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
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
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
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
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 .
ots Originaltext: Helsinn Healthcare SA
Helsinn Healthcare SA
Paola Bonvicini Head of Communication & Press Office
Helsinn Healthcare SA
Judee Shuler, Eisai Inc.
Dave Melin, Eisai Inc.