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1011
Viela Bio Enters Strategic Collaboration wiΩ∑th Mitsubishi Tanabe Pharma to Deve≠∞↑lop and Commercialize Inebilizumab for ≠πAutoimmune Diseases in Japan >∏"and Other Asia Regions
THURSDAY, OCTOBER 10, 2019Viela Bio, Inc.↔< and Mitsubishi Tanabe Pharma Corporat₽±>ion (“MTPC”) today announced a collaboration π→focused on the development and commerc£ialization of inebilizumab ¶σ– Viela’s humanized anti-∑×CD19 monoclonal antibody – in nine Aβ•εsia regions for neuromyelitis optica spectrum Ωαdisorder (NMOSD), as well as otherφ♠' potential future indic≈πations.“This partnership adds to o↑Ωε♣ur ability to commercialize in¥✘φ∞ebilizumab globally, sub∑"ject to regulatory approval,” commented Bing Yao♣ε, Ph.D., Viela’s Executive Chairman and Chief Ex$≥φ÷ecutive Officer. “As a well-e>εstablished pharmaceutical company in Jap'δan, Mitsubishi Tanabe has strong product develo♣ ₽pment and commercializ♥Ωation capabilities in Asia, and we believe±, is an ideal partner for expanding inebilizum±λab’s potential reach to thβδα∞ousands of additional patie✘÷nts in need of viable tre"✔φ<atments, with NMOSD as an initial indication¥γ.”Under terms of the ✔γ♥"collaboration, Viela will receive an₩ up-front licensing fee of $30 mi→♦llion as well as additional payme£♦ nts contingent on cer©≤→Ωtain development and com✔≈₽×mercial milestones, plus payments based, i↕γ£♣n part, on sales revenue. MTPC will be responsibl↓♦<γe for leading development and commercial• ization of inebilizuma€↔σb in Japan, Thailand, South Korea, Indonesia, V<♣ietnam, Malaysia, Philippines,✘φ Singapore, and Taiwan.“Ourβ♥δα organization is delighted '≥₹to partner with Viela to d'↕£evelop and commercialize their promising pro↕★βduct candidate inebilizumab for aγ→utoimmune and inflammatory diseases,” said M↔ε<asayuki Mitsuka, MTPC President & Re☆₹presentative Director. “Inebiδ♠lizumab is an exciting productσ¥π candidate that, based on th¥ €e results from the N-MOmentum pivotal ↔ ☆study, is well-positioned to provide∑ meaningful benefit for γ≠"patients with NMOSD, and potentially addition al diseases, subject to regulatory approval←✘ . We are excited to work with Viela to adv✘©£ance inebilizumab in Japan and ot÷her Asia regions, and look for≈<ward to a productive partnership between our cφ"γ≤ompanies.”The U.S. Food and Drug Administrat >¥ion (FDA) recently accepted &$¶×for review Viela’s Biologics License Application↑±÷$ (BLA) for inebilizumab for the treatme λnt of NMOSD. infor×☆mation source:pharma focus Asia₹¥βThe original link:https:https://www.pha©πrmafocusasia.com/news/viela-bio-ente∞λ₩rs-strategic-collaboration-with-mφ₩•itsubishi-tanabe-pharma-to-develop-and-commerc±↕ ialize-inebilizumab-for-autoimmune-diseases-in-β↕<japan-and-other-asia-regions2019 Asia-paci>γfic pharma IP Leader Sum<σγmit: http://en.zenseegroup.c≥↑☆γom/p/510934/will be heπ¥₽ld in Beijing ≥™↕; on November 14←§π®-15, and will attract more thanελ÷ 500 industry experts from domesti πc and foreign pharmaceutical companies, ®®biotechnology companies, gove≤♠©∞rnments, associations, law firms, intelle★§ctual property agents and other compa>♠↔₽nies to attend.Official registration an•≥™Ωd consultation channels←:Contact：AnnPhone: 021-65650305Email：δ↑≠Marketing@zenseegroup.comhttp://£ ×↔en.zenseegroup.com/p/₩♦510934/ -
1010
4D Pharma collabor4D Pharma collaborates with <$§MSD to develop live biother ♠δ apeutic products for va↓≈ ccinesates with MSD to d≤↔•evelop live biotherape↕ δ←utic products for vaccines
