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1011
Viela Bio Enters Strategic Collaboration with Mitsubishi Tanabe Pharma to Develop and Commercialize Inebilizumab for Autoimmune Diseases in Japan and Other Asia Regions
THURSDAY, OCTOBER 10, 2019Viela Bio, Inc. and Mitsubishi Tanabe Pharma Corporation (“MTPC”) today announced a collaboration focused on the development and commercialization of inebilizumab – Viela’s humanized anti-CD19 monoclonal antibody – in nine Asia regions for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential future indications.“This partnership adds to our ability to commercialize inebilizumab globally, subject to regulatory approval,” commented Bing Yao, Ph.D., Viela’s Executive Chairman and Chief Executive Officer. “As a well-established pharmaceutical company in Japan, Mitsubishi Tanabe has strong product development and commercialization capabilities in Asia, and we believe, is an ideal partner for expanding inebilizumab’s potential reach to thousands of additional patients in need of viable treatments, with NMOSD as an initial indication.”Under terms of the collaboration, Viela will receive an up-front licensing fee of $30 million as well as additional payments contingent on certain development and commercial milestones, plus payments based, in part, on sales revenue. MTPC will be responsible for leading development and commercialization of inebilizumab in Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, Philippines, Singapore, and Taiwan.“Our organization is delighted to partner with Viela to develop and commercialize their promising product candidate inebilizumab for autoimmune and inflammatory diseases,” said Masayuki Mitsuka, MTPC President & Representative Director. “Inebilizumab is an exciting product candidate that, based on the results from the N-MOmentum pivotal study, is well-positioned to provide meaningful benefit for patients with NMOSD, and potentially additional diseases, subject to regulatory approval. We are excited to work with Viela to advance inebilizumab in Japan and other Asia regions, and look forward to a productive partnership between our companies.”The U.S. Food and Drug Administration (FDA) recently accepted for review Viela’s Biologics License Application (BLA) for inebilizumab for the treatment of NMOSD. information source:pharma focus AsiaThe original link:https:https://www.pharmafocusasia.com/news/viela-bio-enters-strategic-collaboration-with-mitsubishi-tanabe-pharma-to-develop-and-commercialize-inebilizumab-for-autoimmune-diseases-in-japan-and-other-asia-regions2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934/ -
1010
4D Pharma collabor4D Pharma collaborates with MSD to develop live biotherapeutic products for vaccinesates with MSD to develop live biotherapeutic products for vaccines
4D pharma plc, a leading pharmaceutical company in the development of live biotherapeutics, today announces that the company has entered into a research collaboration agreement and an option license to use with MSD (trading name of Merck & Co., Inc., in Kenilworth , New Jersey , United States of America) to Discover and Develop Live Biotherapeutic Products ("LBP") for vaccines.Under the terms of the agreement, MicroRx®, the proprietary platform of 4D, will be associated with MSD's expertise in the development and commercialization of new vaccines, in order to discover and develop LPBs as vaccines in maximum three undisclosed indications. 4D has the right, subject to certain conditions, to purchase from MSD for $ 5 million common shares of 4D during the first 12 months of the collaboration. In addition to an initial cash payment, for each indication, 4D will be eligible to receive up to $ 347.5 million in exercise of options and regulatory and development milestone payments, as well as royalties the annual net sales of any licensed product resulting from the collaboration.Duncan Peyton , CEO of 4D, said, "This collaborative research agreement brings together 4D's innovations in the microbiome field and MSD's track record in the development of advanced vaccines. MSD and 4D worked closely together combining world-class scientific knowledge to develop a work plan to advance understanding of this field, with the goal of generating a new class of vaccines in areas where unmet needs are important. "Daria Hazuda , Scientific Director of MSD's Exploratory Science Center and Vice President of Research on MSD's Infectious Diseases and Vaccines Discovery, said, "A key element of our goal at the Center for Exploratory Science is the assessment of emerging areas of emerging biology that are likely to have a major beneficial impact on human health. By applying MicroRx® technology of 4D, we hope to obtain useful information on the role of the host microbiome in modulating the immune response and, ultimately, the protection conferred by vaccines. "information source:pharma focus AsiaThe original link:https:https://www.pharmafocusasia.com/news/4d-pharma-collaborates-with-msd-to-develop-live-biotherapeutic-products-for-vaccines2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934/ -
