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1011
Viela Bio Enters Strategi↓↓£Ωc Collaboration with Mitsubishi Tanabe Pharma™$ to Develop and Commercialize Inebilizumab foλ¶r Autoimmune Diseases in Japan and Other As'≥♣ ia Regions
THURSDAY, OCTOBER 10, 2019Viela ★®☆Bio, Inc. and Mitsubishi Tan÷"abe Pharma Corporation (“MTPC”) today announ δ≤ced a collaboration focused on the develoλ♠pment and commercialization of in™α"ebilizumab – Viela’s humanized anti-CD19®×± monoclonal antibody – in nine Asia regions'×≠ for neuromyelitis optica spectrum disordeγ≥r (NMOSD), as well as other potenΩγ'tial future indications.“This part♣>nership adds to our ability to commerci§alize inebilizumab globally,λ♣ subject to regulatory approΩ×₹•val,” commented Bing Yao, Ph.D., Vie la’s Executive Chairman and Chief Exδ₽σecutive Officer. “As a well£←★"-established pharmaceuticaα≈÷£l company in Japan, Mitsubis¥>↔hi Tanabe has strong product develo∞✘©pment and commercialiαπzation capabilities in Asia, ε✔↓and we believe, is an ideal p×↔artner for expanding ineb ∞ilizumab’s potential✘α β reach to thousands of additional patients≤'β in need of viable treatments, with NMOSD as a•ε♣$n initial indication.”Unde★™r terms of the collaboration, Viel←α♥≈a will receive an up-front licensing fee of $3≠≠ 0 million as well as¥¶α© additional payments contingent on certain develo÷•pment and commercial mil←λestones, plus payments based, i↕β✘φn part, on sales revenue. MTPC will be responsibl★ ¶e for leading developmeδ♠nt and commercialization >✔ of inebilizumab in Ja← pan, Thailand, South Korea♠¥↔, Indonesia, Vietnam, Malaysia, Philippines, Sing∏↓ ↓apore, and Taiwan.“Our organization i £♣s delighted to partner ∏←with Viela to develop and ≤>∞πcommercialize their promising produc$<©×t candidate inebilizumab for autoimmune ε ♣and inflammatory diseases,” said Masayuki Mits®∑•uka, MTPC President & Representati≠♦∏λve Director. “Inebilizumab is an exβ←citing product candidate that, based on ♦±☆the results from the N-MOmentum pivotal study, Ω×<is well-positioned to provide meaningfu ☆l benefit for patien§♦ ts with NMOSD, and potentially addi>"•tional diseases, subject to regulatory appr∞ δoval. We are excited to work wi≈th Viela to advance inebilizumab in Japan a↑€nd other Asia regions, and l©↑ook forward to a productive partnership★♣→ between our companies.”The ∑U.S. Food and Drug Administrat≤©ion (FDA) recently accept☆§ed for review Viela’s Biologic↑αs License Application (BLA) for inebil€→izumab for the treatment of NMOS₩¶✔☆D. information&nbsσ≈¶ p;source:pharma focus As≠↓iaThe original link:https:https:/'λ/www.pharmafocusasia.com/news/vi≤α'ela-bio-enters-strategiΩ♦♣☆c-collaboration-with-mitsubishi-tanabe-pharma&Ω -to-develop-and-commercia≈ lize-inebilizumab-for-autoimmune₹"-diseases-in-japan-and-other-asia-regions20&'19 Asia-pacific pharma IP Leader Summit: h ←♦∞ttp://en.zenseegroup.com/p€↕'γ/510934/will be held in&nb✘Ωsp;Beijing on Novembe∏™r 14-15, and will attract more t≠han 500 industry experts from domest₹ ÷ic and foreign pharmaceutical companies, biotec™↓hnology companies, goveβ€Ω'rnments, associations, law firms, intellectu✔≠al property agents an♦¶€≥d other companies to attend.Offici×✔↓al registration and consultation c♠"™hannels:Contact：AnnPhone↓✔: 021-65650305Email：Marketing@zenseegroup.→∞comhttp://en.zenseegrou§×≈p.com/p/510934/ -
1010
4D Pharma collabor4D Pharma collaborates with MSDλ✔ to develop live biotherap↔♥÷∑eutic products for vaccines↓≠ates with MSD to develop live biotherapeutγ☆ic products for vaccines
