PharmaEngine announced in a briefing on 10 August, that the sales of its new drug ONIVYDE for treating pancreatic cancer presented an upward trend in Japan. While in Korea, the drug will be covered by the national health insurance from August onwards. Together with a licencing agreement for ONIVYDE is expected to generate over $272 million in local dollar, PharmaEngine added.

French drug maker Ipsen acquired ONIVYDE in 2017, thereafter the company contracted a partner in Japan for distribution. The pancreatic cancer drug was approved last year in Japan, which boosted the revenue in H1 for PharmaEngine with TWD$161 million this year. According to PharmaEngine, growing patient needs in Japan plus with Korean payer to cover the cost, the market for ONIVYDE is bullish.

With Ipsen’s assistance, ONIVYDE has submitted China’s NDA filing, said Hong-Ren Wang, president of PharmaEngine. However, the NDA review time is subject to change so the approval could be sometime nearer the end of the year instead of June as forecasted.

In terms of R&D pipeline, PharmaEngine and Ipsen are exploring potential future indications for ONIVYDE, including first-line therapy for pancreatic cancer and second-line treatment for small-cell lung cancer. Patient recruitment for phase 3 trial in pancreatic cancer had been completed, both companies will take next step if the trial result meets or exceeds expectations.

A new drug PEP07, which is being developed by PharmaEngine, has come with preliminary results of tumour growth inhabitation following a pre-clinical study. This drug is likely to be one of the therapeutics for brain cancer, aiming at clinical trials in 2022. Wang added that the company is evaluating 20 more candidates to pair with PEP07 and the decision will most likely be made later this year.

PharmaEngine's net income after tax in the second quarter totalled $165 million, up 117.1% quarter-on-quarter and 1,078% year-on-year, with net income per share of $1.14. Net income after tax in H1 totalled $241 million, up 282.5% YoY, with net income per share of NT$1.66. All amounts in the news refer to Taiwanese dollar.  

News compiled by IBMI; Source in Chinese: news.cnyes.com