Sat, Oct 24, 2015 - Page 13 News List

Taiwan-made cancer drug approved in US

MARKET BOOST:Shares in PharmaEngine, the company behind the new pancreatic cancer drug Onivyde, gained 4.81% before closing at NT$229 in Taipei trading yesterday

By Ted Chen  /  Staff reporter

PharmaEngine Inc (智擎) shares yesterday rose nearly 5 percent after the company announced that its new pancreatic cancer drug, Onivyde, has been approved by food and drug regulators in Taiwan and the US.

“Onivyde is the first cancer drug to begin its clinical development in Taiwan and go on to receive regulatory approval by the US Food and Drug Administration,” PharmaEngine president and chief executive officer Grace Yeh (葉常菁) said in a statement.

“We believe that Onivyde will become an established therapeutic option for the management of metastatic pancreatic cancer in the foreseeable future,” she said.

Shares of PharmaEngine gained 4.81 percent to close at NT$229 in Taipei trading. The stock has risen 6.9 percent from this year’s low of NT$135.5 recorded on Aug. 25, Taiwan Stock Exchange data show.

Formerly designated as project MM-398 by PharmaEngine, Onivyde is a proprietary irinotecan liposome injection. It was jointly developed by PharmaEngine and its licensing partner, US-based Merrimack Pharmaceuticals Inc.

The drug can be used in combination with the chemotherapy drugs fluorouracil and leucovorin for patients with metastatic adenocarcinoma of the pancreas who have completed first-line gemcitabine-based therapy, PharmaEngine said.

Merrimack sponsored the international phase 3 study on the drug that took place between 2012 and last year. The study demonstrated a clinically and statistically significant improvement in the overall survival rate for patients.

Currently, patients with metastatic pancreatic cancer who progress after gemcitabine-based therapy have no set standard of care, PharmaEngine said.

As Merrimack has licensed PharmaEngine to market Onivyde in Taiwan, PharmaEngine earnings in the next two years are expected to climb, on top of the anticipated US$98.5 million in research milestone payments and US$130 million in sales milestone payments, Taishin Securities Investment Advisory Co (台新投顧) said in a research note yesterday.

Net income could reach NT$1.52 billion (US$47 million) or NT$14.93 per share next year, with sales likely to grow 25 percent to NT$2.11 billion from this year, Taishin predicted.

PharmaEngine reported sales totaling NT$505.77 million during the first nine months of the year, up 126.49 percent from the same period of last year, stock exchange data show.

However, Hua Nan Securities Investment Management Co (華南投顧) said Onivyde’s reception in the market will not be known until the drug obtains a US FDA drug code.

Sales of the drug are expected to commence in US and European markets before the end of the first quarter next year, Huan Nan said.

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