PHARMACY MARKET

Ascentage Pharma Announces its 9th Orphan Drug Designation from the US FDA in 2020

Ascentage Pharma | January 05, 2021

Ascentage Pharma (6855.HK), an internationally engaged, clinical-stage biotechnology organization occupied with creating novel treatments for malignancies, persistent hepatitis B (CHB), and age-related sicknesses, today reported that the US Food and Drug Administration (FDA) has allowed an Orphan Drug Designation (ODD) to the organization's novel Bcl-2 inhibitor, APG-2575, for the therapy of patients with intense myeloid leukemia (AML). This is the fourth ODD allowed to APG-2575 by the US FDA, following the past ODDs for the therapy of Waldenström macroglobulinemia (WM), ongoing lymphocytic leukemia (CLL), and numerous myeloma (MM). Until this point, four of Ascentage Pharma's investigational drug up-and-comers have been allowed an aggregate of nine ODDs by the US FDA, a record number for any Chinese biopharmaceutical organization.

AML is an exceptionally heterogenous hematologic threat that is more normal in the old populace with a middle age at analysis of 68 years1. The latest information from the Surveillance, Epidemiology, and End Results Program (SEER) of the US National Cancer Institute (NCI) assessed 19,940 new instances of AML and 11,180 passings from this infection in the United States in 2020. Notwithstanding the critical advances in therapeutics as of late, the 5-year endurance pace of AML stays at 25%–30%, which actually speaks to a huge neglected clinical requirement for treatments with more solid viability and a superior wellbeing profile.

The expression "vagrant medications" alludes to drug items produced for the counteraction, finding, and treatment of uncommon illnesses or conditions. In the United States, a vagrant sign is characterized as a sickness or condition with a pervasiveness of under 200,000 patients in the nation. Since the Orphan Drug Act was passed in 1983, the US government has given motivators and strategy backing to support advancement of vagrant medications. Treatments conceded ODDs by the FDA are equipped for different advancement motivators, including a tax break on consumptions brought about in clinical examinations, a waiver of the New Drug Application (NDA) charge, conceivable exploration award granted by the FDA, and above all, 7 years of US market restrictiveness upon endorsement.

Spotlight

This article is part of a series on Corporate law Society.svg By jurisdiction[show] General corporate forms[show] Corporate forms by jurisdiction[show] Doctrines[show] Related areas[show] Company portal Law portal v t e A company, abbreviated as co., is a legal entity made up of an association of people, be they natural, legal, or a mixture of both, for carrying on a commercial or industrial enterprise. Company members share a common purpose, and unite in order to focus their various talents and organize their collectively available skills or resources to achieve specific, declared goals. Companies take various forms, such as: voluntary associations, which may include nonprofit organizations business entities with an aim of gaining a profit financial entities and banks A company or association of persons can be created at law as a legal person so that the company in itself can accept limited liability for civil responsibility and taxation incurred as members perform (or fail to discharge) their duty within the publicly declared "birth certificate" or published policy. Companies as legal persons may associate and register themselves collectively as other companies – often known as a corporate group. When a company closes, it may need a "death certificate" to avoid further legal obligations.

Spotlight

This article is part of a series on Corporate law Society.svg By jurisdiction[show] General corporate forms[show] Corporate forms by jurisdiction[show] Doctrines[show] Related areas[show] Company portal Law portal v t e A company, abbreviated as co., is a legal entity made up of an association of people, be they natural, legal, or a mixture of both, for carrying on a commercial or industrial enterprise. Company members share a common purpose, and unite in order to focus their various talents and organize their collectively available skills or resources to achieve specific, declared goals. Companies take various forms, such as: voluntary associations, which may include nonprofit organizations business entities with an aim of gaining a profit financial entities and banks A company or association of persons can be created at law as a legal person so that the company in itself can accept limited liability for civil responsibility and taxation incurred as members perform (or fail to discharge) their duty within the publicly declared "birth certificate" or published policy. Companies as legal persons may associate and register themselves collectively as other companies – often known as a corporate group. When a company closes, it may need a "death certificate" to avoid further legal obligations.

