Helsinn Grants Specialised Therapeutics Australia (STA) Rights to Anamorelin, a First-in-Class Compound to Treat Cachexia-Anorexia Related to Non-Small Cell Lung Cancer (NSCLC)

Lugano, Switzerland and Melbourne, Australia (ots) -

Helsinn Healthcare SA and STA reinforce their Cancer Supportive
Care Alliance in Australia and New Zealand with a Distribution and
License Agreement for the innovative phase III ghrelin receptor
agonist

Melbourne biopharmaceutical company Specialised Therapeutics
Australia (STA) has been granted exclusive commercialisation rights
to a new drug for the treatment of NSCLC cachexia-anorexia. This
condition is a serious multifactorial disorder which involves muscle
wasting and metabolic impairment and commonly affects patients with
advanced cancer. STA has reached agreement with Swiss pharmaceutical
company Helsinn Healthcare to in-license the novel ghrelin receptor
agonist anamorelin for both Australia and New Zealand.

This further collaboration follows on from STA's successful
Australian commercialisation of Helsinn's second-generation 5-HT3
antagonist, Aloxi® (palonosetron), as well as STA in-licensing
Helsinn's new fixed dose combination compound,
netupitant-palonosetron, for the prevention of chemotherapy-induced
nausea and vomiting. Under the terms of the latest agreement,
Helsinn will retain all development activities (CMC, preclinical and
clinical) and supply of anamorelin for commercial use. STA will be
responsible for regulatory/clinical development and commercial
activities within Australia and New Zealand.

Anamorelin is a first-in-class therapy being developed for the
treatment of cachexia-anorexia in NSCLC, suitable for once daily oral
administration. Previous phase II trials have demonstrated an
improvement in appetite, an increase in lean body mass and improved
quality of life in patients with cancer cachexia-anorexia. These
trials have also demonstrated a good safety and tolerability profile
(Helsinn data on file). There are currently no approved treatments
for cancer-related cachexia-anorexia in Australia, the EU or in the
US.

Regional Director of Palliative Care for Barwon Health in
Victoria, and a principal investigator for the phase III anamorelin
registration trial, Associate Professor Peter Martin, described
cachexia-anorexia as "a massive issue of concern" for clinicians,
cancer patients and their families. He said it was not uncommon for
patients to lose 5-10% of their body weight, and in extreme cases it
can be significantly higher. "Cachexia-anorexia is an issue right
from diagnosis" Associate Professor Martin said. "Anamorelin has
produced some very encouraging data in placebo-controlled phase II
studies, and we look forward to seeing a compound that is capable of
successfully treating this serious condition."

STA CEO Mr. Carlo Montagner said anamorelin was an important
addition to the company's expanding oncology portfolio, and
specifically the company?s supportive care business. "Our mission is
to expand our portfolio to include treatment options which not only
treat cancer, but address concerns related to this disease and
improve the quality of life for all cancer patients," Mr. Montagner
said. "There are currently no approved or effective drugs to treat
muscle wasting and more generally cachexia-anorexia in cancer
patients. This condition affects a significant number of Australian
and New Zealand patients with advanced cancers and severely
diminishes their quality of life, and potentially compromises
treatment." The anamorelin phase III clinical trial program (ROMANA
1, 2 & 3) began in Q4 2011 and will complete enrolment in the second
half of 2013. It is anticipated that a New Drug Application will be
filed with the FDA in mid-2014. Immediately thereafter, a submission
for Australian regulatory approval will be lodged with the
Therapeutic Goods Administration (TGA). Helsinn Group Chief Executive
Officer, Dr. Riccardo Braglia said he was extremely pleased to
strengthen the existing STA/Helsinn alliance with the latest
anamorelin agreement. "STA has been achieving great results as our
commercial partner for our antiemetic franchise, placing themselves
as one of our best performing partners in the world. Together we will
now strive to reach even better outcomes for Australian and New
Zealand cancer patients fighting cachexia and anorexia."

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 anorexia-cachexia 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 www.helsinn.com

About Specialised Therapeutics Australia Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) is a
biopharmaceutical company dedicated to working with leading
pharmaceutical companies worldwide to provide acute care therapies
for high unmet medical needs to people living in Australia and New
Zealand. The STA therapeutic portfolio and pipeline at present
encompasses oncology and infectious disease.

Currently STA markets two world leading cancer and cancer
supportive care therapies, ABRAXANE® (nab paclitaxel) and ALOXI®
(palonosetron) respectively, and has recently licensed from the
Helsinn Group a fixed-dose combination product (in both oral and
intravenous forms) containing netupitant, a neurokinin-1 (NK1)
receptor antagonist, and Aloxi® (palonosetron), a serotonin-3 (5-HT3)
receptor antagonist.

STA also has interests in the therapeutic areas of respiratory,
dermatology, endocrinology and central nervous system (CNS).
Additional information can be found at
www.specialisedtherapeutics.com.au

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:
www.cancer.gov

Contact:

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

For Specialised Therapeutics Australia Pty Ltd
Emma Power
Monsoon Communications
PH +61 3 9620 3333
emmap@monsoon.com.au