Idogen’s IDO 8 granted orphan drug designation in the USA
Idogen AB (”Idogen”) today annonces that the US Medicines Agency, the FDA, has granted the company´s cell therapy IDO 8 orphan drug designation in the United States as a treatment to reduce factor VIII neutralizing antibodies. These antibodies or inhibitors occur in about 30 % of patients with haemophilia A who are treated with factor VIII concentrates. Factor VIII neutralizing antibodies can also develop in people with normal levels of factor VIII, and interfere with the activity the clotting factor, a condition also called acquired haemophilia A. Orphan drug designation gives several important benefits. Idogen is entitled to free advice from the FDA, and the fees for a future application for registration are significantly reduced. In addition, seven years of market exclusivity is obtained in the United States after a possible registration.
Idogen has previously been granted orphan drug designation in the EU for IDO 8. This is now being complemented with the grant in the United States, a significant progress for the company.
IDO 8 is Idogen’s most advanced project, aimed at developing a tolerogenic cell therapy for patients with severe haemophilia who have developed inhibitory antibodies against their regular treatment. Idogen´s cell therapy has potential to restore the original efficacy of factor VIII treatment.
“The orphan drug designation in the United States means that we now receive support from the FDA during the development work and seven years of market exclusivity after launch. This facilitates further development and potential commercialization of our cell therapy, which targets a well-defined group of hemophilia patients in great need of improved treatment”, Idogen´s CEO Lars Hedbys comments.
For additional information, please contact:
Lars Hedbys, CEO Idogen AB
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 26th of September 2018.
Idogen (Spotlight Stock Market: IDOGEN) develops tolerogenic cell therapies to prevent the patient’s immune system from attacking biological agents, transplanted organs or the body’s own cells or tissue. Idogen’s most advanced product candidate IDO 8 is designed for patients with severe haemophilia A who have developed anti-drug antibodies against their critical treatment with coagulation factor VIII (factor VIII). The company´s second project IDO T is developed to prevent kidney transplant rejection. The treatment is based on the patient's own cells and is expected to have a favorable safety profile and long-lasting effect. The fact that a short treatment has the potential to yield a long-lasting effect is another great advantage. For more information, visit www.idogen.com
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