LUGANO, SWITZERLAND, and Athens, GREECE (ots) - HELSINN HEALTHCARE
SA, a Swiss pharmaceutical group, and GALENICA, a Pharmaceutical
company based in Greece, announce the signing of an agreement
granting GALENICA the exclusive License and Distribution rights for
ALOXI® (Palonosetron hydrochloride) in GREECE.
ALOXI® is the second generation of serotonine (5-HT3) antagonists,
the leading class for the prevention of nausea and vomiting induced
by chemotherapy. ALOXI® has the special features of a strong and long
lasting activity demonstrated in several clinical trials worldwide
and a successful use in USA since September 2003.
In Europe the CHMP recommended ALOXI® approval for the following
- 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® is registered and successfully marketed in USA by Helsinn's
licensee MGI Pharma. The sales achieved a total of $ 159 millions in
2004, fifteen months after its launch, with over a 1 million uses of
the products. Antiemetic guidelines such as the 2004 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.
"We are progressing with our European strategy to find the best
partners and we are glad to count GALENICA in Greece among them",
said Dr. Riccardo Braglia, Managing Director of HELSINN HEALTHCARE
SA. "GALENICA is a leading pharmaceutical company with a strategy to
offer the best oncology treatment and supportive care product to the
Greek patients. We look forward to a successful cooperation".
"In line with our longstanding strategy of heavily investing in
research products in order to have a pronounced contribution in
therapeutics and thus capture a leading position in the
acknowledgement of Greek physicians, we are pleased to conclude such
an important collaboration with HELSINN" said Dr Denis Varelas,
Managing Director of GALENICA s.a. "After all it was a long lasting
relationship with HELSINN that finally materialized as a business
collaboration for Aloxi®."
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 up to 30
times higher receptor binding affinity than currently available
compounds. There has been over 2,800 patients treated during the
phase 3 clinical trials and over 1 million uses after its
commercialization in USA. ALOXI® is effective in preventing both
acute and delayed CINV in patients receiving moderately emetogenic
chemotherapy, the most common chemotherapy regimens used in the
treatment of cancer. For more information about this product please
visit our website: www.palonosetron.net and 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
GALENICA S.A. is a privately owned pharmaceutical company, based
in Athens, Greece. It holds a leading position among the Hellenic
Pharmaceutical companies in terms of sales volume. It is the first
Greek Company focusing on marketing licensed-in ethical products,
pioneering in this vision since its foundation. For more information
about GALENICA please visit www.galenica.gr.
ots Originaltext: Helsinn Healthcare SA
Rachid BenHamza, Ph.D.
Head Business Unit Oncology & Supportive Care.
Pantelis Kapodistrias, Director Pharma (Ethicals)