April 11, 2022

Mireca signs transformative deal with Nasdaq-listed Graybug Vision

TÜBINGEN, GERMANY, April 8th, 2022 — Mireca Medicines GmbH, an ophthalmology start-up company formed to develop treatments for inherited retinal degeneration, today announces it has established an exclusive partnership with Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on transformative medicines for ocular diseases, to develop Mireca’s proprietary cGMP analogues for the treatment of inherited retinal diseases, such as Retinitis Pigmentosa, Leber’s Congenital Amaurosis and Stargardt’s disease, using Graybug’s proprietary sustained-release drug delivery technologies.

Under the terms of the partnership, Graybug gains exclusive access to Mireca’s extensive library of protein kinase G (PKG) modulators and will be responsible for the research, development, manufacturing, as well as commercialization of these cGMP analogues for the treatment of diseases of the eye and ear. Furthermore, Mireca transfers to Graybug an Orphan Drug Designation for the treatment of Retinitis Pigmentosa. Financial terms are not disclosed, but include an upfront payment, milestone payments tied to future clinical development, product approvals, and royalties on commercial sales.

Prof. Dr. Francois Paquet-Durand, Chief Scientific Officer of Mireca, and scientific advisor to Graybug, as well as Mireca’s shareholder Biolog will contribute their longstanding cGMP analogue expertise to support Graybug’s research and development activities. Furthermore, Mireca shareholder RISE (Research Institutes of Sweden) has agreed to manufacture the cGMP analogues for Graybug.

Barbara Brunnhuber, Chief Executive Officer of Mireca, said: “The partnership with Graybug is a breakthrough for Mireca’s cGMP analogues to reach patients suffering from inherited retinal diseases. We are delighted to fully exploit the potential of our compounds in eye and ear applications with such a committed and capable partner, while continuing our own drug development to extend the cGMP approach into neurodegenerative diseases, as well as other disease indications outside of the central nervous system.“

Pieter Gaillard, PhD, Chairman of the Mireca Supervisory Board, said: “Achieving and leveraging this transformative deal is a thrilling reward for building our independent company. It is based on a shoulder-to-shoulder relationship between the executive management and shareholders, fueled with their scientific wealth and enjoying their financial trust. This patient-oriented scientific team holds much promise for developing the next drug products for debilitating diseases.”

About Mireca Medicines GmbH

Mireca is a preclinical stage start-up company based in Tübingen (Germany) aiming to develop its cyclic guanosine monophosphate (cGMP) analogues for diseases with pathways showing a dysregulation of cGMP signaling, affecting the protein kinase G (PKG) pathway.

About Graybug Vision, Inc.

Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for ocular diseases. Its diversified portfolio is designed to treat vision-threatening diseases of the retina, optic nerve, and cornea, by either maintaining effective drug levels in ocular tissues for long periods of time, using innovative technologies such as injectable sustained-release formulations, or by curing diseases with gene therapies.

About Inherited Retinal Diseases (IRDs)

Grouped under the term “inherited retinal diseases,” Retinitis Pigmentosa, Leber’s Congenital Amaurosis, and Stargardt’s disease often result in the degeneration and loss of the light-sensitive cells in the retina, called photoreceptors, leading to visual impairment and blindness. The most common IRDs are caused by a genetic defect in a single gene, out of more than 280 possible genes, which compromises the viability of photoreceptors and leads to photoreceptor cell death. Patients with these conditions may develop symptoms in early childhood, including night blindness or the inability to see segments of the world in front of them. They can take abnormally long periods of time to adjust to changes in lighting, and some patients may even find light uncomfortable. Eventually, most individuals with IRD will lose most of their sight.

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