4D pharma plc, a leading pharmaceutical com♦♦≈pany in the development of live biotherapeutics, today announceπ≠s that the company has§" entered into a rese< §arch collaboration agreement and an op♥α≠tion license to use with MSD (★≠ trading name of Merck & Co., Inc ., in Kenilworth , New ÷♥✘Jersey , United States of America÷£) to Discover and Develop Live Biotherap≤≥eutic Products ("LBP") fo"↑≥₩r vaccines.Under the terms of ≤β∞the agreement, MicroRx®, the proprietary platfo÷&←rm of 4D, will be associated with MSD's ex✔♣pertise in the develδ'opment and commercial↔→™ization of new vaccines, in order to d≠φiscover and develop LPβ¶★→Bs as vaccines in maximum three undisclosed β₹≤☆indications. 4D has t♦♦he right, subject to certain conditions, to pu£™∞rchase from MSD for $ 5 million com&♥mon shares of 4D during the first 12 βγmonths of the collaborationβ"©∞. In addition to an initial cash payment,±Ω for each indication, 4D will be eligible® to receive up to $ 347.5 million in exerci¶&se of options and regul→&↓atory and development mileston∑γe payments, as well as royalties the annu$±al net sales of any li÷÷censed product resulting from the collaborat♣ααion.Duncan Peyton , CEO of 4D, sa↓'± id, "This collaborative reσ∏'>search agreement brings✘"απ together 4D's innovations in the microbiome fiel∑ ≥d and MSD's track record in the development of aφ$dvanced vaccines. MSD and 4D wor"₽ked closely together combining wσ♦orld-class scientific knowledge to develop a ≤♣₹work plan to advance understanding of thi"♦÷s field, with the goal of generating ¶§βa new class of vaccines ₹in areas where unmet ne₹★¥eds are important. "Daria Hazuda , ↓← Scientific Director of MS'×♣D's Exploratory Science Center and Vic←Ωπe President of Research on MSD's Infectious Dis&₹γ↔eases and Vaccines Disc↕¶ε↑overy, said, "A key e§±♥lement of our goal at the Center for Eφ αxploratory Science is the assessm♠↔βent of emerging areas of λ≥emerging biology that are like≠ ₽ly to have a major beneficial impact on human hea↔₩lth. By applying MicroRx® technology o×±≥∏f 4D, we hope to obtain useful in≤↑formation on the role of the host microbiome &←in modulating the immune ©πresponse and, ultimaβ∏£tely, the protection confe↓™rred by vaccines. "information source:phar♦÷ma focus AsiaThe original link:https:https://ww∑γ&w.pharmafocusasia.com/news/4d-¥ ₽↔pharma-collaborates-with-msd-to-d≥$λevelop-live-biotherapeutic-products-for-vac★¥cines2019 Asia-pacific pharma IP Leader ☆₹' Summit: http://en.zenseegro¥₹≤↓up.com/p/510934/will be held in∑> Beijing on ✔€÷November 14-15, and will attract more than >™₽↕500 industry experts from domestic and foreign phσ§σ'armaceutical companies,÷↓ biotechnology companies, gove§≤₽✔rnments, associationsπ∞, law firms, intellectual propertyδφ¥$ agents and other companies to attend✘♦✔ .Official registration and consultation'≤ channels:Contact：AnnPhone:∑σ® 021-65650305Email：Marketing@ze≈βnseegroup.comhttp://en.zenseegroup.com/p/510☆♣934/ -
1009
Goldfinch Bio Announces Li®♦censing Agreement with Takeda for CB1 Monoc≈ £lonal Antibody for the Treatment o®→f Rare and Metabolic Kidney Diπ≠ seases
