Evotec ex­pands pres­ence in Italy with ac­qui­si­tion of for­mer Glax­o­SmithK­line R&D site

Ger­many-based Evotec es­tab­lished its pres­ence in Italy four years ago. Now, it’s bought up more re­al es­tate in the neigh­bor­hood.

Evotec has ac­quired an R&D site in Verona from GSK, the com­pa­ny an­nounced Thurs­day. The com­pa­ny did not dis­close fi­nan­cial de­tails of the deal.

GSK used the site for the spe­cial­ized man­u­fac­tur­ing of fin­ished dose form of cephalosporin. It fea­tures ster­ile pow­der fill to vials, mono­rails and Add-Van­tage vials and flex­i­ble pack­ag­ing lines. It’s ap­proved by the FDA and EMA, as well as and has main­tained glob­al reg­u­la­to­ry ap­provals.

The cam­pus will be re­named the Cam­pus Levi-Mon­tal­ci­ni, in hon­or of Ital­ian No­bel lau­re­ate Rite Levi-Mon­tal­ci­ni. Levi-Mon­tal­ci­ni was award­ed the No­bel Prize in 1986 for her work in neu­ro­bi­ol­o­gy, along with col­league Stan­ley Co­hen, for the dis­cov­ery of nerve growth fac­tor. She died in De­cem­ber 2012. The name was vot­ed for by em­ploy­ees.

In 2017, Evotec ac­quired Ap­tu­it, and has been op­er­at­ing out of its Verona cam­pus. The newest ac­qui­si­tion is about three miles away.

Ciri­a­co Maraschiel­lo

“The ac­qui­si­tion of the Verona R&D cam­pus from GSK, one of the ma­jor R&D cen­tres in the coun­try, means con­ti­nu­ity and fur­ther de­vel­op­ment of R&D ex­cel­lence in Italy,” Ciri­a­co Maraschiel­lo, glob­al head of de­vel­op­ment, said in a state­ment. “Be­com­ing the own­er of the Verona R&D fa­cil­i­ty strength­ens Evotec’s ful­ly in­te­grat­ed R&D so­lu­tions for our part­ners.”

The com­pa­ny, which is based out of Ger­many, has spread its foot­print through­out Eu­rope as of late. In May, the com­pa­ny part­nered with Bris­tol My­ers Squibb to launch be­LAB1407, a $20 mil­lion aca­d­e­m­ic BRIDGE to de­vel­op ear­ly-stage ther­a­peu­tic con­cepts from the uni­ver­si­ties of Birm­ing­ham, Ed­in­burgh, Not­ting­ham, and Dundee, the com­pa­nies said. The goal is to take the sci­ence from these com­pa­nies and turn them in­to spin­off com­pa­nies, us­ing Evotec’s plat­form.

In April, Evotec an­nounced that it would lay out $120 mil­lion to build a new bi­o­log­ics fa­cil­i­ty in Toulouse, France, to ex­pand pro­duc­tion ca­pac­i­ty for ther­a­peu­tic an­ti­bod­ies. That move was boost­ed by a $60 mil­lion in­vest­ment from sev­er­al French gov­ern­ments and in­vestors. The com­pa­ny has part­nered with the US De­part­ment of De­fense and the Bill & Melin­da Gates Foun­da­tion to amp up pro­duc­tion of an­ti­bod­ies.

So­cial im­age: Wern­er Lan­thaler, Evotec

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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