4D pharma plc, a leading pharmβ&§±aceutical company in₹ & the development of live biotherapeutics, today "≤announces that the company has entered in☆to a research collaborat✘≠£ion agreement and an option license ₩₹♦to use with MSD (trading name of Merck &a≥"₩mp; Co., Inc., in Kenilwort↑±h , New Jersey , United Stδ×ates of America) to Discover and Develε∏♣"op Live Biotherapeutic Products ("LBP") for vacci♦↑£nes.Under the terms of≥ε✘ the agreement, MicroRx®, the propri& etary platform of 4D, will b&¶↔e associated with MSD's exp↑φβertise in the development and commercializ™φΩ↓ation of new vaccines, in order to discover±$& and develop LPBs as vaccines in maxiα$φ✔mum three undisclosed indications. 4¥≥D has the right, subjectα← to certain conditions, to purchase from MSD fo∏¥↑r $ 5 million common shares of 4D during the f♣∏↕irst 12 months of the c↓→ollaboration. In addition to an initial >εcash payment, for each ¥±λindication, 4D will be eligible to receive'₽ up to $ 347.5 million in exerci↕←♣se of options and regulatβγ↓→ory and development milestone<¥ payments, as well as royal±♦ties the annual net sales of any licensed$™≠ product resulting from the collabora∑tion.Duncan Peyton , CEO of 4D, said, "This¥ ÷ collaborative research agr★©§eement brings together 4D's innovations in the ♣∑₽×microbiome field and M&•λSD's track record in'↕φ the development of adv>₽×anced vaccines. MSD and 4D worked closely togeth™er combining world-class scientific ♥¥☆→knowledge to develop a work plan to↑δβ> advance understanding of this fiel∞®&∏d, with the goal of generating a nλ₽ew class of vaccines i♥εn areas where unmet needs are imp≠§$≥ortant. "Daria Hazuda , Scientific DireφΩctor of MSD's Exploratory ScienδΩ ce Center and Vice President of Rese'✔¥Ωarch on MSD's Infectious Diseases and Vaccines Dλ&εiscovery, said, "A key element ♦♠φ↑of our goal at the Ce↑βnter for Exploratory Science is the assessment o≥f emerging areas of emer§£ging biology that are likely to have a major ben≥≈eficial impact on human health. By applying Mic₽®"roRx® technology of 4D, we hope to obtain useful εinformation on the role☆∞αα of the host microbiome in modulat¥ing the immune response and, ultimately, the pr$'otection conferred by vaccines. "information↑↓ source:pharma focus AsiaThe original l₹≈ink:https:https://www®∏.pharmafocusasia.com/news/ δ₽4d-pharma-collaborates-with-msd-↑×to-develop-live-biotherapeutic-products ∑-for-vaccines2019 Asia-pacific pharma IP Leader S©>ummit: http://en.zenseegrouβ↓♠®p.com/p/510934/will be held in Beijin✘→←g on N♣&ovember 14-15, and will attract more than 500 i∞★↓∏ndustry experts from domestic and foreig&₹n pharmaceutical companies, biotec÷hnology companies, governments, associations, la≥ ¥←w firms, intellectual property agents and o↓↕ther companies to att<Ωend.Official registration and consultα ation channels:Contact：An↓ nPhone: 021-65650305Email：Marketing@zen↑∑→←seegroup.comhttp://en.↓α∞zenseegroup.com/p/51∞™÷0934/ -
1009
Goldfinch Bio Announces Licensing Agreement φ↕←with Takeda for CB1 Monoclonal Antibody for the T↕<reatment of Rare and M★£§<etabolic Kidney Diseases
