PharmaEssentia Corp. announced that it has submitted to the marketing authorization application of BESREMi (Ropeginterferon alfa-2b, P1101). Application submission/approval/disapproval/each of clinical trials (include interim analysis): The marketing authorization application of BES REMi (Ropeginterfon alfa-2b) 500mcg/mL and 250mcg/0.5mL solution for subcutaneous injection in prefilled syringe for PV has been submitted in Brazil.

Estimated date of completion: According to the review procedure of Brazilian Health Regulatory Agency (ANVISA), the review time and deadlines for ANVISA issuing a final decision regarding marketing authorization (MA) approval for drugs are 120 days for dossiers granted priority review, and 365 days for ordinary MA reviews. The aforementioned deadlines can be extended by a maximum of a third of these periods. The actual review time and approval shall be subject to the decision of ANVISA.

Market situation: Polycythemia Vera (PV) is a chronic, progressive myeloproliferative neoplasm (MPN). Although the overproduction of red blood cell is most dramatic, however, in most cases, there are elevated white blood cells and platelets as well. PV patients are at high risk of cardiovascular complications such as thrombosis and embolism and secondary myelofibrosis or leukemic transformation.

Brazil is the larger country in Latin America. According to the market research, there are more than 100,000 PV patients in Latin America, and the current treatment includes phlebotomy, hydroxyurea (HU), interferon and JAK2 inhibitors. Ropeginterferon alfa-2b is an innovative monopegylated, long-acting interferon invented and manufactured by PharmaEssentia.

Ropeginterferon alfa-2b is approved to treat adult patients with PV in nearly 40 countries in the world, including major new drug markets such as the European Union, the United States, and Japan. The Company entered into an exclusive commercial license agreement with Pint-Pharma GmbH for the registration and commercialization of Ropeginterferon alfa-2b in Brazil, Argentina, Colombia, Chile, Peru, Ecuador, and Mexico.