Xeris Pharmaceuticals Strengthens Its Patent Estate

XERIS PHARMACEUTICALS, INC. | August 20, 2021

Xeris Pharmaceuticals, Inc., a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that it has recently been granted three new patents relating to its formulation technology platforms. The U.S. Patent and Trademark Office granted U.S. Patent Nos. 10,987,399 and 11,020,403 to Xeris, and the China Intellectual Property Office granted Chinese Patent No. ZL201580042185.5 to Xeris. The US ‘399 patent covers storage-stable formulations of pramlintide, and the US ‘403 patent covers storage-stable formulations of benzodiazepines, both using Xeris’ proprietary XeriSol™ formulation technology. The Chinese ’185.5 patent covers pre-filled syringes containing a variety of active pharmaceutical ingredients, using Xeris’ proprietary XeriJect™ technology. These patents, and related patent applications that are pending in these and other patent offices around the world, also cover the uses of such products in treating a variety of diseases and disorders including diabetes.

“Our strategy as a platform company is to patent early and often to continue to strengthen our position as a product development and formulation company. These new patent grants represent a significant expansion of Xeris’ intellectual property portfolio and help us to continue to invest in our innovation into life-saving therapies that can benefit patients worldwide,�� said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “With the recent opening of our Research & Development center in Chicago, led by our Chief Scientific Officer and Xeris co-founder Dr. Steve Prestrelski, we anticipate that we will continue to develop and bring to the market novel solutions for treating and preventing a variety of human diseases and disorders, improving the quality of life for our patients and their families.”

The granting of these patents expands the size of Xeris growing patent portfolio, bringing the total number of patents granted to Xeris worldwide to 121 (16 of which have been granted in the US). In addition to these new patent grants, Xeris has 120 patent applications pending worldwide, and expects to receive patent grants on several of those pending applications within the next several months. These patent grants, which provide Xeris the right to exclude others from making, selling, and using its proprietary technologies, will provide patent protection to Xeris on its proprietary pharmaceutical products for at least the next decade. All patents are owned by Xeris.

About Xeris Pharmaceuticals, Inc.
Xeris is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world. With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable drug products, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

Spotlight

AI Powered Business Intelligence for Life Science Leaders: Save Time, Drive Adoption and Scale Faster

Once the industry has normalized after a turbulent 2020,
life sciences leaders can still count on continued change.
The future will be challenging at best without the support
of next-gen BI as life sciences navigate their businesses
through new or growing competition, economic recovery,
regulatory and political pressures, barriers to market access,
and an increased demand for personalized medicine.

More featured news

Spotlight

AI Powered Business Intelligence for Life Science Leaders: Save Time, Drive Adoption and Scale Faster

Related News

BUSINESS INSIGHTS, PHARMACY MARKET

Cellworks Announces Expansion Into Precision Pharma

Cellworks Group | January 13, 2023

Cellworks Group Inc., a pioneer in personalized therapy biosimulation, announced the introduction of its precision drug development business units. These units will use predictive biosimulation to shorten drug development time-to-market and revive previously researched but disapproved pharmaceutical assets. The two new business units will use Cellworks' computational biology model (CBM) and biosimulation platform to predict responses to pharmaceutical interventions in silico, streamlining the clinical trial by identifying suitable patients more quickly, thereby reducing the time and cost of developing successful pharmaceutical agents. Cellworks precision drug development: Pre-clinical stage Companion molecule development: The Cellworks platform can augment a drug's usability by finding companion molecules that improve performance when combined with the investigational agent. Biomarker development: Cellworks utilizes cell lines and historical patient data to uncover novel biomarkers for investigational agents. This may increase drug success rates by proactively identifying individuals who will respond to an agent. Indication expansion: By utilizing the Cellworks patient database of 100,000+ omics patient profiles and 1,800 oncology cell lines to examine the agent's effectiveness in different indications, the Cellworks platform can identify additional indications where an experimental treatment may be successful. Cellworks precision drug development: Clinical stage Drug revival and repurposing: The platform seeks to anticipate whether certain drugs cause a response, which may be used to identify whether shelved assets can be resurrected via suitable patient selection or the discovery of non-obvious reasons. Clinical trial biosimulation: Through biosimulation clinical trials, the Cellworks platform may anticipate humans' clinical response to pharmaceutical agents in weeks, yielding critical insight years ahead of a traditional clinical practice. Cellworks Platform and Computational Biology Model (CBM) The Cellworks platform biosimulates the impact of specific pharmacological molecules on a given patient or class of patients using the patient's genetic profile. To generate a customized or cohort-specific disease model, multi-omic data from a cohort or patient is fed into the Cellworks computational biology model (CBM). About Cellworks Group Cellworks is one of the leaders in precision medicine. The organization assists physicians and payers in navigating the most efficacious, cost-effective therapies for patients. Its primary therapeutic areas are oncology, immunology, dermatology, and infectious diseases. Its one-of-a-kind biosimulation platform is a unified representation of biological information gathered from disparate databases and used to find cures. The company has the world's strongest trans-disciplinary team of molecular biologists, cellular pathway modelers, and internet software technologists working towards a common goal, i.e., taking on significant diseases to improve patients' lives.

