Sanofi is jet­ti­son­ing its in­fec­tious dis­ease unit to Evotec — hand­ing over cash, staff and a pipeline

Sanofi is spin­ning out its in­fec­tious dis­ease re­search unit to Evotec, the Ger­man con­tract de­vel­op­ment or­ga­ni­za­tion known for its deal savvi­ness. And the Paris-based phar­ma gi­ant $SNY — suf­fer­ing from a long drought that has blight­ed its in­ter­nal R&D ops — is hand­ing over €60 mil­lion (around $74 mil­lion) up­front for the op­er­a­tion along with con­tin­ued fi­nanc­ing, 10 ex­per­i­men­tal in­fec­tious dis­ease projects and 100 of its staffers to get it all go­ing.

Wern­er Lan­thaler

A new in­no­va­tion plat­form will open near Ly­on, France. Evotec will run the place, but the phar­ma part­ner re­tains op­tions to de­vel­op and com­mer­cial­ize any po­ten­tial prod­uct can­di­dates. Sanofi’s big vac­cine unit, how­ev­er, is stay­ing strict­ly out of it.

Any or­ga­ni­za­tion in­ter­est­ed in in­fec­tious dis­ease drug de­vel­op­ment, rang­ing from acad­e­mia, biotech/phar­ma com­pa­nies, foun­da­tions to gov­ern­ment agen­cies, are wel­come to col­lab­o­rate.

“Find­ing a way to mo­ti­vate more pub­lic fund­ing and aca­d­e­m­ic ini­tia­tives for the progress of nov­el an­ti-in­fec­tives on Evotecs’ plat­form will be a key suc­cess fac­tor for this ini­tia­tive,” said Evotec CEO Wern­er Lan­thaler in a state­ment.

Elias Zer­houni

Evotec is al­so bring­ing its own team to the Ly­on plat­form. More than 150 of its sci­en­tists will be ac­tive in this ex­pand­ed drug dis­cov­ery and de­vel­op­ment ef­fort. An­ti-in­fec­tives are one of five core ther­a­peu­tic ar­eas Evotec lists as its main ex­per­tise, hav­ing ac­quired in­fec­tious dis­ease spe­cial­ist CRO Eu­pro­tec back in 2014.

Un­der the agree­ment, which is ex­pect­ed to com­plete in a few months, Sanofi will pro­vide “sig­nif­i­cant fur­ther long-term fund­ing” to sup­port the growth of the port­fo­lio, though num­bers were not spec­i­fied.

These kinds of job swap­ping events aren’t all that un­usu­al in bio­phar­ma. GSK trans­ferred a large group of staffers to a CRO when it re­or­ga­nized its re­search group in North Car­oli­na — which sub­se­quent­ly laid off em­ploy­ees. Take­da has been do­ing the same thing while As­traZeneca and oth­ers have spun out com­pa­nies and drugs to star­tups as they re­vamped and re­fo­cused in­ter­nal op­er­a­tions.

Sanofi tried to down­size its French R&D op­er­a­tions un­der for­mer CEO Chris Viehbach­er, but the unions al­lied with gov­ern­ment of­fi­cials man­aged to pre­vent much of the re­struc­tur­ing that was planned. This time, Sanofi isn’t even hint­ing at lay­offs, not­ing that they are pro­vid­ing all de­part­ing staffers with 5-year em­ploy­ment con­tracts.

It’s no co­in­ci­dence that Sanofi al­so closed on its $11.6 bil­lion deal to ac­quire Biover­a­tiv to­day. The buy­out gives Sanofi rev­enue from ex­ist­ing he­mo­phil­ia drugs, and a pipeline of new ther­a­pies to con­tend with. That deal vir­tu­al­ly co­in­cid­ed with a pact to ac­quire Abl­ynx and its an­ti­body plat­form, fi­nal­ly de­liv­er­ing on a longterm promise to buy in new as­sets.

