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Biozeus Biopharmaceuticals S.A. Announces Orphan Drug Designation of BZ371 for the Treatment of Anterior Ischemic Optical Neuropathy (AION).

Biozeus Biopharmaceutical today announces that the U.S. Food and Drug Administration (FDA) granted Biozeus an Orphan Drug Designation directed to BZ371A for the treatment of Anterior Ischemic Optical Neuropathy (AION). Biozeus becomes the first Brazilian company to obtain an ODD for a compound directed to the treatment of an ophthalmological disease.

The FDA created the Orphan Drug Act to encourage and provide special incentives for companies that develop drugs for orphan diseases (that affect less than 200,000 patients a year). One of the initiatives is the Orphan Drug Designation (ODD), which gives the company exclusive development discounts on fees related to the cost of clinical development, market exclusivity for 7 years after approval (independent of the patent), a waiver of the fee for the application of new drugs along with other benefits to recuperate development and research costs. In addition, the FDA provides special assistance in the design and review of protocols – potentially shortening the time for medication to reach the US market.

Anterior Ischemic Optical Neuropathy (AION) is a disease that causes sudden loss of vision due to ischemia (loss of blood flow) in the optic nerve head. Without oxygen and nutrients delivered by the blood vessel the optic nerve head cells die, compromising the ability to see permanently.

BZ371A is a small synthetic peptide in late preclinical development. BZ371A is the first compound of a brand new therapeutic class called Nitric Oxide Synthase Enhancers. This peptide has the ability to reach the Retina with only one eye drop a day, elevating and maintaining blood flow for more than 24h, preventing loss of vision from ischemia.

“This important achievement concretely demonstrates Biozeus ideals and quality of the work done by the team.” said Paulo Lacativa, CEO of Biozeus. “This accomplishment also represents important added value to the Company’s assets and reinforces our business model, confirming that we are taking the right steps to the successful development of our pipeline.”

About Biozeus Biopharmaceutical, S.A.

Biozeus Biopharmaceutical S.A. is a Drug Development Company, fully owned by BBI Financial I Fund, dedicated to the development of new drugs worldwide. Our goal is to translate commercially promising health products derived from the university research, into new therapies that could reach the market improving and saving lives.

Our business model consists in identifying early-stage drug candidates, from leading Brazilian research institutions, developing them and out-licensing the new drug candidate.