SUDA Allowed First USA Patent for SUD-003 and SUD-004

8th October 2015, ASX Announcement

SUDA has been allowed its first patent in the USA for “Oral Spray Formulations and Methods for Administration of Sildenafil” for the treatment of SSRI-induced erectile dysfunction and pulmonary arterial hypertension 

SUDA Ltd (ASX:SUD), a leader in mucosal drug delivery, today announces that the US Patent and Trademark Office has allowed SUDA’s first patent application for its sildenafil based products, SUD-003 and SUD-004, in the USA. The patent application (US 14/363,245) is titled: Oral Spray Formulations and Methods for Administration of Sildenafil. A patent directed to similar subject matter has already been granted in New Zealand and patent applications are pending in other jurisdictions.

The allowed claims of US 14/363,245 cover the administration of sildenafil, being the active pharmaceutical ingredient in SUD-003 and SUD-004, via oral spray formulations at a pH of between 1.5 and 2.4 for the treatment of sexual dysfunction induced by Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants and for the treatment of pulmonary arterial hypertension.

SSRI-induced sexual dysfunction is a common condition, affecting up to 75% of patients taking SSRIs such as Prozac®, Zoloft® and Paxil®.

PAH is a disease that affects the blood pressure between the heart and the lungs. PAH occurs at all ages; however, the incidence of it increases with age. It is is more common among women, non-Hispanic blacks, and among people aged 75 or older, and heart failure is often linked to the disease. The PAH market is forecast to grow at a CAGR of 5% and to reach $3.6 billion in 2015 (source: Global Data Analysis).

The allowance of US 14/363,245 complements SUDA’s intellectual property portfolio directed to the use of oral spray formulations of sildenafil in the treatment of erectile dysfunction. The Company has a second sildenafil patent family, based on PCT/US2011/03942, which contains patents that have been granted in Australian and Singapore with further patent applications that are pending in the USA and other jurisdictions.

Mr Stephen J Carter, SUDA’s CEO and Managing Director, commented: “We are delighted to have been allowed this patent in the USA. It reinforces our proprietary position covering the oral spray delivery of sildenafil for erectile dysfunction and pulmonary arterial hypertension. Pfizer’s sildenafil tablet, Viagra®, achieved sales of US$1.7 billion in 2014 with the majority generated from sales the US market. Having a strong patent position, particularly in the USA, is critical to our partnering strategy with the pharmaceutical industry.”

To read the full announcement, please click on the link below.