DURLAZA™ - A New Anti-platelet Therapy
Secondary Prevention of Stroke + Acute Cardiac Events
The Company expects to submit a US NDA for DURLAZA to the FDA in Q3 2014 and is planning for an approval and a US commercial launch in Q3 2015.
Over 25 million people in the US that are being treated for the secondary prevention of stroke and acute cardiac events.
EU Approval and Launch
DURLAZA™ was approved in Europe under a Marketing Authorization Application ("MAA"). The Summary of Product Characteristics or SPC in Europe (equivalent to PI or Label, in the US) notes the PGI2 sparing activity of DURLAZA when compared to conventional Aspirin over 28 days. The Company is contemplating a launch beginning in 2016 in EU countries where it is approved, through partnerships.
DURLAZA™ with Zinc Salts
Development has commenced for a second-generation combination product in (successor to DURLAZA™) to incorporate proprietary Yale University zinc salt technology. This new product is expected to provide added benefit to patients taking DURLAZA.
Rx Zinc Salts
The company has commenced the development of a prescription product for the purpose of suppressing stomach acid by raising gastric pH (alone, and/or in combination with other drugs), based upon proprietary zinc salts technology licensed from Yale University.
Researchers at Yale have demonstrated that the proprietary zinc salts exhibit a dose-dependent ability to increase gastric pH and a sustained systemic acid suppression effect when taken up into the parietal cells of the stomach tissue of animals and humans. Additionally, they have shown these salts demonstrate fast action in reducing gastric acid secretion, raising the pH of the stomach in less than 20 to 30 minutes.
The company believes its proprietary zinc salts have promise as a proprietary, once-daily oral adjunct therapy to proton pump inhibitors, or PPIs, for the treatment of patients with gastro-esophageal reflux disease, or GERD, who experience breakthrough symptoms, including nocturnal reflux, while taking PPIs or who do not have adequate response to PPIs. Approximately 40% of PPI patients suffer breakthrough GERD two to four times a week, and 65% of GERD sufferers experience breakthrough at night. Additionally, approximately 20% to 25% of GERD patients taking PPIs do not respond to treatment in the U.S. Other potential markets include pediatric GERD, Zollinger-Ellison syndrome, ulcer disease, and gastric cancer.