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Primary treatment:
The company also said it is conducting a Phase 3 trial of its blood cancer drug and has received positive feedback from reviewers.
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Chen Chen Hee / Staff Reporter
PharmaEssentia Corp (藥華醫藥) announced yesterday that it has applied for marketing approval of its login interferon alpha-2b drug to China’s National Medical Products Administration.
The company is seeking approval for use in the treatment of polycythemia vera, a rare type of blood cancer, it said in a regulatory filing.
The interferon drug, marketed in the US under the name Besremi, is the only approved first-line treatment for polycythemia vera, and its only competitor is US-based I’m Jakafi from Incyte Corp.
Photo: Reuters
The drug is approved for use in the treatment of adults with polycythemia vera in Taiwan, Switzerland, Israel, South Korea, the US and the EU.
The company said in October that it was targeting China and Japan as the next markets for the drug.
PharmaEssentia did not specify an expected completion date for the marketing application and said in the application that it is subject to the Chinese agency’s case acceptance process.
The company added that there are about 400,000 polycythemia vera patients in China.
Polycythemia vera is a chronic, progressive myeloproliferative neoplasm characterized primarily by high red blood cell counts, PharmaEssentia said.
Blood disorders can lead to cardiovascular complications such as thrombosis and embolism, often leading to secondary myelofibrosis and leukemia.
Besremi is PharmaEssentia’s flagship product, with revenue of TWD2.63 billion (US$85.65 million) in the first 11 months of last year, up 383.44% year-on-year, according to the company’s data.
The company reported a net loss of NT$1.22 billion in the first three quarters of last year due to increased marketing, management and R&D costs.
According to company data, this equates to a loss of NT$4.37 per share.
Analysts said the new drug will lead to strong long-term sales growth and operating leverage.
The company is also conducting Phase 3 clinical trials of a drug to treat essential thrombocythemia, a rare disorder in which the bone marrow produces too many platelets.
Yesterday, PharmaEssentia said in a separate filing that it had received positive feedback from its data and safety oversight board on the trial.
The committee is composed of independent experts who review clinical research data for new drugs.
PharmaEssentia confirmed the safety of the trial and recommended that the trial continue according to the protocol, PharmaEssentia said.
Essential thrombocythemia is a myeloproliferative neoplasm characterized by overproduction of platelets in the blood due to genetic mutations.
According to the company, the number of patients with essential thrombocythemia is similar to the number of patients with polycythemia vera.
PharmaEssentia has registered 90% of enrollments in the trial and plans to complete it as soon as possible, he added.
The company’s shares rose 62.8% last year, closing at NT$477 on Friday’s Taipei trading.
The stock joined the MSCI Global Standard Index last month after posting a sizeable profit last year, according to global index provider MSCI Inc.
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