Helsinn Grants Stendhal Rights to Anamorelin, a First-In-Class Compound to Treat Cachexia-Anorexia Related to Non-Small Cell Lung Cancer (NSCLC)

LUGANO, Switzerland and MEXICO CITY, January 29, 2013 /PRNewswire/ --

Stendhal strengthens its pipeline of in-licensed specialty drug products by signing a Distribution and License Agreement with Helsinn Group for an innovative phase III ghrelin receptor agonist.

Swiss pharmaceutical Helsinn Group has granted Latin American specialty company  Stendhal exclusive commercialization rights for Mexico, Venezuela, Colombia, Perú, Ecuador and most of Central American countries, to this novel ghrelin receptor agonist.

Anamorelin is a new first-in-class, once daily drug being developed for the treatment of cachexia-anorexia in NSCLC,

a serious multifactorial disorder which involves muscle wasting, metabolic impairment and loss of appetite and commonly affects people with advanced cancer.

"This is the first step towards what we believe it will be a long and fruitful relationship between two companies sharing the same values," Helsinn Group CEO, Dr. Riccardo Braglia said. "With this new partnership we are further expanding our anamorelin franchise in America and we are achieving this through Stendhal and its really top quality team."

Under the terms of the agreement, Helsinn will retain all development activities (CMC, preclinical and clinical) and supply of anamorelin for commercial use. Stendhal will be responsible for regulatory/clinical development and commercial activities within their territory.

In phase II trials, anamorelin demonstrated to improve appetite, increase lean body mass and improve quality of life in people affected by cancer-related anorexia-cachexia. The phase II trials also showed a good safety and tolerability profile. The anamorelin phase III clinical trial program (ROMANA 1, 2 & 3) began in Q3 2011 and it is proceeding according to plans.

Anamorelin is an important first step towards the goal of creating a strong Oncology and Cancer Supportive Care Business Unit for Stendhal. Mr. Carlos Arenas Wiedfeldt, Stendhal CEO said, "We are excited to enter into this relationship with Helsinn.  Anamorelin will be an important part of our continued expansion in oncology in Latin America."

About Anamorelin and Ghrelin

Anamorelin HCl is an orally administered ghrelin receptor agonist and has been previously studied in approximately 500 subjects, including four completed phase II trials dosing 361 patients with cancer. Complete results from phase II studies are expected to be published in the near future.

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 cachexia-anorexia- 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, Switzerland, and operating subsidiaries in Ireland and 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 Switzerland and Ireland and supplied worldwide to its customers.

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

About Especificos Stendhal S.A. de C.V.

Stendhal is a privately-held specialty pharmaceutical company based in Mexico City and operating in 14 countries in Latin America.  Stendhal's business is developing strong partnerships and launching innovative branded products in the region in order to bring best-in-class products to patients in Latin America.  Stendhal's success is based upon long-term partnerships with market leaders in the following therapeutic areas: HIV, Multiple Sclerosis, CNS, Genetic Disorders, Cardiovascular and Infectious Diseases and, most recently, Oncology. Stendhal is dedicated to being the best choice as a Latin American partner with expertise in local clinical trials, market access, regulatory strategy and commercialization in Latin America.  Further information on Stendhal is available at http://www.stendhalpharma.com.

References:

1. von Haehling, S et al. J Cachexia Sarcopenia Muscle, 2010; 1(1): 1-5.

2. U.S.A. National Cancer Institute Physician Data Query: http://www.cancer.gov

Contact person for Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
PH +41-91-985-21-21
Info-hhc@helsinn.com

Contact person for Stendhal:
Jeff Conroy
Vice President of Corporate Development
PH +1-703-346-0751 (USA)
Jeff.conroy@stendhalpharma.com