BUSINESS INSIGHTS, PHARMA TECH

CONTINUUS Pharmaceuticals Adopts Digital Validation

CONTINUUS Pharmaceuticals | March 15, 2023

On March 14, 2023, ValGenesis, Inc., a leading enterprise validation lifecycle management solutions provider, announced that CONTINUUS Pharmaceuticals has successfully implemented the ValGenesis Validation Lifecycle Management System (VLMS) for efficient management of validation processes across the company in a 100% digital format. CONTINUUS Pharmaceuticals is a rapidly growing small business specializing in end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals. As a spin-out company resulting from a long-term collaboration between MIT and Novartis, CONTINUUS Pharmaceuticals is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of raw materials and APIs to final dosage forms. Due to the immense validation requirements involved in the production of different drug products, CONTINUUS Pharmaceuticals needed an electronic solution that determines the disposition of their assets while switching amongst product lines. By leveraging the ValGenesis VLMS, CONTINUUS Pharmaceuticals has successfully implemented facilities, equipment validation, computer system and utility validation. The ValGenesis VLMS is the system of record for CONTINUUS Pharmaceuticals' engineering team and will be expanded to other teams in the future. The highly automated, real-time, and compliant system provided by ValGenesis minimizes the potential for Good Manufacturing Practice (GMP) non-compliance while accelerating time to market. About CONTINUUS Pharmaceuticals CONTINUUS Pharmaceuticals is an end-to-end integrated continuous manufacturing (ICM) company specializing in pharmaceutical production. The company is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of APIs and raw materials to final dosage forms. It leverages a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), initially developed through a $65 million joint research project between Novartis and MIT. With ICM, it aims to transform and streamline the supply chain of pharmaceuticals by delivering high-quality, lower-cost drugs "on-demand."

RESEARCH, PHARMA TECH

Ionis Pharma's Eplontersen for ATTRv-PN Gets FDA's NDA Acceptance

Ionis Pharmaceuticals, Inc. | March 10, 2023

Ionis Pharmaceuticals, a leading RNA-targeted therapy firm, recently announced that the USFDA has accepted for review a new drug application (NDA) for eplontersen. Eplontersen is an investigational antisense medicine designed to reduce the production of transthyretin (TTR) protein and treat hereditary and non-hereditary forms of ATTR amyloidosis (ATTR). The NDA has been given a Prescription Drug User Fee Act (PDUFA) action date of December 22, 2023. The FDA has declared that no review concerns were detected and made no new data requests. The FDA also stated that it does not intend to conduct a meeting of the advisory committee to discuss the application. ATTR amyloidosis is a systemic disease caused by the accumulation of TTR protein in organs, leading to progressive organ damage and eventually death. Patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) experience ongoing debilitating nerve damage throughout their bodies, resulting in the progressive loss of motor function. The NDA for eplontersen is based on results from the global Phase 3 NEURO-TTRansform study showcased at the International Symposium on Amyloidosis (ISA). In the study, eplontersen showcased a statistically significant and clinically meaningful change relative to the baseline for its co-primary and critical secondary endpoints compared to the external placebo group. In addition, Eplontersen also demonstrated a favorable safety and tolerability profile. Ionis and AstraZeneca announced a strategic partnership to develop and commercialize eplontersen in December 2021. Eplontersen is being developed and commercialized jointly by both businesses in the United States and will be created and commercialized by AstraZeneca throughout the rest of the globe, except Latin America. The FDA granted eplontersen Orphan Drug Designation in the United States in January 2022. Eplontersen is also being studied in the worldwide Phase 3 CARDIO-TTRansform trial for transthyretin amyloid cardiomyopathy (ATTR-CM), a systemic, progressive, and deadly disorder leading to progressive heart failure and death within 3 to 5 years after disease start. About Ionis Pharmaceuticals, Inc. Ionis Pharmaceuticals, Inc. is a leading biopharmaceutical company headquartered in Carlsbad, California. Its unique antisense technology platform allows them to develop RNA-targeted therapies that modify the production of disease-causing proteins, leading to the development of treatments for rare genetic disorders, cardiovascular diseases, and neurodegenerative diseases. The company's most significant achievement is developing and commercializing Spinraza, the first approved treatment for spinal muscular atrophy. Ionis Pharmaceuticals has also developed drugs for other rare diseases, including transthyretin amyloidosis, Huntington's disease, and myotonic dystrophy type 1.