Paul Hudson, AP Images

Sanofi has a name for its in­gre­di­ents spin­off, taps Cen­tri­ent head Karl Rot­thi­er as first CEO

As part of CEO Paul Hud­son’s mis­sion to re­vamp the com­pa­ny’s strat­e­gy around on­col­o­gy and im­munol­o­gy R&D, Sanofi un­wrapped plans in Feb­ru­ary to hive off its lega­cy API busi­ness. But Sanofi wants to main­tain its EU her­itage for the new com­pa­ny, and now has a name and new leader to move the spin­off ahead.

Sanofi will name its ac­tive phar­ma­ceu­ti­cal in­gre­di­ents spin­off Eu­roAPI, a nod to the com­pa­ny’s roots in the EU and planned op­er­a­tions home base for what will be the sec­ond largest in­gre­di­ents pro­duc­er in the world, Sanofi said in a re­lease.

Hop­ing to dri­ve its way to $1.22 bil­lion in sales by 2022, Sanofi has tapped for­mer Cen­tri­ent Phar­ma­ceu­ti­cals CEO Karl Rot­thi­er, a 29-year vet­er­an of bio­phar­ma, to take the lead role at the new com­pa­ny. Eu­roAPI stands to be­come the world’s sin­gle largest pro­duc­er of small mol­e­cule API and sec­ond-largest API pro­duc­er over­all when it launch­es its planned French IPO in 2022, Sanofi said.

Rot­thi­er will help cor­ral what is ex­pect­ed to be an ini­tial work­force of 3,200 em­ploy­ees work­ing across six Sanofi sites in Italy, Ger­many, the UK, France and Hun­gary. The com­pa­ny’s ini­tial port­fo­lio will come with more than 200 APIs ap­proved for prod­ucts in 80 in­ter­na­tion­al mar­kets.

Sanofi an­nounced the API spin­off in Feb­ru­ary 2020 as the French drug­mak­er looks to piv­ot its re­sources around on­col­o­gy and im­munol­o­gy de­vel­op­ment and away from the his­tor­i­cal­ly low-mar­gin API game. How­ev­er, Sanofi isn’t to­tal­ly walk­ing away: The drug­mak­er will hold a 30% in­vest­ment stake in the spin­off and will al­lo­cate enough cap­i­tal to keep the new­co debt-free with “op­ti­mal con­di­tions for suc­cess,” the drug­mak­er said in a re­lease.

With its place near the top of the field en­sured, Eu­roAPI will look to se­cure rough­ly 6% an­nu­al growth each year, Rot­thi­er said in a state­ment. The com­pa­ny will po­si­tion it­self as an EU-based al­ter­na­tive in an API mar­ket large­ly dom­i­nat­ed by in­gre­di­ents pro­duced in In­dia and Chi­na.

Un­like the US, which has been en­gaged in a run­ning trade war with Chi­na dur­ing the Trump ad­min­is­tra­tion, the EU has worked more close­ly with the East Asian coun­try on eco­nom­ic pol­i­cy. How­ev­er, Covid-19 dis­rup­tions have high­light­ed the need for re­dun­dant sup­ply chains for phar­ma­ceu­ti­cals in West­ern na­tions.

With­out its API busi­ness on board, Sanofi is re­align­ing its mis­sion un­der the lead­er­ship of CEO Paul Hud­son, hop­ing to cen­ter its busi­ness growth around its blos­som­ing on­col­o­gy port­fo­lio and block­buster im­munol­o­gy med Dupix­ent, a part­nered drug with New York’s Re­gen­eron. Sanofi is pro­ject­ing around $12 bil­lion in sales for Dupix­ent, which has seen bil­lions in sales so far tied to its ap­proval in atopic der­mati­tis, or eczema.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

Seven years after the FDA first approved Esbriet, the blockbuster Roche IPF drug is getting an expedited review for a second indication.

On Thursday, the agency gave Esbriet priority review for unclassified interstitial lung diseases, or forms of pulmonary inflammation and scarring that don’t fit easily into the over 200 known types of ILD. The move comes 10 months after Esbriet received breakthrough designation and sets Roche up for a decision by May.