Helsinn and Italfarmaco reinforce their alliance through the grant of rights to phase-III ghrelin receptor agonist Anamorelin in Italy

Lugano, Switzerland (ots) -

Helsinn Group grants exclusive distribution and licensing rights to
Italfarmaco for the commercialization of its compound currently in
development for the treatment of anorexia-cachexia syndrome related
to non-small cell lung cancer (NSCLC)

Helsinn Group is pleased to announce that exclusive distribution
and licensing rights to its innovative ghrelin receptor agonist,
anamorelin, in Italy, San Marino and Vatican City have been granted
to its long-established partner Italfarmaco. Anamorelin is an
innovative first-in-class, once daily oral drug currently in phase
III for the treatment of anorexia-cachexia in NSCLC. Cancer
anorexia-cachexia syndrome is a severe multifactorial condition that
involves systemic inflammation, reduced food intake and altered
metabolism, which contribute to the loss of muscle mass and body
weight. This leads to diminished quality of life, functional
impairment and decreased survival. In Phase II trials anamorelin
showed its capability to improve appetite and increase lean body
mass, with a positive impact on the quality of life of cancer
patients, as well as a positive safety and tolerability profile.

"Italy is one of the major pharma markets worldwide, and
Italfarmaco is one of the most relevant Italian pharmaceutical
groups, with a sound expertise in oncology/supportive care, among
other fields. Our companies share a common view on the importance to
safeguard and preserve patients' quality of life and we are very
happy to extend our fruitful and friendly relationship. Anamorelin
will certainly play a significant synergic role within Italfarmaco's
therapeutic assets," said Riccardo Braglia, Helsinn Group CEO.

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 while Italfarmaco will undertake all the commercial
activities within Italy, San Marino and Vatican City. "We are very
excited for this new promising asset, which perfectly fits to our
existing portfolio and long time expertise in the supportive care
arena. Italfarmaco is looking forward to making Anamorelin available
to Italian patient population suffering from such a debilitating
disease", commented Francesco De Santis, President of the Italfarmaco
Group.

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 the 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
www.helsinn.com.

About Italfarmaco Group

Italfarmaco is a multinational pharmaceutical group headquartered
in Italy, with operations in Spain, Portugal, Greece, France, Nordic
Countries, Turkey, Russia, Morocco, Chile, Peru, Colombia and the
United States. Italfarmaco is focused on development, manufacturing
and commercialization of prescription drugs, with high therapeutic
content, in the fields of oncology/supportive care, women health,
thrombosis, and CNS.

Italfarmaco is very well known for its commitment in R&D, with a
number of new chemical entities in clinical stage of development. The
group owns modern, sophisticated industrial plants, devoted to the
GMP production of oral solids and injectables (in Milan) and oral
liquids (in Madrid), where it manufactures its proprietary drugs at
the highest standards of quality. Further information on Italfarmaco
Group is available at www.italfarmaco.com.

Contact Person:
Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
PH +41 91-985-21-21
info-hhc@helsinn.com