Xeris | November 24, 2022
Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that it has entered into a research collaboration and option agreement with Horizon Therapeutics plc. Under the terms of the agreement, Xeris will use its proprietary formulation technology platform, XeriJect™, to develop an ultra-concentrated, ready-to-use, subcutaneous injection of teprotumumab and Horizon will have an option to license the Xeris technology. Teprotumumab is the first and only medicine approved by the U.S. Food and Drug Administration for the treatment of Thyroid Eye Disease a serious, progressive and potentially vision-threatening rare autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the United States. Xeris will receive an upfront payment, and may be entitled to receive development milestones, regulatory milestones, and salesbased milestones, as well as royalties based on future sales if the commercial license option is exercised. Specific financial terms of the agreement were not disclosed.
“We are excited to announce our collaboration with Horizon for the development of a subcutaneous formulation of teprotumumab using our XeriJect technology to potentially enhance the patient experience and delivery of the treatment for Thyroid Eye Disease. This partnership demonstrates the potential value of our technology to enable large molecule subcutaneous injections that provide a more patient friendly regimen that is effective, safe, and more convenient, with potential for improved adherence.”
Paul R. Edick, Chairman and CEO of Xeris
XeriJect formulations are innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >400mg/mL, enable small volume subcutaneous injections and do not settle on storage. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing.
Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.
VIEWS AND ANALYSIS, PHARMACY MARKET
MedRhythms | December 12, 2022
CB Insights today announced that, for the second year in a row, MedRhythms has been named to its annual Digital Health 150, a list that showcases the 150 most promising private digital health companies. This recognition comes a week after MedRhythms received the Most Valuable Digital Therapy award at the Reuters Events Pharma Awards ceremony and less than a month after MedRhythms was named a Fast Company Next Big Things in Tech honoree for the progress that the company has made on its products and their potential to improve access to high quality care.
"From reimagining clinical care, to leveraging tech like AR/VR to improve surgical training, this year's Digital Health 150 winners are transforming the future of healthcare with digital technology. This increasingly global cohort, representing more than 18 countries across five continents, is not only driving better patient outcomes, but making healthcare more accessible. We are excited to follow the meaningful impact and continued success of this year's winners."
Brian Lee, SVP of CB Insights' Intelligence Unit
"Being recognized as a leader in the industry by CB Insights, Reuters Events Pharma and Fast Company is an incredible honor and is a testament to our entire team's commitment to our mission to positively impact the lives of those living with neurologic injury and disease," said Brian Harris, CEO and Co-Founder of MedRhythms. "These recognitions serve as validation of our team's progress to date and, more importantly, as motivation to keep advancing as we push the envelope in healthcare by building next-generation neurotherapeutics that leverage the power of music to bring important interventions to patients around the world."
Utilizing the CB Insights platform, the research team selected these 150 winners from a pool of over 13,000 private companies, including applicants and nominees. They were chosen based on factors including R&D activity, proprietary Mosaic scores, market potential, business relationships, investor profile, news sentiment analysis, competitive landscape, team strength, and tech novelty. The research team also reviewed over 3,000 Analyst Briefings submitted by applicants.
MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. In 2021, MedRhythms announced an oversubscribed Series B financing round of $27M co-led by Morningside Ventures and Advantage Capital. Since raising the Series B financing, MedRhythms has announced that the company has entered into collaborations with Universal Music Group (UMG), the world's largest record label for music content and data, and Biogen, one of the first global biotechnology companies. MedRhythms' most advanced product, which addresses gait impairment in chronic stroke, received Breakthrough Device designation from the U.S. Food and Drug Administration. Earlier this year, MedRhythms finalized a worldwide licensing agreement worth up to $120M with Biogen for the company's second product, which targets gait impairment in multiple sclerosis. In addition to these two assets, the company has a strong pipeline in large markets with high unmet needs and is conducting feasibility studies in collaboration with some of the world's leading clinicians and researchers.
About Fast Company
Fast Company is the only media brand fully dedicated to the vital intersection of business, innovation, and design, engaging the most influential leaders, companies, and thinkers on the future of business. The editor-in-chief is Brendan Vaughan. Headquartered in New York City, Fast Company is published by Mansueto Ventures LLC.
About Reuters Events Pharma
More open so that the strongest ideas and insights are brought to the fore in a transparent, trustworthy manner. More valued by having an authentic approach to building products and services that matter to patients.
MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. The company's pipeline product for chronic stroke walking deficits received Breakthrough Device designation in 2020 and the company raised a Series B financing round in 2021 led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine.