Business Wire

AOP Health: Completed Study Strengthens Clinical Development Program for ropeginterferon alpha 2b (Besremi®) in polycythaemia vera

Share

With the publication of the final results from the LOW-PV study in the New England Journal of Medicine Evidence conducted by Fondazione per la Ricerca dell'Ospedale di Bergamo (FROM) under the leadership of Professor Tiziano Barbui, AOP Health announces an important advancement reinforcing its clinical development program for ropeginterferon alpha-2b (BESREMi®) in polycythaemia vera (PV), a rare blood cancer. The academic LOW-PV study supported and funded by AOP Health and public organizations in Italy complements a series of trials performed by AOP Health over more than 10 years to achieve marketing authorization in Europe and the Middle East. With these clinical studies, including PEGINVERA, PROUD-PV, and CONTINUATION-PV, AOP Health opened a new area of treatment options for patients suffering from PV. A further study (PEN-PV) was performed to develop a pen for self-injection allowing ease of self-administration, exact dosing and minimal waste of the medical product. AOP Health’s comprehensive development program in PV is considered by many key opinion leaders as the most significant development in the field of PV treatment in the past 30 years.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230601005759/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Dr. Rudolf Widmann, Founder and Board Member of the AOP Health Group/ Copyright: Studio Koekart: Natasche Unkart & Isabella Köhler (Photo: Business Wire)

This series of studies has enabled marketing authorizations to be obtained in numerous countries in addition to the AOP Health territories EU, Switzerland, Liechtenstein and Israel and allows patients to have access to BESREMi® in countries including Taiwan, Korea, the US, and Japan. Further studies are ongoing to substantiate the long-term safety and efficacy of BESREMi®. A post-approval safety study (BESREMI-PASS) with a recruitment period of about three years has just completed patient recruitment.

“The global marketing authorizations of BESREMi®, all based on AOP Health´s clinical development program conducted in Europe, are proof of the integrated drug development and commercialization expertise of AOP Health. Our success and know-how allow us to further pursue our goal of making treatment options for rare diseases available to patients worldwide” says Dr. Rudolf Widman, Founder and Board Member of the AOP Health Group.

About BESREMi®

BESREMi® is the first and currently only interferon approved for polycythaemia vera, a myeloproliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythaemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies.

BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered with a pen (250 and 500 ug) for self-injection once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen.

For the EMA Summary of Product Characteristics please visit: BESREMi®

Link: https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf

The drug substance Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Health. In 2009, AOP Health in-licensed the exclusive rights for clinical development and commercialization of ropeginterferon alfa-2b in polycythaemia vera and other MPNs such as chronic myelogenous leukemia (CML) for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.

About AOP Health

The AOP Health Group incorporates several companies including AOP Orphan Pharmaceuticals GmbH with its seat in Vienna, Austria (“AOP Health”). The AOP Health Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the Group has become an established provider of integrated therapy solutions operating from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. The claim “Needs. Science. Trust.” sums up the foundation of the Group’s success: establishing trust through a continually high level of investment in research and development and a highly consistent and pragmatic orientation towards the needs of all stakeholders – especially the patients and their families as well as the healthcare professionals treating them.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Further inquiry
DI Isolde Fally
Isolde.Fally@aop-health.com
+43-676-500 4048
From the US: 011-43-676-500 4048

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Monument Re Transfers €1.4bn Greycastle Portfolio to RGA and Strengthens European Life Insurance Consolidation Platform9.5.2025 15:00:00 EEST | Press release

Monument Re Limited (“Monument”) announces today that it has transferred a legacy €1.4bn reinsurance portfolio, comprising annuity and other life insurance liabilities acquired as part of the 2020 Greycastle transaction, to RGA Americas Reinsurance Company, Ltd. (“RGA”). This transaction releases capital resources that Monument will redirect to its core strategy of consolidation in European life insurance markets. The transaction completed on 2May 2025 following approval by the Boards of Directors of both Monument and RGA and non-objection from the Bermuda Monetary Authority. Monument has taken significant steps in recent months to strengthen its business operations by consolidating its European group support functions in Dublin and by aligning with the recently strengthened regulatory regime in Bermuda. With its strong financial position and best in class capabilities in the Group, Monument remains ideally positioned to build on its success to date and grow its European footprint, del

