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Helsinn Healthcare SA

Palonosetron infusion bag launched in Japan

Lugano, Switzerland (ots)

The Swiss pharmaceutical Helsinn Group announces today that Taiho Pharmaceutical Co. Ltd., Japanese licensee of Helsinn's second generation 5-HT3 receptor antagonist (5- HT3 RA) palonosetron, has launched on the national market the 0.75mg infusion bag formulation of palonosetron hydrochloride (Aloxi®). The infusion bag is an additional formulation to the 0.75mg injectable form already marketed in Japan since 2010. It is an important addition to the palonosetron portfolio for the Japanese market where the infusion bag presentation represents a significant share of the antiemetic sales per unit. "This great accomplishment will further strengthen the very effective collaboration between Helsinn and Taiho and our shared commitment to provide an effective treatment option to patients who are suffering from cancer chemotherapy induced nausea and vomiting," Dr Riccardo Braglia, CEO of the Helsinn Group said. Palonosetron is the No. 1 branded product in value in the Japanese 5- HT3 RA market.

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

Palonosetron (palonosetron hydrochloride) is a highly potent, and selective 5-HT3 receptor antagonist (RA) with a strong receptor binding affinity, a long plasma elimination half-life, and a unique mechanism of action compared to older 5-HT3 RAs. It has been developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer and it is currently the only 5-HT3 RA approved by FDA for the prevention of acute and delayed CINV following moderately emetogenic chemotherapy. Palonosetron demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV with a single intravenous or oral administration. It is currently the only 5-HT3 RA recommended by major anti emesis guidelines for moderately emetogenic chemotherapy (MASCC, ESMO MASCC, NCCN) and highly emetogenic chemotherapy (NCCN). Palonosetron is also approved for Postoperative Nausea and Vomiting in a number of countries including the US, Korea and several Latin American countries. Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions (incidence > or = 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 69 countries world-wide including Japan. Palonosetron, marketed as Aloxi®, is the leading brand in the USA and Japan within the CINV Day of Chemo segment, and it is steadily growing in the main European markets.

For more information about palonosetron, please visit the website: www.aloxi.com

About the 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 .

About Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd.,(http://www.otsuka.com/en/ ) is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology. Its corporate philosophy takes the form of a pledge: "We strive to improve human health and contribute to a society enriched by smiles." In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan and around the world for developing evidence-based medicines for the treatment of cancer. In areas other than oncology, as well, the company creates quality products that effectively treat medical conditions and can help improve people's quality of life. Taiho Pharmaceutical also aims to offer over-the-counter medicinal products that support people's efforts to lead fulfilling and rewarding lives, always putting customers first. For more information about Taiho Pharmaceutical, please visit http://www.taiho.co.jp/english/


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

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