Goldfinch Bio, a U.S.-based, clinical s£δΩtage biotechnology company focused onφ♣<♦ discovering and developing precision medicines$<♣≤ for the treatment of kidney dise"'ases, today announced it entered ←♥ into a license agreemenβ∑¶t with Takeda Pharmaceutical Com←∑pany Limited (“Takeda”) for worldwide ♠☆γ rights to a preclinical, perip×λ•herally-restricted cannabinoid rec £eptor 1 (CB1) monoclonal antibody. Goldfinch$• Bio will assume all deveδεlopment and commercialization responsi ™₹bilities for the treatment of rare and metaboΩ γlic kidney diseases worldwide. Ho≤wever, the agreement grantsα" Takeda the option, priorπγλ€ to the initiation of pivotal π©★₩studies, to request Goldfinch B♦÷$io negotiate with Takeda for sub <∏-licensing of Japanese rig∑hts to Takeda. Financial terms of the agree∞φment were not disclos≈™σ♣ed. Goldfinch Bio plans to file an investigationaα✘λ↑l new drug (IND) appl♠λ¥ication for this CB1 inhibitor, re-named GFB-π 024, in the second half of 2020.“In recent y×<∏←ears, our understanding of the ro ≥ le of CB1 signaling in ex<"✘ acerbating progressive kidney diseases has≈₽ grown substantially. In this context, a ÷₹≥monoclonal antibody directed toward the C≈ ☆B1 receptor is potentially well-suited to elici↑ ""t the beneficial pharma¥≈cology associated with the periph¥∏×eral inhibition of the✘★© CB1 receptor,” said An$λthony Johnson, M.D., Pr♥↓esident and Chief Exe'♠&←cutive Officer of Goldfinch ¥λ♦Bio. “Goldfinch Bio will deploy its biology p≤↔latform and Kidney Genome AtlasTM to develop this ✘♠ therapeutic agent in subsets of ≈←patients with kidney diβ±φ™seases most likely to preferentially respond to÷• CB1 inhibition. With GFB-887, our≤≠γ TRPC5 inhibitor for FSGS, inβ↕✘" Phase 1 clinical development, this peripheral C≤$σB1 inhibitor will be the second clinic-ready p©α∏↑rogram in Goldfinch Bio’s pipeline. W✘λe look forward to collaborating with≈↔ Takeda on this progra↕€ ∑m.”“Goldfinch Bio is ideally suit∞∑♣γed to advance development of this pro∞¶ gram,” said Dan Curran, M< .D., SVP and Head, Raδ∏φΩre Diseases Therapeutic A♣δ♣rea Unit, Takeda. “The appπlication of its precision m$δedicine approach, from candidat≤e target validation through to identificat"♣λβion of potential treatment-relevant ★≠₽subgroups, is unique ☆δ£αin the development of chron←σic metabolic kidney disease treatments.”Preclinic∞π al data support the inhibition of CB1 signaling✔₹↑§ as a novel treatment of Diabetic Nephropa&γεthy (DN) and obesity-related glomerulopathies ✘₩₹(ORG), given the pote←ε≤€ntial metabolic benefits and direct>§♠α effects on the kidney to prevent fibros€≤¶≥is and preserve kidney function. DN develops≈≤Ω in 30 to 40 percent of pat€★ients who have diabeσφtes and is a leading caus♠λ♣e of morbidity, morta∑≠★€lity and end-stage kidney disease "δin the United States and woγ✔rldwide. ORG is a rare✘≥✘€ kidney disorder characterized by ₽≈significant proteinuria and pro$↓gressive renal dysfunction. Althougπ≥h both DN and ORG are increasing in π prevalence in parallel £" with the obesity epidemic↓∏$, well-established dis £∑₩ease modifying therapies are lacking. Goldfinch∞∞§ Bio plans to initiate a phase 1 study for GFB-02®•∑4 in 2H 2020.information source×✔α:pharma focus AsiaThe original link:htσγtps://www.pharmafocusasia.com≤/news/goldfinch-bio-announces-licensi★'§¥ng-agreement-with-takeda-for-cb1-↕₽monoclonal-antibody-for-the-treatment-∞©®of-rare-and-metabolic•≈-kidney-diseases2019 Asia-pacific pharma α IP Leader Summit: http://en.zenseegr★₹↑oup.com/p/404716/ will₹¥ be held in Beijing&nbs£'×♥p; on November 14-15, and will att₽σract more than 500 inε"dustry experts from domestic and foreign ph→ €armaceutical companies, biotechnology compa≥∏ nies, governments, associations, l×"≈±aw firms, intellectual propert←y agents and other companies <←®¥to attend.Official registration § and consultation channels:Contac₩®↓&t：AnnPhone: 021-6565>∞α₽0305Email：Marketing@zenseegroup.comhttp://e♥₹'n.zenseegroup.com/p/510934/ -
1008