IFF Completes Divestiture of Nitrocellulose Business9.5.2025 15:00:00 EEST | Press release

IFF (NYSE: IFF) today announced that it has completed the divestiture of its nitrocellulose business, including Walsrode Industrial Park in lower Saxony, Germany, to Czechoslovak Group (CSG). The business manufactures nitrocellulose strictly for industrial purposes, serving customers primarily in coatings and printing inks, and had been part of IFF’s Pharma Solutions business unit. “The divestiture of our nitrocellulose business builds upon our deleveraging journey and enables us to focus on our core businesses,” said Erik Fyrwald, IFF CEO. “I’d like to thank our nitrocellulose colleagues for their dedication and wish them continued success as part of CSG.” Welcome to IFF At IFF (NYSE: IFF), we make joy through science, creativity and heart. As the global leader in flavors, fragrances, food ingredients, health and biosciences, we deliver groundbreaking, sustainable innovations that elevate everyday products—advancing wellness, delighting the senses and enhancing the human experience.Le

CPAC Systems AB Announces Strategic Minority Investment in Flying Fish9.5.2025 13:33:00 EEST | Press release

CPAC Systems AB, a leader in advanced control systems and embedded vessel and commercial vehicle technology, today announced a strategic minority investment in Flying Fish Maritime Innovations B.V., a pioneer in advanced shared water mobility solutions and robust, cost-effective hydrofoil technology. The investment underscores both companies’ commitment to redefining water-based transportation through innovation, sustainability, and seamless integration. It marks the beginning of a deeper collaboration aimed at enabling smarter, cleaner, and more connected mobility on the water — for both recreational and commercial applications. “We are thrilled to support Flying Fish and their impressive work in redefining water mobility,"saidMarcus Wingolf, CEO of CPAC Systems. "Our investment in Flying Fish represents a strategic alignment of our technical proficiencies and innovative ambitions. This partnership opens exciting new possibilities for integration and sustainable transformation across

Kioxia Receives IEEE Corporate Innovation Award9.5.2025 10:00:00 EEST | Press release

Kioxia Corporation, a world leader in memory solutions, today announced that it has received the IEEE Corporate Innovation Award from the Institute of Electrical & Electronics Engineers (IEEE), the world’s largest technical professional organization dedicated to advancing technology for the benefit of humanity. This award recognizes Kioxia's outstanding contribution in the field of electrical and electronics engineering through its BiCS FLASH™ technology, a low-cost, high-capacity 3D flash memory innovation. The award ceremony was held on April 24 in Tokyo. The IEEE Corporate Innovation Award is a globally-recognized honor bestowed upon organizations that have developed innovative technologies, products or services that have made a substantial contribution to the advancement of electrical and electronics engineering. Since its inception in 1985, the award has been presented to leading electronics manufacturers and IT companies worldwide, and Kioxia is proud to be the seventh Japanese c

Suzano Reports Record First-Quarter Revenue9.5.2025 03:12:00 EEST | Press release

Suzano, the world’s largest pulp producer, announces its first quarter results for 2025 (1Q25) with record net revenue of R$11.6 billion, up 22% on the same quarter last year (1Q24). The result was driven by the exchange rates, increased pulp sales volumes from the new Ribas do Rio Pardo mill, higher paper volume and prices and the positive contribution from our paperboard mills recently acquired in the U.S. The record revenues occurred despite a series of planned downtimes in the quarter, including production lines of the Três Lagoas Unit, Mucuri Unit, and Aracruz Unit, and the Ribas do Rio Pardo Unit’s first scheduled maintenance downtime. Sales exceeded 3 million tonnes in the quarter, a rise of 12% compared to 1Q24, comprising 2.7 million tonnes of pulp and 390 thousand tonnes of paper, up 10% and 25%, respectively, on the same quarter last year. Adjusted EBITDA totaled R$4.9 billion, a 7% increase over 1Q24. Operating cash generation totaled R$2.6 billion, rising 5% on 1Q24. Net p

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye