Helsinn, Mundipharma sign distribution, license and supply agreements for anamorelin

HelsinnFeb 16 2016

This exclusive agreement strengthens previous alliances with Mundipharma and its network of independent associated companies in cancer supportive care across multiple territories worldwide.

Helsinn, the Swiss pharmaceutical Group focused on building quality cancer care, today announce that they have entered into distribution, license and supply agreements with Mundipharma and its network of independent associated companies granting exclusive rights to anamorelin in Norway, Finland, Sweden, Denmark and Iceland.

Under the terms of the new agreements, Helsinn retains all development rights as well as regulatory and clinical development activities in the above mentioned countries and the supply of anamorelin to Mundipharma for commercial use. Mundipharma obtains exclusive rights to marketing, distribution and sales of anamorelin in Norway, Finland, Sweden, Denmark and Iceland. Helsinn already has existing alliances with Mundipharma, for anamorelin, in Brazil, Middle East and North Africa, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, China, Hong Kong, Macao, Switzerland and Liechtenstein.

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 has characteristics such as reduced appetite/food intake and unintended weight loss (mainly due to muscle loss) which are known to lead to early deaths of people with cancer. It is estimated that over 50% of late-stage cancer patients suffer from cancer anorexia-cachexia. K.C.H. Fearon et al (Sep 2002). Cancer cachexia. Int J Cardiol 85 (1): 73–81. PMID 12163211

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, Vice Chairman and CEO of Helsinn Group, said: "Anamorelin has been shown to significantly increase lean body mass and appetite in two pivotal Phase III studies, aspects that strongly impact the quality of life for people with Cancer Anorexia-Cachexia. Helsinn has an established relationship with Mundipharma, with existing alliances in several territories, and we are delighted that we will be able to extend these to Norway, Finland, Sweden, Denmark and Iceland."

Anders Fogstrup, Head of the Nordic Mundipharma network of independent associated companies, said: "The addition of Anamorelin to our portfolio is an exemplification of our aim to work with companies that share our high standards in delivering effective treatment options which meet the needs of both patients and payers. Thanks to our European reach, strong commercial focus and expertise, the strength of the Mundipharma network of independent associated companies is an attractive proposition to potential partners and we envisage increased expansion over the next decade."