Last Updated : Tuesday, January 21, 2020 00:33:53

CADILA inks licensing agreement to market Anemia treatment in China

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Ahmedabad headquartered pharmaceutical products manufacturing company Cadila Healthcare Ltd said of having entered into licensing agreement with China Medical System Holdings for marketing anemia treatment in Greater China.

The press-release titled, “Zydus and China Medical System Holdings enter into a License Agreement for Desidustat in Greater China”, enclosed with the regulatory filing as submitted by the company to the Indian Bourses, further highlighted that, Desidustat, currently undergoing Phase III clinical development is a novel oral HIF—PH inhibitor for treating Anemia in Chronic Kidney Disease Patients and the agreement provides Zydus access to markets in Greater China, where more than 120 million patients are estimated to be living with Chronic Kidney Disease (CKD).

The release in details, further read that, Zydus, a leading discovery based global pharmaceutical company today announced that it has entered into a licensing agreement with China Medical System Holdings Limited (CMS) for the development and commercialization of Desidustat, a novel oral HlF-PH inhibitor for the treatment of anemia in patients with Chronic Kidney Disease (CKD) not—on—dialysis and for the treatment of Anemia CKD patients on dialysis in Greater China (Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan).

It has been reported that more than 120 million people are estimated to be living with CKD in China.

CKD is a serious medical condition which is an unmet healthcare need involving gradual loss of functioning of kidneys eventually leading to kidney failure.

If kidneys are healthy they will naturally secrete beneficial levels of a hormone called erythropoietin (EPO), which encourages red blood cell production that carry oxygen to the muscles and brain.

If the kidneys are impaired they will produce reduced levels or tire of EPO production completely, leading to fatigue and anemia.

Anemia is one of the frequent complications of CKD.

A survey in China showed that the prevalence of anemia in patients at CKD stage 1 t0 5 were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively.

The target—achieving rate was only 8.2% for anemia patients in non— dialysis CKD and 35.2% for dialysis CKD, showing unmet healthcare need.

Under the license agreement, CMS will pay Zydus an initial upfront payment, regulatory milestones, sales milestones and royalties on net sales of the product.

The commercial terms of the license agreement are confidential.

CMS will be responsible for development, registration and commercialization of Desidustat in Greater China.

Zydus had initiated two Phase III trials of Desidustat.

The DREAM—ND Phase III trial is being conducted in CKD patients not-on-dialysis.

The DREAM—D Phase is being conducted in CKD patients on Dialysis.

Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed good safety profile.

The Phase 1 trials were earlier completed in Australia.

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