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Mitotech Partners with Essex Bio-Technology for Late-stage Clinical Program in Dry Eye Disease

Mitotech S.A, a Luxembourg based clinical stage biotechnology company, announced entering a partnership agreement with Essex Bio-Investment for Phase 3 clinical program in Dry Eye Disease. Under the agreement Essex Bio-Investment will fund U.S. clinical program for Mitotech’s lead compound SkQ1 with approximately $17m allocated towards the first Phase 3 study starting as early as Fall 2018.

“We are excited to have established a strategic partnership with Mitotech to co-develop SkQ1 on the global stage, through a Phase 3 clinical study in the United States,” said Malcolm Ngiam, President of Essex Bio-Investment, “Mitotech recognizes Essex Bio-Technology’s strong presence in China and the region, with strengths in research, clinical development and sales, by entrusting us to develop the product, and we look forward to SkQ1 cementing our position as a leader in Dry Eye Disease and Ophthalmology.”

Mitotech’s molecule SkQ1, has been shown to relieve inflammation, tissue degeneration, and tear quality deficit. Unlike the current standards of care, SkQ1 deals with Dry Eye Disease on a cellular level by protecting the eye from oxidative stress. Oxidative stress – a phenomenon widely evident in patients suffering from Dry Eye – happens when the amount of ROS produced inside cells and tissues grows beyond normal levels. One of the primary sources of ROS inside cells is an organelle called the mitochondria, and SkQ1 has been proven to target and neutralize mitochondrial ROS to restore cellular function.

In Russia Mitotech has already won regulatory approval for its eye drop formulation of SkQ1, called Visomitin – and about 1 million units of Visomitin have been sold in the Russian market since it was commercially launched. “We are delighted to enter this collaboration with Essex Bio-Technology, this partnership is a great strategic fit for us as Essex Bio-Technology specializes in ophthalmology, and specifically in treatments for Dry Eye”, said Natalia Perekhvatova, CEO of Mitotech S.A. “Our previous clinical studies in Dry Eye showed that our drug protected cornea from damage, improved quality of the tear and made patients feel better at the same time. We are getting very positive feedback from the Russian market, both from physicians and patients. This new partnership will allow us to jump-start late-stage SkQ1 development in the U.S. If successful in Phase 3 studies, SkQ1 will be the first molecule in the class of mitochondria targeted cardiolipin protectors to reach approval stage in the U.S. We believe this novel approach may provide a safe and effective treatment for Dry Eye by countering not just one, but several factors of the disease simultaneously.”

Mitotech has previously conducted a 28-day U.S. Phase 2 study of SkQ1 ophthalmic solution in patients with Dry Eye Disease with statistically significant response against placebo in several signs and symptoms. The first planned Phase 3 study will be designed to confirm those results and the results of Mitotech’s clinical studies in Russia.

About EssexBio
Essex Bio-Technology Limited is a bio-pharmaceutical company, started in early 90’s, a pioneer in bio-pharmaceutical industry in China, that develops, manufactures and commercialises genetically engineered therapeutic rb-bFGF, a basic fibroblast growth factor, with established mechanism of action in cellular proliferation, differentiation and migration.

The Company currently has five commercialised bio-pharmaceutical products, formulated with rb-bFGF, in China, out of which 3 are approved by CFDA as Category I drugs. The products are being marketed & sold as Beifushu, Beifuji & Beifuxin, for treatment of ocular surface wounds and topical (skin) surface wounds respectively. Beifuji is the first in the world to have obtained approval from CFDA for commercialisation in 1998.

The Company focuses on two main therapeutics; Ophthalmology and Surgical arena of topical (skin) surface wounds, which primarily covers Dermatology, Stomatology and Obstetrics & Gynaecology, while selectively pursuing therapeutics in Neurology, Oncology and Orthopaedics. The Company maintains a pipeline of multi-project in R&D and on various stages of clinical programs, of which several projects involving growth factors and antibody and a handful of projects are on unit dose for Ophthalmic and Respiratory disease.

The Company’s products and its 3rd party products are marketed and sold through more than 5,400 hospitals in China and are managed directly by its 39 regional sales offices with about 1,410 sales and marketing people. Its 3rd party products; notably are inclusive of Xalacom eye drops and Xalatan eye drops of Pfizer (for Ophthalmology), Iodized Lecithin Capsules (for Ophthalmology), Yi Xue An Granules (for Obstetrics & Gynaecology) and Carisolv Products (for Stomatology).

About Mitotech S.A
Mitotech S.A. is a clinical-stage Luxembourg-based biotechnology company developing novel drugs for the treatment of predominantly age-related disorders. The core technology behind Mitotech products is based on a novel class of small molecules – mitochondria targeting cardiolipin peroxidation inhibitors. Company’s lead compound SkQ1 is being developed in several drug formulations covering a variety of therapeutic areas with major focus on ophthalmology and neurodegenerative diseases. Mitotech successfully completed Phase II clinical study for Dry Eye Disease in the U.S. with other indications also approaching clinical stage of development.

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