari­able things in there,” he said. “It came re­al­ly about from our own past knowl­edge, that’s where prod­ucts usu­al­ly go next.”

The site can pro­duce batch­es rang­ing from 1 liter to 200 liters in vol­ume.

Ten23’s head­quar­ters are in Basel, Switzer­land, in a space it took over from a US com­pa­ny that makes med­i­cines for pets and live­stock. In a Sep­tem­ber in­ter­view, Mahler hint­ed that there were a few deals on the hori­zon, but wasn’t ready to dis­cuss those any fur­ther. He echoed the same sen­ti­ment was Mon­day on a call with End­points News, say­ing that more news prob­a­bly will come out in a few months.

As a part of ten23’s sus­tain­abil­i­ty com­mit­ment, it an­nounced a part­ner­ship with Sev­en Clean Seas in 2021. The or­ga­ni­za­tion will help the CD­MO cut back on its use of plas­tic and sin­gle-use prod­ucts, pre­vent­ing them from wind­ing up in the ocean. In No­vem­ber, it re­vealed its board of di­rec­tors, which fea­tures Nikhil Pa­tel and Richard Re­ly of the 3i Group.

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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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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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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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.

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.

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.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.