Helsinn Group And Eisai Inc. Announce Inclusion Of AKYNZEO (netupitant/palonosetron) In ASCO Antiemetics Guideline Update

LUGANO, Switzerland and WOODCLIFF LAKE, N.J., Nov. 13, 2015 /PRNewswire/ -- Helsinn Group and Eisai Inc. announced today that the American Society of Clinical Oncology (ASCO) has published a focused update to its clinical practice guidelines for antiemetics in oncology recognizing AKYNZEO^® (netupitant/palonosetron) as an additional option for the prevention of acute and delayed nausea and vomiting in patients receiving highly-emetogenic chemotherapy regimens.

The update, which ASCO stated was specifically made to incorporate guidance on the use of AKYNZEO, was published online in the Journal of Clinical Oncology in advance of a full update of the 2011 guidelines. ASCO practice guidelines are a benchmark for clinical practice among the oncology community.

AKYNZEO is indicated in the U.S. 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. 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.

"Helsinn is pleased that ASCO has included AKYNZEO in its antiemesis guidelines to help patients prevent CINV," said Silvia Sebastiani, Head of Medical Education and Post Registration Studies at Helsinn. "The prompt update of guidelines, as soon as new therapeutic options are available, is in line with Helsinn's mission to provide quality care for patients with cancer."

"Antiemetics serve a vital role in reducing the risk of nausea and vomiting," said Alton Kremer, Deputy President, Oncology PCU and Chief Medical Officer, Global Oncology Business Unit, Eisai Inc. "As a patient-focused company, Eisai is pleased that ASCO has provided an expedited guidance for antiemetics to recommend AKYNZEO as an additional agent for the prevention of chemotherapy-induced nausea and vomiting. This recognizes AKYNZEO's potential value for patients suffering from this common, and often debilitating, side effect of chemotherapy."

Chemotherapy-induced nausea and vomiting (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.

AKYNZEO was approved by the U.S. Food and Drug Administration in October 2014 and by the European Commission in May 2015. AKYNZEO is the first fixed combination oral agent that targets two distinct signaling pathways associated with CINV by combining netupitant, an NK₁ receptor 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 – which may include 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.

ASCO's clinical practice guidelines serve as a guide for doctors and outline appropriate methods of treatment and care. Guidelines can address specific clinical situations (disease-oriented) or use of approved medical products, procedures, or tests (modality-oriented). Using the best available evidence, ASCO expert panels identify and develop practice recommendations for specific areas of cancer care that would benefit from the availability of practice guidelines. Topics for guidelines are selected on the basis of significant clinical or economic importance; presence of variations in patterns of, or access to, care; availability of suitable data; and ethical considerations.

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About AKYNZEO^® (netupitant/palonosetron)
AKYNZEO is indicated in the U.S. 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. AKYNZEO is an oral fixed combination of a 5-HT₃ receptor antagonist, palonosetron, and an NK₁ receptor 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.

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 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: 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 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 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, 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 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. 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 helping 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 and Pennsylvania, as well as a global demand chain organization that includes 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.

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