French biotech lands man­u­fac­tur­ing deal in step to­ward com­mer­cial­iza­tion of rare bone dis­ease drug

As a start­up, it can some­times be tough to think too far ahead in the fu­ture. How­ev­er, with a ma­jor man­u­fac­tur­ing part­ner­ship an­nounced Wednes­day, CTO Ca­r­ole Schwint­ner and her team at MaaT Phar­ma are tak­ing the first steps to­ward es­tab­lish­ing a long-term game plan for the sev­en-year-old com­pa­ny.

The French biotech and CD­MO Skyephar­ma will part­ner to build the largest spe­cial­ized man­u­fac­tur­ing fa­cil­i­ty for mi­cro­bio­me-based ther­a­peu­tics. The plant will help MaaT in­crease its out­put by ten-fold by 2030, with the aim to pro­duce sev­er­al thou­sand en­e­mas of the lead can­di­date MaaT-013, to treat Graft-ver­sus-Host dis­ease (GvHD), which hap­pens when do­nat­ed bone mar­row or stem cells view the re­cip­i­ent’s body as for­eign, and do­nat­ed cells and bone mar­row at­tack the body. It will al­so pro­duce “sev­er­al hun­dreds of thou­sands cap­sules” of MaaT-033, for pa­tients who re­ceive an al­lo­gene­ic stem cell trans­plan­ta­tion.

Ca­r­ole Schwint­ner

Through the part­ner­ship, the two com­pa­nies will build a 1,500-square-me­ter man­u­fac­tur­ing site in France, with the po­ten­tial to dou­ble in size if need­ed to in­crease man­u­fac­tur­ing ca­pac­i­ty. The let­ter of in­tent was signed in Sep­tem­ber 2021, the com­pa­nies dis­closed in a re­lease, and fi­nan­cial terms are still un­der wraps. The site will be op­er­a­tional by 2023 and will host MaaT Phar­ma’s team and equip­ment. Skyephar­ma, mean­while, will lend MaaT ex­per­tise in prod­uct qual­i­ty, reg­u­la­to­ry af­fairs and large-scale pro­duc­tion. MaaT al­so will ben­e­fit from Skyephar­ma’s ex­per­tise on de­layed-re­lease for­mu­la­tion. While MaaT could have fo­cused on its own man­u­fac­tur­ing plans, the new deal al­lows MaaT to fo­cus on what it knows best: its pipeline.

“(Skyephar­ma has) al­ready many years of ex­pe­ri­ence. Their sites have been al­ready in­spect­ed by the French, Amer­i­cans, and sev­er­al oth­er in­spec­tors,” Schwint­ner said in an in­ter­view with End­points News. “It’s im­por­tant for us to have some­thing re­al­ly sol­id, and they bring this part of ex­per­tise on top of it…Rather than try­ing to build an en­tire­ly new thing, they have some­thing al­ready its been chal­lenged and val­i­dat­ed.”

Last month, MaaT com­plet­ed its Phase II/III tri­als ear­ly, and da­ta from four out of five in­tend­ed co­horts showed sat­is­fac­to­ry safe­ty and “good mi­cro­bio­me en­graft­ment” de­ter­mined by the pres­ence of spe­cif­ic gut bac­te­ria.

Through the deal, MaaT will ac­cel­er­ate MaaT-03X, which us­es a mi­cro­bio­me ecosys­tem co-fer­men­ta­tion tech­nol­o­gy, and re­cent­ly was award­ed two pub­lic grants.

MaaT has moved can­di­dates in­to six dif­fer­ent clin­i­cal tri­als in its sev­en years of ex­is­tence and should be sign­ing up its first par­tic­i­pant in MaaT-013’s Phase III tri­al any day now. Its can­di­date us­es mi­cro­bio­me-based ther­a­peu­tics to flush good gut bac­te­ria in­to a pa­tient’s sys­tem through an en­e­ma for­mu­la­tion. The com­pa­ny prides it­self on the pre­ci­sion of its donor screen­ing, qual­i­ty con­trol and di­ver­si­ty of bac­te­ria in its prod­uct. That is for­mu­lat­ed us­ing fe­ces from healthy donors.

The com­pa­ny land­ed €18 mil­lion in its Se­ries B fi­nanc­ing round in Feb­ru­ary 2020.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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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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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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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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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.