Helsinn and Chugai Pharma Marketing Enter into Agreement for Rights of Anamorelin, Currently in Development for Treatment of

    Helsinn and Chugai Pharma Marketing Enter into Agreement for Rights of
   Anamorelin, Currently in Development for Treatment of Anorexia-Cachexia
       Syndrome Related to Non-small Cell Lung Cancer in top EU Markets

PR Newswire

LUGANO, Switzerland, November 12, 2013

LUGANO, Switzerland, November 12, 2013 /PRNewswire/ --

Swiss Pharma Group Helsinn seals an alliance with Japanese company Chugai by
granting exclusive distribution & licensing rightstocommercialize its
innovative phase III ghrelin receptor agonist in Germany, France,Benelux, UK
and Ireland

Swiss-based Helsinn group has granted Chugai Pharma Marketing Ltd., a
wholly-owned subsidiary of Chugai Pharmaceutical Co., Ltd., exclusive
commercialization rights to their innovative ghrelin receptor agonist,
anamorelin, for the three major European pharma markets.

Anamorelin is a new first-in-class, oral, once daily drug, currently in phase
III for the treatment of anorexia-cachexia in NSCLC, a detrimental
multifactorial disorder that affects over 50% of people with cancer and in
which systemic inflammation, reduced food intake and altered metabolism
contribute to loss of muscle mass and reduction of body weight leading to
reduced quality of life, functional impairment and decreased survival.

Phase II trials have highlighted how anamorelin can improve appetite, increase
lean body mass and have a positive impact on the quality of life of patients
with cancer suffering from anorexia-cachexia. A good safety and tolerability
profile was also shown. Phase II data have recently been presented at the
ECCO/ESMO 2013 meeting in Amsterdam while the phase III clinical trial program
(ROMANA 1, 2 & 3) that started in Q3 2011 is proceeding as expected.

"We are extremely pleased of this new, important collaboration with Chugai and
we are very confident it will be significantly fruitful for both parties. This
milestone is an additional recognition of anamorelin's promising clinical
development in the cancer supportive care arena", said

Riccardo Braglia, Helsinn Group CEO. "We are confident that our product can
improve the quality of life of cancer patients in these European countries",
he concluded.

Under the terms of the agreement, Helsinn will retain all development
activities (CMC, preclinical and clinical) and supply of anamorelin for
commercial use. In addition, Helsinn will be responsible for the regulatory
and clinical development whilst Chugai Pharma Marketing will undertake all the
commercial actions within Germany, France, Benelux, UK and Ireland.

"This alliance is a result of our shared vision with Helsinn to introduce an
important new treatment to reduce the burden of anorexia-cachexia syndrome in
cancer patients. Anamorelin will give physicians a totally new option that
could potentially change the way they treat patients with advanced cancer in
the future. It is Chugai's commitment and dedication to bring innovative
medicines to patients, and we are confident that Anamorelin's novel mechanism
of action and strong supporting data will lead to a successful introduction of
this medicine to patients and physicians." said John Halls, Managing Director
of Chugai Pharma Marketing.

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 http://www.helsinn.com.

About ChugaiPharma Marketing

Chugai Pharma Marketing Ltd. is the headquarters of all Chugai's commercial
activities throughout Europe and co-ordinates the European marketing
operations through subsidiaries located in the UK, France, and Germany.
Products which are currently marketed in those countries include "RoActemra^®
(tocilizumab)", a humanized anti-human IL-6 receptor monoclonal antibody,
"Granocyte^® (lenograstim)", a G-CSF preparation, and "Antepsin^®
(sucralfate)", an antiulcer agent (marketed in the UK and Ireland).

About Chugai

Chugai Pharmaceutical is one of Japan's leading research-based pharmaceutical
companies with strengths in biotechnology products. Chugai, based in Tokyo,
specializes in prescription pharmaceuticals and is listed on the 1st section
of the Tokyo Stock Exchange. As an important member of the Roche Group,
Chugai is actively involved in R&D activities in Japan and abroad.
Specifically, Chugai is working to develop innovative products which may
satisfy the unmet medical needs, mainly focusing on the oncology area.

In Japan, Chugai's research facilities in Gotemba and Kamakura are
collaborating to develop new pharmaceuticals and Ukima is conducting research
for technology development for industrial production. Overseas, Chugai
Pharmabody Research was established in Singapore in January 2012 for
conducting research focusing on the generation of new antibody drugs by
utilizing Chugai's proprietary innovative antibody engineering technologies.
Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development
activities in the United States and Europe.

The consolidated revenue in 2012 of Chugai totaled 391.2 billion yen and the
operating income was 76.4 billion yen. We are aiming at the consolidated
revenue of 416.0 billion yen and operating profit of 77.5 billion yen in IFRS
core basis, in 2013.

Additional information is available on the Internet at
http://www.chugai-pharm.co.jp/english.

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

Chugai
Chugai pharmaceutical Co., Ltd.
Corporate Communications Dept.
Media Relations Group
PH +81-3-3273-0881
pr@chugai-pharm.co.jp

SOURCE Helsinn Healthcare SA
 
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