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 CINVBy Helsinn Healthcare Sa, PRNE
Tuesday, January 11, 2011
LUGANO, Switzerland and WOODCLIFF LAKE, New Jersey, January 12, 2011 - 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(R) (palonosetron hydrochloride) Injection 0.25 mg
Palonosetron hydrochloride, marketed as ALOXI(R), 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
Important Safety Information
- The most common side effects of ALOXI(R) for the prevention of CINV are headache and constipation. - ALOXI(R) 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(R) should not be taken if you have a hypersensitivity to the drug or any of its components.
For more information about ALOXI(R) see full prescribing
information at www.ALOXI.com.
ALOXI(R) 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
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
Contact: Helsinn Healthcare SA Paola Bonvicini Head of Communication & Press Office Helsinn Healthcare SA Ph: +41-91-985-21-21 firstname.lastname@example.org Eisai Inc. Media Inquiries Judee Shuler Eisai Inc. Ph: +1-201-746-2241 email@example.com Investor Inquiries Dave Melin Eisai Inc. Ph: +1-908-255-6378 firstname.lastname@example.org
Contact: Helsinn Healthcare SA, Paola Bonvicini, Head of Communication & Press Office, Helsinn Healthcare SA, Ph: +41-91-985-21-21, info-hhc at helsinn.com . Eisai Inc. Media Inquiries: Judee Shuler, Eisai Inc., Ph: +1-201-746-2241, judee_shuler at eisai.com ; Investor Inquiries: Dave Melin, Eisai Inc., Ph: +1-908-255-6378, david_melin at eisai.com .
Tags: Helsinn Healthcare SA, January 12, Lugano, new jersey, Switzerland, Switzerland And Woodcliff Lake