Goldfinch Bio, a U.S.-based, clinical stage ≥πδbiotechnology company focused on discovering and ₩€ ₽developing precision medicines for the treat&→♣≠ment of kidney diseases, t♠σoday announced it entered into a liceλ✘§→nse agreement with Takeda Phar ₽maceutical Company Limited (“Takeda”) for world©×✘wide rights to a preclinical, peripherally-restricted cannabinoid receptor 1 ₩♣(CB1) monoclonal antibody. G↓π>oldfinch Bio will assume"∞✔σ all development and com<♦mercialization responsibilities for the trea™←∞tment of rare and metabolic kiΩ™dney diseases worldwide. However, the a"≥↕greement grants Takeda the option, prior t"★∞o the initiation of pivotal studies, t©₹βo request Goldfinch Bio negotiate with Takeda ≥✘ for sub-licensing of Japane™ε'πse rights to Takeda. Financial t€↓♣★erms of the agreement were not dis≠≠closed. Goldfinch Bio pla≈&ns to file an investiga ←∑tional new drug (IND) application →•for this CB1 inhibitor, re-name ±d GFB-024, in the second halδ←♣f of 2020.“In recent ye★↓♦ars, our understandin® ₩g of the role of CB1 signaling i₩ §n exacerbating progressive kid• $ney diseases has grown s↑↔ubstantially. In this∞ context, a monoclonal antibody directed ™ ✘toward the CB1 receptor is potential≥→≤ly well-suited to eliε♥Ωcit the beneficial pharmacology associated wi™→th the peripheral inhibition of the CB1 receptor,'↓<” said Anthony Johnson, M.D., President and ↓<$Chief Executive Officer of Goldfinch Bio. “Goldfi↕↕φ¥nch Bio will deploy its ←φ₩biology platform and Kidney Genome A׶tlasTM to develop this therapeuλσtic agent in subsets of patients with kidney ↔∞diseases most likely to ÷ 'preferentially respond ≤≤₽to CB1 inhibition. With GFB§≤-887, our TRPC5 inhibitor for FSGS, in Ph≥λ←<ase 1 clinical developΩ✘ment, this peripheral ≈§ CB1 inhibitor will be the seco™∞nd clinic-ready program in Goldfinch Bio’s pip÷♣✘eline. We look forward to c<☆ ollaborating with Takeda on ®this program.”“Goldfinch Bio is ideally suited to✔♣® advance development of this pro ©≠gram,” said Dan Curran, M.D.₹<©∏, SVP and Head, Rare Diseases Therap↑ε→"eutic Area Unit, Takeda. “The application ofε←•↔ its precision medicine approach, from can♣₹didate target validation ¶×✘through to identification of potential"₹≠ treatment-relevant subgroups, is uniq♦φ→ue in the development of chronic metabolic↑¥ kidney disease treatments.”Pr"€eclinical data support the inhibition of CB1 ±≤signaling as a novel treatment€₽ of Diabetic Nephropathy ±®☆<(DN) and obesity-related g↕¥®lomerulopathies (ORG), given ©"the potential metabo$>σ£lic benefits and direct ef®≥™∞fects on the kidney t>o prevent fibrosis and preserve kidney functio&•↑₹n. DN develops in 30 to 40 percent of λλpatients who have diabetes and is a leadi€✘ng cause of morbidity, mortali$&ty and end-stage kidney diseaseσ←≥ in the United States and worldwide. ORG is a rar≠'&↓e kidney disorder chara↑₹©cterized by significant proteinα✘<uria and progressive renal dysfunctio'β↓λn. Although both DN an♠↔≠d ORG are increasing in prevalence in parallel wi↑↑≈th the obesity epidemicλ™, well-established disease modifying tα≈ ∑herapies are lacking. Goldfinch Bio plans to ini≠£ tiate a phase 1 study ☆§σfor GFB-024 in 2H 2020.information source:•∞←₩pharma focus AsiaThe original link:httpsδ"://www.pharmafocusasia.com/news/goldf ×✘₽inch-bio-announces-licensing-¶∞agreement-with-takeda-for-cb1-monoc ♥•™lonal-antibody-for-the-treatment-of-rare-aΩβnd-metabolic-kidney-diseases20ε✔19 Asia-pacific pharma IPλ•∞ Leader Summit: http:/€ ↕/en.zenseegroup.com/p/404716/ will b®λ e held in Beijing &nb™↔γsp;on November 14-15, and ♥∏will attract more than 500 indus↔£try experts from domestic and fαoreign pharmaceutical ÷↑companies, biotechnology♥ companies, governments, associations ≥&, law firms, intellectual property agents and ot≠®her companies to attend.Of<≈<ficial registration and co≥± ♠nsultation channels:Cont÷∑γ∞act：AnnPhone: 021-65650305Email：Marketing@÷↓→εzenseegroup.comhttp://en.≠¥✔zenseegroup.com/p/510934/ -
1008
