Lotus Inks Deal With CKD to Distribute Darbepoetin Alpha Biosimilar

Lotus Pharmaceutical and Chong Kun Dang (CKD) Pharmaceutical have entered into a distribution partnership for biosimilar darbepoetin alpha (CKD-1110), a second-generation epoetin for the treatment of anemia associated with chronic renal failure (CRF).

The drug references Nesp/Aranesp sold by Japan-based Kyowa Kirin, and Lotus noted in its statement that sales of this originator have grown 15% annually over the past 3 years.

CKD received approval to market the biosimilar in October 2019 from the Japanese Ministry of Health, Labor and Welfare. The company touted CKD-1110 as the first darbepoetin alpha biosimilar.

A Growing Franchise

The collaboration gives Lotus the marketing rights for distribution of the product in Taiwan and South East Asian markets, a franchise that Lotus valued at around $30 million yearly. The status of regulatory approvals for CKD-1110 in Taiwan and South East Asia was not indicated.

The market for darbepoetin alpha in Asia is considered robust because CRF is among the top causes of death. In the United States, 15% of US adults are estimated to have CRF (ratio, > 1:7), a percentage consistent with a global market rate cited by Lotus. More than 37% of US adults 65 years and older have CRF.

“This deal not only strengthens our nephrology franchise in in the region, but also enhances our regional presence by adding more complex products to our growing biosimilars portfolio,” Petar Vazharov, CEO of Lotus, said.

Lotus, a diverse biopharmaceutical supplier, has identified movement into biosimilars as a valuable growth engine for its pharmaceuticals distribution network in Asia. The company has a pre-existing partnership with Reykjavik, Iceland–based Alvotech, a company that specializes in development and manufacturing of biosimilars and in August announced a partnership to collaborate with Teva to bring biosimilars to the US market. Teva would fulfill a commercialization role in that partnership.

Company Background

Alvotech is an independent sister company to Alvogen, which in 2014 acquired a 67% stake in Lotus in a deal valued at $200 million. Lotus then took over management of Alvogen’s Asian operations. At the time, Lotus had an FDA-approved manufacturing facility for cytotoxic oral formulations. The partnership gave Lotus and Alvogen manufacturing and product development resources in North America, Taiwan, South Korea, and Romania.

The deal with Alvogen also gave Lotus access to a 30-country sales and marketing network. At the time, the 2 companies intended to collaborate on developing difficult-to-produce generic products for the US market.

The Lotus deal with CKD gives Lotus 5 biosimilar products in its pipeline of products targeted for distribution in Asian markets. The others include bevacizumab, adalimumab, trastuzumab, and teriparatide products.