Lugano, Switzerland, October 14, 2015: Helsinn Group announces that AKYNZEO® (netupitant/palonosetron)has been nominated by the Galien Foundation within the category "Best Pharmaceutical Agent of the Year" at the ninth annual Prix Galien USA Awards.
The Prix Galien, set up in France by the pharmacist Roland Mehl and since expanded across Europe, Canada and the US, is designed to recognize the technical, scientific and clinical research skills necessary to develop innovative medicines and devices. Nominees include biomedical products across three categories, biotechnology, pharmaceutical, and technology products, that advance human health and which have been approved by the U.S. Food and Drug Administration during the past five years.
Riccardo Braglia, Chief Executive Officer of Helsinn Group commented, "We are delighted that Helsinn’s product AKYNZEO® has been nominated for Best Pharmaceutical Agent 2015. AKYNZEO® plays a significant role in preventing nausea and vomiting in both the acute and delayed phases following chemotherapy treatment, providing additional treatment options for patients.”
The Prix Galien USA Committee comprises 10 renowned leaders from the biomedical industry and academia, including five Nobel Laureates, and is responsible for evaluating nominees. Winners will be honored at the Prix Galien USA Awards Ceremony on October 27, 2015 at 6:30 p.m., at the American Museum of Natural History in New York City.
For further information on The Galien Foundation Prix Galien Awards, please visit:http://www.prnewswire.com/news-releases/the-galien-foundation-announces-2015-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-agent-and-best-medical-technology-300124894.html
About AKYNZEO® (netupitant/palonosetron)
AKYNZEO is indicated 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
- Most common adverse reactions: headache, asthenia, dyspepsia, fatigue, constipation and erythema
- 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
In 2010, 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 (Chemistry, Manufacturing and Controls, preclinical and clinical), obtaining regulatory approvals and holding the New Drug Application (NDA). AKYNZEO will be 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 productand 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.
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