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Agreements

Date: 2012-08-14

Type of information: Development agreement

Compound: microRNA therapeutics for three exclusive targets which are currently in pre-clinical development

Company: Regulus Therapeutics (USA) AstraZeneca (UK)

Therapeutic area: Cancer - Oncology - Cardiovascular diseases - Metabolic diseases

Type agreement:

R&D
development
commercialisation

Action mechanism:

anti-microRNA. Regulus' lead program for atherosclerosis targets microRNA-33, which has a unique mechanism of action for the management of cholesterol levels. The inhibition of microRNA-33 with anti-miRs promotes reverse cholesterol transport, or RCT, which is the efflux of cholesterol from specific cholesterol-laden inflammatory cells called macrophages in atherosclerotic plaques. Treatment with anti-microRNA-33 in an atherosclerotic mouse model led to reduction in arterial plaque size by 35% (Rayner et al., J Clin Invest. 2011) and treatment in non-human primates increased circulating levels of HDL-C by 50%. By enhancing RCT, anti-miR-33 differs from other emerging therapeutic strategies that focus only on raising HDL-C in circulation.

Disease: atherosclerosis, cardiovascular diseass, metabolic diseases, cancers

Details:

* On August 14, 2012, Regulus Therapeutics, a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, has entered into a strategic alliance with AstraZeneca to discover, develop, and commercialize microRNA therapeutics for three exclusive targets which are currently in pre-clinical development. These targets are focused on cardiovascular and metabolic diseases and oncology. Regulus and AstraZeneca will collaborate on three microRNA targets, which include Regulus\' lead cardiovascular/metabolic disease program targeting microRNA-33 for the treatment of atherosclerosis. 

Financial terms:

Under the terms of the agreement, AstraZeneca will make a $28 million payment which includes an equity investment and an upfront payment to Regulus. Regulus will lead preclinical development and, if successful, could receive pre-clinical milestone payments.  AstraZeneca will lead and fund the clinical development and commercialization of these programs. In addition, Regulus could also receive clinical milestones based on the successful development of microRNA therapies in each target area. Regulus is also eligible to receive significant launch and commercial milestone payments and royalties contingent on the successful commercialization of microRNA therapeutic products by AstraZeneca.

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Is general: Yes