LUGANO and BASEL, Switzerland,
September 3, 2015 /PRNewswire/ --
This exclusive agreement builds on
broad partnerships with Mundipharma in
cancer supportive care across multiple global
territories
Helsinn, the Swiss Group focused on building quality cancer
care, and Mundipharma, today announce that they have entered into
distribution, license and supply agreements granting exclusive
rights to anamorelin in Switzerland and Liechtenstein.
Under the terms of the new agreements, Helsinn retains all
international development as well as regulatory and clinical
development activities and the supply of anamorelin for
commercial use. Mundipharma obtains exclusive rights to
registration, marketing, promotion, distribution and sales of
anamorelin in Switzerland
and Liechtenstein.
Helsinn already has existing partnerships with Mundipharma, for
anamorelin, in Brazil,
Middle East and North Africa, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, China, Hong
Kong and Macao.
Anamorelin is a novel, once-daily, orally active ghrelin
receptor agonist in development for the treatment of Cancer
Anorexia-Cachexia in patients suffering from non-small cell lung
cancer (NSCLC), an area of significant unmet medical need. Also
known as the wasting syndrome, Cancer Anorexia-Cachexia
characteristics such as reduced appetite/food intake and unintended
weight loss (mainly due to muscle loss) are known to lead to early
deaths of cancer patients. It is estimated that over 50% of
late-stage cancer patients suffer from cancer
anorexia-cachexia.[1]
By mimicking ghrelin, the so-called "hunger hormone" secreted by
the gastrointestinal tract,
anamorelin was shown to increase lean
body mass and improve appetite in patients with non-small cell lung
cancer who are suffering from Cancer Anorexia-Cachexia in two
pivotal large-scale 12-week Phase III studies, ROMANA 1 and ROMANA
2.
Riccardo Braglia, CEO of
Helsinn Group, said: "Helsinn has a successful existing
collaboration with Mundipharma in a number of territories and we
are delighted that they will be our partner in Switzerland. We believe that anamorelin
could offer a significant improvement on current treatment options
for Cancer Anorexia-Cachexia, increasing lean body mass, and
alleviating patient concerns."
Dr. Athanasios Zikopoulos,
General Manager of Mundipharma Medical Company Basel: "We are excited to enter
into this collaboration with Helsinn for Switzerland. Improving the quality of
patients' lives through effective therapies is one of our core
commitments, and we believe that anamorelin, when
approved, will make a significant contribution to help further
this goal in cancer supportive care."
About anamorelin and
ghrelin
Anamorelin HCl is an investigational selective, novel,
orally active ghrelin receptor agonist that is in development for
the treatment of Cancer Anorexia-Cachexia in NSCLC patients.
Ghrelin is an endogenous peptide secreted by the stomach. Upon
binding to its receptor, ghrelin stimulates multiple pathways in
the positive regulation of body weight, lean body mass, appetite
and metabolism.
Anamorelin is administered orally at 100mg, once
daily. In phase II trials, anamorelin was shown to
increase body weight compared with placebo and to improve
patient-reported symptoms, including
appetite.[2]
Anamorelin recently completed phase III studies (the
ROMANA program) in NSCLC patients with cachexia. In ROMANA 1 and
ROMANA 2, anamorelin increased in respect to placebo body
weight, lean body mass, improved patient's symptoms and concerns
related to anorexia-cachexia and was generally well
tolerated.[3]
About the Helsinn Group
Helsinn is a family run, privately owned pharmaceutical group
focused on building quality cancer care with a large portfolio of
products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has 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 the therapeutic area of cancer care.
Helsinn Group in‐licenses early‐to‐late stage new chemical
entities, completing their development by performing preclinical
and clinical studies and associated manufacturing activities.
Helsinn then prepares necessary regulatory filings in order to
achieve marketing approvals worldwide. Helsinn's products are
out‐licensed to its global network of marketing and commercial
partners that have been selected for their local market knowledge
and high ethical standards. Helsinn supports these partners by
providing a full range of product and scientific management
services, including commercial, regulatory, and medical marketing
advice. In March 2013, Helsinn
established a new commercial organization within its subsidiary,
Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales
and marketing activities within the U.S. market. Helsinn's products
are manufactured according to the highest quality, safety, and
environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied
worldwide to customers.
Further information on Helsinn Group is available at
http://www.helsinn.com
About Mundipharma
The Mundipharma independent associated companies are privately
owned companies and joint ventures covering the world's
pharmaceutical markets. These companies are committed to bringing
to patients the benefits of pioneering treatment options in the
core therapy areas of pain, respiratory, oncology and inflammatory
conditions. Through innovation, design and acquisition, the
Mundipharma independent associated companies deliver important
treatments to meet the most pressing needs of patients, healthcare
professionals and health systems worldwide.
For further information please visit:
http://www.mundipharma.com
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1. K.C.H. Fearon et al
(Sep 2002). Cancer cachexia. Int J
Cardiol 85 (1): 73-81. PMID 12163211
2. Garcia JM, Friend J, Allen S. Therapeutic potential of
anamorelin, a novel, oral ghrelin mimetic, in patients with
cancer-related cachexia: a multicenter, randomized, double-blind,
crossover, pilot study. Support Care Cancer.
2013;21(1):129-137.
3. Temel J, et al, Annals of Oncology, Volume 25, Supplement 4,
2014 (Abstract 1483O_PR)
For more information please contact:
Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
PH +41-91-985-21-21
info-hhc@helsinn.com
Mundipharma Medical Company, Basel
Dr. Athanasios Zikopoulos
General Manager
Tel. +41-61-205-11-11
info@mundipharma.ch
http://www.mundipharma.ch
For media / external inquiries
Consilium Strategic Communications
Mary-Jane Elliott / Jessica Hodgson / Matthew Neal / Laura
Thornton
Tel: +44(0)203-709-5700
Helsinn@consilium-comms.com
SOURCE Helsinn Group