Idogen: Positive decision for Idogen's orphan designation application in Europe

Press release as pdf

The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) has reached a positive decision regarding Idogen’s application for orphan drug designation in Europe. This means that the COMP has made the assessment that the application meets all the necessary criteria and they will therefore recommend that the European Commission grants Idogen a formal orphan drug designation.

An orphan drug designation provides several important benefits for Idogen. A product that is classified as an orphan drug receives market exclusivity in the EU for ten years following marketing authorization, regardless of the period of validity of any patents, which is important for the value of any market position or license agreement. Idogen also receives free consultation for scientific advice, and fee reductions for regulatory applications for the marketing authorization.

"Patients with hemophilia and antibodies against the factor VIII treatment is a vulnerable patient population and there is a great need for new treatments, which COMP's decision confirms. The news is very encouraging and we are now awaiting the formal decision. Orphan drug designation is an important milestone in our development and represents a clear increase in value for this product.” CEO Lars Hedbys comments.

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 12th of December 2016.


Press release as pdf  Further information about Idogen

Publicerat: 12/12/2016 8:00:03 AM

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