1009
Goldfinch Bio Announces Licensing Agreement with Takeda for CB1 Monoclonal Antibody for the Treatment of Rare and Metabolic Kidney Diseases
Goldfinch Bio, a U.S.-based, clinical stage biotechnology company focused on discovering and developing precision medicines for the treatment of kidney diseases, today announced it entered into a license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) for worldwide rights to a preclinical, peripherally-restricted cannabinoid receptor 1 (CB1) monoclonal antibody. Goldfinch Bio will assume all development and commercialization responsibilities for the treatment of rare and metabolic kidney diseases worldwide. However, the agreement grants Takeda the option, prior to the initiation of pivotal studies, to request Goldfinch Bio negotiate with Takeda for sub-licensing of Japanese rights to Takeda. Financial terms of the agreement were not disclosed. Goldfinch Bio plans to file an investigational new drug (IND) application for this CB1 inhibitor, re-named GFB-024, in the second half of 2020.“In recent years, our understanding of the role of CB1 signaling in exacerbating progressive kidney diseases has grown substantially. In this context, a monoclonal antibody directed toward the CB1 receptor is potentially well-suited to elicit the beneficial pharmacology associated with the peripheral inhibition of the CB1 receptor,” said Anthony Johnson, M.D., President and Chief Executive Officer of Goldfinch Bio. “Goldfinch Bio will deploy its biology platform and Kidney Genome AtlasTM to develop this therapeutic 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 Phase 1 clinical development, this peripheral CB1 inhibitor will be the second clinic-ready program in Goldfinch Bio’s pipeline. We look forward to collaborating with Takeda on this program.”“Goldfinch Bio is ideally suited to advance development of this program,” said Dan Curran, M.D., SVP and Head, Rare Diseases Therapeutic Area Unit, Takeda. “The application of its precision medicine approach, from candidate target validation through to identification of potential treatment-relevant subgroups, is unique in the development of chronic metabolic kidney disease treatments.”Preclinical data support the inhibition of CB1 signaling as a novel treatment of Diabetic Nephropathy (DN) and obesity-related glomerulopathies (ORG), given the potential metabolic benefits and direct effects on the kidney to prevent fibrosis and preserve kidney function. DN develops in 30 to 40 percent of patients who have diabetes and is a leading cause of morbidity, mortality and end-stage kidney disease in the United States and worldwide. ORG is a rare kidney disorder characterized by significant proteinuria and progressive renal dysfunction. Although both DN and ORG are increasing in prevalence in parallel with the obesity epidemic, well-established disease modifying therapies are lacking. Goldfinch Bio plans to initiate a phase 1 study for GFB-024 in 2H 2020.information source:pharma focus AsiaThe original link:https://www.pharmafocusasia.com/news/goldfinch-bio-announces-licensing-agreement-with-takeda-for-cb1-monoclonal-antibody-for-the-treatment-of-rare-and-metabolic-kidney-diseases2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/404716/ will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934/ -
1008
Prometheus Biosciences, Inc., Enters Into Multi-Target Strategic Collaboration with Takeda to Develop Targeted Therapies for Inflammatory Bowel Disease
Prometheus Biosciences, Inc., a biopharmaceutical company committed to the discovery, development, and commercialization of a broad portfolio of novel precision therapeutics and companion diagnostics for patients living with unmet needs in gastroenterology and autoimmune diseases, announced that it has entered into a global, multi-target strategic collaboration with Takeda Pharmaceutical Company Limited (Takeda) to discover, develop, and commercialize novel therapies for inflammatory bowel disease (IBD). The collaboration combines the proprietary bioinformatics discovery platform and companion diagnostic tools developed by Prometheus Biosciences with Takeda's expertise in gastroenterology and drug development, in order to discover and advance up to three targeted IBD therapeutics and companion diagnostics. Prometheus Biosciences will be responsible for the identification and validation