Hanmi Pharmaceutical and Enzychem Lifesciences are gearing up to fight against Amgen, the leader of the neutropenia treatment market.
Neutropenia, a reduction of neutrophils in the blood, is a side effect of a chemotherapy or radiation therapy in cancer treatment. Neutropenia causes fever and painful ulcers and damages the immune system. If severe, the infection may be fatal.
Cancer therapy-induced neutropenia is commonly treated with an injection of G-CSF (granulocyte colony-stimulating factor) to stimulate neutrophils production. Amgen’s first-generation drug Neupogen and second-generation Neulasta are leading the G-CSF class medications.
Neulasta, which sells overwhelmingly more than Neupogen, sold 5 trillion won ($4.37 billion) around the world in 2017. Eighty-seven percent of the revenue came from the U.S. where copy drugs are fewer.
The American Society of Clinical Oncology recommends a preventive use of a G-CSF agent if a cancer patient’s incidence of febrile neutropenia is expected to be over 20 percent. The global neutropenia treatment market is predicted to reach 10.9 trillion won by 2020, according to Credence Research.
Despite its dominance over a decade, Neulasta has shortcomings -- a patient has to visit a hospital every time to get a subcutaneous injection, and particular patients cannot use the medication.
Hanmi and Enzychem are preparing to commercialize “best-in-class” drugs that will complement the Amgen treatment’s demerits.
Hanmi is developing Rolontis, which has a similar efficacy of Neulasta with an increased half-life to offer better user convenience. While Neulasta needs to be injected once a week, Rolontis can be taken once every three weeks.
In a phase-3 trial, Rolontis injected once every three weeks proved non-inferiority to Neulasta in efficacy. The two had a similar frequency of side effects.
Hanmi’s drug candidate was at risk when the company’s partner firm Spectrum Pharmaceuticals voluntarily withdrew its biologics license application (BLA) for Rolontis from the Food and Drug Administration on March 15.
However, analysts said it was due to lack of data regarding the process of production, downplaying the withdrawal as a slight delay of the development schedule.
Enzychem is aiming to commercialize an innovative drug to treat neutropenia with a mechanism entirely different from conventional ones.
Enzychem’s investigational drug EC-18 is an oral medication, raising user convenience radically. Unlike Neulasta that activates STAT3 factor promoting cancer progression, EC-18 inhibits the factor and prevents neutrophil exudation from the blood, according to Enzychem. With anticancer efficacy and fewer side effects, EC-18 can also be administered to patients going through radiation therapy, it added.
In an animal study, EC-18 significantly reduced the duration of neutropenia from 7.4 days to a maximum of 2.6 days.
Enzychem is testing EC-18 in phase-2 trials in Korea and the U.S. The company hopes that the drug could obtain an innovative drug designation after the completion of the phase-2 study.
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