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01.10.2012 – 12:48

Helsinn Healthcare SA

Oral Palonosetron shows safe and effective control of nausea and vomiting induced by multiple cycles of chemotherapy

Lugano, Switzerland & Vienna, Austria (ots)

New data presented at the 2012 meeting of the European Society of Medical Oncology (ESMO) in Vienna show antiemetic efficacy maintained across the chemotherapy cycles and a positive safety profile

The oral formulation of palonosetron, the second generation 5-HT3 receptor antagonist (5-HT3 RA), is effective and safe in preventing chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of moderate emetogenic chemotherapy (MEC), according to the data presented by Prof Steven Grunberg, Professor of Medicine and Pharmacology, Division of Hematology and Oncology, University of Vermont, USA, at the ESMO (European Society of Medical Oncology) Vienna 2012 Congress today. "Palonosetron, a pharmacologically distinct 5-HT3 RA offers superior CINV prevention compared with other 5-HT3 RAs when administered as a single intra-venous dose", Prof Grunberg said. Palonosetron is approved by the European Medicine Agency (EMA) and the US Food and Drug Administration (FDA) for the prevention of CINV in the intra- venous dosage of 0.25 mg and in the oral dosage of 0.50 mg, with a demonstrated comparable clinical effect of the two formulations. "In our multicenter, open-label study, patients received a single 0.75 mg dose of oral palonosetron to best evaluate the safety of the oral formulation of multiple cycles of chemotherapy", prof Grunberg explained.

217 patients, enrolled in 22 study centers in Europe, Mexico and the United States, received oral palonosetron with or without - at investigator discretion - concomitant administration of dexamethasone (8 mg on the first day of treatment) 1 hour prior to MEC for up to a maximum of 4 consecutive cycles. The total number of evaluated cycles was 654; on average 3 per patient, with about half of the patients receiving 4 cycles.

Antiemetic efficacy was maintained across the chemotherapy cycles with overall complete response rates (i.e.: no emesis and no need for rescue medication) ranging from 55 to 60% of the patients over the 3-4 cycles.

"The majority of adverse effects were of mild intensity, with headache the most common one. The few severe, serious adverse effects in the safety profile did not raise clinical concerns. In conclusion, we can say that oral palonosetron is well tolerated and effective in preventing CINV over multiple cycles in patients receiving MEC", Prof Grunberg said.

About Chemotherapy-induced nausea and vomiting (CINV)

Chemotherapy-induced nausea and vomiting is among the most dreaded side effects following therapy in patients with cancer. Despite prophylaxis, on the day of chemotherapy, up to 30-45 percent of patients experience nausea or vomiting or require rescue therapy following administration of certain types of emetogenic chemotherapy. The 5-HT3 receptor plays a pivotal role in the process of emesis, and agents that antagonise these receptor subtypes are the basis for control of this effect. Following the development of the first generation 5-HT3 receptor antagonists, such as ondansetron and granisetron, in the late '80s and early '90s, in recent years new compounds have been made available for preventing CINV, including palonosetron.

About Palonosetron

About Palonosetron (Aloxi®, Onicit®, Paloxi®) 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®, Onicit®, and Paloxi® in more than 60 countries world-wide. Palonosetron, marketed as Aloxi®, 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 Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland and the United States. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas. Helsinn is an important player in cancer supportive care. Helsinn Group in- licenses early-to-late stage new chemical entities, completes their development through the performance of pre-clinical /clinical studies and Chemistry, Manufacturing, and Control (CMC) development, and files and attains their market approvals worldwide. Helsinn's products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how whom Helsinn assists and supports by providing 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 products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland and supplied worldwide to its customers. Further information on Helsinn Group is available at www.helsinn.com.


Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
Phone: +41/91/985'21'21
E-Mail: Info-hhc@helsinn.com

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