DUBLIN, IRELAND, May 11th, 2005 - HELSINN BIREX THERAPEUTICS LTD,
one of the Irish companies of the Swiss pharmaceutical group Helsinn
Healthcare SA, announced today that the company received the first
delivery of ALOXI" (palonosetron hydrochloride) from Helsinn Birex
Pharmaceuticals LTD, Dublin, on 9th May 2005 and that it officially
began sales and marketing of the product on 10th May 2005.
On 30th March 2005, the European Commission granted ALOXI"
marketing authorization through a European Centralised Registration
Procedure, with the approved indications for:
- the prevention of acute nausea and vomiting associated with highly
emetogenic cancer chemotherapy, and
- the prevention of nausea and vomiting associated with moderately
emetogenic cancer chemotherapy.
ALOXI", available as a single 0.25mg I.V. dose in a 5ml vial, is a
second generation of serotonin subtype 3 (5-HT3) receptor
antagonists, characterized by a strong and long efficacy to prevent
nausea and vomiting in cancer patients undergoing chemotherapy.
ALOXI" has a high receptor binding affinity which is at least 30
times higher than that of first-generation 5HT3 receptor antagonists,
and it has an extended plasma half-life of approximately 40 hours.
In clinical trials, ALOXI" demonstrated prevention of acute CINV and
persistence of protection in delayed phase, especially during the
period of major risk (days 2 and 3). In these trials, ALOXI" was
compared with active comparators, and showed a consistent and
favourable difference with respect to ondansetron and dolasetron.
Adverse reactions observed in the pivotal trials were similar in
frequency, intensity, and duration with ALOXI(r) as with ondansetron
and dolasetron, with most common drug-related adverse reactions being
headache (9%) and constipation (5%).
Recently published data (Grunberg S. et al. Incidence of
chemotherapy-induced nausea and emesis after modern antiemetics.
Cancer, 100 (10): 2261-8, 2004) showed that cancer patients are still
missing an adequate control of chemotherapy induced nausea and
vomiting (CINV) and the medical community is keeping the antiemetic
guidelines updated with new improvements which can help the patients
cope with this debilitating side effect. A recent example is the
National Comprehensive Cancer Network (NCCN, www.nccn.org), an
alliance of 19 of the world's leading cancer centers, which indicated
ALOXI" as the treatment of choice for the prevention of acute and
delayed nausea and vomiting due to moderately emetogenic
The product is already commercialized in USA since September 2003
by Helsinn's partner MGI Pharma, where approximately 1.5 million uses
have been completed successfully.
"After successfully obtaining the Centralized Registration
Procedure in Europe for the first time, we are confident that the
launch of ALOXI" in the EU countries will mark another significant
phase for ALOXI" and for the Helsinn Group". said Dr. Riccardo
Braglia, Managing Director of HELSINN HEALTHCARE SA. "This step
reinforces Helsinn's focus on Cancer and Supportive Care and
strengthens our mission to help cancer patients by offering new
therapies to reduce cancer side effects. Moreover we are proud that
our subsidiary Helsinn Birex Therapeutics Ltd is the first to launch
Aloxi in EU".
"We believe that Aloxi is a better 5HT3 drug" said Jim O'Leary,
General Manager of the Irish Subsidiary, "and from this month also
the Irish cancer patients will benefit of less nausea and vomiting
Helsinn has recently announced a number of licensing and
distribution agreements in many European countries: Cambridge
Laboratories for the UK, Ribosepharm for Germany, Italfarmaco for
Spain, Galenica for Greece, CSC for Austria and several Central and
European countries and PharmaSwiss for Slovenia, the Baltic States
and several Eastern countries.
For more information about this product please visit our website:
www.palonosetron.net and www.aloxi.com
About Chemotherapy-Induced Nausea and Vomiting (CINV)
CINV is estimated to affect 85% of cancer patients undergoing
chemotherapy and can result in a delay or discontinuation of
chemotherapy treatments. The supportive care area is becoming of
paramount importance to help patients deal with adverse events of
anticancer therapies. With good supportive care drugs, cancer
patients are able to tolerate the anti-cancer treatment to a greater
extent, improving their chances of completing their treatment course
successfully with a better quality of life.
About HELSINN HEALTHCARE
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group
with headquarters in Switzerland and is the worldwide licensor of
ALOXI". HELSINN's core business is the licensing of pharmaceuticals
in niche therapeutic areas. The company's business strategy is to
in-license early-stage new chemical entities and complete their
development from the performance of pre-clinical/clinical studies and
CMC development to the attainment of market approvals in strategic
markets (U.S. and Europe). HELSINN's products are eventually
out-licensed to its marketing partners for distribution. The active
pharmaceutical ingredients and the finished dosage forms are
manufactured at HELSINN's cGMP facilities and supplied worldwide to
its customers. For more information about HELSINN, please visit
ots Originaltext: Helsinn Healtcare SA
Contact person HELSINN:
Rachid BenHamza, Ph.D., Head Business Unit Oncology & Supportive