A new polycythemia vera (PV) drug developed by PharmaEssentia Corp (PEC, 藥華醫藥) is likely to be a major growth catalyst next year, after it obtains approval for commercialization in the US and European markets, analysts said.
The new drug, P1101, is a long-acting interferon that should produce positive results in phase-three clinical trials, Yuanta Securities Investment Consulting Co (元大投顧) analyst Peggy Lee (李珮菁) said in a note on Tuesday.
“Its launch in the US and EU markets should usher in rapid sales growth,” Lee said, forecasting PharmaEssentia sales to grow from this year’s NT$17 million (US$524,837) to NT$1.38 billion next year and to NT$3.23 billion in 2018.
The company is also expected to improve its balance sheet by posting a net profit of NT$163 million next year from a net loss of NT$877 million this year, with profit surging to NT$1.2 billion in 2018, Lee said.
Interferons are signaling proteins made and released by host cells in response to the presence of viruses, bacteria, parasites and tumor cells that cause cells to heighten their anti-viral defenses.
PharmaEssentia said its pegylation technology platform is designed to increase the efficacy of protein drugs by prolonging their circulation in the bloodstream by targeting polyethylene glycol at a specific and defined region of the protein.
Daiwa Capital Markets analyst Christine Wang (王琦清) said P1101 has been designated an orphan drug by European and US authorities, which grants a number of incentives, such as periods of exclusive sales rights.
Orphan drug status would bring fast-track status and pricing benefits for the company, Wang said in a note earlier this month.
Taipei-based PharmaEssentia — which is set to shift its shares to the over-the-counter Taipei Exchange from the prepartory Emerging Stock Market on July 19 — has licensed Austria-based AOP Orphan Pharmaceuticals AG for the sales of P1101 in Europe.
The company is seeking a partner to oversee the drug’s commercialization in the US and has plans to gain approval for P1101 as a treatment for essential thrombocythemia, hepatitis B and C, Wang said.
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