Related News

PHARMACY MARKET

LIDDS Next Step with NanoZolid® formulated docetaxel

LIDDS AB | February 22, 2022

LIDDS AB announced that the next step in the development of NanoZolid®-formulated docetaxel will be to conduct a short clinical study to understand the immunological effects observed in the Phase I clinical study NZ-DTX-001. In the NZ DTX-001 study, activation of systemic inflammatory biomarkers was observed, which can provide improved conditions for treatment with so-called checkpoint inhibitors and result in treatment effect in non-injected tumors. In the clinical phase I study with nanodotax, which ended in October 2021, an activation of systemic inflammatory biomarkers was observed, which may open up the possibility of a combination therapy with so-called checkpoint inhibitors in cancer immunotherapy. Clinical studies have shown that systemically administered docetaxel significantly improves the response to treatment with checkpoint inhibitors. If LIDDS can show a similar effect with locally administered nanodotax but without systemic side effects, which risk inhibiting the specific immune response against the tumors, both improved efficacy and safety could be achieved. LIDDS has shown in preclinical studies that locally administered nanodotax has as good effect as systemically administered docetaxel but without systemic side effects. In order to provide a better foundation for decision-making in the clinical development of nanodotax, LIDDS has chosen to take over the sponsorship of the previously approved investigator driven trial on prostate cancer patients. The study provides an important analysis opportunity of the immunological response as the included patients will have their prostate surgically removed, which can be analyzed in detail. The study is planned to be conducted at one clinical site and is expected to include ten patients. “Based on the exciting activation of immunoregulatory molecules we saw in the Phase I study, it is important to confirm the mechanism of action of nanodotax. The increased understanding of the mechanism will more promptly lead us to the right form of treatment and patient group. The results may possibly also pave the way for more effective combination treatments, which is considered crucial for the commercial positioning of nanodotax and it justifies a further study” Nina Herne, CEO of LIDDS In December 2021, LIDDS announced the top-line data of the clinical Phase I study NZ-DTX-001. It was demonstrated that NanoZolid® in combination with docetaxel was safe and well tolerated, reaching the primary endpoint of the trial. The data also showed that the systemic docetaxel exposure was low and that activity in injected lesions was observed. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers that are considered important for efficient recruitment and activation of immune effector cells and for creating a good environment for treatments with immune-modulating drugs such as check-point inhibitors. The information was submitted for publication, through the agency of the aforementioned contact person, on February 21, 2022 at 16.30 CET. LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a clinically validated drug development technology and superior in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in clinical and preclinical phase for cytostatics and immunoactive agents. LIDDS (LIDDS) shares are listed on Nasdaq First North Growth Market. Redeye AB, certifiedadviser@redeye.se, +46 (0)8 121 576 90, is a certified adviser to LIDDS.

Read More

BUSINESS INSIGHTS

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.

Read More

RESEARCH

MindMed Signs Partnership with Swiss Psychedelic Drug Discovery Startup MindShift Compounds AG

MindMed | February 15, 2021

MindMed, a leading psychedelic medicine biotech company announced another partnership with Swiss startup MindShift Compounds AG to develop and patent next-gen psychedelic compounds with psychedelic or empathogenic properties. As a component of this partnership, MindMed and MindShift Compounds AG have agreed to develop next-gen psychedelic and empathogenic substances together. The first initial compounds have just been combined by MindShift Compounds AG and related patent applications were documented by MindMed. MindMed plans to begin first-in-human Phase 1 clinical trials as ahead of schedule as Q1 2022 through its existing clinical preliminary stage for psychedelic and empathogenic compounds in Switzerland. The partnership on these initial targets will expand MindMed's current, grounded clinical pipeline with extra reinforcement and expansion compounds with comparative and possibly improved restorative properties. The connected combination intellectual property and drug technology will be possessed through and through by MindMed, and MindShift Compounds AG will give all intellectual property identified with the new psychedelic compounds only to MindMed. This partnership adds to MindMed's existing IP portfolio development endeavors in progress in collaboration with the University Hospital Basel's Liechti Lab for exemplary psychedelic compounds including LSD, MDMA, Psilocybin, MDMA-LSD combinations, personalized dosing technologies and a LSD Neutralizer technology, which depend on multiple clinical trials and long stretches of exploration led by the Liechti Lab. MindMed plans to work with the accomplished drug discovery group at MindShift Compounds AG to encourage extensively cover preclinical psychedelics investigation into novel compounds and hopes to continue to record a substantial number of licenses on countless novel substance matters, production innovations, and later clinical applications, allowing MindMed to additionally unite its leading situation in the in general psychedelic-medicine market as it moves these next-gen compounds into the clinic through advanced patient clinical trials. MindShift CEO, Dr. Felix Lustenberger, said "Our innovative psychedelic drug-discovery platform based in Switzerland is pioneering next-gen psychedelic compounds that complement in a synergistic pipeline approach the later-stage development work underway at MindMed. The compounds we are working on are typically derivatives or analogues of known substances with psychedelic properties, such as phenethylamines, tryptamines, and ergolines, and are therefore enhanced versions of both the established and classic psychedelic compounds such as mescaline, psilocybin, DMT, and LSD, as well as compounds with expected combined psychedelic-empathogenic effect profiles. These novel chemical structures, for example MDMA and LSD-like compounds, are designed and synthesized with expected ameliorated psychoactive properties and duration-of-effect profiles with potential added therapeutic benefits." About MindMed MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic-inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company's groundbreaking approach to developing the next generation of psychedelic-inspired medicines and therapies.

Read More