Helsinn Healthcare SA

Helsinn and Taiho Pharmaceutical Co., Ltd. to Extend Relationship
License Agreement for Japan on Potential New Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)

Lugano, Switzerland and Tokyo, Japan (ots) - Helsinn Group of Switzerland and Taiho Pharmaceutical Co., Ltd., Japanese licensee of Helsinn's second generation 5-HT3 receptor antagonist palonosetron, announce today the signing on April 12, of a licensing agreement granting Taiho the development and commercialization rights for a new product for potential use in the prevention of chemotherapy-induced nausea and vomiting (CINV) in Japan. 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 will be responsible for the CMC development. Helsinn's chemical plant in Switzerland will provide both APIs and Helsinn will manufacture the product in the group's plant located in Ireland and will also be responsible for the supply of the product for clinical and commercial use in Japan. Taiho will be responsible, in strict collaboration with Helsinn, for conducting preclinical and clinical development and for obtaining regulatory approvals in Japan, and holding the New Drug Application, on the basis of studies already performed by Helsinn and in collaboration with Helsinn.

Riccardo Braglia, CEO of Helsinn group, said: "We are very proud of the existing successful collaboration with Taiho Pharmaceutical in Japan. At the beginning of last year our Japanese partner launched palonosetron on the national market and, within less than one year, our drug became the market leader in its class. Now our collaboration is extending to the netupitant-palonosetron fixed dose combination and we are sure that the success will reiterate."

"We are delighted to extend our relationship with Helsinn with this license agreement in addition to our strong collaboration with palonosetron." Mr Toru Usami, President and Representative Director of Taiho Pharmaceutical Co., Ltd. Said, "with netupitant - palonosetron fixed dose combination product, we hope to further contribute in the area of supportive care in oncology."

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 Palonosetron (Aloxi®, Onicit®, Paloxi®)

Palonosetron (palonosetron hydrochloride) is a second generation 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. A single intravenous dose of palonosetron provides better protection from CINV than first-generation 5-HT3 receptor antagonists.

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. Palonosetron has been developed by the Helsinn Group in Switzerland and today it is marketed as Aloxi®, Onicit®, and Paloxi® in more than 50 countries world-wide. Palonosetron, marketed as Aloxi®, is the leading brand in the USA within the CINV Day of Chemo segment, and it is steadily growing in the European markets.

For more information about palonosetron, please visit the website: 

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 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 Taiho Pharmaceutical

Taiho Pharmaceutical Co., Ltd. (Taiho) is a company engaged in discovery, development, manufacturing and marketing of pharmaceutical products, with its headquarters in Tokyo, Japan. Taiho is a leading company of oncology field in Japan.

For more information about Taiho, please visit the company's website 
at: www.taiho.co.jp/english/index.html 


Helsinn Healthcare SA
Paola Bonvicini
Head of Communication & Press Office
Helsinn Healthcare SA
Ph: +41 91-985-21-21

Taiho Pharmaceutical:
Public Relations Department
Taiho Pharmaceutical Co., Ltd.
Ph: + 81-3-3293-2878

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