Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Dan­ish biotech Gubra an­nounced a re­search col­lab­o­ra­tion and li­cense agree­ment with Bay­er to de­vel­op pep­tide ther­a­peu­tics to treat car­diore­nal dis­eases. The col­lab­o­ra­tion will uti­lize Gubra’s pep­tide drug dis­cov­ery plat­form to iden­ti­fy po­ten­tial can­di­dates.

This is not the first time Gubra has part­nered with a com­pa­ny on pep­tide ther­a­peu­tics — they part­nered with Boehringer In­gel­heim back in 2017 to cre­ate pep­tide ther­a­peu­tics to treat obe­si­ty.

“We are very pleased to en­ter this re­search col­lab­o­ra­tion and li­cense agree­ment with Bay­er,” said Gubra CEO Hen­rik Blou in a state­ment. “We are pleased that the po­ten­tial of our tech­nol­o­gy is be­ing rec­og­nized by such a qual­i­fied part­ner ca­pa­ble of ad­vanc­ing in­no­v­a­tive med­i­cines in­to the clin­ic.”

As part of the agree­ment, Gubra will re­ceive an undis­closed pay­ment up­front, as well as up to $253 mil­lion for reach­ing de­vel­op­ment and com­mer­cial­iza­tion mile­stones.

Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Sam­sung Bioepis and Bio­gen an­nounced to­day that the FDA has ap­proved Lu­cen­tis biosim­i­lar By­ooviz for three in­di­ca­tions:

  • Neo­vas­cu­lar (wet) age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD)
  • Mac­u­lar ede­ma fol­low­ing reti­nal vein oc­clu­sion (RVO)
  • My­opic choroidal neo­vas­cu­lar­iza­tion (mC­NV)

While By­ooviz is the first oph­thal­mol­o­gy biosim­i­lar ap­proved in the Unit­ed States, this ap­proval was like­ly a mat­ter of time as CHMP had rec­om­mend­ed the drug’s ap­proval back in June.

By­ooviz was ap­proved in Eu­rope on Au­gust 18 and in the UK on Au­gust 31.

“We are very ex­cit­ed to be able to open a new chap­ter with the ap­proval of By­ooviz in the US,” said Bio­gen SVP and glob­al head of biosim­i­lars Ian Hen­shaw in a state­ment.

How much will BY­OOVIZ cost? Bio­gen spokesper­son Al­li­son Parks de­clined to say.

“Be­cause we’re not launch­ing un­til June, it’s too pre­lim­i­nary to an­nounce pric­ing,” Parks told End­points News. “We will work in part­ner­ship with ex­ter­nal stake­hold­ers, in­clud­ing pay­ers and providers to en­sure a pre­dictable and sus­tain­able ac­cess po­si­tion is de­vel­oped for BY­OOVIZ.”

Syn­log­ic un­veils da­ta from mul­ti­ple clin­i­cal stud­ies on PKU

Mass­a­chu­setts biotech Syn­log­ic an­nounced pos­i­tive da­ta from clin­i­cal stud­ies look­ing at two en­gi­neered mi­crobes to treat phenylke­tonuria, or PKU — SYNB1618 and SYNB1934.

SYNB1618 showed re­duc­tions of pheny­lala­nine (Phe) at dif­fer­ent dose lev­els, across mul­ti­ple time points, in an in­ter­im analy­sis of a Phase II Syn­Phe­ny-1 study. SYNB1934, an op­ti­mized strain evolved from SYNB1618, showed two-fold high­er ac­tiv­i­ty than SYNB1618 in a head-to-head Phase I study in healthy vol­un­teers, as mea­sured by bio­mark­ers of Phe me­tab­o­lism.

Based on these clin­i­cal da­ta, Syn­log­ic will start plan­ning a piv­otal Phase III study.

“These events mark a ma­jor mile­stone for Syn­log­ic’s Syn­thet­ic Bi­ot­ic plat­form. We look for­ward to com­plet­ing our Phase 2 Syn­Phe­ny-1 study and ad­vanc­ing the PKU pro­gram in­to a piv­otal study,” said Syn­log­ic pres­i­dent and CEO Aoife Bren­nan in a state­ment.

Glax­o­SmithK­line to em­bark on clean en­er­gy in­vest­ment

As GSK CEO Em­ma Walm­s­ley par­tic­i­pat­ed at the open­ing event for New York Cli­mate Week, GSK an­nounced ma­jor up­dates on ef­forts to achieve cer­tain en­vi­ron­men­tal goals, in­clud­ing ma­jor new in­vest­ment in re­new­able elec­tric­i­ty at man­u­fac­tur­ing sites in the UK and US.

There is al­so a new ini­tia­tive to re­duce green­house gas emis­sions from its me­tered dose asth­ma in­halers, which ac­count for al­most half of the com­pa­ny’s car­bon emis­sions.

“For GSK, our sus­tain­abil­i­ty com­mit­ments are an in­te­gral part of our strat­e­gy, mak­ing our busi­ness more re­silient, pro­tect­ing our op­er­a­tions and ul­ti­mate­ly help­ing us to achieve health im­pact on a glob­al scale while de­liv­er­ing re­turns for our share­hold­ers,” said Walm­s­ley.

GSK said these in­vest­ments al­so co­in­cid­ed with con­fir­ma­tion of the glob­al phar­ma­ceu­ti­cal and med­ical tech­nol­o­gy sec­tor reach­ing the Race to Ze­ro ‘break­through’ tar­get of 20% of ma­jor com­pa­nies (by rev­enue) com­mit­ting to net ze­ro car­bon emis­sions by 2050.

FDA ac­cepts Mar­i­nus’s NDA on epilep­sy seizure treat­ment

Mar­i­nus Phar­ma­ceu­ti­cals an­nounced to­day that the FDA ac­cept­ed Mar­i­nus’ NDA for the use of ganax­olone in the treat­ment of seizures as­so­ci­at­ed with rare ge­net­ic epilep­sy CD­KL5 de­fi­cien­cy dis­or­der.

The NDA was grant­ed pri­or­i­ty re­view and the FDA as­signed a PDU­FA ac­tion date of March 20, 2022. In its ac­cep­tance let­ter, the FDA in­di­cat­ed that it is not cur­rent­ly plan­ning to hold an ad­vi­so­ry com­mit­tee meet­ing to dis­cuss the ap­pli­ca­tion.

“We be­lieve that ganax­olone has the po­ten­tial to pro­vide mean­ing­ful clin­i­cal ben­e­fit for pa­tients and we look for­ward to work­ing close­ly with the FDA dur­ing the re­view process,” said Mar­i­nus CEO Scott Braun­stein in a state­ment.

Ganax­olone re­ceived or­phan drug des­ig­na­tion and Rare Pe­di­atric Dis­ease (RPD) des­ig­na­tion for CDD in June 2017 and Ju­ly 2020, re­spec­tive­ly.

The ac­cep­tance of the NDA for fil­ing en­ables the biotech to draw $30 mil­lion un­der its May 2021 fi­nanc­ing agree­ment with in­vest­ment firm Oak­tree Cap­i­tal Man­age­ment, based on cer­tain con­di­tions de­scribed in the cred­it agree­ment. If the NDA is ap­proved by the end of next year, an ad­di­tion­al $30 mil­lion is avail­able un­der the agree­ment.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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