PharmaEssentia Corporation announced Submission of Marketing Authorization Application of BESREMi (Ropeginterferon alfa-2b) for PV in Argentina. New drug name or code:BESREMi (Ropeginterferon alfa-2b, P1101). Indication:Treatment of adults with Polycythemia Vera (PV) Planned development stages: Submission of marketing authorization application in Argentina.

Current development stage: (1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): The marketing authorization application of BESREMi (Ropeginterferon alfa-2b) 500mcg/mL and 250mcg/0.5mL solution for subcutaneous injection in prefilled syringe for PV has been submitted in Argentina. (2)Risks and mitigation measures to be taken by the company upon disapproval of the competent authority: N/A (3)Strategies to be taken by the company upon approval by the competent authority: N/A (4)Accumulated investment expenditure incurred: In consideration of the future marketing strategy and to protect the rights of the company and investors, no public disclosure will be made for the time being. Upcoming development plan: Review of the marketing authorization application in Argentina (1)Estimated date of completion: According to the review procedure of Argentina National Administration of Drugs, Food and Medical Devices (ANMAT).

The actual review time and approval shall be subject to the decision of ANMAT. (2)Estimated responsibilities: N/A. 7.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. 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.