NHP-554C - Anti-platelet Therapy - Secondary Prevention of Stroke + Cardiac Events
NHP-554C, the Company's most advanced product candidate, is being developed as an anti-platelet therapy for the secondary prevention of stroke and cardiovascular events. An NDA filing is expected in 2011 and a US commercial launch in 2012.
EU Approval and Launch - NHP-554C was approved in Europe under a Marketing Authorization Application ("MAA"). The Company is pursuing a launch in 2011 and 2012 in the 9 EU countries where it is approved and an extension of MAA approval to other EU countries.
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 prostaglandin derivative that induces platelet aggregation. Unfortunately, currently available aspirins (both immediate release and enteric coated) cause gastrointestinal (GI) side effects and inhibit vascular prostacyclin, a prostaglandin derivative that acts to prevent platelet activation and serves as a vasodilator.
NHP-554C Advantages - NHP-554C represents a unique product opportunity that was developed in consultation with a Nobel laureate to address the shortcomings of conventional aspirin products. NHP-554C inhibits thromboxane (which induces platelet aggregation) like other aspirin products, but NHP-554C also reduces insult to the gastrointestinal ("GI") tract, preserves vascular prostacyclin (which inhibits clot formation), and provides continuous platelet turnover protection, all as a result of its specially designed 24 hour controlled-release profile. These significant advantages position NHP-554C as a substantially more efficacious and safer version of aspirin, which the Company believes supports the product's viability as a commercially attractive prescription product.
NDA Filing - Based on a pre-NDA meeting with the FDA in December, 2009, the Company plans to file an NDA for NHP-554C in mid 2014 for the secondary prevention of stroke and cardiovascular events (consistent with the current FDA professional labeling for aspirin).