Drug developer PharmaEngine Inc (智擎) saw its shares soar close to the 7 percent daily limit yesterday after the company’s new drug for treating pancreatic cancer received a “fast-track” designation in the US on the previous day.
The shares rose 6.84 percent to close at NT$242, outperforming the over-the-counter benchmark index, which was up 1.81 percent.
The US Food and Drug Administration said the drug — MM398 (PEP02) — could satisfy an unmet medical need and the designation would expedite the process for the treatment to enter the US market, PharmaEngine said in a statement.
The drug — used as a second-line medicine for patients treated with gemcitabine — has completed phase-three clinical trials in the US, PharmaEngine said.
The Taiwanese company’s US partner, Merrimack Pharmaceuticals Inc, would file a new drug application by the end of this year, it said.
After Merrimack files the application, PharmaEngine will book a milestone payment of US$5 million, Peter Wu (吳兆升), director of corporate development at PharmaEngine, said by telephone yesterday.
From January through last month, the company posted revenue of NT$226.4 million (US$7.31 million), up more than sevenfold from NT$27.44 million the previous year because of a licensing payment of US$7 million in September after Merrimack licensed the distribution rights of MM398 in Europe and Asia — outside Taiwan — to Baxter International Inc, Wu said.
The payment also carried PharmaEngine into the black last quarter, as it posted a profit of NT$193.44 million, or earnings per share of NT$1.93, a company filing with the Taiwan Stock Exchange showed.
The figure was up from a loss of NT$69.71 million the previous year and a loss of NT$28.34 million the previous quarter, it said.
PharmaEngine is likely to book an additional licensing payment of US$39.5 million based on the development of MM398, Wu said.
Looking ahead, PharmaEngine is likely to book milestone payments of US$70 million if Baxter files or completes regulatory approval for MM398 in Europe and Asia, Wu said, adding that — based on sales of the drug in the two regions — the company is likely to receive milestone payments of US$130 million in total.
Baxter plans to submit for regulatory approvals for the drug outside the US starting next year, Merrimack said.
PharmaEngine also can book tiered royalties for sales of MM398 in Europe and Asia, and it expects sales of the drug to reach US$500 million a year, it said.
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