Helsinn Group and Eisai Inc. Announce Inclusion of AKYNZEO® (netupitant/palonosetron) in 2015 NCCN® Antiemesis Guidelines

Lugano, Switzerland and Woodcliff Lake, N.J., April 15, 2015 – Helsinn Group and Eisai Inc. jointly announced today the decision of the National Comprehensive Cancer Network (NCCN) to include AKYNZEO®inthe 2015 NCCN Antiemesis Guidelinesas a recommended option for patients receiving both highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).

AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeats courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Approved by the U.S. Food and Drug Administration in October 2014, AKYNZEO is the first approved fixed combination oral agent that targets two distinct signaling pathways associated with chemotherapy-induced nausea and vomiting (CINV) by combining netupitant, an NKreceptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule. Current treatment guidelines for the prevention of CINV call for combinations of medicines – including 5-HT3 receptor antagonists, NK1 receptor antagonists, and corticosteroids – based on the emetogenic potential, the likelihood that a drug will cause nausea or vomiting, of the chemotherapy regimen the patient will receive.

“We are pleased that the NCCN has recommended the use of AKYNZEO as an option for patients receiving HEC and MEC,” said RuiRong Yuan, MD, Chief Medical Officer, Eisai Global Oncology Business Unit, and Vice President, Medical Affairs, Americas Region, Eisai Inc. “The NCCN Guidelines are an important resource for health care providers and patients. This recommendation provides a guide for decision-making in cancer management, based on the best available evidence, that may help prevent nausea and vomiting for patients with cancer following chemotherapy.”

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.

“Helsinn is delighted with the NCCN recommendation,” said Silvia Sebastiani, Head of Medical Education and Post-Registration Studies at Helsinn. “This change is in line with our mission of supporting people with cancer, providing them with the tools to help cope with nausea and vomiting caused by anti-cancer treatment.”

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) document provides evidence-based, consensus-driven management to help patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care—including physicians, nurses, pharmacists, payers, patients and their families—with the ultimate goal of advancing patient care in the fight against cancer.

About AKYNZEO® (netupitant/palonosetron)

AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeats courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of a 5-HT3 receptor antagonist, palonosetron, and an NKreceptor antagonist, netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Additional applications for NEPA are planned worldwide. On March 26, 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending that AKYNZEO be granted in the European Union marketing authorization for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin‑based cancer chemotherapy and moderately emetogenic cancer chemotherapy.

AKYNZEO Important Safety Information

Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known      hypersensitivity to other 5-HT3 receptor antagonists
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with the concomitant use of serotonergic drugs.  Serotonin syndrome can be life-threatening.  Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs

Adverse Reactions

  • Most common adverse reactions: are headache, asthenia, dyspepsia, fatigue, constipation and erythema

Drug Interactions

  • Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days
    • Dexamethasone doses should be reduced when given with AKYNZEO. A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after a single dose of netupitant
    • Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased
  • Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO

Use in Specific Populations

  • Avoid the use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease

AKYNZEO is available by prescription only.

For more information about AKYNZEO, click here for the full Prescribing Information.

About Helsinn and Eisai

Helsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for AKYNZEO in the United States. Under the terms of the agreement, Helsinn is responsible for conducting all development activities, obtaining regulatory approvals and holding the New Drug Application (NDA). AKYNZEO is co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. subsidiary of Helsinn.

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 U.S. 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 preclinical and clinical studies and 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. 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.

About Eisai Inc.

At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families and help to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

For more information please contact:

Helsinn Group

Paola Bonvicini

Head of Communication

& Press Office

PH +41 91-985-21-21

[email protected]

Eisai Inc.

Media Inquiries                                                               Investor Inquiries

Laurie Landau                                                                   Alex Scott

Eisai Inc.                                                                           Eisai Inc.

(201) 746-2510                                                                 (201) 746-2177

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