Oncology: Palonosetron Approved in Japan, Second Pharmaceutical Market Worldwide

By Helsinn Healthcare Sa, PRNE
Tuesday, January 19, 2010

The Second Generation 5-HT(3) Receptor Antagonist Palonosetron Available in More Than 50 Countries Worldwide, Including US, EU and Japan

LUGANO, Switzerland and TOKYO, January 20 - Today, Taiho Pharmaceutical Co., Ltd., Japanese licensee of Helsinn's
second generation 5-HT(3) receptor antagonist palonosetron, gained marketing
approval in Japan for this drug indicated for the prevention of
chemotherapy-induced nausea and vomiting (CINV) (including delayed phase) in
patients with cancer.

Palonosetron will be marketed as Aloxi(R).

The approval of Aloxi(R) is based on the compelling results of a large
multicenter randomized double-blind clinical trial (PROTECT study) conducted
in Japan which demonstrated the superiority of palonosetron versus
granisetron in the delayed phase. Palonosetron has been developed by the
Helsinn Group in Switzerland, world-wide licensor of the drug. Today the
product is approved in 62 countries, including US (since 2003) and EU
(approved in 2005).

Aloxi(R) (palonosetron) is the leading brand in the USA within the CINV
Day of Chemo segment, and it is steadily growing in the major European
markets. The worldwide sales of palonosetron totalled more than 400 million
US dollars
in 2008 and continued to increase in 2009.

"The marketing approval granted to palonosetron in Japan, the second
largest pharma market worldwide, is a key achievement for our company",
Riccardo Braglia, Helsinn's Group Chief Executive Officer, said. "This is the
first ever approval we have gained in Japan, and we must acknowledge the
essential role played by our partner Taiho, leading oncology firm in this
country", he concluded.

"To contribute to the improvement of cancer treatment, Taiho is putting
its effort in research and development of not only anticancer agents but also
agents to alleviate adverse reactions induced by cancer chemotherapy,"
commented Toru Usami, President of Taiho Pharmaceutical. "With the marketing
approval of Aloxi(R), we hope to provide a new treatment option to patients
who are suffering from cancer chemotherapy induced nausea and vomiting."

About Palonosetron (Aloxi(R), Onicit(R), Paloxi(R))

Palonosetron (palonosetron hydrochloride) is a second generation 5-HT(3)
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 acute and
delayed CINV in patients receiving Moderately Emetogenic Chemotherapy (MEC).
A single intravenous dose of palonosetron provides better protection from
CINV than first-generation 5-HT(3) receptor antagonists throughout a 5-day
post-chemotherapy period*. According to the NCCN (National Comprehensive
Cancer Network) Guidelines palonosetron is the preferred 5-HT(3) receptor
antagonist to be used in a combined regimen with an NK-1 antagonist and
dexamethasone to prevent nausea and vomiting induced by Highly Emetogenic
Chemotherapy (HEC).

Palonosetron is contraindicated in patients known to have
hypersensitivity to the drug or any of its components. The most commonly
reported adverse reactions (incidence more 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:

*This sentence refers to Moderately Emetogenic Chemotherapy (MEC) setting

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in
Lugano, Switzerland, and subsidiaries in Ireland and USA.

Helsinn's unique business model is focused on the licensing of
pharmaceuticals and medical devices in therapeutic niche areas. The Group
in-licenses early 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

Helsinn's products are sold directly, through the Group subsidiaries, or
eventually 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.

Helsinn is the worldwide licensor of palonosetron and of the original
nimesulide, a non-steroidal anti-inflammatory drug (NSAID) distributed in
more than 50 countries worldwide.

Helsinn, with a workforce of around 450 employees in Switzerland, Ireland
and USA, reported a 2008 turnover of over CHF 280.3 million (about EUR 178
), covering 75 countries worldwide, with over 20% of this turnover
invested in R&D.

For more information about Helsinn Group, please visit the website:

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 the leading company of oncology field
in Japan.

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

    Contact person at Helsinn Healthcare SA:
    Paolo Ferrari
    Head of International Marketing
    HELSINN Healthcare SA
    Ph: +41-91-985-21-21

    Contact person at Taiho Pharmaceuticals:
    Mitsutoshi Utatsu
    Public Relations Dep.
    TAIHO Pharmaceuticals Co., Ltd.
    Ph: +81-3-3293-2878

Contact person at Helsinn Healthcare SA: Paolo Ferrari, Head of International Marketing, HELSINN Healthcare SA, Ph: +41-91-985-21-21, info-hhc at helsinn.com; Contact person at Taiho Pharmaceuticals: Mitsutoshi Utatsu, Public Relations Dep., TAIHO Pharmaceuticals Co., Ltd., Ph: +81-3-3293-2878

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