Natto: From supplements to pharmaceuticals - Drug Master File is completed
NattoPharma ASA has completed the first version of the "Drug Master File" (DMF) - for the substance MK7. The DMF is financed through operational costs, for a major part through 2014. DMF is a document that describes in detail a substance that is ready for documentation of biological effects and medical usefulness for treating diseases. A DMF equals "Chemistry, Manufacturing and Control portion" of an NDA document (New Drug Application) - which is the document regulatory authorities in Europe, USA, Japan and the rest of the world requires to assess whether a substance should be approved as a drug.
In 2013, NattoPharma ASA announced for the first time that the company is planning to develop a vitamin K2 drug. In relation with the press release regarding the acquisition of the remaining part of Vitasynth Ltd. in 2014, the company communicated that it "was on track with its pharmaceutical development program."
"We are proud to announce that the first version of the DMF document is completed earlier than planned. NattoPharma continues with studies of biological effects and medical usefulness of MK7 as part of the pharmaceutical product development process. We are dedicated towards getting a drug to the market, "says Hogne Vik CEO in NattoPharma.
In the short term, NattoPharma ASA is engaged in getting the MK7 molecule approved as a drug in some countries, based on the aforementioned DMF and existing biological documentation. As of February 2015, MK7 is classified as a drug in Tunisia, while applications for drug approvals are in process in Lebanon, Iraq and Kuwait. It is expected to get the product registered as a drug in one or more of these countries during the next 3-18 months. With such drug-approvals, MK7 could be included in reimbursement schemes (paid by various health insurance schemes).
The pharmaceutical documentation program required for drug-approvals in Europe, USA, Japan and large parts of the world continues. Costs beyond the completion of the DMF will - as previously announced - be financed through specific partner agreements, and not by NattoPharma's normal operating budgets.
About NattoPharma ASA
NattoPharma develops and sells vitamin K2 with preventive effects against osteoporosis and cardiovascular disease. The company is also in the process of developing vitamin K2 to prescription medicine. The company builds competitive advantage with clinical research, filing of patent applications and rights, as well as through strong sales and marketing efforts. NattoPharma has exclusive rights to sell and market the brand MenaQ7® (Vitamin K2 / MK-7) globally, offering currently their products as ingredients in dietary supplements, functional food and medical food.
For more information, please contact:
Hogne Vik
CEO, NattoPharma
Mobile: +47 97 53 53 26
E-mail: hogne.vik@nattopharma.com
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