Helsinn Healthcare SA

Helsinn and Vifor Pharma sign Licensing and Distribution agreement for Netupitant-Palonosetron fixed dose combination

Lugano/Glattbrugg, Switzerland (ots) - Helsinn Healthcare SA and Vifor Pharma, announced that the companies have entered into an exclusive license and distribution agreement for netupitant-palonosetron fixed dose combination, a Helsinn product currently in the development stage for the treatment of chemotherapy-induced nausea and vomiting (CINV). Under the agreement, Vifor Pharma will have rights to distribute the product in Switzerland, France, Spain, Portugal, the Netherlands, Belgium and Luxembourg. Vifor Pharma will also assume responsibility for registering the product in Switzerland.

The agreement refers to the fixed dose combination of netupitant, a novel NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist that is already marketed in the main markets worldwide under the trade names Aloxi®, Onicit® and Paloxi®, through Helsinn's network of partners, including Vifor Pharma in Switzerland, Benelux and France. Netupitant-palonosetron fixed dose combination is still in the development phase, with the oral form expected to have phase III clinical results available soon. "Chemotherapy-induced nausea and vomiting is a frequent and severe side effect of most cancer treatments. While various treatments already exist, nausea remains an area with a major unmet need that netupitant-palonosetron fixed dose combination will effectively address," said Riccardo Braglia, CEO of the Helsinn Group. "Vifor Pharma is a long-standing partner for Helsinn and we are glad this agreement will further extend our collaboration," Dr. Braglia added.

"Helsinn is a leader in managing cancer supportive care. Together we will provide patients and doctors with an innovative product that improves quality of life significantly," commented Thierry Volle, Head of International Business Operations, Vifor Pharma.

About netupitant-palonosetron fixed dose combination (NEPA)

NEPA is a novel single-day fixed-dose combination of a highly selective NK1 receptor antagonist, netupitant, and a pharmacologically and clinically distinct 5-HT3 receptor antagonist, palonosetron targeting two critical pathways associated with chemotherapy induced nausea and vomiting (CINV).

The phase III investigational program has recently been concluded.

NEPA is currently in the pre-submission status to the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA) for the prevention of acute and delayed CINV following both highly and moderately emetogenic chemotherapy.

About Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland, the United States and China. 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 Vifor Pharma

Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.

For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com

Contact:

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

Vifor Pharma
Beatrix Benz Head Global Communications
Tel.: +41/58/851'80'16
E-Mail: communications@viforpharma.com



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