Hanmi Pharmaceutical Co. and its partner Spectrum Pharmaceuticals of the U.S. announced on Dec. 18 that they have recently reached an agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) for the Phase 3 clinical trial of its novel SPI-2012 (eflapegrastim), formerly known as “LAPS-GCSF,” to treat persistent neutropenia.
It will be a randomized, active controlled trial with pegfilgrastim under the brand name Neulasta that will enroll 580 newly diagnosed early-stage breast cancer patients who will receive chemotherapy. Also, the trial will be conducted in numerous countries, including Korea and the U.S.
SPI-2012 is the treatment of persistent neutropenia based on Hanmi's proprietary Lapscovery technology, allowing an injection in each cycle of chemotherapy.
Hanmi Pharmaceuticals, which completed Phase 1 clinical trials in the U.S., has started the joint development from the Phase 2 clinical trial of SPI-2012 with Spectrum after signing the licensing agreement in 2012. Once the product is ultimately commercialized, Spectrum will own the worldwide rights, except for Korea, China and Japan.
Currently, neutropenia constitutes a large global market estimated to be 6 trillion won (US$5.07 billion).
Lee Gwan-sun, president and CEO of Hanmi Pharmaceuticals, said, “SPI-2012 is the first drug to enter the global Phase 3 clinical trial among Hanmi’s Lapscovery pipelines. Through joint development with Spectrum, we will focus our R&D competence in order to commercialize the product as soon as possible.”
Rajesh C. Shrotriya, president and CEO of Spectrum Pharmaceuticals, said, “The Phase 2 clinical trial suggests that SPI-2012 is more effective than its competitor Neulasta (pegfilgrastim). After commercialization of SPI-2012, the company expects to take a leap forward, based on its competitiveness in the market.”
Meawhile, Spectrum Pharmaceuticals, currently listed on the NASDAQ in the U.S., is a biotechnology company that focuses on developing new anticancer medicines. Also, it has five related new drugs, including Fusilev, the treatment of osteosarcoma, and Zevalin, the treatment of non-Hodgkin’s lymphoma.