Ocuphire Pharma, Inc.

Partnerships

Let’s Help Patients See the Night Sky More Clearly…Together

At Ocuphire Pharma, we’re interested in business development opportunities to in-license additional novel ophthalmic mid-stage clinical drug candidates as well as to partner with pharmaceutical companies for late-stage development, regulatory and commercialization collaborations in key global markets.

Viatris, Inc.

Viatris, Inc.

Ocuphire has a partnership with Viatris, Inc. to develop and commercialize Nyxol® eye drops as a preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size by uniquely blocking the alpha-1 receptors found only on the iris dilator muscle without affecting the ciliary muscle. Nyxol has been studied in a total of 12 clinical trials (3 Phase 1, 5 Phase 2, 4 Phase 3) across three indications, including single-use for reversal of pharmacologically-induced mydriasis (RM), and once-daily for treatment of presbyopia and dim light (night) vision disturbances (DLD), pending regulatory approvals. Nyxol’s NDA under the 505(b)(2) pathway for the first indication, RM, has been accepted with a PDUFA date assigned of September 28, 2023. Nyxol is currently in Phase 3 for presbyopia and DLD.

BioSense

BioSense

On March 10, 2020, Rexahn amended the BioSense Agreement to advance the development and commercialization of RX-3117 for all human uses in the Republic of Singapore, China, Hong Kong, Macau, and Taiwan. Rexahn granted BioSense an exclusive license to develop and commercialize pharmaceutical products containing RX-3117 as a single agent for all human uses in these countries and assigned to BioSense all of Rexahn’s patents and patent applications related to RX-3117. Under the BioSense Agreement, Rexahn is eligible to receive milestone payments in an aggregate of up to $84 million upon the achievement of development, regulatory and commercial goals and will also be eligible to receive tiered royalties.

BioSense is an emerging biotech company established to address the business needs of the global biopharmaceutical market with a focus on China, Europe, and the U.S. The company is based in New Jersey (US) and Suzhou (China). The organization’s mission is to bridge the gap between undercapitalized biopharmaceutical projects, resources and markets to add value to its stakeholders and address significant unmet medical needs and bring affordable treatment options to patients. BioSense’s expert team of international biopharma executives and seasoned investors has extensive experience in developing, registering, and commercializing some of the most successful products in key markets, including US, Europe, and China, plus the business management and cross-cultural knowledge.

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Zhejiang Haichang Biotechnology Co., Ltd.

Zhejiang Haichang Biotechnology Co., Ltd.

On February 8, 2020, Rexahn entered into an agreement with HaiChang, pursuant to which Rexahn granted HaiChang an exclusive, royalty-bearing, sublicensable worldwide license to research, develop and commercialize RX-0201 and RX-0301. RX-0301 is a potential potent inhibitor of the synthesis of the protein kinase Akt-1, which Rexahn believes plays a critical role in cancer cell proliferation, survival, angiogenesis, metastasis, and drug resistance. RX-0301 is currently in preclinical development by HaiChang as a nano-liposomal formulation of RX-0201 (Archexin®) using HaiChang’s proprietary QTsome™ technology. HaiChang is pursuing certain preclinical and clinical activities through completion of a Phase 2a proof-of-concept clinical trial in hepatocellular carcinoma.

Zhejiang Haichang Biotechnology Co., Ltd. is a privately-owned specialized biotechnology company headquartered in Hangzhou, China, focused on the development and manufacture of complex intravenous pharmaceutical products including liposome and microsphere products, primarily for cancer treatment.

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As part of the Rexahn merger transaction, several oncology product candidates developed by Rexahn had established licensing arrangements with BioSense and HaiChang. Prior Rexahn shareholders may receive certain cash payments from the grant, sale or transfer of rights to Rexahn’s existing intellectual property or pursuant to payments received by BioSense or HaiChang during a certain period following Closing on account of the Contingent Value Rights (CVR) Agreement. The CVRs will be issued pursuant to the CVR Agreement and Shareholder Representative Services LLC (“SRS”) will act as representative of holders of the CVRs.