Amarin Corporation plc announced that Tanabe Seiyaku Co. Ltd., its Japanese partner for the development of a once daily Morphine Sulphate formulation, has submitted a New Drug Application (NDA) dossier for this formulation to the Ministry of Health, Labor and Welfare (MHLW) for regulatory review. This submission follows the successful conclusion of an extensive clinical program undertaken by Tanabe in Japan.
The formulation is indicated for the relief of moderate to severe pain, and was developed by Amarin's European oral product development facility, Amarin Development AB, based in Malmo, Sweden. Four dosage strengths have been developed -- 20, 30, 60 and 120 mg -- all of which utilise Amarin's patented Diffusion Controlled Vesicle (DCV) technology for the controlled release of morphine sulphate over a period of up to 24 hours. As part of the development process, the DCV technology has been successfully transferred to Tanabe's Osaka facility; the product will be manufactured there for commercial sale once approved.
Rick Stewart, chief executive officer of Amarin, commented, "We are pleased that our long term relationship and collaboration with Tanabe has again come to fruition with the filing of this NDA to the MHLW. DCV Morphine OD is the first product to be filed in Japan using our proprietary DCV technology, which has been utilised in five product formulations worldwide. In addition to our strong franchise in neurology products, this submission serves as an important step toward expanding our presence in pain management. We look forward to the future successful commercialisation of this product."
Amarin and Tanabe have a long established relationship relating to controlled-release products. In the late 1980's Amarin developed for Tanabe a controlled release formulation of diltiazem, which is sold today through various licensees in over 30 territories across the world. To date, over three billion of these tablets have been manufactured and used in the treatment of patients with cardiovascular disease.
Amarin's DCV system is used for the controlled release of substances for periods up to 24 hours. The patented technology consists of a tablet core, incorporating the active ingredient, surrounded by a water-insoluble membrane containing minute particles of water-soluble material. The soluble particles dissolve when the tablet is ingested, resulting in a macro-porous film structure through which drug is released at a steady rate. In addition to Tanabe Seiyaku, principal licensees for the technology include Pharmacia and Sanofi-Synthelabo. Over 4 billion tablets incorporating the DCV technology have been manufactured and used effectively by patients in more than thirty countries.