After recent consultation with the FDA this November, Merrion Pharmaceuticals is preparing for its Phase III study for Orazol™. 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 laste 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 license 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® 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 table formulation with weekly dosing.