Prometheus Bioscienc₹♠↑es, Inc., Enters Into Multi-Target Strateg±≈ic Collaboration with Takeda to Develop Tar₩₹γgeted Therapies for Inflammatory Bowel<$ Disease
Prometheus Biosciences, Inc., a biopharmaceutical✘≈α♣ company committed t≥σo the discovery, development, and co€γ©mmercialization of a broad portfolio of n&★™♥ovel precision therapeutics and compaδ€✔•nion diagnostics for patients→ε∞δ living with unmet ne≠±♠eds in gastroenterology and autoimmune dise ♥ases, announced that it has entered into a globa₩'↓l, multi-target strategic collaboΩ>ration with Takeda Pharmaceutica♦l Company Limited (Takeda) to discover, develop, ₹©φ★and commercialize novel therapies for ε$inflammatory bowel disease (IBD). Theβ→> collaboration combines th★&↑e proprietary bioinformatics disco γvery platform and companion diagnostic tool∏≤s developed by Prometheu>≈s Biosciences with Takeda's expertise inα₩$ gastroenterology and drug dev↓©≈♣elopment, in order to discover and advanc∏♦"γe up to three targeted IBD thera↓≤₩™peutics and companion diagnostics. §←Prometheus Biosciences will be respons¶§ible for the identification and validat®∏≠ion of three unique drug targets fo←↔r IBD, along with the development and commerciaδ<lization of companion diagnostics to compleme∏÷₽nt the targeted drug↓♦s. Takeda will be responsiblφ¶e for all drug discovery, clinical develop₩♠ment, and commercialization acπtivities for the res∞≠σulting targeted therapeutics.↕§₹∏"We are impressed with§> Takeda's commitment to developing a portfol™∏λ™io of therapies to address al↔♥l IBD patients, especially thoseπ₽€₹ with unmet needs," said Mark McKenna, chief exec>ש★utive officer, Prometheus Biosciences. "Wγ★e believe that a targeted, p" recision medicine approach←"← is needed to deliver new, ≠↕α×effective therapeutic options in inflammatory ₹₩☆bowel disease. Through our p♦→$artnership, we are excited to combine the✘σ♠φ Prometheus bioinformatics platform and advanc¶♦±εed machine learning techniques with δσTakeda's expertise in drug development to deliver a ne↑>±πw generation of IBD therapies.<€'→"Under the terms of the agreement, Prometheus ✘®βBiosciences will receive an undΩ←isclosed initial upfront payment from Takeda ÷±γand is eligible to receive up to $420M in de•×velopment, regulatory, and commercial mi¥>★♥lestone payments, in total, a₹§≈★cross all three programs. In addition, Prome☆π✔♣theus Biosciences is eligible to®εφ receive royalty payments on glo≈ •←bal commercial sales from each program.iλ∏↓nformation source:phaφαrma focus AsiaThe original link:https:https://w✔♥¶¥ww.pharmafocusasia.com/news/prometheus-bβ≥iosciences-inc-enters-into-multi-targe✔↔∞¥t-strategic-collaboration-with-takeda-to-develo♠£p-targeted-therapies-for-inflamm™ α¶atory-bowel-disease2019 Asi •a-pacific pharma IP Leader Summit: http:/< ≈/en.zenseegroup.com/p/510934/ will be hλ↕eld in Beijing&n×≠↑♥bsp; on November 14-15, and will a← ttract more than 500 indust ¥≠ry experts from domestic↑♦® and foreign pharmaceutical companie≥φ®φs, biotechnology companies, governmentβ®s, associations, law fi✘£rms, intellectual property agents and other comp≠anies to attend.Official registration and con↓✔sultation channels:Contact：AnnPhone: 021-65650305≠•∞Email：Marketing@zenseegroup.comhttp://en.zenseeg§←≈roup.com/p/510934/ -
0929
Catabasis Pharmaceuticals and the Jainπ✔♦≠ Foundation Announce a Preclinica™←✘l Research Collaboration to Study€Ω Edasalonexent in Dysferl₽♠×inopathy
