BUSINESS INSIGHTS, PHARMACY MARKET
PRNewswire | May 04, 2023
Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and H&T Presspart have entered in a strategic partnership to advance the development of Presspart's Sunriser© Capsule-based Dry Powder Inhaler platform. The demand for inhalable drugs that require higher drug loads and the delivery of cohesive materials has increased, making it necessary to develop more efficient solutions. To meet this demand, the two companies will work together to develop the Sunriser© Dry Powder Inhaler. This innovative and best-in-class capsule-based platform is flexible enough to address both the challenges of classic carrier-based and spray-dried engineered formulations.
This partnership is an extension of a successful collaboration that has spanned several years on developing and commercializing innovative dry powder inhalation devices. As part of the joint development agreement, Hovione will exclusively partner with Presspart to exploit the Sunriser© device in the field of engineered formulations for dry powder inhalation. Presspart will remain responsible for the manufacturing of the Sunriser© device. To provide further insights into the benefits of this partnership for the industry, a joint workshop will be held today, May 3rd, at the Respiratory Drug Delivery (RDD) Europe 2023.
"New inhalable therapies are often requiring delivery of higher doses of cohesive and sensitive powders. Our priority is to ensure maximum efficiency in delivering these drugs to the right locations in the lung," says Dr. Jean-Luc Herbeaux, Hovione´s CEO. He adds: "We are thrilled to expand our current partnership with Presspart and combine our expertise in the fields of engineered particles and inhalers for the benefit of our customers and patients."
Christian Kraetzig, President of H&T Presspart, commented "Following our successful collaboration with Hovione on the PowdAir Plus DPI device development, we are once again extremely pleased to be working with Hovione in developing this next generation high performance DPI device. As the market leader in respiratory components and devices, this strategic partnership will allow H&T Presspart to expand its portfolio within the growing field of dry powder technology."
Pharmaceutical companies partnering with Hovione to develop their new inhalable drugs using the Sunriser© device can leverage Hovione´s unparalleled expertise in inhalable APIs, formulation, filling, and analytical characterization. Additionally, with H&T Presspart's state-of-the-art device manufacturing and supply, from lab to commercial cGMP scale, companies can benefit from a comprehensive approach to drug development. This partnership enables pharmaceutical companies to access top-notch expertise and cutting-edge technology, ensuring the successful development and commercialization of innovative inhalable drugs.
Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices.
RESEARCH, PHARMA TECH
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.
BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 24, 2023
Curia, a leading contract research, development and manufacturing organization, today announced a collaboration with Corning Incorporated to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration with Corning’s Advanced-Flow™ Reactor (AFR) team includes the first installation of Corning’s G1 production system, designed for the continuous industrial production of active pharmaceutical ingredients (API).
Continuous flow chemistry is critical for the development and manufacture of pharmaceutical intermediates and APIs, and provides advantages compared with traditional batch processing. It is an inherently safer technology that delivers faster and more robust material production with a higher selectivity of desired products.
“Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, Research & Development, Curia. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.”
The G1 production reactor includes an updated set of dosing lines and controls that enable continuous operations and compliance to cGMP standards.
“Collaborating with an innovation-focused company like Curia will help drive advancements in the chemical-processing industry,” said Alessandra Vizza, business director, Corning Advanced-Flow Reactors. “The implementation of Corning’s G1 production system can deliver a host of benefits. The system is an inherently safer technology that will help Curia reduce time to market with higher-quality chemical and API processing, increased efficiency of chemical and API synthesis, and lower production costs.”
“Additionally, the space-saving, energy-conserving, and waste-reducing benefits of Corning’s AFR Technology may help customers reduce the environmental impact of their manufacturing business – a key attribute as the field continues to gain momentum in the U.S. and around the world,” said Vizza.
Curia’s expertise and global network of facilities, combined with Corning’s continuous flow technology, can help drive business efficiencies and, ultimately, improve patients’ lives.
Curia is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure.