Lugano, Switzerland, and Osaka, Japan, January 22, 2021 - Helsinn Group (Lugano,
Switzerland; CEO: Riccardo Braglia, “Helsinn”) and Ono Pharmaceutical Co., Ltd. (Osaka,
Japan; President and Representative Director: Gyo Sagara; “ONO”) announced today that ONO
received the manufacturing and marketing approval of Adlumiz® (generic name: anamorelin
hydrochloride) Tablet 50mg (“Adlumiz”), a ghrelin receptor agonist, for the treatment of cancer
cachexia in malignant tumors of non-small cell lung cancer, gastric cancer, pancreatic cancer
or colorectal cancer in Japan.
This approval is mainly based on the results from the following two clinical studies conducted in
Japan in patients with cancer cachexia:
1. Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study
in cancer cachexia patients with non-small cell lung cancer (ONO-7643-04)
2. Phase III multi-center, open-label, uncontrolled study in cancer cachexia patients with
gastric, pancreatic or colorectal cancer (ONO-7643-05)
Cancer cachexia is a complex metabolic disorder syndrome, characterized by decreased body
weight (especially decreased muscle mass) and anorexia associated with cancer. It has been
well documented that cancer cachexia causes a significant impact on patients’ quality of life and
prognosis. To date, an effective treatment method for cancer cachexia has not yet been
established.
Anamorelin is a selective, novel, orally active ghrelin receptor agonist. Ghrelin is an endogenous
peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates
multiple pathways in the positive regulation of body weight, muscle mass, appetite and
metabolism. Anamorelin has shown effects in increasing body weight and muscle mass, as well
as appetite in patients with cancer cachexia.
Riccardo Braglia, Helsinn Group Vice Chairman and CEO commented: “We are delighted
that Ono’s application has been successful for the treatment of cancer cachexia in Japan. This
is an important milestone towards the improvement of the quality of life for all cancer cachexia
patients, a condition that is still largely untreatable.”
Kiyoaki Idemitsu, Corporate Executive Officer and Executive Director, Clinical
Development of ONO commented: “We are extremely pleased that Adlumiz has been
approved for the indication of cancer cachexia in Japan. We believe that today’s approval can
provide a promising new treatment option for the patients suffering from cancer cachexia for
which there previously were no other approved treatment methods”.