Printer Friendly
The Free Library
5,074,106 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

LIGAND SUBMITS MAA FOR ONZAR IN EUROPE.


Ligand Pharmaceuticals Incorporated (Nasdaq: LGND LGND Luminance Ground ), San Diego, has submitted a regulatory application to market its anti-cancer medicine ONZAR(TM) (denileukin diftitox) in the European Union for the treatment of cutaneous T-cell lymphoma Cutaneous T-Cell Lymphoma Definition

Cutaneous T-cell lymphoma (CTCL) is a malignancy of the T-helper (CD4+) cells of the immune system.
Description
 (CTCL CTCL Cutaneous T Cell Lymphoma ) patients.

As a result of achieving this milestone, Ligand will receive a $1 million payment from its European marketing and distribution partner Elan.

Ligand also announced that ONZAR has been granted orphan drug designation by the European Commission. This designation currently provides, upon approval, 10 years of market exclusivity for the treatment of CTCL.

"We expect to work closely with the European regulatory authorities toward an efficient review and availability of this important new therapeutic for patients with CTCL," said David E. Robinson, Ligand's chairman, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "ONZAR is our largest-selling product in the United States, where it is marketed as ONTAK(R) (denileukin diftitox). If approved in Europe, ONZAR will join Targretin(R) capsules and Panretin(R) gel, which were launched this quarter, and Targretin gel, whose MAA MAA
abbr.
macroaggregated albumin
 is under review, as we bring our U.S. product line to Europe."

Ligand applied to the European Agency for the Evaluation of Medicinal Products (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) via the centralized procedure to market ONZAR for the treatment of persistent or recurrent CTCL in patients whose malignant cells express the p55 (CD25) component of the IL-2 receptor and who have received one or more prior systemic therapies.

The U.S. Food and Drug Administration approved ONTAK in the United States in February 1999. In the United States, clinical studies are being conducted to evaluate the safety and efficacy of ONTAK in large-market diseases, including T- and B-cell non-Hodgkin's lymphomas (NHL NHL Non-Hodgkin's lymphoma, see there ) and chronic lymphocytic leukemia chronic lymphocytic leukemia
n. Abbr. CLL
Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms.
 (CLL CLL
abbr.
chronic lymphocytic leukemia


CLL,
n.pr See leukemia, chronic lymphocytic.

CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid
). Promising early-stage research from the recent American Society of Hematology meeting showed that ONTAK had anti-cancer activity in CLL patients, and that combination treatment with Ligand's Targretin (bexarotene) boosted the activity of ONTAK in CTCL patients.

Ligand has exclusive agreements with three companies to market and distribute its near-term oncology products, when approved, outside the United States:

-- Ferrer International, S.A., in Spain, Portugal, Greece, and Central and South America.

-- Alfa Wassermann S.p.A. in Italy.

-- Elan Pharma International Limited for key markets including Germany, France, the United Kingdom and other Northern European countries.

About Ligand

Ligand Pharmaceuticals Incorporated discovers, develops and markets new drugs that address critical unmet medical needs of patients in the areas of cancer, skin diseases, men's and women's hormone-related diseases, osteoporosis, metabolic disorders, and cardiovascular and inflammatory diseases. Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription technology.

Full prescribing information for Ligand's products can be obtained in the United States from Ligand Professional Services by calling 800-964-5836, or on Ligand's internet site at http://www.ligand.com.

For more information, call 858/550-7850.
COPYRIGHT 2002 Worldwide Videotex
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Worldwide Biotech
Date:Feb 1, 2002
Words:463
Previous Article:SCIOS LICENSES NATRECOR TO GLAXOSMITHKLINE FOR EUROPE.
Next Article:CORIXA/BEAUFOUR IPSEN TO DEVELOP ANERGIX.MG TECHNOLOGY.
Topics:



Related Articles
High-strength compound of highly saturated nitrile and its applications.
Ligand Files Marketing Authorization Application for Panretin Gel in Europe.
Ligand and Alfa Wassermann Enter Into Marketing and Distribution Agreement for Italy for Ontak, Targretin and Panretin.
Winstar awarded 4 fed contracts.(Metropolitan Area Acquisitions awards)(Brief Article)
European CPMP Recommends Approval for Ligand's Panretin Gel; First Product for Ligand Europe.
Ligand's Targretin Capsules Recommended for Approval by European CPMP; Second Product for Ligand Europe Commercialization.
Ligand Submits Marketing Authorization Application --MAA-- for ONZAR--TM-- in Europe; Submission Triggers Milestone Payment from Elan.
Ligand Reports Record Financial Results for Full Year and Fourth Quarter 2001; Product Sales Double for Year, Driving Total Revenues Up 59%.
MEDIGENE AG SUBMITS ELIGARD MAA TO GERMAN REGULATORY AGENCY.
GERMAN REGULATORY AUTHORITY COMPLETES INSPECTION OF ATRIX.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles