PharmaEssentia Corp. rare blood cancer drug Ropeginterferon alfa-2b (referred to as Ropeg or P1101) is experiencing continued growth in sales in the United States. The company reported a revenue of NT$588 million for February, marking a growth of 15.81% compared to the previous month and a significant increase of 91.09% compared to the same period last year.
Ropeg has obtained approvals for polycythemia vera (PV) in multiple countries, including Europe, the United States, South Korea, Japan, and Taiwan, contributing to its ongoing global sales growth. PharmaEssentia Corp. has indicated that the number of patients with essential thrombocythemia (ET), Ropeg's second indication, is comparable to PV, with even fewer existing treatment options. With the expected market expansion following Ropeg's approval for ET, it is anticipated to become the second growth engine for the company.
The global Phase III pivotal clinical trial for Ropeg in ET (SURPASS ET) completed enrollment of 174 patients by the end of October last year, with data expected to be available as early as the end of this year. To enhance participation of ET patients in the United States, PharmaEssentia Corp. is actively conducting a single-arm clinical trial (EXCEED ET) in the country, aiming to enroll 64 patients. EXCEED ET applies to a broader range of ET patients compared to the enrollment criteria for SURPASS ET. Already, 62 patients have been enrolled in EXCEED ET, and in the two weeks prior to enrollment closure, an additional 35 patients have been screened and await entry into the trial, surpassing the original enrollment target significantly.
Additionally, PharmaEssentia Corp. is actively expanding Ropeg's new indications and its pipeline of new drugs. Ropeg's Phase II clinical trial for relapsed or refractory adult T-cell leukemia/lymphoma (ATL) has received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Moreover, the Phase I clinical trial for its long-acting granulocyte colony-stimulating factor P2203 has formally applied for human clinical trial review from Taiwan's Ministry of Health and Welfare, thereby further expanding its research and development scope.
