Helsinn Group and Angelini Ink an Agreement for License Rights to Phase-III Ghrelin Receptor Agonist Anamorelin in Central & Eastern Europe

PR Newswire

LUGANO, Switzerland, January 15, 2014/PRNewswire/

Swiss Pharma Group Helsinn grants exclusive distribution and licensing rights to Angelini, through its subsidiary company CSC Pharmaceuticals, for the commercialization in Austria, Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovak Republic, Georgia, Russia and the other CIS countries of its compound currently in development for the treatment of anorexia-cachexia syndrome related to non-small cell lung cancer (NSCLC)

Swiss-based Helsinn Group secures a new deal for anamorelin by granting Angelini, through its subsidiary company CSC Pharmaceuticals, exclusive commercialization rights to their innovative ghrelin receptor agonist, anamorelin, in several Central & Eastern European countries.

Anamorelin is a novel first-in-class, oral, once daily drug for the treatment of anorexia-cachexia in NSCLC. The phase III trial program (ROMANA 1, 2 & 3) is proceeding according to expectations.

Anorexia-cachexia syndrome is a severe multifactorial condition that affects more than 50% of cancer patients and involves systemic inflammation, reduced food intake and altered metabolism. These contribute to the loss of muscle mass and body weight, leading to diminished quality of life, functional impairment and decreased survival.

Phase II results highlight that anamorelin can improve appetite, increase lean body mass and have a positive impact on the quality of life of patients with cancer suffering from this condition, along with a positive safety and tolerability profile.

"CSC and its parent company Angelini are among Helsinn's most successful and long-standing partners, with a strong focus on innovative, niche-oriented products," said Riccardo Braglia, Helsinn Group CEO. "We are very happy to extend our fruitful and friendly relationship, which will bring this new important option to reduce the burden of anorexia-cachexia syndrome to many European patients and their families as well as their caregivers," he added.

"We are particularly keen on strengthening our enduring partnership with Helsinn through an innovative drug against a syndrome that affects many cancer patients," said Gianluigi Frozzi, CEO of Angelini Pharma Division.

Helsinn will retain all development tasks (CMC, preclinical and clinical) and supply of anamorelin for commercial use. The Swiss Group will also be responsible for the regulatory and clinical development whereas Angelini will undertake all the commercial activities within the relevant territory.

About Anamorelin and Ghrelin

Anamorelin HCl is a selective, novel, orally active ghrelin receptor agonist and has been previously studied in approximately 500 subjects, including four completed phase II trials dosing 361 patients with cancer. Anamorelin is currently being tested in two phase III studies, ROMANA 1 and ROMANA 2 evaluating anamorelin HCI for the treatment of anorexia-cachexia syndrome in patients with advanced non-small cell lung cancer (NSCLC). The two studies 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, also known as the "hunger hormone", is a multiacting peptide secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the regulation of body weight, lean body mass, appetite and metabolism.

About Cancer Anorexia-Cachexia Syndrome (CACS)

Cancer anorexia-cachexia is a multifactorial syndrome that cannot be fully reversed by conventional nutritional support, and in which systemic inflammation, reduced food intake and altered metabolism contribute to loss of muscle mass and reduction in body weight. Patients with CACS have reduced quality of life, physical disability and shortened survival. CACS is often under-recognized despite of its frequency (more than 50% of cancer patients develop cachexia) and its strong implications, such as reduction of treatment tolerance, response to therapy and shortened survival. With no standard of care and limited efficacy of current approaches, there is a need of a multimodal treatment for this multifactorial condition.

About Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland, 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 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 Switzerland and Ireland and supplied worldwide to its customers.

Further information on Helsinn Group is available at http://www.helsinn.com.

About Angelini

Angelini, a privately owned International group, is leader in the healthcare and wellbeing market in the pharmaceutical and mass-market sectors. Founded in Italy in 1919, the group has branches in 20 countries and employs about 3.800 people. In 2012 the consolidated turnover was over 1.350 billion Euros.

In the Pharmaceutical sector Angelini has branches in Italy, Spain, Austria, Portugal, Poland, Czech Republic, Slovak Republic, Hungary, Romania, Bulgaria, Slovenia, Croatia, Greece, Turkey, USA, Pakistan and India; its products are distributed worldwide in over 60 countries. At an international level, the company focuses mainly on pain relief, inflammation, CNS, cold & flu, oral care & sore throat, gynaecology, disinfection. R&D department is currently focused on the following research areas: pain/inflammation; CNS; infection. Angelini is one of the top four pharmaceutical companies in Italy by sales and volume and leader in self-medication sector thanks to brands like Tachipirina, Moment and Tantum Verde.

In the Personal Care sector, Fater, joint venture between Angelini and Procter & Gamble, is Italian market leader in the happy, lady napkins and incontinence sectors with the brands Pampers, Lines, Linidor and Dignity.

In the Machinery sector, Fameccanica, joint-venture with Procter & Gamble, is world leader in the design and implementation of integrated production lines for the absorbent sanitary product industry.

Angelini also operates in the following sectors: real estate (Italy and Spain), perfumery (Idesa in Spain, ITF in Italy and Germany) and wine growing and agriculture (Tenimenti Angelini in Italy).

Contact Person:

Helsinn Group

Paola Bonvicini

Head of Communication & Press Office

PH +41-91-985-21-21



Fabio Pieroni

Corporate Communication Director

PH +39-06-78053366


Fonte: Helsinn Healthcare SA

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