Ropeginterferon alfa-2b, or P1101, is a novel, long-acting, mono-pegylated interferon therapeutic discovered by PharmaEssentia, who plans to apply for its approval as first-line treatment for PV in a number of markets, including the USA. If approved, ropeginterferon alfa-2b is expected to be the first interferon approved for PV and the only FDA approved first-line treatment for PV. It may offer better tolerability and convenience due to its once-every-two-week dosing, as compared to other pegylated interferons, which are dosed once per week. The Company plans to commercialize ropeginterferon alfa-2b in major markets such as North America, Asia, and South America. Additionally, PharmaEssentia has exclusively licensed the rights to ropeginterferon alfa-2b for European, Commonwealth of Independent States (CIS), and Middle Eastern market commercialization for the treatment of myeloproliferative neoplasms (MPN) to AOP Orphan, a multinational biotechnology company based in Vienna, Austria.
Prior results from a phase I/II trial of ropeginterferon alfa-2b in PV patients, referenced as AOP2014 in a study sponsored and conducted by AOP Orphan, were presented at ASH Annual Meetings in 2012, 2013 and 2014. Encouraging study results stated: the overall clinical response rate including reduction of red and white blood cells and platelets was around 90% and after 6 to 12 months of treatment, 45-50% of patients showed complete response. Importantly, after one year all patients were largely independent from phlebotomies. Hematological responses correlated with molecular responses: JAK2V617F appears to be the key mutation driving PV and the allelic burden of this mutated clone was significantly reduced by treatment with ropeginterferon alfa-2b. Several patients achieved undetectable mutated JAK2 levels.2
Interferon-based therapeutics have been used for over 30 years to treat various MPNs, including PV, and have been shown to induce beneficial clinical, hematological, molecular and histopathological responses in a number of clinical studies. These unique and important benefits of interferon, including ropeginterferon alfa-2b, are now gaining significant interest and the results from several mid- and late-stage clinical trials will be presented during ASH 2016.
About Polycythemia Vera
Polycythemia vera is a cancer of the blood-building cells in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. This condition may result in circulatory disorders such as thrombosis and embolism, as well as malignant transformation to myelofibrosis or leukemia.
About PharmaEssentia Corporation
PharmaEssentia Corporation (Taipei Exchange:6446) is a global biopharmaceutical company, with headquarters in Taipei, Taiwan, delivering efficacious, safe and cost-effective therapeutic products for the treatment of human diseases while aiming to bring long lasting value to stakeholders. PharmaEssentia was founded in 2003 by a group of Taiwanese-American executives and high-ranking scientists from leading US biotechnology and pharmaceutical companies in order to develop treatments for myeloproliferative neoplasms, hepatitis and other diseases. The company mission and never-ceasing commitment is the improvement of health and quality of life for patients suffering from such diseases.
PharmaEssentia's lead therapeutic candidate, ropeginterferon alfa-2b (P1101), a new generation PEG-Interferon-alfa-2b, was developed using the Company's pegylation technology platform resulting in pegylated interferon 8 to 14 times more pure than products currently available on the market. Data suggests improved tolerability, less frequent dosing requirements, increased patient compliance and thus better long-term treatment outcomes. Ropeginterferon alfa-2b is being developed for a variety of indications, including myeloproliferative neoplasms (MPNs) and hepatitis B and C.
Ko-Chung Lin, Ph.D.
Founder & CEO
Tel: +886-2-26557688 #7802
The Ruth Group
The Ruth Group
1. The PROUD-PV study was sponsored and conducted by AOP Orphan in Europe. Ropeginterferon alfa-2b (P1101) is referenced as AOP2014 in the study.
2. H. Gisslinger, Veronika Buxhofer-Ausch et. al, "Efficacy and Safety Of AOP2014/P1101, a Novel, Investigational Mono-Pegylated Proline-Interferon Alfa-2b, In Patients With Polycythemia Vera (PV): Update On 51 Patients From The Ongoing Phase I/II Peginvera Study," Blood, vol. 122, no. 21, p. 4046, 2013.
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