The 5-HT3 Receptor Antagonist Aloxi(R) Launched in Japan
By Helsinn Healthcare Sa, PRNEWednesday, April 21, 2010
LUGANO, Switzerland and TOKYO, Japan, April 22, 2010 - Helsinn Healthcare SA, Switzerland, and Taiho Pharmaceutical Co., Ltd.,
Japanese licensee of Helsinn's second generation 5-HT3 receptor antagonist
palonosetron, announce the launch of Aloxi(R) injection today.
Aloxi was developed in Japan by Taiho in close cooperation
with Helsinn, based on the license agreement between Taiho and Helsinn of
January 2004, and its marketing approval was obtained on 20 January 2010.
Chemotherapy-induced nausea and vomiting can be classified
into 'acute nausea and vomiting' which appears within 24 hours after
chemotherapy administration, or into 'delayed nausea and vomiting' which
appears after 24 hours from chemotherapy administration up to 120 hours. In
Japan, only limited efficacy for delayed nausea and vomiting has been shown
with currently available agents.
With a single administration before chemotherapy (cisplatin,
etc), Aloxi showed to be effective not only in acute nausea and vomiting, but
also in delayed nausea and vomiting, in which currently available agents were
not able to show adequate efficacy. Aloxi has a prolonged plasma half-life of
approximately 40 hours, and possesses high binding affinity and selectivity
towards the 5-HT3 receptors. Furthermore, use of Aloxi is recommended for the
prevention of chemotherapy induced nausea and vomiting following Moderately
Emetogenic Chemotherapy (non AC/EC) in the 2009 International Antiemetic
Guideline of the European Society for Medical Oncology (ESMO)/ Multinational
Association of Supportive Care in Cancer (MASCC).
Aloxi is approved in 63 countries worldwide, reaching global sales of
more than 400M USD (approx. 36B yen) last year.
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 > 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 markets.
For more information about palonosetron, please visit the website:
www.aloxi.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 the leading company
of oncology field in Japan.
For more information about Taiho, please visit the company's Web site
at: www.taiho.co.jp/english/index.html
About Helsinn Group
Helsinn is a privately owned pharmaceutical group with
headquarters in Lugano, Switzerland and 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
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.
Helsinn is the worldwide licensor of palonosetron, a second
generation 5-HT3 receptor antagonist, for the prevention of
chemotherapy-induced nausea and vomiting (CINV) in patients with cancer and
of post-operative nausea and vomiting (PONV), 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 2009 turnover of over CHF 305
million (about EUR 200 million), covering 85 countries worldwide, with over
20% of this turnover invested in R&D.
For more information about Helsinn Group, please visit the
website: www.helsinn.com
Contact person at Helsinn Healthcare SA: Paolo Ferrari Head of International Marketing Helsinn Healthcare SA Ph: +41-91-985-21-21 info-hhc@helsinn.com Contact person at Taiho Pharmaceutical: Mitsutoshi Utatsu Public Relations Dep. TAIHO Pharmaceutical 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 Pharmaceutical: Mitsutoshi Utatsu, Public Relations Dep., TAIHO Pharmaceutical Co., Ltd., Ph: +81-3-3293-2878
Tags: April 22, Europe, Helsinn Healthcare SA, Japan, Lugano, Switzerland And Tokyo