Micropump® Aspirin, or NHP-554, is a proprietary, once-daily oral 24-hour controlled-release aspirin product. Micropump® Aspirin is a novel oral dosage form that exhibits an extended release profile specifically designed to continuously deliver aspirin in the circulation over a 24 hr time period. This unique characteristic makes NHP 554 particularly suited to the secondary prevention of stroke and cardiovascular events, indications for which aspirin is currently used. The design of the Micropump® microparticles allows for a prolonged transit time to release in the circulation, with a plasma mean residence time extended up to 24 hours. Over-the-counter ("OTC") aspirin is currently only available in immediate and delayed release (enteric coated) formulations, which release aspirin into the circulation over a shorter period of time. Therefore, Micropump® Aspirin is intended to extend therapeutic coverage as compared to the OTC aspirin products currently available.
- Anti-platelet Aspirin Therapy - Secondary Prevention of Stroke + Acute Cardiac Events
NHP-554C, the Company's most advanced product candidate, is being developed for the secondary prevention of stroke and acute cardiovascular events. A US NDA is expected to be submitted to FDA in 2013, with US approval and a US commercial launch in 2014.
Market Opportunity - Over 100 million people globally currently take aspirin daily to prevent heart attack and stroke. Aspirin prevents clot formation through the inhibition of thromboxane, a naturally-occurring prostaglandin derivative in the body that induces platelet aggregation.
NHP-554C Advantages - NHP-554C represents a unique product opportunity that was developed in consultation with a Nobel laureate to improve treatment over conventional aspirin products, via its specially designed 24 hour controlled-release profile.
US NDA Submission - Based on 2 pre-NDA meetings with the FDA, NHP plans to submit an NDA for NHP-554C in mid 2013 for the secondary prevention of stroke and acute cardiovascular events (consistent with the current FDA monograph: professional labeling for aspirin products). Approval is expected in 2014.
NHP-554CZ - Antiplatelet Aspirin Therapy
NHP-554CZ, a combination form of NHP-554C (utilizing Yale IP involving zinc salts), potentially represents an improved second generation Micropump® Aspirin product. Development is expected to begin in 2012.