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LOTUS RECEIVED TENTATIVE APPROVAL FOR ITS ANDA FOR LENALIDOMIDE FROM US FDA

Posted on 25.9.2020

Lotus Pharmaceutical Co., Ltd. (“Lotus” or “the Company”, Taiwan TWSE ticker: 1795) today announced that the Company received tentative approval for its ANDA (“Abbreviated New Drug Application”) for Lenalidomide Capsules (generic version of REVLIMID®) 2.5mg, 5mg, 10mg, 15mg, 20mg, and 25mg from US FDA. The Company expects to launch the product as per its settlement agreement with the originator in the US beginning on a confidential date that is some time after March 2022.

Petar Vazharov, Chief Executive Officer of Lotus, commented: “We are so excited to achieve another important milestone for our leading oncology portfolio – after obtaining approval of Lenalidomide in Europe as the first generic, we are now also among the first to receive an approval in the US which solidifies Lotus’ core competence as the global preferred partner in oral oncology. Lenalidomide is the first product fully developed and manufactured in our facilities in Taiwan and covers at least 81 countries with 23 countries approved, including the tentative approval in the US, 26 counties under registration, and 12 submissions under preparation as potential markets in the world. We have successfully launched the product in selected European countries in February 2019 and we are confident that we will continue to deliver with our evolving portfolio. “

Lenalidomide Capsules are indicated for the treatment of multiple myeloma. As disclosed by the originator, REVLIMID® 2019 sales were around US$10bn globally.

Lotus and Alvogen settled US REVLIMID® patent litigation with Celgene on March 30th, 2019. In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Lotus and Alvogen with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after the March 2022 volume-limited license date that Celgene previously provided to Natco. For each consecutive twelve-month period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Lotus and Alvogen cannot exceed certain agreed-upon percentages. Although the agreed-upon percentages are confidential, they increase gradually each period to no more than a single-digit percentage in the final volume-limited period. In addition, Celgene has agreed to provide Lotus and Alvogen with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026.