Porton Biopharma limited (PBL) is working with Ohara Pharmaceutical Co., Ltd. who has today submitted a New Drug Application for Erwinase® in Japan. The submission was specifically timed because the 17th December is considered to be “a lucky day” in the Japanese Rokuyo calendar and is known as Taian, 大安 . This is an auspicious good luck day for all concerned and is particularly good for wedding ceremonies and starting new business ventures, hence why it was chosen.
The submission follows on from an earlier notice to PBL as the manufacturer of Erwinase® that it had gained accreditation* in the category of “foreign drug manufacture” from the Japanese Ministry of Health, Labour and Welfare for the product which is used to treat cancers including Acute Lymphoblastic Leukemia and Malignant Lymphoma.
This achievement is the result of PBL closely working with Ohara Pharmaceuticals to provided information on our biopharmaceutical manufacturing facilities and regulatory processes to the Japanese Pharmaceuticals and Medical Devices Agency.
Commenting on the notice Dr Alan Jennings, Director of Regulatory Affairs at PBL, said “We are pleased that we have secured this first step in our strategic planning to develop a market for Erwinase ® in Japan. PBL is committed to this and will continue working with our Japanese partners to progress through the next stages of the regulatory process, with the ultimate aim of providing the product in Japan”.
The full Ohara press release can be viewed on the Ohara website or by opening the links below
Porton Biopharma is the sole manufacturer of Erwinase® which is licenced to and distributed and marketed on a world-wide basis by our partner Jazz Pharmaceuticals.
*The certificate of accreditation, AG20500117 is pursuant to Article 13-3 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products and Cosmetics (Act No 145, 1960).