Supportive Care in Cancer: Palonosetron Recommended 5-HT3 Antagonist for Emesis Prevention by MASCC/ESMO

LUGANO, Switzerland -

- Anticipated at the Rome 2009 MASCC International Symposium the Outcome of the 2009 Joint MASCC (Multinational Association for Supportive Care in Cancer)/ESMO (European Society of Medical Oncology) Antiemetic Guideline Update Meeting New important acknowledgment for palonosetron, the second generation 5-HT3 receptor antagonist for prevention of chemotherapy induced nausea and vomiting (CINV). In April, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology on Antiemesis included palonosetron, as the “preferred” 5-HT3 antagonist in the combined regimen recommended for emesis prevention in patients undergoing highly emetogenic chemotherapy (HEC). Last week, MASCC (Multinational Association for Supportive Care in Cancer) and ESMO (European Society of Medical Oncology) decided to recommend palonosetron for the prevention of CINV induced by moderately emetogenic chemotherapy (MEC). The main outcome of MASCC/ESMO antiemesis guidelines, that will be published in July, has been released at the recent MASCC 2009 International Symposium held in Rome. MASCC/ESMO announced that the combined regimen palonosetron and multiday dexamethasone is recommended to prevent acute and delayed vomiting and nausea following the chemotherapy of moderate risk.

About Palonosetron (Aloxi(R), Onicit(R), Paloxi(R))

Palonosetron (palonosetron hydrochloride) is a selective 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 is a second generation 5-HT3 receptor antagonist, and 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 chemotherapies. A single intravenous dose of palonosetron (0.25 mg) provides better protection from CINV than first-generation 5-HT3 receptor antagonists throughout a 5-day post-chemotherapy period. This means that a single administration of palonosetron also grants protection during the delayed phase of CINV in MEC.

Palonosetron 0.075 mg IV is also approved by FDA as a single intravenous dose administered immediately before the induction of anaesthesia for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions (incidence greater than or equal to 2 percent) in CINV trials with palonosetron were headache (9 percent) and constipation (5 percent), and they were similar to the comparators. In PONV trials, the most commonly reported adverse reactions were QT prolongation (5 percent), bradycardia (4 percent), headache (3 percent), and constipation (2 percent), similar to placebo.

Palonosetron has been developed by Helsinn Group of Switzerland and today it is marketed as Aloxi(R), Onicit(R), and Paloxi(R) in more than 40 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 further information concerning its efficacy and safety please see the Marketing Authorization documents in each Country, typically the Summary of Product Characteristics. 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 subsidiaries in Ireland and USA. Helsinn is the worldwide licensor of palonosetron.

Helsinn’s unique business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early 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 subsidiaries, or eventually 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.

For more information about Helsinn Group, please visit the website: www.helsinn.com

Helsinn Healthcare SA Paolo Ferrari Head of International Marketing Tel.: +41/91/985-21-21 E-Mail: info-hhc@helsinn.com

Source: Helsinn Healthcare SA

Helsinn Healthcare SA, Paolo Ferrari, Head of International Marketing, Tel.: +41/91/985-21-21, E-Mail: info-hhc at helsinn.com