David Lee, Servier US CEO (Servier)

Once aim­ing to dou­ble on­col­o­gy pipeline, Servier's US branch touts rapid pace in build­ing its foothold in the space

The US sub­sidiary of French phar­ma Servi­er has on­ly been in ex­is­tence for a touch un­der three years, but it hasn’t wast­ed a sec­ond — snap­ping up col­lab­o­ra­tion agree­ments and oth­er deals that have pro­pelled the com­pa­ny to­ward its main goal of be­com­ing a ma­jor play­er in the on­co­log­i­cal ther­a­peu­tics in­dus­try.

David Lee, Servi­er Phar­ma­ceu­ti­cals’ CEO, told End­points News that bio­phar­ma is mak­ing a clear shift to­ward tar­get­ing can­cer ther­a­pies of all kinds, and Servi­er wants to be a part of it. Lee was named head of Servi­er’s US com­mer­cial branch when it launched in Ju­ly 2018, and his goal was am­bi­tious: dou­ble the com­pa­ny’s on­col­o­gy port­fo­lio by 2025.

Servi­er’s al­ready on pace to ex­ceed that bench­mark — tripling the com­pa­ny’s port­fo­lio rather than mere­ly dou­bling it.

“We’re able to in­vest a lot of our rev­enue in R&D, and then we start­ed com­mit­ting 50% of that spend in R&D in­to on­col­o­gy — so we’re re­al­ly fo­cus­ing on on­col­o­gy,” Lee said. “And the goal re­al­ly is to re­al­ly build out on­col­o­gy the way we did in car­dio­vas­cu­lar and car­di­ol­o­gy (ther­a­pies). So this is our pri­ma­ry fo­cus.”

That fo­cus has spurred three prod­ucts tar­get­ing hema­to­log­ic ma­lig­nan­cies, a port­fo­lio of GI tu­mor prod­ucts, bi­o­log­ics, and a se­ries of small mol­e­cules from a part­ner­ship with No­var­tis — in oth­er words, set­ting the stage for “very con­se­quen­tial pipelines” down the road, Lee said.

“The goal is to re­al­ly kind of de­vel­op a fran­chise,” he said. “To fur­ther go deep­er in­to liq­uid tu­mors … and then to build out (our im­pact in) sol­id tu­mors.”

Servi­er’s blitz in­to the field of on­col­o­gy ther­a­peu­tics has in­clud­ed its par­ent com­pa­ny mak­ing a whirl­wind se­ries of deals over the past year which have helped speed up Lee’s ad­mit­ted­ly-am­bi­tious goals from when he took the helm of the US branch.

In April, Servi­er bought up Sym­phogen, a then-pri­vate biotech com­pa­ny fo­cused on re­com­bi­nant an­ti­bod­ies to be used in on­col­o­gy treat­ments. which will en­able it to strength­en its an­ti­body ca­pa­bil­i­ties in on­col­o­gy. And on Dec. 21, the com­pa­ny an­nounced two ma­jor deals — the first, pur­chas­ing Agios Phar­ma­ceu­ti­cals, a tar­get­ed on­col­o­gy busi­ness, for up to $2 bil­lion; and the sec­ond, col­lab­o­rat­ing with Boston-area biotech Cel­sius Ther­a­peu­tics to seek tar­get­ed ther­a­pies for col­orec­tal can­cer.

Five years ago, when Lee was the head of Shire’s glob­al ge­net­ic dis­eases and on­col­o­gy fran­chis­es, he re­calls an in­dus­try es­ti­mate that in­vest­ments in can­cer ther­a­peu­tics would grow some­where be­tween 7% and 11% in the next half-decade. As far as he’s aware, Lee said the in­dus­try has def­i­nite­ly hit the 11% mark.

“The two most ex­cit­ing ar­eas in our phar­ma­ceu­ti­cal in­dus­try right now are on­col­o­gy and these rare ge­net­ic dis­eases,” he said. “(It’s) kind of the two ar­eas in phar­ma­col­o­gy you re­al­ly see that are re­flect­ed in the val­u­a­tions and the pre­mi­ums that peo­ple are pay­ing for these deals.”

This can be at­trib­uted to two main fac­tors, Lee spec­u­lates.

“Num­ber one is much more tar­get­ed ther­a­pies com­ing to on­col­o­gy. So, you have a lot of these new as­sets that are paired with bio­mark­ers (and) di­ag­nos­tic tools that can re­al­ly get us to more tar­get­ed pa­tient pop­u­la­tions,” he said. “Num­ber two is a lot of these as­sets are go­ing to small­er tu­mors. So small­er pa­tient pop­u­la­tions and more niche tu­mor types.”

Servi­er is not do­ing a stand­alone pre­sen­ta­tion at JP Mor­gan this year, but Lee said the com­pa­ny planned to have many meet­ings with in­dus­try stake­hold­ers over the next few days as it con­tin­ues to ex­pand an in­creas­ing­ly di­verse drug port­fo­lio.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,600+ biopharma pros reading Endpoints daily — and it's free.

Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,600+ biopharma pros reading Endpoints daily — and it's free.