Orazol™ is a unique weekly tablet formulation of zoledronic acid designed to provide the same dose as a monthly infusion.
Following consultation with the FDA, Merrion has a defined regulatory pathway for its Phase III programme for Orazol. The Phase III study in approximately 1,000 subjects should allow Orazol to be approved under the FDA's abbreviated section 505(b)(2) procedure 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.
Adjuvant breast cancer therapy is the long term treatment of patients aimed at preventing cancer reoccurrence and progression and increasing overall survival. In the US alone, 600,000 patients annually undergo adjuvant breast cancer therapy.
Early stage breast cancer is a multibillion dollar market with limited new treatment options. Orazol is a high potential, late stage licensing opportunity as a potential blockbuster product with an abbreviated development path, limited clinical risk and issued US patent protection to 2027.
Extensive data from large scale trials (Azure Trial and ABSCG- 12) have demonstrated that the addition of zoledronic acid to standard therapy has a statistically significant clinical benefit, 21% reduction in risk of reoccurrence and 29% increase in overall survival (Azure - post menopausal patients) and 35% reduction in risk of reoccurrence and 36% reduction in risk of progression (ABSCG-12 premenopausal patients with medically reduced estrogen levels).
Orazol offers a significant commercial opportunity as a multi year treatment to reduce risk of cancer progression or recurrence and increase overall survival. Orazol presents a unique market opportunity in the postmenopausal breast cancer population addressing key unmet needs, with a defined regulatory pathway and limited clinical risk, as there is extensive phase III data from large scale zoledronic acid studies supporting its anti-cancer effect.
Developed using Merrion's proprietary GIPET Technology, Orazol provides an ideal product profile to achieve high market penetration, as a well tolerated tablet formulation with weekly dosing.
|November 2010||Merrion finalises its Phase III development program for Orazol™ in the USA|
|May 2010||Merrion Pharmaceuticals is issued a key US patent for Orazol™|
|March 2010||Merrion Pharmaceuticals plc announces issuance of key United States Patent|
Orazol™ Scientific Literature & Poster Presentations
|Orazol™ (MER-101) Poster Presentation Safety Profile of Zoledronic Acid in a Novel Formulation - Presented at AACR-NCI-EORTC Molecular Targets & Cancer Therapeutics Conference, Boston, Nov 2009|
|Orazol™ (MER-101) Poster Presentation Studies of Bioavailability & Food Effect of MER-101 Zoledronic Acid Tablets - Presented at ASCO Breast Cancer Symposium, San Francisco Oct 2009|
|Orazol™ (MER-101) Poster Presentation final Phase II Study - Presented at ASCO, American Society of Clinical Oncology Annual Meeting May 2009|
|Orazol™ (MER-101) Poster Presentation - Presented at the AAPS November 2007|
|Orazol™ (MER-101) Poster Presentation - Presented at the AACR - NCI - EORTC International Conference on "Molecular Targets and Cancer Therapeutics October 2007|
The AZURE trial - Does Adjuvant Zoledronic acid redUce REcurrence in patients with high-risk localised breast cancer?
R Burkinshaw, H Thorpe, S Pollard, R Bell, D Dodwell, D Cameron, R Coleman
Academic Unit of Clinical Oncology, University of Sheffield, Sheffield, United Kingdom
Endocrine Therapy plus Zoledronic Acid in Premenopausal Breast Cancer
Michael Gnant, M.D., et. al., for the ABCSG-12 Trial Investigators N Engl J Med 2009;360:679-91.
Zoledronic Acid Effectively Prevents Aromatase Inhibitor-Associated Bone Loss in Postmenopausal Women with Early Breast Cancer Receiving Adjuvant Letrozole: Z-FAST Study 36-Month Follow-up Results
Adam M. Brufsky, et. Al.,
Clinical Breast Cancer, Vol. 9, No. 2, 77-85, 2009