FDA Agrees to Special Protocol Assessment (SPA) to Evaluate the Safety and Efficacy of a Fixed-Dose Combination (FDC) of Netupitant and Palonosetron in the Prevention of CINV
Lugano, Switzerland/Woodcliff Lake, NJ (ots)
Helsinn Group and Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has agreed to the safety and efficacy protocols for Phase III trials with an investigational oral fixed-dose combination of netupitant and palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV).
Netupitant, a highly selective NK1 receptor antagonist, is thought to work by blocking the action of substance P, an endogenous neurotransmitter contained in high concentrations in the vomiting center of the brainstem that can stimulate the vomiting reflex. Palonosetron is a serotonin-3 (5-HT3) receptor antagonist. The 5-HT3 receptor has been demonstrated to selectively participate in the emetic response.
Riccardo Braglia, CEO of Helsinn Group, said: "We are very excited that the netupitant-palonosetron FDC is entering Phase III, as this is an important milestone towards our goal of giving cancer patients additional options for the prevention of CINV in the future."
Recently Helsinn signed a licensing agreement with Eisai Inc., granting the company rights for the new FDC product in the United States. Under the terms of the agreement, Helsinn is responsible for conducting all development activities (Chemistry and Manufacturing Controls [CMC], preclinical and clinical), obtaining regulatory approvals, and holding the New Drug Application (NDA). If approved by the FDA, the fixed-dose combination product will be co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics Inc., the U.S. franchise of the Swiss group, established with the acquisition of Sapphire Therapeutics Inc. in 2009.
Lonnel Coats, President and CEO of Eisai Inc., said: "We are pleased that the FDA has agreed to the Special Protocol Assessment, and look forward to the possibility of further expanding our oncology portfolio in an effort to make a difference in patients' lives."
About Special Protocol Assessments
A Special Protocol Assessment (SPA) is an agreement between the sponsor and the FDA indicating that the sponsor's proposed trial protocol, including, clinical endpoints and statistical analyses, are acceptable to support regulatory approval of the treatment being evaluated. FDA approval for the product is dependent on efficacy results, adverse event profiles and an evaluation of the benefit/risk of a treatment as demonstrated in the clinical trials.
About ALOXI® (palonosetron hydrochloride) Injection 0.25 mg
Palonosetron hydrochloride, marketed as ALOXI®, in the United States, is used in adults to help prevent nausea and vomiting on the day of chemotherapy that is highly likely to cause nausea and vomiting or up to five days following chemotherapy that is moderately likely to cause nausea and vomiting.
Important Safety Information
- The most common side effects of ALOXI® for the prevention of CINV are headache and constipation.
- ALOXI® has not been studied in children under 18 years of age
- Tell your healthcare professional if you are taking other medications or if you are pregnant or breastfeeding.
- ALOXI® should not be taken if you have a hypersensitivity to the drug or any of its components.
For more information about ALOXI® see full prescribing information at: www.ALOXI.com
ALOXI® is available by prescription only.
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland and subsidiaries in Ireland and USA. Helsinn's unique business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early to late stage new chemical entities, completes their development from the performance of pre- clinical/clinical studies and Chemistry, Manufacturing and Control (CMC) development, to the filing for and attainment of their market approval worldwide.
Helsinn's products are sold directly, through the Group subsidiaries, or alternatively out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice.
The active pharmaceutical ingredients and the finished dosage forms are manufactured at Helsinn's cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers. Helsinn, with a workforce of around 450 employees in Switzerland, Ireland and USA, reported a 2009 turnover of over CHF 305.0 million (about EUR 232.0 million at the current conversion exchange rate), covering 85 countries worldwide, with over 20% of this turnover invested in R&D.
For more information on the Helsinn Group please visit the website: www.helsinn.com
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai has a global product creation organization that includes U.S.- based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody- based programs. For more information about Eisai, please visit www.eisai.com .
Contact:
Helsinn Healthcare SA
Paola Bonvicini Head of Communication & Press Office
Helsinn Healthcare SA
Tel.: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com
Eisai Inc.
Media Inquiries
Judee Shuler, Eisai Inc.
Tel.: +1/201-746-2241
E-Mail: judee_shuler@eisai.com
Investor Inquiries
Dave Melin, Eisai Inc.
Tel.: +1/908-255-6378
E-Mail: david_melin@eisai.com