Helsinn and MGI Pharma Announce sNDA for Aloxi Capsules Accepted for Review by U.S. FDA
03/01/2008 18:01
PR Newswire
LUGANO, Switzerland, January 3 /PRNewswire/ -- Helsinn Healthcare S.A., Switzerland, a privately owned pharmaceutical
group and its partner, MGI Pharma (Nasdaq: MOGN), a biopharmaceutical
company focused in oncology and acute care, today announced that a
supplemental New Drug Application (sNDA) for Aloxi(R) (palonosetron
hydrochloride) Capsules for oral administration was accepted for filing by
the U.S. Food and Drug Administration (FDA). Aloxi Injection is approved by
the FDA for the prevention of acute nausea and vomiting associated with
initial and repeat courses of moderately and highly emetogenic cancer
chemotherapy and for the prevention of delayed nausea and vomiting
associated with initial and repeat courses of moderately emetogenic cancer
chemotherapy.
The sNDA for Aloxi Capsules was submitted to the FDA on
October 24, 2007. The acceptance for review of the NDA represents the FDA's
determination that the application is sufficiently complete to permit a
substantive review of the data. The filing of the application by the FDA does
not represent any opinion regarding the safety, efficacy or approvability of
Aloxi Capsules for oral administration. Under PDUFA (Prescription Drug User
Fee Act) III, the FDA's goal is to review and act on the NDA by August 22,
2008.
About Aloxi(R) (palonosetron hydrochloride) Injection
Aloxi is approved by the U.S. FDA for the prevention of acute
nausea and vomiting associated with initial and repeat courses of moderately
and highly emetogenic cancer chemotherapy and for the prevention of delayed
nausea and vomiting associated with initial and repeat courses of moderately
emetogenic cancer chemotherapy. Aloxi is the first and only 5-HT3 receptor
antagonist to be indicated for the prevention of delayed CINV caused by
moderately emetogenic cancer chemotherapy. The most common adverse reactions
related to Aloxi were headache (9%) and constipation (5%). Aloxi is
contraindicated in patients known to have hypersensitivity to the drug or any
of its components. Please see the Aloxi package insert, available at
http://www.mgipharma.com and http://www.aloxi.com, for important additional
details.
About MGI PHARMA
MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and
acute care that acquires, researches, develops, and commercializes
proprietary products that address the unmet needs of patients. MGI PHARMA
markets Aloxi(R) (palonosetron hydrochloride) Injection, Dacogen(R)
(decitabine) for Injection, and Gliadel(R) Wafer (polifeprosan 20 with
carmustine implant) in the United States. The Company directly markets its
products in the U.S. and collaborates with partners to reach international
markets. For more information about MGI PHARMA, please visit
http://www.mgipharma.com.
About HELSINN HEALTHCARE
HELSINN is a privately owned pharmaceutical group with
headquarters in Switzerland. Helsinn's core business is the licensing of
pharmaceuticals in therapeutic areas (oncology, cancer supportive care, pain
and inflammation, gastrointestinal).
The company's business strategy is to in-license early-stage
new chemical entities and to complete their development from the performance
of pre-clinical/clinical studies and CMC development to the attainment of
market approvals in strategic markets (U.S. and Europe). Helsinn's products
are eventually out-licensed to its worldwide consolidated network of partners
for distribution. Helsinn's key products in the US are Aloxi(R)
(palonosetron), distributed by MGI Pharma and Gelclair(R). The active
pharmaceutical ingredients and the drug products are manufactured at
Helsinn's cGMP facilities and supplied worldwide to its customers. Helsinn's
chemical business focuses on the pharmaceutical chemical process development
and manufacturing of advanced intermediates, Active Pharmaceutical
Ingredients (APIs) and High Potency Active Ingredients (HPAIs) for both the
Helsinn group and its outsourcing partners. For more information about
Helsinn, please visit http://www.helsinn.com
Helsinn Healthcare Contact:
Paolo Ferrari - Head of Marketing -
Oncology and Supportive Care
Tel: +41-91-985-21-21
E-mail: info-hhc@helsinn.com
Helsinn Healthcare Contact: Paolo Ferrari - Head of Marketing - Oncology and Supportive Care, Tel: +41-91-985-21-21, E-mail: info-hhc@helsinn.com