Anamorelin is currently being tested in two phase III studies, ROMANA 1 and ROMANA 2, running in parallel are evaluating anamorelin HCI for the treatment of anorexia-cachexia in patients with advanced non-small cell lung cancer (NSCLC). The two studies will enroll approximately 477 patients each in over 15 countries, with sites in North America, Europe, Russia, Australia and the Middle East. Patients who complete ROMANA 1 or 2 have the option of continuing treatment in the ROMANA 3 safety extension study.
Ghrelin is a hormone that is predominantly produced in the stomach. As the first identified "hunger" hormone, administration of ghrelin rapidly stimulates appetite, which may lead to increased food intake and body weight, as well as other physiologic activities including increasing lean body mass and stimulating gastric emptying.
About Cancer-related Cachexia-anorexia
Cachexia-anorexia is a common yet life-threatening consequence of advanced cancer. The condition causes a decline in lean muscle mass, reduced strength and a decrease in physical function that can begin early in the course of a patient's cancer. In addition, it results in a compromised metabolism, making chemotherapy less tolerable.(1) Up to 80 percent of advanced cancer patients experience cachexia-anorexia and it is the cause of death in 20 to 40 percent of these patients.(2) There are no approved treatments for cancer-related cachexia-anorexia in
the United States
or in much of the world.
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano,
, and operating subsidiaries in
the United States
. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas. Helsinn is an important player in cancer supportive care. Helsinn Group in-licenses early-to-late stage new chemical entities, completes their development through the performance of pre-clinical /clinical studies and Chemistry, Manufacturing, and Control (CMC) development, and files and attains their market approvals worldwide. Helsinn's products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how whom Helsinn assists and supports by providing a full range of product and scientific management services, including commercial, regulatory financial, legal, and medical marketing advice. The active pharmaceutical ingredients and the finished products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in
and supplied worldwide to its customers.
Further information on Helsinn Group is available at
About Specialised Therapeutics Australia Pty Ltd
Specialised Therapeutics Australia Pty Ltd (STA) is a biopharmaceutical company dedicated to working with leading pharmaceutical companies worldwide to provide acute care therapies for high unmet medical needs to people living in
. The STA therapeutic portfolio and pipeline at present encompasses oncology and infectious disease.
Currently STA markets two world leading cancer and cancer supportive care therapies, ABRAXANE® (
paclitaxel) and ALOXI® (palonosetron) respectively, and has recently licensed from the Helsinn Group a fixed-dose combination product (in both oral and intravenous forms) containing netupitant, a neurokinin-1 (NK1) receptor antagonist, and Aloxi® (palonosetron), a serotonin-3 (5-HT3) receptor antagonist.
STA also has interests in the therapeutic areas of respiratory, dermatology, endocrinology and central nervous system (CNS). Additional information can be found at