Pharma Focus Europe

Unicycive Announces Exclusive License and Development Agreement with Lotus for Renazorb in the Republic of Korea

Friday, February 03, 2023

Unicycive Therapeutics, Inc., a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that it has entered into an exclusive license agreement with Lotus Pharmaceutical, a leading global pharmaceutical company, for the development and commercialization of Renazorb® (lanthanum dioxycarbonate) in the Republic of Korea. Renazorb is Unicycive’s novel phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients.

"We are especially pleased to announce our second partnership for Renazorb in Asia and are delighted to be working with Lotus, a renowned global pharmaceutical leader. We believe this collaboration provides the optimal infrastructure for the further development and commercialization of Renazorb in the Korean market,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Hyperphosphatemia continues to be a serious problem for end stage renal patients around the world, particularly as compliance with currently available phosphate binders is challenging. There remains a need for a new treatment with a product profile that has meaningful patient adherence benefits, such as Renazorb.”

“At Unicycive, one of our key goals is to bring Renazorb to hyperphosphatemia patients around the world and this latest partnership underscores our commitment to that mission. We continue to advance discussions with potential partners in other key geographies and look forward to building on the foundation of global partnerships we have initiated in Asia,” added Dr. Gupta.

“The partnership with Unicycive is a testament to our efforts to bring novel treatment options for patients with chronic diseases. Nephrology is one of the key therapeutic areas for Lotus, and Alvogen Korea, an affiliate of Lotus group has been dominant and has contributed to the nephrology market with its other blockbuster products, such as Epoetin for CKD treatment, which has leading market share (45% based on 3Q 2022 IQVIA data). Renazorb® is expected to provide another high value of clinical benefits to CKD patients in Korea,” said Petar Vazharov, Chief Executive Officer of Lotus.

Under the terms of the agreement, Lotus will be responsible for development, registration filing and approval of Renazorb in the Republic of Korea. In addition, Lotus will have sole responsibility for the importation of the drug product from Unicycive and for the costs of commercialization of Renazorb in the Republic of Korea.

Unicycive will receive an upfront payment of $750,000 and may receive up to $4.45 million in milestone payments and tiered royalties upon achievement of prespecified regulatory and commercial achievements.

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