of three unique drug targets for IBD, along with the development and commercialization of companion diagnostics to complement the targeted drugs. Takeda will be responsible for all drug discovery, clinical development, and commercialization activities for the resulting targeted therapeutics."We are impressed with Takeda's commitment to developing a portfolio of therapies to address all IBD patients, especially those with unmet needs," said Mark McKenna, chief executive officer, Prometheus Biosciences. "We believe that a targeted, precision medicine approach is needed to deliver new, effective therapeutic options in inflammatory bowel disease. Through our partnership, we are excited to combine the Prometheus bioinformatics platform and advanced machine learning techniques with Takeda's expertise in drug development to deliver a new generation of IBD therapies."Under the terms of the agreement, Prometheus Biosciences will receive an undisclosed initial upfront payment from Takeda and is eligible to receive up to $420M in development, regulatory, and commercial milestone payments, in total, across all three programs. In addition, Prometheus Biosciences is eligible to receive royalty payments on global commercial sales from each program.information source:pharma focus AsiaThe original link:https:https://www.pharmafocusasia.com/news/prometheus-biosciences-inc-enters-into-multi-target-strategic-collaboration-with-takeda-to-develop-targeted-therapies-for-inflammatory-bowel-disease2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/ will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934/ -
0929
Catabasis Pharmaceuticals and the Jain Foundation Announce a Preclinical Research Collaboration to Study Edasalonexent in Dysferlinopathy
Catabasis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, and the Jain Foundation, a non-profit foundation whose mission is to cure muscular dystrophies caused by dysferlin protein deficiency, announced a preclinical research collaboration to study edasalonexent (CAT-1004) in Dysferlinopathy. Dysferlinopathy (Limb-girdle muscular dystrophy type 2B / Miyoshi myopathy) is a serious rare disease that causes progressive muscle weakness for which there are currently no approved treatment options. Edasalonexent is in Phase 3 development for the treatment of Duchenne muscular dystrophy (DMD) and has the potential to benefit patients with other diseases, such as Dysferlinopathy.In Dysferlinopathy, muscles lack dysferlin and as a result NF-kB is chronically activated. Edasalonexent, an oral small molecule designed to inhibit NF-kB, has the potential to slow disease progression in dysferlin-deficient populations. Under this collaboration, Catabasis and the Jain Foundation are conducting a preclinical study to evaluate the potential of edasalonexent as a therapeutic intervention for Dysferlinopathy by measuring disease progression in dysferlin-deficient mice treated with edasalonexent. The study will utilize magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) to measure muscle volume, fat accumulation, and other changes in the dysferlin-deficient mice. Initial results are expected in the first half of 2020.“We look forward to working with Catabasis to advance research for Dysferlinopathy,” said Laura Rufibach, Ph.D., and Doug Albrecht, Ph.D., Co-Presidents of the Jain Foundation. “Patients with Dysferlinopathy (LGMD2B / Miyoshi myopathy) experience a progressive and debilitating decline in muscle function which significantly impacts their lives. As there are currently no treatment options, we are excited to explore the potential of edasalonexent to benefit those living with this disease.”“The chronic activation of NF-kB is a key driver in many neuromuscular disorders, including Duchenne muscular dystrophy. Evidence of NF-kB activation in Dysferlinopathy suggests a similar disease mechanism and opportunity for intervention. In the MoveDMD trial and open-label extension, treatment with edasalonexent slowed disease progression compared to the off-treatment control period. Through this collaboration, we look forward to learning more about the potential of edasalonexent in Dysferlinopathy, where, similar to Duchenne, there is also a significant unmet need,” said Andrew Nichols, Ph.D., Chief Scientific Officer at Catabasis Pharmaceuticals.information source:pharma focus AsiaThe original link:https:https://www.pharmafocusasia.com/news/catabasis-pharmaceuticals-and-the-jain-foundation-announce-a-preclinical-research-collaboration-to-study-edasalonexent-in-dysferlinopathy2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/404716/ will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934/
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