Ohara Pharmaceutical have submitted a new drug application for PBL’s Erwinase® in Japan.
The submission was made on 17 December, as this is considered to be a lucky day on the Japanese Rokuyo calendar. The day is known as Taian and often used for wedding ceremonies and new business ventures.
The submission follows an earlier notice, which stated that Ohara Pharmaceutical had gained accreditation for Erwinase® from the Japanese Ministry of Health, Labour and Welfare in the category of foreign drug manufacture.
Commenting on the notice, director of regulatory affairs Dr Alan Jennings said "We are pleased that we have secured this first step in our strategic planning to develop a market for Erwinase®.
We are committed and will continue working with our partners to progress through the next stages of the regulatory process, with the ultimate aim of providing the product in Japan".
Erwinase® is used to treat cancers, including Acute Lymphoblastic Leukemia and Malignant Lymphoma.
PBL has worked closely with Ohara Pharmaceuticals in order to achieve accreditation, providing information on its biopharmaceutical manufacturing facilities and regulatory processes to the Japanese Pharmaceuticals and Medical Devices Agency.