Prometheus Biosciencπ≈es, Inc., Enters Into Multi-Target Strategic Coll↑¶♦aboration with Takeda to Develop± Targeted Therapies for Inflammatory Bowe¥₩l Disease
Prometheus Biosciences, Inc., a >∞biopharmaceutical company committed to the dis™↑σ♥covery, development, and commφ×÷ercialization of a broad portfolio of n→↓₽ovel precision therapeutics and"§₩ companion diagnostics f¶€♦or patients living wi±♦™πth unmet needs in gastr←>oenterology and autoimmune diseas€<es, announced that it h×♦♦as entered into a global, multi-target stγ">♣rategic collaboration wi¶δ←♥th Takeda Pharmaceutical Comp☆→☆Ωany Limited (Takeda) to disco≥€&ver, develop, and commercialize novel £><therapies for inflammatory bowel £✘€disease (IBD). The collaborat£♣•↓ion combines the proprietaΩ×ry bioinformatics discovery platfo≠©≠<rm and companion diagnostic tools dev←÷₹eloped by Prometheus Biosciences with Tak®↔eda's expertise in gastroenterology and✔α drug development, in'♥ order to discover and advance up to ↕∑★three targeted IBD thera$ peutics and companion di÷↕agnostics. Prometheus Bioscience∞₽®αs will be responsible for th★←πe identification and validat∞¥₹ion of three unique drug targets for IBD, al₽αong with the development and commercialization λ÷↕of companion diagnostics to complem¶§∏ent the targeted drugs. Takeda will be responsibl♥✔¶e for all drug discovery, cli♠≥nical development, and commercialization ac↔&tivities for the resulting targeted therapeuti→↑cs."We are impressed with Takeda'Ω€☆>s commitment to developing a portfolio of therapi×δ♠±es to address all IBD patβε<σients, especially those with unmet nee↓₩ds," said Mark McKen✔↕na, chief executive officer, Prometheus≠★ Biosciences. "We ✘§believe that a targeted, p >recision medicine approach is needed ♦αto deliver new, effective therapeutic≈£© options in inflammatory bowel ♦"↕$disease. Through our partnership, we are excited ☆δto combine the Prometheus bioinfo₩£rmatics platform and advanced machine Ωλ₹learning techniques with Takeda's ex≠εεpertise in drug deve↓αlopment to deliver a new generati£€∞ on of IBD therapies."Under theφ≠γ terms of the agreement, Prometheus Biosciences≥ will receive an undisclosed initial upfron ↑₹γt payment from Takeda and is eligible to ™'∞receive up to $420M in development, regulatory ↓, and commercial mil¥÷<estone payments, in toΩ•×tal, across all thre↑₹e programs. In addition, Promethe♣♥us Biosciences is eligible to receive royalty pa↓♣γyments on global commerci♦al sales from each program.in∞σβformation source:pharma focus Asπ≤α★iaThe original link:https:http™αs://www.pharmafocusasia.com/↕®↓news/prometheus-biosciences-inc-en€σters-into-multi-target-strategi₹γc-collaboration-with-takeda-to-develop-target↑✔Ω$ed-therapies-for-inflamma÷☆σtory-bowel-disease2019 Asia-pacific phar×"ma IP Leader Summit: http://en.zen¶↔seegroup.com/p/510934δ∏✔↔/ will be held in Beijin ♦g on November £'↔14-15, and will attract more than 500 industry÷→ experts from domestic and foreign pharmace πutical companies, biotechnology comp± <♣anies, governments, associat•★ions, law firms, intellectual property ag♠'"♦ents and other companies ®≠∏to attend.Official registrati¥εon and consultation channels:Con<∑¥∑tact：AnnPhone: 021-65650305Email：Marketing@z βenseegroup.comhttp://en.zenseegroש♠up.com/p/510934/ -
0929
Catabasis Pharmaceuticals and the Jain βλ Foundation Announce a Preclinical ♠♦♥Research Collaboration to Stu∞™✘ dy Edasalonexent in Dysferlinopathy
