PharmaEssentia was selected as one of the 2022 Industry Award Honorees, underscoring the significance of the introduction of BESREMi for the underserved MPN community
BURLINGTON, Mass.–(BUSINESS WIRE)–PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that it will receive a 2022 Industry Innovation Award from the National Organization for Rare Disorders (NORD�) for the introduction of BESREMi® (ropeginterferon alfa-2b-njft) as a treatment for polycythemia vera (PV), a rare blood cancer. PharmaEssentia will accept the award at the 2022 Rare Impact Awards ceremony in Cleveland, OH on June 26, 2022.
BESREMi was approved by the U.S. Food and Drug Administration in November 2021 as the only FDA-approved interferon for adults with PV, a type of myeloproliferative neoplasm (MPN). BESREMi is recommended in treatment guidelines for use in both high-risk and low-risk settings, addressing a clear, unmet need within the PV community and representing a shift toward earlier intervention to reduce the risk of disease progression. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.
This recognition from NORD for our dedication to the rare disease community and for our efforts to provide innovative solutions for people living with PV is an incredible honor and signifies the significant momentum in R&D for rare disease communities with few or no treatment options, said Meredith Manning, President of the Americas, PharmaEssentia. We couldnt have achieved this without the strong support and collaboration from across the community, and we remain focused on these collaborations to open new doors for patients and their families, advance the science of MPNs and apply inspired thinking to meaningfully improve lives.
For nearly 40 years, a significant aspect of NORDs mission has been to lessen the burden experienced by those living with a rare disease, said NORD President and CEO Peter L. Saltonstall. The Rare Impact Awards provides us with a unique opportunity to honor those who put the rare community first. NORD is proud to present PharmaEssentia with an Industry Innovation Award for their dedication to research and innovation for those living with PV.
The Rare Impact Awards program, a part of the Living Rare, Living Stronger NORD Patient and Family Forum, recognizes and celebrates the individuals, groups and companies making extraordinary strides on behalf of the millions of Americans impacted by rare disease.
About Polycythemia Vera
Polycythemia Vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.1
About BESREMi
BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. After one year, patients with stable complete hematologic response (CHR) can be treated with BESREMi every four weeks.
BESREMi has orphan drug designation for treatment of PV in the United States. The product was approved by the European Medicines Agency (EMA) in 2019 and has received approval in Taiwan and South Korea. BESREMi was invented and is manufactured by PharmaEssentia.
Important Safety Information
IMPORTANT SAFETY INFORMATION AND INDICATIONS
WARNING: RISK OF SERIOUS DISORDERS
Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions reported in > 40% of patients in the PEGINVERA study (n=51) were influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain. In the pooled safety population (n=178), the most common adverse reactions greater than 10%, were liver enzyme elevations (20%), leukopenia (20%), thrombocytopenia (19%), arthralgia (13%), fatigue (12%), myalgia (11%), and influenza-like illness (11%).
DRUG INTERACTIONS
Patients on BESREMi who are receiving concomitant drugs which are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification for these concomitant drugs. Avoid use with myelosuppressive agents and monitor patients receiving the combination for effects of excessive myelosuppression. Avoid use with narcotics, hypnotics or sedatives and monitor patients receiving the combination for effects of excessive CNS toxicity.
USE IN SPECIFIC POPULATIONS
Please see accompanying full Prescribing Information, including Boxed Warning.
About PharmaEssentia
PharmaEssentia Corporation (TPEx: 6446), based in Taipei, Taiwan, is a rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, the company aims to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today the company is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung. For more information, visit our website or find us on LinkedIn and Twitter.
Forward Looking Statement
This press release contains forward looking statements, including statements regarding the timing of BESREMis availability in the United States, the commercialization plans and expectations for commercializing BESREMi in the United States, and the potential benefits or competitive position of BESREMi. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include PharmaEssentias ability to launch BESREMi in the United States, whether BESREMi is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for BESREMi, and the ability to receive FDA and other regulatory approvals for additional indications for BESREMi. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website, and the FDA website, is not incorporated by reference into this press release and is included for reference purposes only.
1 Cerquozzi S, Tefferi A. Blast Transformation and Fibrotic Progression in Polycythemia Vera and Essential Thrombocythemia: A Literature Review of Incidence and Risk Factors. Blood Cancer J (2015) 5, e366; doi:10.1038/bcj.2015.95.
Contacts
Kellie Hotz, kellie_hotz@pharmaessentia-us.com
HO CHI MINH CITY, VIETNAM - Media OutReach Newswire - 24 December 2024 - JustMarkets…
BANGKOK, THAILAND - Media OutReach Newswire - 24 December 2024 - The Asia Corporate Excellence…
HOHHOT, CHINA - Media OutReach Newswire - 23 December 2024 - China's National Forestry and…
HONG KONG SAR - EQS Newswire - 23 December 2024 - Novautek Autonomous Driving Limited…
JAKARTA, INDONESIA - Media OutReach Newswire - 23 December 2024 - V-GREEN and PT Xanh…
Increase in opportunities predicted for high-speed optical transceivers and miniaturized connectivity solutions to address data-intensive…