Helsinn's Akynzeo for CINV prevention receives EC approval

HelsinnJun 2 2015

• First Fixed Dose Combination Targeting Two Key Pathways Involved in CINV

Helsinn, the Swiss Group focused on building quality cancer care, announces today that on 27^th May 2015, the European Commission (EC) approved Akynzeo^® (netupitant-palonosetron) for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in the European Union.

The decision followed the Positive Opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on March 26 2015 and is applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.

Akynzeo^® is a new oral fixed dose combination of a highly-selective NK₁ receptor antagonist, and palonosetron, a 5-HT₃ receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV).

CINV is one of the most common side effects of chemotherapy. Its management has been refined over the past several decades, but despite the existence of effective treatments and clear antiemetic guidelines, many patients still suffer from CINV, particularly during the delayed phase after chemotherapy. Studies show that patients often receive antiemetic drug regimens that are inconsistent with CINV treatment guidelines, which call for multiple-pathway targeted antiemetic prophylaxis.

Akynzeo® provides a combination of two antiemetics in a single oral capsule. A scheme of an NK₁ receptor antagonist, a 5-HT₃ receptor antagonist and dexamethasone meets the guidelines' recommendation for optimal antiemetic therapy following highly emetogenic and anthracycline cyclophosphamide based chemotherapy.

As stated in the CHMP Summary of opinion, the "simplification of therapy by decreasing the number of individual dose units to be taken by the patient may furthermore improve patient compliance."

Akynzeo^® will be distributed in Europe by Helsinn's network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how.

Akynzeo^® was already approved 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, on October 10th 2014 and by the Australian Therapeutic Goods Administration (TGA) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, May 4^th 2015.

Additional regulatory submissions for netupitant/palonosetron fixed dose combination are underway worldwide.

Riccardo Braglia, Helsinn Group Chief Executive Officer, commented: "Helsinn is proud to announce the EU approval of Akynzeo^® by the EC, which will allow us to provide patients living with cancer across Europe with an improved option for CINV protection. Akynzeo^® will play a significant role in preventing nausea and vomiting in both the acute and delayed phases following chemotherapy treatment, which could lead to more treatment options for the patient."