Labopharm Europe Limited: Labopharm Europe Opens New Headquarters in Dublin, Ireland

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12:11:17 PM
January
23 2004

Labopharm Europe Limited: Labopharm Europe Opens New Headquarters in Dublin, Ireland

Company Nearing Commercialisation of Once-Daily Formulation of Tramadol in Europe /PR Newswire/DUBLIN, Ireland

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Labopharm Europe Limited, a wholly owned subsidiary of Canada-based Labopharm Inc. (TSX: DDS), today announced the official opening of its new head office in Dublin, Ireland.

"With a critical mass of expertise in the speciality pharma sector, Dublin is the ideal location for Labopharm Europe's new headquarters," said James F.X. Fahy, Director, Labopharm Europe Limited. "We look forward to continuing to build relationships, both within the local pharmaceutical community and across Europe, as we work towards the European commercialisation of Labopharm's once-daily formulation of tramadol and build Labopharm's presence internationally."

Labopharm is nearing commercialisation of its first product, a once-daily formulation of the analgesic tramadol. In Europe, tramadol is currently available in generic immediate-release formulations that require dosing up to six-times daily and branded sustained-release formulations that require twice- daily dosing. In January 2003, Labopharm reported the positive results of its European Phase III trial for its formulation of once-daily tramadol, which achieved both its primary and secondary end points. In March 2003, Labopharm initiated the regulatory approval process in Europe for once-daily tramadol, commencing the Mutual Recognition Procedure (MRP) with the submission of a Marketing Authorization Application (MAA) with regulatory authorities in France. Under the MRP, approval in France should facilitate rapid approval across the rest of the European Union and in many non-EU countries.

"Labopharm Europe has played a key role in completing preparations for the market launch of once-daily tramadol in Europe," said Anthony C. Playle, Managing Director, Labopharm Europe Limited. "Over the longer-term, Labopharm Europe will be integral in our parent Company's development internationally towards its stated goal of becoming a fully integrated speciality pharmaceutical company."

Labopharm Europe has been responsible for securing licensing and distribution agreements for once-daily tramadol in 18 European countries, including France (with Aventis France), Italy (with Gruppo Angelini), Spain and Portugal (with Esteve SA) and 14 Eastern European countries with CSC Pharmaceuticals.

Labopharm Europe was established in 2002 to address the regulatory, marketing and supply chain management functions in the commercialisation of Labopharm Inc.'s products in Europe. Labopharm Europe is also responsible for Labopharm Inc.'s business development activities in Europe, including securing agreements to develop new products and exploring merger and acquisition opportunities.

Labopharm's Development Program for Once-Daily Tramadol

Labopharm is pursuing a global strategy in commercialising once-daily tramadol, focusing initially on Europe and the United States and, subsequently, the rest of the world. In addition to initiating the regulatory approval process in Europe, Labopharm, in preparation for its proposed NDA filing in the US, has completed two double-blind, multi-centre, randomised trials to evaluate the full 24-hour efficacy and safety of its once-daily formulation of tramadol in reducing moderate to moderately severe pain in patients suffering from osteoarthritis. The data from these trials will be combined with data from the previously completed European regulatory submission to form the basis of the Company's NDA submission. To date, Labopharm has treated approximately 1,800 patients in various clinical studies as part of its international once-daily tramadol program.

About Tramadol

Tramadol is a centrally acting analgesic indicated for moderate to moderately severe pain that may be associated with conditions such as osteoarthritis, lower back spasm, cancer, and other acute and chronic conditions. Because tramadol is well tolerated compared to anti-inflammatory drugs, it can be used by patients who are at risk of developing gastrointestinal bleeding and those with kidney problems. Tramadol reduces pain by binding to -opioid receptors and by inhibiting the re-uptake of the neurotransmitters norepinephrine and serotonin, a unique advantage over other analgesics. The worldwide market for tramadol is estimated to be in excess of US$1 billion annually.

About Labopharm Inc.

Labopharm Inc. (TSX: DDS) is an international speciality pharmaceutical company focused on the development of drugs incorporating the Company's proprietary advanced controlled-release technology, Contramid(R). Contramid(R) can be applied to a wide variety of drugs in solid oral dosage form, improving their oral administration and performance and is used to develop products that are either bio-equivalent to existing, branded products, or are new branded products. Labopharm's lead in-house product, a once-daily formulation of the analgesic tramadol, is under regulatory review in Europe and through the treatment stage of pivotal Phase III clinical trials in the US. The Company's pipeline includes a combination of both in-house and partnered programs with four products in clinical trials and another four undergoing pre-clinical development. Labopharm is also developing implantable mini-tablets based on Contramid(R) for local administration of drugs and novel nano-carrier systems!
using polymeric micelles for both systemic and targeted delivery of water- insoluble drugs. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Corporation's current expectations regarding future events. The forward- looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the successful and timely completion of clinical studies, the uncertainties related to the regulatory process and the commercialisation of the drug thereafter. Investors should consult the Corporation's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Corporation disclaims any obligation to update these forward-looking statements.

per maggiori informazioni: Europe: Anthony C. Playle, Managing Director, Labopharm Europe Limited, Tel: +353-1-854-0140, Europe@labopharm.com; North America: Lawrence Chamberlain, The Equicom Group, Investor Relations, Tel: +1-416-815-0700, lchamber@equicomgroup.com

Source by Laborpharm


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