Lugano, Switzerland and Porto, Portugal, September 8, 2015:
Helsinn, the Swiss Group focused on building quality cancer care, and BIAL - Portela & Ca. S.A. (“BIAL”), one of the largest Iberian pharmaceutical companies, today announce that they have entered into an agreement for the exclusive distribution and licence rights to Anamorelin in Spain, Portugal, Angola and Mozambique.
Under the terms of the agreement, Helsinn retains all international regulatory and clinical development activities and the supply of Anamorelin for commercial use. BIAL will be responsible for all distribution and marketing activities in the designated territories.
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. Cancer anorexia-cachexia is a multifactorial syndrome defined by an ongoing loss of skeletal muscle mass, the inability to be fully reversed by conventional nutritional support and a progressive functional impairment. In addition to its physical impact, cancer anorexia-cachexia has also a marked psychological impact that decreases the quality of life of both patients and their families. By mimicking ghrelin, the so-called “hunger hormone” secreted by the gastrointestinal tract, Anamorelin has been shown to improve lean body mass and appetite in patients with non-small cell lung cancer (NSCLC) who are suffering from cancer anorexia-cachexia.
Riccardo Braglia, CEO of Helsinn Group, said “This new agreement with BIAL is an important step for Anamorelin as it can bring us into Spain and Portugal, two key markets for Helsinn. We are confident that this first agreement between Helsinn and BIAL will form the foundation of a trusted partnership between our companies. Anamorelin has demonstrated in phase III development trials a clear potential to improve lean body mass and improve the concerns of patients with cancer-anorexia cachexia.”
Commenting on the deal, António Portela, CEO of BIAL, said. “We are delighted to be working with Helsinn Group and to have the opportunity to bring to the market such a potentially promising treatment to improve the quality of life of people suffering from such a devastating disease as cancer. This partnership marks the entering of BIAL in the oncology market. Our excitement is reinforced by the possibility to commercialize Anamorelin not only in Portugal, but also in Spain, Mozambique and Angola. This helps us to achieve our corporate mission to provide innovative and high quality medicines to fulfill the unmet medical needs of the health care professionals, patients and their families.”
 Fearon K et al., Definition and classification of cancer cachexia: an international consensus. Lancet Oncol 2011;12:489–95
 Vaughan VC et al., Cancer cachexia: impact, mechanisms and emerging treatments. J Cachexia Sarcopenia Muscle 2013;4:95–109
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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 has shown to increase body weight compared with placebo and to improve patient-reported symptoms, including appetite.
Anamorelin recently completed phase III trials (the ROMANA program) in NSCLC patients with cachexia. In ROMANA 1 and ROMANA 2, Anamorelin increased, with respect to placebo, body weight, lean body mass, improved patient’s symptoms and concerns related to anorexia-cachexia and was generally well tolerated.
 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.
 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, USA 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 pre-clinical/clinical studies as well as 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. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice.
Helsinn has built a large product portfolio of cancer care products with the alliance of over 65
global partners. 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 www.helsinn.com
Founded in 1924, BIAL is an innovative international pharmaceutical company with the mission to discover, develop and provide therapeutic solutions within the area of health. In recent decades, BIAL has focused on quality, innovation and internationalization.
It is the partner of choice for many companies, having a strong presence in the Iberian Peninsula as well as in countries in Latin America and in several French- or Portuguese-speaking African countries.
BIAL is strongly committed to therapeutic innovation, investing more than 20% of its turnover in research and development (R&D) every year, placing it among the most innovative European companies. Key research areas for BIAL are the central nervous system, the cardiovascular system and allergen immunotherapy.
BIAL Group has launched the first drug of Portuguese patent, an anti-epileptic, already available in the US market and in several European countries. The second pharmaceutical of its own research, for the treatment of the Parkinson disease, Opicapone, is already under review by the European Medicines Agency (EMA). The company expects to introduce more new medicines and vaccines to the market in the next years, which will be an added impetus to its international expansion.
Further information about BIAL can be found at www.bial.com.
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