Unicycive Therapeutics Acquires Renazorb (Lanthanum Dioxycarbonate) from Spectrum Pharmaceuticals for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease

LOS ALTOS, Calif., Dec. 14, 2020 /PRNewswire/ -- Unicycive Therapeutics, Inc., a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced it has entered a licensing agreement with Spectrum Pharmaceuticals for Renazorb (lanthanum dioxycarbonate), a late-stage asset for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD).

Renazorb is a non-aluminum, non-calcium, phosphate binder manufactured using a patent-protected nanotechnology process. Renazorb has been shown to offer unique phosphate binding characteristics, which have the potential to treat hyperphosphatemia in CKD patients with meaningful patient adherence benefits such as smaller and fewer number of pills per dose than the current standard of care.

"Renazorb offers an opportunity to rapidly develop an alternative treatment for hyperphosphatemia based on a long history of the use of lanthanum compounds for phosphate binding but with a potential to significantly enhance ease of dosing and thereby improve patient adherence," said Shalabh Gupta, M.D., President and Chief Executive Officer of Unicycive.

"In the United States alone, phosphate binders are used to treat nearly 500,000 people with hyperphosphatemia annually. The majority of approved phosphate binders require patients to take up to 12 pills per dose three times daily. This poses a significant treatment burden on patients, many of whom have comorbidities. An alternate effective treatment with three easy-to-swallow pills per dose should offer a significant advantage to patients and clinicians for the management of this difficult disease," said Pablo E. Pergola, MD, PhD, Renal Associates PA and research director of the Clinical Advancement Center, PLLC, San Antonio, Texas.

"Renazorb, a compelling potential treatment for patients with complications from chronic kidney disease, was not a good strategic fit with Spectrum's focus on oncology," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We are pleased to have licensed this product to Unicycive which is developing treatments for kidney diseases and is well-suited to carry out the development work for this product."

Under the terms of the asset purchase agreement, Unicycive has acquired global rights for Renazorb and all its trademark and associated patents, and Spectrum has received an equity interest in Unicycive along with milestone and royalty payments.

About Unicycive

Unicycive is a biotechnology company developing novel treatments across multiple therapeutic areas, currently focusing on kidney diseases. Unicycive's lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. Unicycive's other drug, UNI-494, is a new chemical entity with issued composition of matter patent protection in late preclinical development for the treatment of acute kidney injury.

Forward-looking statement - Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to Unicycive's business and its future, including the timing of the submission of the NDA for Renazorb, the timing and results of FDA decisions, including with respect to the Renazorb NDA, the future potential of Unicycive's existing drug pipeline, Unicycive's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Unicycive and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

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SOURCE Unicycive Therapeutics Inc.