Lugano (ots) - HELSINN HEALTHCARE SA signed an Agreement with
THERABEL PHARMA under which it granted THERABEL PHARMA the exclusive
License and Distribution rights to distribute, market and sell Aloxi®
(palonosetron hydrochloride) in France, Belgium, Luxemburg and The
Aloxi® is a strong and long-lasting antiemetic belonging to the
second generation of serotonin (5-HT3) antagonists, the leading class
for the prevention of nausea and vomiting induced by chemotherapy.
Aloxi® showed a great efficacy during the acute and delayed phase
after chemotherapy treatment vs. other first generation 5-HT3. The
products is already commercialised in the US, where over three
million uses have been completed successfully. In March 2005, Aloxi®
was granted registration approval in Europe under a centralised
procedure by the EMEA with the following indications:
- the prevention of acute nausea and vomiting associated with
highly emetogenic cancer chemotherapy,
- the prevention of nausea and vomiting associated with moderately
emetogenic cancer chemotherapy, following single intravenous (IV)
Aloxi® is currently on the market in some European countries, as
well as in several countries of Latin America where the tradename is
There is still a medical need among cancer patients and the
medical community still need a better prevention of Nausea and
Vomiting due to chemotherapy treatments. International guidelines are
always updated with novelties to indicate the best treatments
available for the medical community and in 2004 the US National
Comprehensive Cancer Network (NCCN) guidelines indicated Aloxi® as
the treatment of choice for the prevention of acute and delayed
nausea and vomiting due to moderately emetogenic chemotherapies.
"HELSINN is delighted to sign this new Aloxi® agreement and to
extend our long-lasting co-operation with THERABEL PHARMA" said Dr.
Riccardo Braglia, Managing Director of HELSINN HEALTHCARE.
"THERABEL PHARMA's sound knowledge of the pharmaceutical market,
their strong commitment to make Aloxi® a first ranking product in the
antiemetic market, as well as our long-standing relationship for our
leading NSAID product, nimesulide, have contributed to our decision
to enter into this agreement, which will certainly see the successful
introduction of Aloxi® to the medical community and to patients
suffering from nausea and vomiting induced by chemotherapy".
"THERABEL PHARMA is very happy to pursue its fruitful
collaboration with HELSINN by signing this contract with an exciting
and challenging project and to offer to the patients a new efficient
antiemetic drug. Aloxi® will reinforce THERABEL PHARMA's position at
hospital in France and Benelux by a strategic and complementary area
of development. We strongly believe that Aloxi will be a drug of
choice for the prevention and treatment of chemotherapy induced
nausea and vomiting", said THERABEL PHARMA.
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.
Aloxi® is a selective 5-HT3-receptor antagonist, developed for the
prevention of CINV, with a long half-life of 40 hours and at least 30
times higher receptor binding affinity than currently available
compounds. Since its availability in USA in September 2003, there are
over 3 million successful uses of Aloxi®. The product showed to be
effective in preventing both acute and delayed CINV in patients
receiving emetogenic chemotherapies. For more information about this
product please visit our website: www.aloxi.com.
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 www.helsinn.com
About THERABEL PHARMA
THERABEL PHARMA is a medium size privately-owned pharmaceutical
group, operating in 5 European countries, France, Italy, Belgium,
Luxemburg and The Netherlands. The consolidated turnover of THERABEL
PHARMA is ¤138 million, with a 9% sales increase in 2005. The main
objective of THERABEL PHARMA is to focus all its strengths and
talents exclusively on serving the medical profession and patients by
providing innovative prescription medicines. THERABEL PHARMA aims to
become an European pharmaceutical group that is firmly established in
all major countries of the European Community, while preserving our
human-scale structure, our philosophy, our ethics and our freedom of
ots Originaltext: Helsinn Healthcare SA
Rachid BenHamza, Ph.D.
Head Business Unit Oncology & Supportive Care.