EQT Group ac­quires VC firm in $500M+ deal; Sanofi se­lects IPO lead­ers for 2022 API spin­out — re­port

Pri­vate in­vest­ment group EQT an­nounced an agree­ment this morn­ing to buy out Life Sci­ence Part­ners, a Eu­ro­pean VC firm with more than $2.5 bil­lion un­der man­age­ment.

While de­tails are not com­plete, EQT agreed to $520 mil­lion up­front — 25% in cash and 75% in new EQT shares. There is al­so po­ten­tial for a $29 mil­lion earn-out pay­ment, ac­cord­ing to an EQT state­ment.

Michael Bauer, Part­ner and Co-Head of EQT’s Glob­al Health­care sec­tor team, said, “We are tru­ly ex­cit­ed about the op­por­tu­ni­ty to join forces with LSP and form EQT Life Sci­ences. The EQT and LSP teams have com­ple­men­tary skill sets, and the com­bi­na­tion will al­low us to sup­port health­care com­pa­nies and their man­age­ment teams in a unique way.”

EQT plans to close the trans­ac­tion by some­time ear­ly next year.

Sanofi choos­es big bankers to lead API spin­out in 2022 IPO — re­port

Sanofi SA has picked Bank of Amer­i­ca, BNP Paribas and JP­Mor­gan to lead EU­ROAPI to an IPO some­time next year, ac­cord­ing to Bloomberg News.

The French phar­ma wants to raise close to $1.2 bil­lion in the IPO, and more banks could get added to the list­ing ros­ter.

Sanofi an­nounced plans just be­fore the Covid-19 pan­dem­ic to cre­ate a new ac­tive phar­ma­ceu­ti­cal in­gre­di­ents com­pa­ny, hop­ing the spin­out could gen­er­ate around 1 bil­lion eu­ros in sales. The Big Phar­ma said at the time that it planned to re­tain around 30% in the com­pa­ny and would con­sid­er Paris as a list­ing venue.

And this past Jan­u­ary, Sanofi un­veiled EU­ROAPI as the name of the new unit and tapped Karl Rot­thi­er as the first CEO. The spin­out’s ini­tial port­fo­lio will come with more than 200 APIs ap­proved for prod­ucts in 80 in­ter­na­tion­al mar­kets.

Free­line claims ear­ly win in Fab­ry dis­ease pro­gram

UK gene ther­a­py biotech Free­line Ther­a­peu­tics gave in­vestors an up­date this morn­ing on its in­ves­ti­ga­tion­al Fab­ry dis­ease treat­ment FLT190, cur­rent­ly in a Phase I/II clin­i­cal tri­al, say­ing the can­di­date proved durable in the sec­ond pa­tient test­ed.

Fab­ry dis­ease is an in­her­it­ed me­tab­o­lism dis­or­der — re­sult­ing from the ab­sent or marked­ly de­fi­cient ac­tiv­i­ty of lyso­so­mal en­zyme α-galac­tosi­dase A, or α-Gal A.

“En­zyme ex­pres­sion da­ta from the sec­ond pa­tient in our Phase I/II dose-find­ing tri­al of FLT190 are high­ly en­cour­ag­ing, with ex­pres­sion of al­pha-galac­tosi­dase A reach­ing near-nor­mal lev­els and the pa­tient thus far re­main­ing off en­zyme re­place­ment ther­a­py since dos­ing,” said Free­line CEO Michael Pari­ni. Ac­cord­ing to a com­pa­ny state­ment, the pa­tient was last dosed more than 16 weeks ago.

A third pa­tient will be dosed some­time ear­ly next year.

The biotech al­so an­nounced that it is work­ing with reg­u­la­to­ry au­thor­i­ties to up­date study pro­to­cols for FLT180a for he­mo­phil­ia B to in­clude ad­di­tion­al da­ta col­lec­tion, and that it will ini­ti­ate a Phase I/II tri­al on the in­ves­ti­ga­tion­al can­di­date by Q1 next year.

Wednes­day’s up­date comes af­ter the com­pa­ny an­nounced a two-year de­lay on a piv­otal tri­al for he­mo­phil­ia B in Feb­ru­ary to work on CMC feed­back from the FDA. The pro­gram was ini­tial­ly slat­ed to en­ter a piv­otal Phase IIb/III study be­fore the end of the year.

In the same state­ment, Free­line an­nounced they are adding a new CMO in Pamela Foulds, who joins the biotech just a few months af­ter now-for­mer CEO There­sa Heg­gie spent on­ly a year at the helm.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Renhong Tang, Simcere co-CEO

Almi­rall part­ners up with Sim­cere in po­ten­tial $500M+ deal — with plans to take IL-2 can­di­date glob­al

A Chinese pharma is looking to go international with one of its preclinical candidates, and it’s teaming up with a Spanish company in a new pact potentially worth half a billion dollars to do just that.

Simcere and Almirall announced Thursday that the two companies had reached a deal for Simcere’s IL-2 mutant fusion protein drug candidate, called SIM0278. According to a statement, Almirall gets an exclusive right to develop and commercialize the drug candidate in all indications and markets outside of China, Hong Kong, Taiwan and Macau.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Man­u­fac­tur­ing roundup: Ace­to re­brands to Actylis; WuXi STA opens an­oth­er fa­cil­i­ty

A New York-based manufacturer has rebranded after netting several acquisitions in the past few years.

Aceto, a manufacturer of ingredients and raw materials, has rebranded to Actylis. The move will bring all 10 acquisitions the company has made in the past several years under one banner.

“Actylis unites multiple industry specialists with a wide range of capabilities into a new, global enterprise with a unique hybrid approach that is greater than the sum of its parts. This consolidation enables us to offer customers across diverse locations and industries highly flexible, customized solutions addressing their specific needs while assuring reliable on-time delivery of the high-quality ingredients essential to their success,” said CEO Gilles Cottier in a statement.