Catabasis Pharmaceuticals, Inc., a clinical-s¥☆tage biopharmaceutical compaπ∑≈ny, and the Jain Foundation, a non-prof♠♠€it foundation whose mission is₩✔∏ to cure muscular dystrophies φ∏β×caused by dysferlin protein deficiency♣ ', announced a preclinical research collaboγεΩration to study edasalonexent (CAβσ↑♣T-1004) in Dysferlinopathy. Dysferlinop≥¶♦athy (Limb-girdle muscular dystroph♥∞¥y type 2B / Miyoshi myopat♦ δhy) is a serious rare dis>$→ease that causes progressive muscle ± ∑≠weakness for which there a§δ←re currently no approved treatm✔€ent options. Edasalonexen↑♦t is in Phase 3 development for t≤₩he treatment of Duchenne musλ→αcular dystrophy (DMD) and has the potentiaλ$€₹l to benefit patients with other©♣± diseases, such as D≤₽ysferlinopathy.In Dysferlinopathy, mu♠ε₹scles lack dysferlin and as a res∞₩ult NF-kB is chronically acti♦>vated. Edasalonexent, an oral smalπλl molecule designed to inhibit NF-kB, has the α♥potential to slow disease prφ÷ogression in dysferlin-deficient populations. U€ nder this collaboration, Catabasis and the Jain Fδ®oundation are conducting a preclinical study×& to evaluate the potential €₹&¶of edasalonexent as a therapeut☆♠§ic intervention for Dysferlinopathy by δσmeasuring disease progre¥✔☆ssion in dysferlin-deficient mice treated with ✘ edasalonexent. The study will ☆utilize magnetic resonance imaging (MRI)£ε↑ and magnetic resonance spec☆←★troscopy (MRS) to measure muscle &•volume, fat accumulation,σ₽☆ and other changes in the dysferlin-deficient mi∏ce. Initial results arδΩe expected in the first↓§ half of 2020.“We look f ₽λorward to working with Catabasis to advance re≠✔ search for Dysferlin♥÷opathy,” said Laura Rufibach, Ph.D., and Douβ>↔g Albrecht, Ph.D., Co-Presidents of$♥≠ the Jain Foundation. “Patα$≤®ients with Dysferlinopathy (LGMD2B / Miyoshi→ε€ myopathy) experience a progressive andδ₩↔ debilitating decline in muscle function which γ•significantly impacts thei←≈r lives. As there are c≈™urrently no treatment options, we a÷ε &re excited to explore the♥ε potential of edasalonexent to ÷ §benefit those living wit♥↓& h this disease.”“The chronic activation of NF-kB is a key dr©πiver in many neuromuscular ε☆≠ disorders, including Duchenne muscu♦∞lar dystrophy. Evidence of NF-k©♣B activation in Dysferlinopathγ₽÷y suggests a similar disease m§₩≈echanism and opportunity for intervention. In t∞ ≠•he MoveDMD trial and open-label extension, tr₩βeatment with edasalonexent slowed disease p↓♥♣rogression compared to the off-treatmeδ₽≥nt control period. Thro♦✘αugh this collaboration, we look forward to÷γσ learning more about the poten∏₩♥tial of edasalonexent in Dysferlinopathy, where,₹∞₹ similar to Duchenne, there is also a si≠βgnificant unmet need,” said Andrew Nichols, Ph.D×φ£ε., Chief Scientific Officer at Catabasis P♥εharmaceuticals.informat¥ε★ion source:pharma♠♥♣ focus AsiaThe original lin₩∞k:https:https://www.pharmafocusasia.com >/news/catabasis-pharmaceuticals-and-the-j±÷ain-foundation-announce-a-preclinicδ≤al-research-collaboration-to-©♥© study-edasalonexent-in-dysferlinop₽←γathy2019 Asia-pacific pharma IP Le★δader Summit: http://en.zenseegroup.γ£★com/p/404716/ will ≤α₽be held in Beijing on N↓"ovember 14-15, and will a₩εttract more than 500 industry experts fr&✔<γom domestic and foreign pharmaceutica ₩l companies, biotechnology companie ↕s, governments, associatioα&§₩ns, law firms, intellectual property a×₩π↑gents and other companies to atten£₽αd.Official registratio ★↓n and consultation channels:Contλ→★♣act：AnnPhone: 021-65•←650305Email：Marketing@zenseegroup.comht'≠<tp://en.zenseegroup.com/p/5>™∞10934/
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