Lugano, Switzerland,  June 2, 2015 – 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[1], 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.”

[1] http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/003728/WC500184907.pdf

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, 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 and high ethical standards. 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 the 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

AKYNZEO Important Safety Information (please refer to SmPC for Full Safety Information)

Contraindications

• AKYNZEO is contraindicated in case of hypersensitivity to the active substances or to any of the excipients.
• AKYNZEO is contraindicated during pregnancy.

Warning and Precautions

• Patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration.
• Serotonin syndrome has been reported with the use of 5-HT3 receptor antagonists either alone or in combination with other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs).
• Since AKYNZEO contains a 5-HT3 receptor antagonist caution should be exercised in the concomitant use of AKYNZEO with medicinal products that increase the QT interval or in patients who have or are likely to develop prolongation of the QT interval.
• Systemic exposure to chemotherapy agents and other medicines metabolised by CYP3A4 may ncrease when administered with or after AKYNZEO. Patients should be closely monitored adverse reactions that may arise from this additional exposure to relevant chemotherapies and other medicines.
• Breastfeeding should be discontinued during treatment with AKYNZEO.

Use in Specific Populations

• Avoid use of AKYNZEO in patients with end stage renal disease.
• AKYNZEO should be used with caution in patients with severe hepatic impairment.
• The safety and efficacy of AKYNZEO in the paediatric population have not been established. No data are available.

Drug Interactions

• When AKYNZEO is used concomitantly with medications that induce CYP3A4 activity, netupitant plasma concentrations could be reduced and this may result in decreased efficacy of AKYNZEO.  AKYNZEO can increase plasma concentrations of concomitantly administered medications that are metabolised via CYP3A4.  The inhibitory effect on CYP3A4 can last for multiple days.
• Dexamethasone doses should be reduced when given with AKYNZEO.
• Exposure to docetaxel and etoposide was increased when co-administered with AKYNZEO. No consistent effect was seen with cyclophosphamide after netupitant co-administration
• Consider the potential effects of increased plasma concentrations of erythromycin, midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO.
• Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampicin as this may decrease the efficacy of AKYNZEO. Concomitant administration with strong CYP3A4 inhibitors such as ketoconazole should be approached with caution.
• In vitro data shows that netupitant inhibits UGT2B7, caution is recommended when netupitant is combined with an oral substrate of this enzyme (e.g.zidovudine, valproic acid, morphine).
• In vitro data show that netupitant is a P-gp inhibitor. Caution is recommended when netupitant is combined with digoxin or with other P-gp substrates such as dabigatran, or colchicine.

Adverse Reactions

• The most common side effects reported with AKYNZEO are headache (seen in 3.6% of patients), constipation (3.0%) and fatigue (1.2%). For the full list of all side effects and restrictions, see the SmPC.

AKYNZEO is available by prescription only.

Please review Product Information before prescribing at https://www.helsinn.ch/downloads/Akynzeo_Day190_PI _24March_clean.pdf

Akynzeo® is under license from Helsinn Group, Switzerland.

For more information about AKYNZEO, visit www.AKYNZEO.com

For more information please contact:

Helsinn Group

Paola Bonvicini

Head of Communication & Press Office

PH +41 91-985-21-21

info-hhc@helsinn.com

For media / external enquiries

Consilium Strategic Communications 

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

Tel: +44 (0)203 709 5700

Helsinn@consilium-comms.com

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[1] http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/003728/WC500184907.pdf