Swiss-based Helsinn Group and Mundipharma sign for rights to Phase III Netupitant-Palonosetron fixed dose combination for China

Lugano, Switzerland (ots) - The two companies sign a distribution
and license agreement for an investigational therapy for the
prevention of chemotherapy-induced nausea and vomiting covering
China, Hong Kong and Macao

Helsinn and Mundipharma announce the signature of a new, exclusive
license and distribution agreement, covering China, Hong Kong and
Macao, for netupitant- palonosetron fixed dose combination (NEPA), a
Helsinn product under development for the treatment of
chemotherapy-induced nausea and vomiting. This Agreement consolidates
the alliance between the companies which was established with the
granting of rights to the same combination product sealed earlier
this year in Middle East and North African countries and in late 2012
in selected South-Eastern Asian countries. Besides China, Hong Kong
and Macao, the Mundipharma Group of companies therefore plans to
distribute the product in further key markets in Asia-Pacific, the
Middle East and North Africa.

NEPA is a fixed dose combination of netupitant, a novel NK1
receptor antagonist and palonosetron, a second generation 5-HT3
receptor antagonist already present in the main markets world-wide
under the trade names Aloxi®, Onicit® and Paloxi®. Positive results
of the phase III pivotal trials have been announced last spring and
data have been presented during this year's Annual Meeting of the
American Society of Clinical Oncology (ASCO) and at the European
CanCer Organization (ECCO) Congress.

The U.S. Food and Drug Administration (FDA) has recently accepted
for review the submission of the NEPA New Drug Application (NDA). The
proposed indication is for the prevention of acute and delayed CINV
in both highly and moderately emotegenic chemotherapy. Helsinn is
preparing submission of a Marketing Authorisation Application (MAA)
to the European Medicines Agency (EMA).

Under the terms of the Agreement, Helsinn will retain all
regulatory and clinical development activities (CMC, preclinical and
clinical) related to China, as well as the supply of NEPA for
commercial use in all territories. Mundipharma will undertake
responsibility for registering the product in all other countries
included in the deals. "We are extremely pleased of this new
agreement signed with Mundipharma which adds China, Hong Kong and
Macao to the existing territories of our alliance for NEPA. According
to IMS, the Chinese market for 5-HT3 antagonists is worth over 300
million USD, growing at a double-digit rate, and NEPA may represent a
significant advance in the management of CINV." said Mr. Riccardo
Braglia, Helsinn Group CEO. "Mundipharma brings to us an expertise
built and consolidated through a 20-year presence in the country and
a significant recognition of their reliability and proficiency by the
Chinese oncological and supportive care universe," he added.

"We are committed to pursuing new and innovative treatments that
markedly improve the quality of patients' lives in every market we
are present. By launching NEPA in China, we hope to provide
healthcare professionals access to a treatment option for cancer
patients that optimizes prevention of chemotherapy-induced
conditions. Our collaboration with Helsinn Group marks a new
milestone, given their proven track record of innovation in cancer
supportive care," said Mr Raman Singh, Regional Managing Director of
Mundipharma Asia, Latin America, Middle East and North Africa.

About netupitant-palonosetron fixed dose combination (NEPA)

NEPA is a novel single-day fixed-dose combination of a highly
selective NK1 receptor antagonist, netupitant, and a
pharmacologically and clinically distinct 5-HT3 receptor antagonist,
palonosetron targeting two critical pathways associated with
chemotherapy induced nausea and vomiting (CINV).

The phase III investigational program has recently been concluded.

The U.S. Food and Drug Administration (FDA) has recently accepted
for review the submission of the NEPA New Drug Application (NDA). The
proposed indication is for the prevention of acute and delayed CINV
in both highly and moderately emotegenic chemotherapy. Helsinn is
preparing submission of a Marketing Authorisation Application (MAA)
to the European Medicines Agency (EMA).

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, 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 Mundipharma

Mundipharma's independent associated companies are privately owned
entities covering the world's pharmaceutical markets. Mundipharma is
a prime example of a company that consistently delivers high quality
products while standing by the values that represent the company. Our
mission is to alleviate the suffering of patients with cancer and
non-cancer pain and to substantially improve their quality of life.
Mundipharma is dedicated to bringing to patients with severe and
debilitating diseases the benefit of novel treatment options in
fields such as moderate-to-severe pain, oncology, respiratory
disease, rheumatoid arthritis, antiseptics and laxatives.

For more information please visit: www.mundipharma.asia

Contact Person:

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

Mundipharma
Stephenie Vasko
Communications Director - Asia, Latin America & Middle East
PH +65 6303 9732
stephenie.vasko@mundipharma.com.sg