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ArcticZymes Technologies Regulatory Filings 2014

Mar 26, 2014

3538_iss_2014-03-26_3fc75430-edc3-48cc-a686-3440a7c448dc.html

Regulatory Filings

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MHRA has finalized the review of Woulgan® Biogel

MHRA has finalized the review of Woulgan® Biogel

Biotec BetaGlucans AS has today been informed that MHRA, the UK

Medicines and Healthcare Products Regulatory Agency, has finalized the

review of the medicinal part of the Woulgan® Biogel dossier, and that

their Decision Notification Report has been forwarded to Presafe. MHRA

has been consulted as Competent Authority by the Notified Body, Presafe,

to assess and approve the quality and role of SBG in Woulgan® Biogel.

The final issuance of a CE-certificate for Woulgan® Biogel can now be

finalized by the Notified Body. It is expected that Presafe will have

the formal approval ready within soon.

For more information, please contact:

CEO Svein W. F. Lien, tel +47 922 89 323

About Biotec BetaGlucans AS:

Biotec BetaGlucans is a wholly owned subsidiary of Biotec Pharmacon ASA.

Biotec BetaGlucans develops and manufactures novel immunomodulating

products. The newly developed Woulgan® Biogel, for use in wound healing,

contains the company's proprietary substance SBG® (soluble beta-glucan),

which supports the wound healing process. When receiving CE-mark for the

product the company is ready to start an evaluation study in regular

clinical use together with the wound care world leader Smith & Nephew.

More information on www.biotec.no/beta-glucans/