Oral oncology and specialty pharmaceutical Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, 1795:TT) today confirmed the launch of Vinorelbine 20, 30 and 80mg soft capsules in Europe. The product is a generic alternative of Pierre Fabre Médicament’s Navelbine® (note1) indicated for treatment of advanced non-small-cell lung cancer (NSCLC) and advanced breast cancer when other treatment is not appropriate. Vinorelbine is a semisynthetic derivative of vinblastine and oral formulation in the form of softgel capsules are marketed mainly in Europe and Asia. The Company believes this is the first generic in form of softgel capsules in the world due to higher entry barrier across development and manufacturing.
Lotus Chairman Robert Wessman said that the Company filed the product through multiple decentralized procedures (DCP) in October 2017 and has received end-of-procedure confirmations (EOP) starting March this year. With the first shipment confirmed today, the Company is gearing up for imminent launch in European countries including Spain, Italy, UK, Portugal, Romania, Hungary through partnerships. He added, “We are proud to be the first and the only approved generic in the market as it has always been our commitment to offer affordable alternatives to cancer patients. We are also happy to announce that this product is co-developed by our Taiwan Nantou R&D and India CRO team (Norwich Clinical Service). We proved that cross-border collaboration is a value-adding model for our oncology pipeline.”
According to IQVIA, Vinorelbine softgel capsules currently recorded a branded market of US$ 130 million in Europe and roughly US$ 30 million in Asia.
Note 1: Navelbine® is a trademark and brand of PIERRE FABRE MEDICAMENT