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news.Merrion is preparing for the Phase III study of Orazol after the recent consultation with the US Food and Drug Administration (FDA) in November 2010.
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Orazol is a tablet formulation of zoledronic acid, made possible by Merrion’s proprietary Gipet technology, for which there are issued US Orazol patents to 2027.
Merrion said that 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.
Merrion’s study is expected to compare Orazol against placebo as an adjuvant breast cancer treatment with a primary endpoint of Disease Free Survival of patients with breast cancer.
Merrion stated that Orazol would provide a new treatment, which could improve prognosis, in combination with existing treatments, for early stage breast cancer patients, if approved.
Merrion CEO John Lynch said that 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," Lynch said.
"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.