Sanofi los­es its Ger­man CSO and di­a­betes chief to Grü­nen­thal; Roche touts longterm ad­van­tages of Ocre­vus in treat­ing mul­ti­ple scle­ro­sis

Sanofi has lost its glob­al di­a­betes R&D chief and re­gion­al CSO Philip Just Larsen to Ger­man phar­ma gi­ant Grü­nen­thal, leav­ing the com­pa­ny in a lurch to fill his shoes at the com­pa­ny’s Frank­furt of­fice. At Grü­nen­thal, Larsen will serve as chief sci­en­tif­ic of­fi­cer, where he will get to flex his neu­ro back­ground.

Philip Just Larsen

“As an MD PhD with clin­i­cal neu­rol­o­gy ex­per­tise, I have first-hand ex­pe­ri­ence in pain man­age­ment, the core com­pe­tence at Grü­nen­thal,” Larsen said in a state­ment. “I am thrilled to con­tribute to the de­vel­op­ment of in­no­v­a­tive med­i­cines for high un­met med­ical needs in pain.” Be­fore join­ing Grü­nen­thal, Larsen spent six years at Sanofi — first as SVP and glob­al head of its di­a­betes di­vi­sion, and lat­er as CSO of the Ger­man hub in ad­di­tion to his for­mer role.

By ex­it­ing Sanofi for the Ger­man drug­mak­er, Larsen gets to helm an ac­tive R&D group. Grü­nen­thal plans to in­tro­duce four or five new prod­ucts by 2022 with hopes of be­com­ing a $2 bil­lion busi­ness. Larsen will like­ly stay busy as the com­pa­ny dumps more in­vest­ment in R&D — along with buy­ing up spe­cial­ty drug pro­grams.

Roche is tout­ing a 4-year scan of the da­ta from its piv­otal work on their MS drug Ocre­vus, demon­strat­ing a con­tin­u­ous de­cline in dis­ease ac­tiv­i­ty. Sig­nif­i­cant­ly, re­searchers al­so not­ed that among pa­tients who switched from Rebif, there was a “near-com­plete si­lenc­ing of T1Gd+ le­sions per scan at one and two years (0.476 pre-OLE to 0.007 and 0.004 T1Gd+ le­sions per scan), as well as an 85 and 97 per­cent de­crease in N/ET2 le­sions per scan at years one and two, re­spec­tive­ly.”

→ The Bris­bane, CA-based an­ti-ag­ing com­pa­ny Uni­ty Biotech­nol­o­gy has set the terms for its up­com­ing IPO. Uni­ty plans to sell 5 mil­lion shares at $16 to $18 per share, look­ing for around $85 mil­lion and a mar­ket cap of around $786 mil­lion. Un­less they can do bet­ter. 

→ South Ko­rea’s Pep­tron has raised $24 mil­lion to back de­vel­op­ment work on a new for­mu­la­tion of the GLP-1 di­a­betes drug ex­e­natide for CNS dis­eases. The biotech says it land­ed an ex­clu­sive li­cense from the Na­tion­al In­sti­tute on Ag­ing on IP cov­er­ing the de­liv­ery of a sus­tained re­leased ver­sion of the drug that will be aimed through the blood-brain bar­ri­er to get at Alzheimer’s and Parkin­son’s. “The sup­port we have re­ceived from our NIH col­lab­o­ra­tors as well as our in­vestors has al­lowed us to make sig­nif­i­cant progress in ad­vanc­ing a nov­el pro­pri­etary for­mu­la­tion of SR-ex­e­natide to GMP man­u­fac­tur­ing and Phase 2 clin­i­cal stud­ies in Parkin­son’s dis­ease,” said CEO Ho-Il Choi.

Alder Bio­phar­ma­ceu­ti­cals $AL­DR is piec­ing to­geth­er its in­ter­im team in the lead-up to an NDA for their CGRP mi­graine drug eptinezum­ab. Er­ic Carter, a biotech vet who’s been con­sult­ing for the com­pa­ny, is step­ping in as in­ter­im CMO. He’ll be re­port­ing to in­ter­im CEO Paul B. Cleve­land, who took the top spot fol­low­ing the abrupt de­par­ture a few weeks ago of CEO Randy Schatz­man, who found­ed the com­pa­ny. Alder is wide­ly viewed as a big step be­hind the lead­ers in this field, with Am­gen/No­var­tis in the lead.

With ad­di­tion­al re­port­ing by Brit­tany Meil­ing.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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