Biomay AG, a global leader in allergy immunotherapy products, announced today that CE mark designation has been achieved for an innovative medical device indicated for the treatment of IgE-mediated diseases, which has been co-developed by the company together with a world-leading medical device manufacturer.
The product is an immune apheresis column which contains a single chain antibody fragment with very high affinity to human IgE, covalently linked to a solid support. The antibody ligand has been discovered in the laboratory of Prof. Rudolf Valenta at the Medical University of Vienna; Biomay holds the patent rights. Process development and GMP manufacturing of the affinity ligand has been performed by Biomay, while the device itself is manufactured and will be marketed by the development partner.
High levels of IgE are the underlying cause of several important diseases with significant unmet needs, including allergic asthma, atopic dermatitis and severe rhinoconjunctivitis. Inactivation or removal of IgE is therefore a very desirable therapeutic target. In a recently completed clinical trial the device has been shown to very efficiently and selectively remove IgE from the plasma of patients with allergic asthma; it can be safely used even in patients with very severe disease. This trial was the basis of CE mark approval.
Biomay has already received several milestone payments and is entitled to royalties on sales.
Rainer Henning, CEO of Biomay commented: "It is very rewarding for Biomay that this innovative product incorporating our proprietary antibody fragment will now reach the market, validating our scientific approach to treatment of IgE mediated diseases. We are very confident that the IgE adsorber will add new hope for severely ill patients with an allergic background who currently have very few treatment options."
About Biomay (September 2015):
Biomay AG is a privately held biopharmaceutical company based in Vienna, Austria. The company is committed to be a leader in the discovery and development of innovative allergy therapeutics. Besides participation in this project, the company develops a pipeline of recombinant vaccines against allergies caused by airborne allergens. The lead product BM32, indicated for grass pollen allergy, has recently successfully completed a phase 2b proof-of-concept clinical trial. www.biomay.com