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LABOPHARM GRANTS TRAMDOL MARKETING RIGHTS TO PURDUE PHARMA.


Labopharm Inc.(TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
: DDS (1) (Digital Data Storage) See DAT.

(2) (Data Dictionary System) See QuickBuild and OpenDDS.

(3) (Dataphone Digital S
) and Purdue Pharma Purdue Pharma L.P., is privately-held pharmaceutical company founded by physicians. It is located in Stamford, Connecticut.

Purdue is best known for painkillers, but they have also branched into other areas such as oncology and nutraceuticals.
 L.P. sign a definitive licensing and distribution agreement under which Labopharm, through its subsidiary, Labopharm Europe Limited, has granted Purdue Pharma Products L.P. the exclusive right to market, sell and distribute Labopharm's once-daily formulation of the 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  tramadol in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , its territories and possessions. Labopharm will retain co-promotion rights for certain medical specialties Medical Specialties
See also anatomy; disease and illness; drugs; health; remedies; surgery.

adenography

the science of the description of glands. — adenographic, adj.
.

"With our anticipated NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  submission later this year, our number one priority was signing a partner to allow us to commercialize our tramadol product in the world's largest pharmaceutical market," said James R. Howard-Tripp, 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. , Labopharm Inc. "We are pleased not only with the terms of the agreement, which include a royalty rate commensurate with our expectations, but also with the collaborative nature of our marketing partnership. As examples, our companies will form a joint marketing team to prepare for the launch of our product. Following launch, Purdue will assist us in achieving one of our key strategic goals by building and training Labopharm's own sales force to allow us to pursue certain specialty markets in the U.S."

Under the terms of the agreement, Labopharm will receive payments of up to US$170 million, including an up-front licensing fee of US$20 million, a payment of up to US$40 million upon regulatory approval of Labopharm's product by 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.
), and payments upon the product meeting specified sales targets. Labopharm will receive royalty rates ranging from 20 to 25% of product sales. In addition, the costs of hiring, training and compensating Labopharm's sales force will be borne by Purdue.

"There is a huge unmet need for more medications to manage pain and this once-daily formulation of tramadol may offer a valuable therapeutic option to healthcare professionals and patients with moderate to moderately severe pain," said Michael Friedman, president and CEO of Purdue. "Through this agreement, Purdue reinforces its leadership position in, and commitment to, pain management. Pending FDA approval of this once-daily tramadol formulation, we believe that we would be in a strong position to capture a significant portion of the tramadol market."

"As the premier U.S. marketer of long-acting pain medications, including OxyContin Ox·y·con·tin

A trademark for the drug oxycodone.


oxycodone hydrochloride

ETH-Oxydose, OxyContin, OxyFast, Oxy-IR, Oxynorm (UK), Roxicodone, Supeudol (CA)

Pharmacologic class: Opioid agonist
(R) (oxycodone oxycodone /oxy·co·done/ (-ko´don) an opioid analgesic derived from morphine; used in the form of the hydrochloride and terephthalate salts.

ox·y·co·done
n.
 HCl controlled-release) Tablets and MS Contin MS Contin® is a time-released formulation of morphine, usually taken every twelve hours for chronic pain. It is the brand name for morphine sulfate marketed by Purdue Pharma. (R) (morphine sulfate morphine sulfate,
n brand names: Duramorph PF, MS Contin, Roxanol;
drug class: narcotic analgesic (Controlled Substance Schedule II);
action:
 controlled-release) Tablets, and with its extensive patent portfolio related to controlled-release tramadol, Purdue is the ideal partner for our product in the United States," said Dr. Allan Mandelzys, vice president, Business Development, Labopharm Inc. "Purdue has a proven track record of success in the long-acting analgesic market. Prior to the launch of generic products in 2004, annual sales of OxyContin reached approximately US$2 billion."

The agreement is subject to Hart-Scott-Rodino clearance in the United States.

About Labopharm's Commercialization Program for Once-Daily Tramadol

Labopharm is pursuing a global commercialization program for its once-daily formulation of tramadol. In the United States, the company has completed two Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  clinical studies and is currently engaged in a third. Labopharm is currently compiling its New Drug Application, which it expects to submit to the Food and Drug Administration before year-end. In Europe, Labopharm's once-daily tramadol product has been approved in France and the company is completing the Mutual Recognition Procedure process, which will provide regulatory approval across the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the

European Community
. The company anticipates launching its product in Europe before year-end. To date, Labopharm has secured marketing partnerships for 20 European countries, including four of the five largest tramadol markets and covering more than 80% of the total European tramadol market.

About Tramadol

Tramadol is a centrally acting analgesic that is indicated for the treatment of moderate to moderately severe pain in adults. The worldwide market for tramadol is estimated to be valued at US$1.3 billion, and IMS Health estimates that the worldwide sales volume of tramadol has grown at a compounded annual rate of 14% over the past five years. In the United States, where tramadol is currently available only as immediate-release formulations typically requiring four to six doses per day, Verispan estimates that more than 17 million prescriptions were written for tramadol products in 2004 and that the U.S. market for tramadol products has grown at a compounded annual rate of 11% over the last five years.

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products.

For more information, visit http://www.purduepharma.com or call 203/588-8069.

About Labopharm Inc.

Labopharm Inc. (TSX: DDS) is an international, specialty pharmaceutical company focused on the development of drugs incorporating Contramid(R), the company's proprietary advanced controlled-release technology. Labopharm's lead in-house product, a once-daily formulation of the analgesic tramadol, has been approved in France and the company has initiated the Mutual Recognition Procedure process, which will facilitate regulatory approval across the European Union. In the U.S., the company's once-daily tramadol product is in pivotal Phase III clinical trials. The company's pipeline includes a combination of in-house and partnered programs with products both in clinical trials and in preclinical development.

For more information, visit http://www.labopharm.com or call 450/686-1017.
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Publication:Worldwide Biotech
Geographic Code:1USA
Date:Jul 1, 2006
Words:880
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