Merrion Pharmaceuticals plc
Merrion Finalises Its Phase III Development Program for Orazol(TM) in the USA
Merrion Pharmaceuticals plc 16.11.2010 08:00 --------------------------------------------------------------------------- DUBLIN, Ireland, Nov. 16, 2010 (GLOBE NEWSWIRE) -- After recent consultation with the FDA in November 2010, Merrion is preparing for its Phase III study for Orazol(TM). If successful, the Phase III study will allow a new drug application for Orazol to be made under the FDA's abbreviated approval procedure section 505(b)(2) using a single Phase III study. The study will compare Orazol against placebo as an adjuvant breast cancer treatment with a primary endpoint of Disease Free Survival of patients with breast cancer. If approved, this drug would provide a new treatment, which could improve prognosis, in combination with existing treatments, for early stage breast cancer patients. Merrion has been focused on an oral form of this drug (zoledronic acid) for the bone metastases indication. However this trial would expand Orazol's potential by allowing Orazol to be used for early treatment of breast cancer in addition to bone metastases for late stage cancer patients. Zoledronic acid has been shown to improve Disease Free Survival in large-scale Phase III clinical studies, involving thousands of breast cancer patients. Commenting on the announcement, John Lynch, Chief Executive Officer, said: 'Merrion is still focused on licensing Orazol and believes this news will facilitate its discussions. Following the conclusion of its licensing discussions, Merrion would anticipate that, in conjunction with a licence partner, it would request a special protocol assessment (SPA), from the FDA, of the detailed protocol. Subject to approval from the FDA, the intention is to commence Phase III trials in 2011.' Merrion has previously received scientific advice from the Committee for Medicinal Products for Human Use (CHMP) agreeing the approval pathway for Orazol in Europe for the existing bone metastases indication. Following a licensing agreement, Merrion would seek agreement from the CHMP to expand the use of Orazol to earlier stage breast cancer treatment. Orazol, Merrion's lead product, is a unique tablet formulation of zoledronic acid, made possible by Merrion's proprietary GIPET(R) technology, and for which there are issued US Orazol patents to 2027. Orazol provides an ideal product profile to address the market needs, as a well-tolerated tablet formulation with weekly dosing. CONTACT: Merrion Pharmaceuticals Jonathan O'Connell + 353 (0) 1 6423300 info@merrionpharma.com www.merrionpharma.com Goodbody Stockbrokers Diane Hodgson Linda Hickey + 353 (0) 1 6670400 Brunswick Group Jon Coles Will Carnwath + 44 207 404 5959 merrion@brunswickgroup.com News Source: NASDAQ OMX 16.11.2010 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Merrion Pharmaceuticals plc United States Phone: Fax: E-mail: Internet: ISIN: US9901027097 WKN: End of Announcement DGAP News-Service ---------------------------------------------------------------------------
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