PharmaEssentia Corp (藥華醫藥) shares have jumped 80.56 percent since the company obtained a US polycythemia vera (PV) drug license for its new interferon drug Besremi (ropeginterferon alfa-2b-njft) on Nov. 12.
Shares on Friday closed at NT$195 in Taipei trading, up from the stock’s closing price of NT$108 on Nov. 12.
PV is a rare, chronic and life-threatening blood cancer linked to a stem cell mutation in the bone marrow that results in an overproduction of blood cells and places sufferers at risk of having a blood clot, stroke or heart attack.
PharmaEssentia is preparing to make Besremi available in the US in the coming weeks, which is expected to contribute sales and earnings to the company going forward, Yuanta Securities Investment Consulting Co (元大投顧) said in a note on Thursday.
“Besremi is the first first-line PV drug approved by the US Food and Drug Administration (FDA), and can be used on any PV patients regardless of prior treatments,” Yuanta said. “We see a positive outlook for Besremi sales in the US going forward, despite that the new drug’s pricing of US$180,000 per person per year is higher than previously expected.”
In the US, the number of people with PV who are administered Besremi is projected to rise by 800 per year after the drug is launched there, with US sales of Besremi likely to reach US$100 million next year and increase by US$100 million every year after that, Yuanta said.
“Besremi might also cut into the sales of other first and second-line PV drugs, with an estimated revenue of US$900 million in the US in 2030,” it said.
PharmaEssentia last week reported revenue of NT$42.4 million (US$1.52 million) for last month, up 53.2 percent month-on-month and 10.65 percent year-on-year. Cumulative revenue in the first 10 months of the year totaled NT$318.9 million, an increase of 5.13 percent from last year.
With the new drug, the company has high hopes that its balance sheet will improve after posting losses per share of NT$4.74 in the first three quarters of the year, a company regulator filing showed.
In the US, Besremi has been designated an orphan drug for PV, and with the FDA’s approval, PharmaEssentia would have seven years of orphan drug exclusivity (ODE) in the US market.
Aside from the US, Besremi has received approval in Taiwan, the EU and South Korea for PV treatment, the company said.
The company has also recruited 87 people, more than half of the number it plans to recruit, for global clinical phase 3 trials of Besremi to treat essential thrombocythemia, it said.
PharmaEssentia expects to recruit all 160 participants needed for the trials by the second quarter of next year and to complete the trials in the middle of 2023, the company added.
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