Biotec Pharmacon files first part of registration file for Woulgan® Bioge
Biotec BetaGlucans AS, wholly owned subsidiary of Biotec Pharmacon ASA,
has today filed the first part of the registration file for its new and
novel Woulgan® Biogel product.
Svein Lien, CEO of Biotec Pharmacon says: "This is an important
milestone in our efforts to commercialize our novel beta-glucans for
advanced wound healing. This is a market in need of new products and we
have high expectations to our Woulgan® Biogel product that has received
a lot of attention in the industry and among health care professionals."
The filing, which is the Medicinal Product part of the Technical Dossier
is filed with the Notified Body, DNV Nemko Presafe AS. They will submit
the file to the UK Medicines and Healthcare products Regulatory Agency
(MHRA) for their review and approval. This Medicinal Product part of the
Technical Dossier refers to the ancillary part of the Medical Device and
is needed for the Notified Body to approve and subsequent issue a CE
-Mark for the product enabling it to be sold in Europe.
The non medicinal part of the Technical Dossier will be filed to the
Notified Body next week.
For further information:
CEO Svein W. F. Lien: +47 92289323
About Biotec Pharmacon:
Biotec Pharmacon is a biopharmaceutical company that develops and
manufactures new immunomodulatory products and cold adapted marine
enzymes. The wholly owned Biotec BetaGlucans AS focuses on identifying,
developing and commercializing innovative products to meet unmet medical
needs in wound treatment, cancer and gastroenterology. The company's
technology is protected by a large patent portfolio covering amongst
others applications of yeast beta glucans as adjuvants in conjunction
with monoclonal antibodies. The subsidiary ArcticZymes AS aspires to
become a leading supplier of novel enzymes for diagnostics and genetic