Printer Friendly
The Free Library
14,537,783 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

NEUROMED LICENSES PHASE 3 CHRONIC PAIN PRODUCT FROM ALZA.


Neuromed Pharmaceuticals Ltd., a biopharmaceutical company developing next-generation chronic pain drugs, has licensed from ALZA Corporation the exclusive U.S. rights to develop and commercialize OROS OROS Operating Return On Sales
OROS Oregon Radiation Oncology Society
(R) Hydromorphone, an extended release formulation of a potent opioid analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs  in Phase 3 clinical development.

Under the terms of the agreement Neuromed will make an upfront payment of $30 million, additional regulatory milestone payments, and will pay royalties based on commercial sales of the product. Neuromed will develop and market the product in the U.S., while ALZA will retain the rights to develop and market the product in other countries. ALZA will manufacture the product for Neuromed as well as for other markets in which the product is sold.

OROS(R) Hydromorphone was developed by ALZA and uses the OROS(R) PUSH-PULL(TM) delivery system to release the opioid at a controlled rate. OROS(R) Hydromorphone has been approved in Germany and other European countries and is marketed by Janssen-Cilag under the name JURNISTA(TM). The product received an Approvable Letter from the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) in October, 2000. Neuromed anticipates that one successful adequate and well-controlled clinical trial will be needed to support approval of OROS(R) Hydromorphone in the U.S.

"Our licensing of the U.S. rights to OROS(R) Hydromorphone from ALZA is an excellent fit with Neuromed's strategy to address the significant need for alternative chronic pain treatments," said Dr. Christopher Dr. John R. Christopher, known popularly as "Dr. Christopher" was one of very few nationally prominent doctors of herbal medicine of the middle third of the 20th century, a "dark ages" of herbalism and was responsible for the herbal renaissance of the 1960s.  Gallen, president & 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.  of Neuromed. "Hydromorphone is an effective and well-known pain reliever and we believe a once-daily version can provide a significant benefit for the large number of patients with moderate to severe pain that require pain relief around the clock."

"OROS(R) Hydromorphone is a perfect fit with our existing programs, including our partnered N-type calcium channel The N-type calcium channel is a type of voltage-dependent calcium channel. Like the others of this class, the α1 subunit is the one that determines most of the channel's properties.  program and our own T-type calcium channel The T-type calcium channel is a type of voltage-dependent calcium channel. Like the others of this class, the α1 subunit is the one that determines most of the channel's properties.

T-type calcium channel blockers are used primarily as antiepileptics.
 blocker program," Dr. Gallen added. "Neuromed will develop a specialized sales force to market OROS(R) Hydromorphone in the U.S. upon FDA approval. The addition of a commercial presence in the U.S. will allow Neuromed to market niche products while continuing its dedication to the research and discovery of novel, breakthrough analgesics Analgesics Definition

Analgesics are medicines that relieve pain.
Purpose

Analgesics are those drugs that mainly provide pain relief.
." Hydromorphone is a Schedule II opioid that has been widely used for many years under the brand name DILAUDID(R) and is also available from various generic manufacturers. Current formulations of hydromorphone marketed in the U.S. are immediate release, requiring dosing several times per day.

OROS(R) Hydromorphone employs the OROS(R) osmotic osmotic,
adj pertaining to osmosis.

osmotic pressure,
n See pressure, osmotic.



osmotic

emanating from or pertaining to the pressure of osmosis.
 drug delivery technology.

The OROS(R) osmotic drug delivery technology provides controlled drug The United Kingdom Misuse of Drugs Act 1971 aimed to control the possession and supply of numerous listed drugs and drug-like substances. The act allowed and regulated the use of some Controlled Drugs (designated CD) by various classes of persons (e.g.  release over an extended period and has been employed as a sustained release formulation for many successful products, including CONCERTA(R), DITROPAN XL(R), COVERA-HS(R), and PROCARDIA XL(R). Four dosage strengths of OROS(R) Hydromorphone (8 mg, 16 mg, 32 mg and 64 mg) are currently marketed in Europe, with an additional lower strength (4 mg) in development.

OROS(R) Hydromorphone is an investigational product and is not approved by the FDA for use in the U.S. OROS(R) Hydromorphone has been studied in more then 1000 pain patients. The most common adverse events seen in clinical trials to date were opioid-related events of constipation, nausea, somnolence somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess.

som·no·lence
n.
1. A state of drowsiness; sleepiness.

2.
, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including OROS(R) Hydromorphone.

About Neuromed Neuromed is a privately held biopharmaceutical company in business to develop safer and more effective pain drugs. We are combining our pharmaceutical expertise in research, development and commercialization to improve existing pain treatments as well as develop new pain medicines.

For more information visit www.neuromed.com or call 604/909-2547.
COPYRIGHT 2007 Worldwide Videotex
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, 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:Jun 1, 2007
Words:606
Previous Article:TOPOTARGET UNVEILS AVUGANE PHASE II TRIAL FOR ACNE VULGARIS.(Clinical report)
Next Article:CHMP ADOPTS POSITIVE OPINION FOR ALEXION'S SOLIRIS IN EUROPE.
Topics:



Related Articles
FDA warns health professionals about painkiller's dangers. (Duragesic) (Brief Article)
Faulty 'pain patch' cited in negligence suits.
ALZA 1994 Annual Report Discloses New Products in Development, Cites Progress Toward Commercializing Products.
Neurex Launches Phase III Program for SNX-111 for the Treatment of Chronic Pain.
Corporate Profile for Alza Corp., dated April 4, 1997.
NorthStar R&D Licenses Analgesic Drugs from Endo Pharmaceuticals Inc.
Selected Ongoing Clinical Trials [*].(cancer pain research)
Using Heart-Centered Hypnotherapy and Emotional Freedom Technique in dealing with chronic pain.
THERATECHNOLOGIES GETS US $12 MILLION FOR MACROFLUX.
Neuromed Pharmaceuticals and Merck & Co., Inc. Announce Agreement for Novel N-type Calcium Channel Compounds.

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