Helsinn Group and Angelini ink an agreement for license rights to phase-III ghrelin receptor agonist Anamorelin in Central & Eastern Europe

Lugano, Schweiz (ots) - 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)

Lugano, Switzerland, January 15, 2014 - 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
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 nappy, 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:
Contact Person
Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
PH +41 91-985-21-21
info-hhc@helsinn.com

Angelini
Fabio Pieroni
Corporate Communication Director
PH +39 06 78053366
f.pieroni@angelini.it