Lugano and Basel, Switzerland 03 September 2015 – Helsinn, the Swiss Group focused on building quality cancer care, and Mundipharma, today announce that they have entered into distribution, license and supply agreements granting exclusive rights to anamorelininSwitzerland and Liechtenstein.

Under the terms of the new agreements, Helsinn retains all international development as well as regulatory and clinical development activities and the supply of anamorelin for commercial use. Mundipharma obtains exclusive rights to registration, marketing, promotion, distribution and sales of anamorelin in Switzerland and Liechtenstein.

Helsinn already has existing partnerships with Mundipharma, for anamorelin, in Brazil, the Middle East and North Africa, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, China, Hong Kong and Macao.

Anamorelin is a novel, once-daily, orally active ghrelin receptor agonist in development for the treatment of Cancer Anorexia-Cachexia in patients suffering from non-small cell lung cancer (NSCLC), an area of significant unmet medical need. Also known as the wasting syndrome, Cancer Anorexia-Cachexia characteristics such as reduced appetite/food intake and unintended weight loss (mainly due to muscle loss) are known to lead to early deaths of cancer patients. It is estimated that over 50% of late-stage cancer patients suffer from cancer anorexia-cachexia.[1]

By mimicking ghrelin, the so-called “hunger hormone” secreted by the gastrointestinal tract, anamorelin was shown to increase lean body mass and improve appetite in patients with non-small cell lung cancer who are suffering from  Cancer Anorexia-Cachexia in two pivotal large-scale 12-week Phase III studies, ROMANA 1 and ROMANA 2.

Riccardo Braglia, CEO of Helsinn Group, said: “Helsinn has a successful existing collaboration with Mundipharma in a number of territories and we are delighted that they will be our partner in Switzerland. We believe that anamorelin could offer a significant improvement on current treatment options for Cancer Anorexia-Cachexia, increasing lean body mass, and alleviating patient concerns.”

Dr. Athanasios Zikopoulos, General Manager of Mundipharma Medical Company Basel: “We are excited to enter into this collaboration with Helsinn for Switzerland. Improving the quality of patients’ lives through effective therapies is one of our core commitments, and we believe that anamorelin, when approved, will make a significant contribution to help further this goal in cancer supportive care.”

About anamorelin and ghrelin

Anamorelin HCl is an investigational selective, novel, orally active ghrelin receptor agonist that is in development for the treatment of Cancer Anorexia-Cachexia in NSCLC patients. Ghrelin is an endogenous peptide secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, lean body mass, appetite and metabolism.

Anamorelin is administered orally at 100mg, once daily. In phase II trials, anamorelin was shown to increase body weight compared with placebo and to improve patient-reported symptoms, including appetite.[2]

Anamorelin recently completed phase III studies (the ROMANA program) in NSCLC patients with cachexia. In ROMANA 1 and ROMANA 2, anamorelin increased in respect to placebo body weight, lean body mass, improved patient’s symptoms and concerns related to anorexia-cachexia and was generally well tolerated.[3]

[1] K.C.H. Fearon et al (Sep 2002). Cancer cachexia. Int J Cardiol 85 (1): 73-81. PMID 12163211

[2] Garcia JM, Friend J, Allen S. Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: a multicenter, randomized, double-blind, crossover, pilot study. Support Care Cancer. 2013;21(1):129–137.

[3] Temel J, et al, Annals of Oncology, Volume 25, Supplement 4, 2014 (Abstract 1483O_PR)

About the Helsinn Group

Helsinn is a family-run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, and the United States and a representative office in China. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.

Helsinn Group in‐licenses early‐to‐late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn’s products are out‐licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge and high ethical standards. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn’s GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers.

Further information on Helsinn Group is available at

About Mundipharma

The Mundipharma independent associated companies are privately owned companies and joint ventures covering the world’s pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of pain, respiratory, oncology and inflammatory conditions. Through innovation, design and acquisition, the Mundipharma independent associated companies deliver important treatments to meet the most pressing needs of patients, healthcare professionals and health systems worldwide.

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For more information please contact:

Helsinn Group

Paola Bonvicini

Head of Communication & Press Office

PH +41 91-985-21-21

[email protected]

Mundipharma   Medical Company, Basel Dr.   Athanasios Zikopoulos General   Manager Tel.   +41 61 205 11 11 [email protected]   For   media / external inquiries Consilium Strategic   Communications  Mary-Jane Elliott /   Jessica Hodgson / Matthew Neal / Laura Thornton Tel: +44 (0)203 709  5700 [email protected]

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