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Helsinn Group Integrated Licensing Integrated Manufacturinng Irish Pharmaceuticals
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History
1976Helsinn Healthcare S.A. was established in Chiasso, Switzerland, originally named Biex Solaris AG., and incorporated. The Helsinn Group starts up.
1977A world-wide licensing agreement with Wyeth-American Home for Fentiazac® was signed.
1980A world-wide licensing agreement with 3M Pharmaceuticals for Nimesulide was signed.
1983A chemical plant was built in Biasca, Switzerland: Helsinn Chemicals S.A.
1990An Irish company, Birex Pharmaceuticals Ltd. was acquired: now Helsinn Birex Pharmaceuticals Ltd.
1993The Helsinn Chemicals Ireland facility started its production activity.
1994New headquarters in Pazzallo-Lugano, Switzerland for Helsinn Healthcare S.A.
1997New premises for Helsinn Birex Pharmaceuticals Ltd.
1998World-wide licensing agreements were signed with Syntex and Wyeth for two new product candidates, Palonosetron and Oxaprozin.
1999Helsinn Advanced Synthesis S.A., the start of the construction of a new plant in Biasca, Switzerland.
2000A new commercial company, Ergha Healthcare Ltd., was set-up in Dublin, Ireland.
2003Palonosetron obtained market approval from the FDA in the USA and was launched in September under the tradename Aloxi®. Helsinn in-licensed the product Gelclair®.
2004Marketing authorisation recommended for Palonosetron (Aloxi®, Onicit®) in the EU.
2005Aloxi® was launched on the Irish market, the first EU market. In May, Helsinn signed an in-licensing agreement with Roche for worldwide rights for the patented phase II product Netupitant.
2006Start of Phase III clinical program for Aloxi® in Japan. Aloxi® PONV studies completed.
2007A new warehouse as well as a new packaging facility at Helsinn Birex Pharmaceuticals Ltd., Dublin, Ireland for Aloxi®.
Phase II Netupitant study started at the end of December for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).
Helsinn’s Active Pharmaceutical Ingredients and High Potency Active Ingredients contract manufacturing sites in Biasca, Switzerland were successfully inspected by the FDA.
Helsinn Chemicals S.A., Biasca, Switzerland obtained full accreditation by the Pharmaceuticals and Medical Devices Agency (Japan).
2008The FDA approval of Aloxi® injection for the prevention of Post-Operative Nausea and Vomiting.The New Drug Application for palonosetron injection for Chemotherapy-Induced Nausea and Vomiting submitted in Japan.
Aloxi® injection for the prevention of Post-Operative Nausea and Vomiting was launched in the USA.
Helsinn’s drug facility, Helsinn Birex Pharmaceutical Ltd., Dublin, Ireland was successfully inspected by the FDA.
The FDA approved Aloxi® capsules for the prevention of Chemotherapy-Induced Nausea and Vomiting.
Helsinn signed a partnering agreement with Zealand Pharma, Denmark for the development and worldwide commercialization of the product ZP1846 TIDE, a novel GLP-2 agonist for Chemotherapy-Induced Diarrhoea.
The Phase II Netupitant CINV trials were completed.
Start of Netupitant clinical trials in Overactive Bladder (OAB) in Q4.
Submission of registration dossier for Palonosetron-Aloxi® capsules for oral administration
2009Helsinn acquired Sapphire Therapeutics Inc., USA and Helsinn Therapeutics (U.S.), Inc. was established.


Helsinn announces new plans aimed at creating a competitive Manufacturing Organization focused on highly potent compounds with strong R&D and production capabilities. This plan also saw the selling of Helsinn Chemicals Ireland Ltd, Dublin, Ireland to the Italian company Medinco C.F.M. Group.
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