Evotec and Vi­for launch joint kid­ney dis­ease ven­ture

Two years af­ter they be­gan col­lect­ing and an­a­lyz­ing da­ta from kid­ney banks across the UK, Evotec has launched a joint ven­ture with Vi­for to build new ther­a­pies off of those da­ta.

Ste­fan Schulze

The project is 50:50, the com­pa­nies said, but will launch with a €25 mil­lion ($27.7 mil­lion) in­jec­tion from Vi­for, the Ga­len­cia spin­off. Clin­i­cal and com­mer­cial costs of any po­ten­tial ther­a­pies that emerge from the part­ner­ship will be split even­ly be­tween the two com­pa­nies, with var­i­ous opt-out rights from a pre­de­ter­mined prof­it shar­ing agree­ment. Any drugs that get out of the clin­ic will be out­li­censed to Vi­for for reg­is­tra­tion and com­mer­cial­iza­tion.

In June 2017, Ger­man-based Evotec joined the NUR­TuRE con­sor­tium to col­lect in­for­ma­tion from the UK Re­nal Reg­istry and 14 kid­ney dis­ease cen­ters in hopes of un­cov­er­ing key dri­vers of such ail­ments, first­ly chron­ic kid­ney dis­ease and nephrot­ic syn­drome, that would then of­fer a path to­ward new treat­ments.

Swiss-based Vi­for has long fo­cused heav­i­ly on kid­ney dis­eases, mar­ket­ing Mircera, Veltas­sa and Velphoro, among oth­er drugs. Evotec’s unique ap­proach to pre­clin­i­cal work has at­tract­ed a slew of high-pro­file col­lab­o­ra­tors, in­clud­ing No­vo Nordisk, Boehringer In­gel­heim, Cel­gene, No­var­tis, Pfiz­er, Sanofi and Take­da. They are still part of a 5-year CDK col­lab­o­ra­tion with Bay­er signed in 2016.

Un­like those pre­vi­ous deals where part­ners as­sume au­to­mat­ic rights to re­sult­ing prod­ucts, Vi­for will be li­cens­ing ex­per­i­men­tal com­pounds in the joint­ly owned pipeline to take over reg­is­tra­tion and com­mer­cial­iza­tion once clin­i­cal tri­als are com­plet­ed.

“The cre­ation of the joint ven­ture will en­able us to iden­ti­fy new tar­gets for re­nal ther­a­pies to bol­ster our pipeline,” Vi­for COO Ste­fan Schulze said in a state­ment. “We will now have ac­cess to Evotec’s best-in-class drug dis­cov­ery as well as pre-clin­i­cal ca­pa­bil­i­ties with­out hav­ing to ex­pand our own R&D in­fra­struc­ture.”

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This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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