Helsinn Group Receives Positive CHMP Opinion for Akynzeo® (netupitant/palonosetron) for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in the European Union  

First New Fixed-Dose Combination Targeting Two Key Pathways Involved in CINV

Lugano, Switzerland, 30 March 2015 – Helsinn, the Swiss Group focused on building quality cancer care, today announced that the European Medicines Agency (EMA) has adopted a positive opinion recommending that the Helsinn-owned Akynzeo® (netupitant-palonosetron), a new oral fixed-dose combination of a highly-selective NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, be granted approval for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin‑based cancer chemotherapy and moderately emetogenic cancer chemotherapy.

The Committee for Medicinal Products for Human Use (CHMP) is the committee of the European Medicines Agency responsible for preparing opinions on questions concerning medicines for human use.

This is the first opinion given by the CHMP for a fixed-dose combination targeting two key pathways involved in chemotherapy-induced nausea and vomiting (CINV) and will now be reviewed by the European Commission, which has the authority to approve medicines in the European Union (EU).

Akynzeo® was approved on October, 10th 2014 by the US Food and Drug Administration (FDA), for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

“After the approval of Akynzeo® by the FDA, we are proud to achieve this latest milestone with Akynzeo® providing patients going through cancer treatment across Europe with an additional option for CINV protection,” said Riccardo Braglia, Helsinn Group Chief Executive Officer. “We anticipate that, when approved, Akynzeo® will play a significant role in preventing nausea and vomiting in both the acute and delayed phases, following moderately or highly emetogenic chemotherapy regimens. Simplification of therapy by decreasing the number of individual dose units may furthermore improve patient compliance and guidelines adherence.”

The positive CHMP opinion was based on data from Phase 2 and Phase 3 studies with Akynzeo® including more than 2500 patients undergoing treatment with moderately and highly emetogenic chemotherapy regimens for a variety of tumor types. The adverse events reported with AKYNZEO were consistent with the safety profile of the NK1 and 5-HT3 receptor antagonist classes of drugs.

About the Helsinn Group

Helsinn is a family-run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, and the USA and a representative office in China. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.

Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing pre-clinical/clinical studies as well as associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn’s products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. Helsinn has built a large product portfolio of cancer care products with an alliance of over 65 global partners. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn’s GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com

For more information please contact:

Helsinn Group

Paola Bonvicini

Head of Communication & Press Office

PH +41 91-985-21-21

[email protected]

For media / external inquiries

Consilium Strategic Communications

Mary-Jane Elliott / Jessica Hodgson / Matthew Neal / Laura Thornton

Tel: +44 (0)203 709 5700

[email protected]

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