Helsinn and Taiho Pharmaceutical Co., Ltd. to Extend Relationship

By Helsinn Healthcare Sa, PRNE
Tuesday, April 12, 2011

License Agreement for Japan on Potential New Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)

LUGANO, Switzerland and TOKYO, April 13, 2011 - 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

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(R), Onicit(R), Paloxi(R))

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 is greater than or equal to 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(R), Onicit(R), and Paloxi(R) in more than 50 countries world-wide.
Palonosetron, marketed as Aloxi(R), is the leading brand in the USA within
the CINV Day of Chemo segment, and it is steadily growing in the European

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

For more information about Taiho, please visit the company's website at:


    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


will not be displayed