Tue, Jul 10, 2018 - Page 12 News List

Biotech stocks rally on overseas regulatory news

By Ted Chen  /  Staff reporter

Shares in OBI Pharma Inc (台灣浩鼎) and PharmaEngine Inc (智擎) rallied yesterday as the biotechnology firms announced encouraging progress in their new drug development pipelines over the weekend.

OBI Pharma on Sunday announced that the US Food and Drug Administration has granted orphan drug designation for OBI-3424, the company’s hepatocellular carcinomas (HCC) drug.

The stock yesterday gained 5.7 percent to close at NT$157.5 in Taipei trading.

The designation, which is granted for rare diseases with fewer than 200,000 patients in the US, brings benefits upon marketing approval, including market exclusivity, reduced or waived regulatory fees and protocol assistance during the approval process.

The drug is designed to selectively release a potent DNA alkylating agent in patients with an overexpression of the AKR1C3 enzyme, whereas other traditional alkylating agents, such as cyclophosphamide and ifosfamide, are non-selective, the company said.

AKR1C3 is also a marker found in other treatment-resistant and difficult to treat cancers, such as castrate-resistant prostate cancer and T-cell acute lymphoblastic leukemia, it said.

The company has outlined plans to streamline the drug’s clinical development process by targeting patients with AKR1C3 overexpression.

PharmaEngine Inc (智擎) on Sunday announced that it would receive US$3 million in milestone payments as Onivyde, its new pancreatic drug, commences sales in its third EU market.

The windfall is expected to boost the company’s earnings per share by NT$0.61, it said.

The company last month reported that a global pivotal trial for PEP503, a soft tissue sarcoma drug it is developing with France’s Nanobiotix SA, has met its primary and secondary endpoints, which would aid the approval process ahead.

PEP503 is activated with radiotherapy via Nanobiotix’s NanoXray, a class III medical device, and is designed to promote patients’ immune system response against tumors, the company said.

Other indications being explored include head and neck cancer, as well as liver, colorectal and prostate cancer, the company added.

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