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Helsinn Healthcare SA

Helsinn Healthcare S.A. and Eisai Inc. Extend Relationship Enter U.S. Licence and Co-promotion Agreement for Potential New Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)

Lugano, Switzerland/Woodcliff Lake, NJ, USA (ots)

Helsinn
Healthcare S.A. and Eisai Inc. today announce the signing of a 
licensing agreement granting Eisai Inc. commercialization rights for 
a new product for potential use in the prevention of 
chemotherapy-induced nausea and vomiting (CINV) in the United States.
The arrangement covers the development of a fixed-dose combination 
product (in both oral and IV forms) containing netupitant, a 
neurokinin-1 (NK1) receptor antagonist, and palonosetron, a 
serotonin-3 (5-HT3) receptor antagonist.
Under the terms of the agreement, Helsinn Healthcare S.A. will be 
responsible for conducting all development activities (CMC, 
preclinical and clinical), obtaining regulatory approvals, and 
holding the New Drug Application. If approved by the Food and Drug 
Administration, the fixed dose combination oral and IV products will 
be co-promoted in the United States by Eisai Inc. and Helsinn 
Therapeutics (U.S.) Inc. Helsinn's manufacturing affiliate in 
Ireland, Helsinn Birex Pharmaceuticals Ltd., will be responsible for 
the manufacture and supply of finished product for clinical and 
commercial use in the United States.
In addition, Helsinn Therapeutics (U.S.) Inc. has signed a Detail 
Service Agreement with Eisai Inc. to co-promote the existing brand 
Aloxi® (palonosetron hydrochloride) in the U.S. market. As a result, 
Helsinn Therapeutics (U.S.) Inc. will recruit and hire a dedicated 
sales force to visit primarily clinical oncologists in the United 
States.
Riccardo Braglia, CEO of Helsinn group, said: "We are very proud 
that the existing successful collaboration with Eisai Inc. in the 
U.S. for Aloxi® is now extending to a co-promotion of Aloxi® and, if 
approved, to Netupitant-Palonosetron FDC, and the strengths of our 
two companies will enable patients to have additional treatments for 
CINV now and in the future."
"Eisai is committed to satisfying unmet medical needs and 
contributing to the health and well-being of people worldwide," said 
Lonnel Coats, President and COO of Eisai Inc. "Our expanded 
relationship with Helsinn further demonstrates our focus on oncology 
and supportive care and will help to strengthen our presence in the 
area of anti-emesis therapy."
About Netupitant
Netupitant is a highly selective NK1 receptor antagonist, an 
antiemetic that works by blocking the action of Substance P, an 
endogenous neurotransmitter contained in high concentrations in the 
vomiting center of the brainstem that can stimulate the vomiting 
reflex. The fixed-dose combination of netupitant and palonosetron is 
entering Phase III for the prevention of acute and delayed nausea and
vomiting following both highly and moderately emetogenic 
chemotherapy.
About Aloxi® About Palonosetron (Aloxi®, Onicit®, Paloxi®)
Palonosetron hydrochloride is a selective 5-HT3 receptor 
antagonist, developed for the prevention of chemotherapy-induced 
nausea and vomiting (CINV) in patients with cancer, with a long 
half-life of 40 hours and at least 30 times higher receptor binding 
affinity than currently available compounds. Palonosetron 
demonstrates, in clinical trials and clinical practice, a unique 
long-lasting action in the prevention of CINV. The product has shown 
to be effective in preventing both Day 1 and Days 2-5 CINV in 
patients receiving moderately emetogenic chemotherapies (MEC). A 
single intravenous dose of palonosetron (0.25 mg) provides better 
protection from CINV than first-generation 5-HT3 receptor antagonists
throughout a 5-day post-chemotherapy period in MEC setting. This 
means that a single administration of palonosetron also grants 
protection during the Days 2-5 phase of CINV. Palonosetron is 
contraindicated in patients known to have hypersensitivity to the 
drug or any of its components. The most commonly reported adverse 
reactions (incidence ? 2 percent) in CINV trials with palonosetron 
were headache (9 percent) and constipation (5 percent), and they were
similar to the comparators.
For indications and dosages in your country, please refer to the 
Summary of Product Characteristics approved by your local 
authorities.
Palonosetron has been developed by Helsinn Group of Switzerland 
and today it is marketed as Aloxi®, Onicit®, and Paloxi® in more than
50 countries world-wide.
In the EU, palonosetron is marketed as Aloxi® through a 
distribution license granted by Helsinn to several pharmaceutical 
companies. For more information about palonosetron please visit the 
website www.aloxi.com
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with 
headquarters in Lugano, Switzerland, and operating subsidiaries in 
Ireland and USA. Helsinn's business model is focused on the licensing
of pharmaceuticals and medical devices in therapeutic niche areas. 
The Group in-licenses early to late stage new chemical entities, 
completes their development from the performance of 
pre-clinical/clinical studies and Chemistry, Manufacturing and 
Control (CMC), development to the filing for and attainment of their 
market approval worldwide. Helsinn's products are sold directly 
through the Group's subsidiaries or out-licensed to its network of 
local marketing and commercial partners, selected for their deep in- 
market knowledge and know-how, and assisted and supported with 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 dosage
forms are manufactured at Helsinn's cGMP facilities in Switzerland 
and Ireland, and supplied worldwide to its customers. For more 
information about Helsinn Group, please visit the website: 
www.helsinn.com
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 
U.S. pharmaceutical companies (based on retail sales). The company 
began marketing its first product in the United States in 1997 and 
has rapidly grown to become a fully integrated pharmaceutical 
business with fiscal year 2009 (year ended March 31, 2010) sales of 
approximately $3.9 billion. Eisai's areas of commercial focus include
neurology, gastrointestinal disorders and oncology/critical care. The
company serves as the U.S. pharmaceutical operation of Eisai Co., 
Ltd.
Eisai has a global product creation organization that includes 
U.S.- based R&D facilities in Maryland, Massachusetts, New Jersey, 
North Carolina and Pennsylvania as well as manufacturing facilities 
in Maryland and North Carolina. The company's areas of R&D focus 
include neuroscience; oncology; vascular, inflammatory and 
immunological reaction; and antibody- based programs. For more 
information about Eisai, please visit: www.eisai.com

Contact:

Paola Bonvicini
Head of Communication & Press Office
Helsinn Healthcare SA
Tel.: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com

Lynn Kenney
Corporate Communications Eisai Inc.
Tel. : +1/201-746-2294
E-Mail: lynn_kenney@eisai.com

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