Vitaros®

Our product, Vitaros®, is a topical cream for the treatment of erectile dysfunction. Vitaros® is locally applied and contains alprostadil plus our novel excipient. The product delivers rapid onset (generally five to thirty minutes) and treatment duration of approximately one to two hours. Vitaros® local delivery provides a first line alternative to oral treatment. In addition to patients who prefer topical treatment as their first treatment option, patients with complications that preclude them from using orally delivered systemic treatments can benefit from Vitaros®. The product is approved in Canada and certain countries in Europe, Latin America and the Middle East and is being commercialized in several countries in Europe.

TARGETING THE UNTREATED ERECTILE DYSFUNCTION MARKET.

It is estimated that, worldwide, 150 million men suffer with erectile dysfunction. Factors contributing to the appearance of the disease or its severity include medical history, tobacco use and age. Erectile dysfunction is also found in men with cardiovascular disease.

Other prescription medicines are available for the treatment of erectile dysfunction, including phosphodiesterase inhibitors. Phosphodiesterase inhibitors are effective for the treatment of Erectile Dysfunction but also have reported side effects such as those that affect the cardiovascular system, headaches, muscle aches, impaired hearing and vision.

Whereas phosphodiesterase inhibitors are taken in the form of a tablet, Vitaros® was designed for direct application and to provide a rapid onset with significant efficacy and a favorable safety profile. Vitaros® was studied in over 3,000 patients and demonstrated positive, clinically meaningful responses in measures of erectile function.

Because men with erectile dysfunction often have other diseases, Vitaros® was also evaluated in these populations. Men with erectile dysfunction and accompanying diseases including diabetes, cardiovascular disease and prostatectomy also had clinically meaningful enhanced erectile function with Vitaros®. Vitaros® was well-tolerated in patients, including those with additional diseases.

Availability of a locally acting product that is safe and effective addresses an unmet medical need. Men who are resistant to taking oral medication or have diseases that may preclude them from other treatments now have an alternative with Vitaros®.