Helsinn Announces License Agreement With Specialised Therapeutics for Palonosetron in Australia

By Helsinn Healthcare Sa, PRNE
Sunday, October 31, 2010

Leading Anti-Nausea Drug Available to Australian and New Zealand Cancer Patients

LUGANO, Switzerland and MELBOURNE, Australia, November 1, 2010 - Australians can now access a new drug to prevent acute (and delayed
phase) nausea and vomiting which may occur in cancer patients undergoing
chemotherapy(1). This follows an agreement between the Swiss pharmaceutical
group Helsinn and Specialised Therapeutics Australia Pty Ltd (STA).

The agreement grants Specialised Therapeutics Australia the exclusive
License and Distribution rights for palonosetron (palonosetron hydrochloride)
in Australia and New Zealand.

Palonosetron is a patented second generation 5-HT3 receptor antagonist,
which is differentiated to older 5HT3 antagonists by its higher receptor
binding affinity and longer duration of its activity (1,2.)

Palonosetron has been available internationally after being registered in
the USA in 2003, and is indicated for the prevention of acute nausea and
vomiting associated with highly emetogenic chemotherapy, and the prevention
of nausea and vomiting associated with moderately emetogenic chemotherapy.

Today the product is approved in 63 countries, with annual sales of over
400 million US dollars last year.

Specialised Therapeutics Australia Chief Executive Officer Mr. Carlo
said the acquisition of palonosetron was an important step in the
continued development of the company's drug portfolio, with a commitment to
oncology treatment and management.

"The Helsinn group has done a first class job of developing palonosetron
and we are delighted to become their Australian partner for this product," he

"We have made clear our strategy of building Specialised Therapeutics
Australia through the acquisition and growth of specialist medicines."

"By in-licensing palonosetron we are demonstrating our on-going
commitment to this strategy.

Palonosetron is an excellent fit in our growing portfolio and we look
forward to driving its growth."

Helsinn group Chief Executive Officer, Dr. Riccardo Braglia said he
looked forward to co-operating with STA on the Australian launch.

"We are delighted to sign this new agreement with Specialised
Therapeutics Australia and look forward to initiating a successful
co-operation for palonosetron in Australia," he said.

"STA has demonstrated a commitment to grow products in the specialist
oncology market, while the patients and the medical community in Australia
will enjoy the benefits of an innovative antiemetic like palonosetron."

Palonosetron is listed on the Pharmaceutical Benefits Scheme (PBS) from
November 1st, 2010 for the management of nausea and vomiting associated with
cytotoxic chemotherapy being used to treat malignancy which occurs within 48
hours of chemotherapy administration.


(1.) Aloxi product Information

(2.) Wong E, et al Br J Pharmacol 1995; 114: 851-859.

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. 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-HT3 receptor antagonists throughout a 5-day
post-chemotherapy period*. Palonosetron is contraindicated in patients known
to have hypersensitivity to the drug or any of its components. The most
commonly reported adverse reactions 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:

*This sentence refers to Moderately Emetogenic Chemotherapy (MEC)

About Specialised Therapeutics Australia Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to
identify, develop and commercialise innovative anti-cancer and other
specialised therapies for the Australasian market. ABRAXANE(R) (nanoparticle
albumin-bound paclitaxel) is the first of such therapies. Based in Melbourne,
, the privately held company is currently developing several more
important therapeutic agents for release in Australia and New Zealand.

About the 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's
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 305.0 million (about EUR 232.0
at the current conversion exchange rate), with over 20% of this
turnover invested in R&D.

The products licensed by Helsinn are sold in 85 countries worldwide.

For more information on the Helsinn Group please visit the website

    For further information please contact:

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

    Emma Power
    Monsoon Communications
    Ph: +61(0)3-9620-3333 or

For further information please contact: Paolo Ferrari, Head of International Marketing, Helsinn Healthcare SA, Ph: +41-91-985-21-21, info-hhc at helsinn.com; Emma Power, Monsoon Communications, Ph: +61(0)3-9620-3333 or, +61(0)419-149-525

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