Catabasis Pharmaceuticals, Inc., a←∞ clinical-stage biopharmφ✘€∞aceutical company, and the Jain Foundation<$π, a non-profit foundation whose ↓♣>→mission is to cure muscular dystrophi¶₽∑es caused by dysferlin protein deficiency, an •$≥nounced a preclinical res×£∞earch collaboration t≈✘✘o study edasalonexent (CAT-1004) in Dysferlino↓≥♥↓pathy. Dysferlinopathy (Limb-girdleφ÷♠ muscular dystrophy type 2★δקB / Miyoshi myopathy) is a serious ra"↕re disease that causes p rogressive muscle weakness for whi×✔↔§ch there are currently no approveβαd treatment options. Edasalonexent is ✔←•in Phase 3 development for t€Ω←he treatment of Duchenne muscular dystrophy (DMD)≥←© and has the potential to benefit patients wit÷φ βh other diseases, such as Dysferlinopath$≠λy.In Dysferlinopathy,¶$≈> muscles lack dysferlin an™♠d as a result NF-kB is chroΩλ>σnically activated. Edasalonexen ★€t, an oral small molecule designed to inhibitε ♦$ NF-kB, has the potential to slow d♠'∑™isease progression in dysferlin♣•-deficient populations. Under this c♠₹ollaboration, Catabasis and t§↑♠he Jain Foundation are conducting a p•✘reclinical study to evaluate '∏÷ the potential of edasalonexent as a therapeutic©≈γ intervention for Dysferlinopathy by meas•✔uring disease progression in dysferlin-d÷∑'↓eficient mice treated with edasalonexent. The≤& study will utilize magnetic r§₩esonance imaging (MRI) and ©↑magnetic resonance spectros∞☆♦copy (MRS) to measure×← ↓ muscle volume, fat ac♠cumulation, and other ≠©changes in the dysferlin-dε"eficient mice. Initial results ar σ®e expected in the first half of 20§≥→20.“We look forward to wo≥∏rking with Catabasis ₩☆©Ωto advance research for Dysferlinopathy,” said ¥ Laura Rufibach, Ph.D., anε d Doug Albrecht, Ph.D., Co-Presidents of the J♥γain Foundation. “Patients with Dys™δ∞ferlinopathy (LGMD2B / Miyoshi myopathγ♠y) experience a progressive and debilitatinδε∏g decline in muscle function which significantl£"y impacts their lives. As there ≥σ♣ are currently no treΩα¶atment options, we are exci↑÷σted to explore the po$εtential of edasalonexent to bene∏♥ fit those living with this disease.”“The₽↔Ω chronic activation of NF™←"-kB is a key driver in many nπ≤♦euromuscular disorders, including Duche®↕nne muscular dystrophy. Evidence ♠of NF-kB activation in Dysferlinopaε"thy suggests a similar disease mechanism and opp←∑ortunity for intervention. In the Mov∏ eDMD trial and open-label♦ε > extension, treatment with edasa™§≠lonexent slowed disease progression compareλ¥≠d to the off-treatment control period. Throu•≠§₩gh this collaboration, we look φ↓γforward to learning more about the potentβ≥♠ial of edasalonexent in Dysferlinopathy, wh•™☆ere, similar to Duchenne, ✔₽₩there is also a significant ≤§unmet need,” said Andrew Nichols, Ph.D., Chief Scεientific Officer at Catabasis Pharmacγ<×euticals.information source:phar₩₹ma focus AsiaThe original link:https:httε±♣Ωps://www.pharmafocusasia.com/news/catabasis-pharm•¥£aceuticals-and-the-jain-foundation-an"δ®nounce-a-preclinical-re€≤search-collaboration-to-study-edasalonexent©♣♠-in-dysferlinopathy2019 Asia-pacifi±γc pharma IP Leader Summit: http://eσ∏ n.zenseegroup.com/p/404716/ will ✔€₽be held in Beijing πε★¶on November 14-15, and will attract more ↕than 500 industry experts from¶'✔ domestic and foreign pharmaceutical companies,↔÷ biotechnology compa♠★nies, governments, associations, εε®®law firms, intellectual property λagents and other companies to attend.Officα♥σ ial registration and consultation channels:±£Contact：AnnPhone: 021-656>±δ50305Email：Marketing@zenseegroup.comhttp:₹♣//en.zenseegroup.com/p/510934/
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