R&D chief Elias Zer­houni said the deal doesn’t mean that Sanofi is giv­ing up on in­fec­tious dis­ease:

Sanofi has a long and es­tab­lished his­to­ry in the fight against in­fec­tious dis­eases, and we re­main com­mit­ted to ad­dress­ing glob­al health chal­lenges through our de­vel­op­ment ef­forts and vac­cines. Re­search in the field of an­ti-in­fec­tives is an area where build­ing crit­i­cal mass through part­ner­ing is par­tic­u­lar­ly im­por­tant. This new French based open in­no­va­tion cen­ter will ben­e­fit from the high qual­i­ty sci­ence ecosys­tem.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

Step­ping on Roche's toes, Mer­ck cuts in­to SCLC niche with third-line Keytru­da OK

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.

UP­DAT­ED: Roche fields first ap­proval for Ro­z­lytrek in the run-up to a show­down with Bay­er, Pfiz­er

While it’s wait­ing to hear back from FDA reg­u­la­tors, Roche is be­gin­ning the vic­to­ry lap for en­trec­tinib in Japan.

Roche is giv­ing Bay­er a run for their mon­ey with this tu­mor-ag­nos­tic drug, which tar­gets NTRK gene fu­sions. Now dubbed Ro­z­lytrek, it’s sanc­tioned to treat adult and pe­di­atric pa­tients in Japan with neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase fu­sion-pos­i­tive, ad­vanced re­cur­rent sol­id tu­mors.

In­vestors fret as VBI's hep B vac­cine fails key sec­ondary PhI­II study goal

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.

Image: Shutterstock

Gene ther­a­py R&D deals turn red hot as Big Phar­ma steps up to play

This September will mark the 20th anniversary of the death of Jesse Gelsinger, a young man suffering from X-linked genetic disease of the liver. He was killed in a gene therapy study conducted by Penn’s James Wilson, and the entire field endured a lengthy deep freeze as the field grappled with the safety issues inherent in the work.

Some thought gene therapy R&D would never survive. But it did. And this year marked a landmark approval for Zolgensma, a new gene therapy for spinal muscular atrophy Novartis priced at $2.1 million.

“Gene therapy is the hottest item on the block now. But there was a time when we first got into this trial, where there wasn’t a person in the world who believed that gene therapy would work. We have to remember that,” noted gene therapy investigator Jerry Mendell told SMA News Today.

We’re still right on the pioneering frontier when it comes to getting approvals for gene therapies and launching marketing campaigns with the European green light for bluebird's leading program last Friday underscoring the nascent nature of the field. But gene therapy R&D is booming, and has been for several years now.

The rapid growth of gene therapy clinical development is well known, but we decided to put some numbers on it, to quantify what’s going on. DealForma chief Chris Dokomajilar took a lot over the past 10 years, as the number of deals, R&D partnerships and buyouts steadily gained steam, spiking last year and on track to maintain the surge in 2019.

The upfronts and totals for the dollars on deals so far in 2019 is already close to the 2018 mark, underscoring a new phase of negotiations as the major players step up to gain a piece of the late-stage and commercial action.

Once again, we’re looking at an “overnight” biotech success story, decades in the making.

At some point, that may start to brake the numbers we’re seeing. But for now, as rivals line up to compete for frontline prominence across a range of diseases, the arrows are all pointed north.

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Albert Bourla appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

UP­DAT­ED: Pfiz­er CEO Al­bert Bourla is back in the M&A game, but why is he pay­ing $11.4B for Ar­ray?

Pfiz­er $PFE has cut short its time on the side­lines of bio­phar­ma M&A.

Mon­day morn­ing the phar­ma gi­ant un­veiled an $11.4 bil­lion deal to ac­quire Ar­ray Bio­Phar­ma, beef­ing up its on­col­o­gy work and adding a new re­search hub in Boul­der, Col­orado to its glob­al op­er­a­tions.

At $48 a share, Ar­ray $AR­RY in­vestors will be get­ting a 62% pre­mi­um off the Fri­day close of $29.59.

Pfiz­er, which has strug­gled to gain all the up­side promised in past buy­outs like Medi­va­tion, high­light­ed the ac­qui­si­tion of 2 ap­proved drugs in the deal — Braftovi (en­co­rafenib) and Mek­tovi (binime­tinib).

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