Essex Bio-Technology Limited (the Company, together with its subsidiaries, the Group) wishes to announce that Essex Bio-Investment Limited (Essex Bio-Investment), a wholly-owned subsidiary of the Group has on 13 October 2022 successfully secured (i) a patent and know-how licence agreement; and (ii) a patent assignment deed (together as the Agreements) in relation to SkQ1 , an active pharmaceutical ingredient, from Mitotech S.A. (Mitotech), in which Mitotech granted the Group worldwide (excluding Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia) (Global) rights and interests in SkQ1, transferable and irrevocable, in the field of ophthalmology exclusively.
Pursuant to the Agreements, Mitotech has agreed to assign, among others, all the rights of a list of inventions and patents, and to grant an exclusive, transferable and irrevocable Global licence to Essex Bio-Investment, free from encumbrance, to use a list of patents owned by Mitotech relating to SkQ1 to develop, manufacture, sell and supply any therapeutic products or therapies applying to the eye and its adnexa (the “Products”), apply for and obtain Global regulatory approval for clinical trials, and obtain marketing authorisation in relation to the Products.
Following the signing of the Agreements, a fourth supplementary agreement in relation to the co-development agreement dated 16 July 2018 (the “Co-Development Agreement”) was entered into between Essex Bio-Investment, Mitotech and Mitotech LLC on 13 October 2022, in which Mitotech LLC and Mitotech will waive all and any rights under the Co-Development Agreement in relation to the US FDA VISTA programme (the clinical studies on an ophthalmic solution containing SkQ1 for the dry eye disease (the “VISTA Programme”)).
The Board considers that securing the Agreements relating to SkQ1 is an important measure to provide the Group with flexibility and independence in the continuing development of the VISTA Programme in the field of dry eye disease, and will allow the Group to further explore development of other indications of ophthalmic products to meet the clinical and commercial needs of the Global market.
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.
About SkQ1
SkQ1 addresses DED through a novel mechanism of action, acting on the mitochondria at a cellular level. Unlike current standards of care, which act primarily as anti-inflammatory agents, SkQ1 has been shown to not only relieve inflammation but also improve tissue degeneration and tear quality deficit by targeting oxidative stress within the eye. The VISTA programme (the clinical studies on an ophthalmic solution containing SkQ1 for the dry eye disease) has now progressed to the Phase 3 clinical stage in the United States. In VISTA-1 – a Phase 2b/3 clinical study in the United States (NCT03764735) and VISTA-2 – a Phase 3 clinical study in the United States (NCT04206020) – SkQ1 showed evidence of efficacy in reducing both the signs and symptoms in dry eye subjects. Additionally, glaucoma, Leber’s Hereditary Optic Neuropathy (LHON), dry AMD, and uveitis programmes for SkQ1 ophthalmic solution are at pre-clinical stage.
About Essex Bio-Technology Limited (HKG: 1061)
Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic b-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Shilishun (Iodized Lecithin Capsules) etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 10,710 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.
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