CKD-1110 is a second-generation epoetin indicated for the treatment of anaemia associated with chronic renal failure. Under the agreement, Lotus will conduct a clinical trial of CKD-1110 for sales licenses in Taiwan, Vietnam and Thailand and will market the product exclusively in these countries after gaining sales approval. CKD will receive both a down payment and milestone payments.

Chronic renal failure has a high prevalence globally. A recent study estimated that 15% of US adults have the disease, a percentage consistent with a global market rate cited by Lotus. Among the currently available treatments, the reference product of CKD-1110 (NESP®) is the best-selling second generation epoetin with volumes growing by 15% year-on-year over the last three years. Lotus estimated the value of its markets of interest to be US$30 million annually.

Petar Vazharov, Chief Executive Officer of Lotus, commented: ‘This newly-executed agreement marks multiple milestones echoing our long term strategy to provide quality and affordable healthcare – this deal not only strengthens our Nephrology franchise in the region, but also enhances our regional presence by adding more complex products to our growing biosimilars portfolio’.

Darbepoetin alfa will be the fifth biosimilar product in Lotus’ pipeline of products targeted for distribution in Asian markets, complementing its well-established generics business. Lotus has the rights to commercialize bevacizumab and adalimumab in several Asian countries and has submitted trastuzumab in Korea, and teriparatide in both Taiwan and Thailand for marketing authorization.

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