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. Vitaros^® is approved in Canada and 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^®.

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. Vitaros^® is approved in Canada and 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^®.

FEMPROX

Femprox^® is in development for the treatment of Female Sexual Dysfunction or FSD. Like our Erectile Dysfunction product, Femprox^® is a cream designed for local application and composed of alprostadil and our novel excipient.

FEMPROX IS DESIGNED TO TREAT WOMEN THAT ARE NOT ABLE TO GET SEXUALLY EXCITED OR AROUSED.

Unlike Erectile Dysfunction, FSD is not well understood even though the disorder may be more prevalent. Experts believe that this disorder is more complicated than Erectile Dysfunction. Women with FSD may have a combination of problems including pain, lack of interest, orgasm dysfunction, vaginal dryness and the inability to become excited. These problems may be either physiological, psychological or both. Distress often accompanies the disorder and is a recognized component of FSD. Women that have diabetes, cardiovascular disease, hypertension or use tobacco may have a higher chance of developing this disorder. Similar to Erectile Dysfunction, FSD occurrence increases as women get older.

Femprox^® is designed to treat women that are not able to get sexually excited or aroused. Because lack of arousal is often accompanied by a lack of interest or desire, the disorder is referred to as Female Sexual Interest/Arousal Disorder or FSIAD. We believe that alprostadil within the Femprox^® cream exerts a relaxant effect on vulvar and clitoral blood vessels in women leading to increased blood flow. The blood flow increase leads to genital engorgement and enhanced secretion. The resultant increase in lubrication and sensory feedback may contribute to a clinically significant increase in sexual arousal in women with FSIAD.

In a Proof-of-concept trial with ~400 women having arousal disorders, Femprox^® showed increases in measures of sexual arousal providing support for further development. Additionally, the local application of Femprox^® was well-tolerated in these women.

Currently, there are no approved medications for FSIAD offering no treatment options for these women. Our goal with Femprox^® development is to address this unmet medical need by offering a local treatment option for women with FSIAD.

RayVa

What is Raynaud’s Phenomenon?

First described in the 1800’s, it is the transient loss of blood flow to the extremities, however, the primary cause remains unexplained.

Raynaud’s phenomenon (RP) is fairly common with a reported prevalence up to 5% with a disproportionately higher number of women affected. Triggers for an RP attack include cold temperatures, caffeine, smoking or emotional stress. Attacks are the result of reduced blood flow to areas including fingers, toes, nose and ears. Depending upon the severity, the affected areas may turn pale or blue followed by redness once the blood flow is restored. Accompanying the changes in blood flow are pain and tingling sensations.

RP is described as either primary or secondary. Primary RP is often first recognized in younger individuals that have a family history and the attacks tend to be mild. Individuals with secondary RP are older and often have autoantibodies or connective tissue disease, including scleroderma, and their attacks are more intense and painful. Repeated episodes may be associated with ulceration and changes in the appearance of the affected areas. While the blood vessels appear normal in individuals with primary RP, the blood vessels are narrowed and irregular with secondary RP.

Individuals incorporate lifestyle changes including wearing gloves, smoking cessation and limiting stress to prevent triggering RP attacks. Currently, there are no approved treatments for RP in the United States for primary or secondary RP.

RayVa^® or alprostadil topical cream is being developed to treat the symptoms associated with Raynaud Phenomenon secondary to systemic sclerosis. The active pharmaceutical ingredient in RayVa^® is alprostadil and, with DDAIP-HCl, allows local delivery of the vasodilator to the site of action. Besides vasodilation, alprostadil may have longer term benefits that will be evaluated during the clinical development of RayVa^®.