SUDA Granted Japanese Patent for its Sldenafil-Based Products

SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that the Japan Patent Office has issued SUDA’s first Japanese patent for its sildenafil-based products, SUD-003 and SUD-004. The patent is titled: Oral Spray Formulations and Methods for Administration of Sildenafil. A patent application directed to similar subject matter has also been approved in Russia.

KEY TAKEAWAYS:

• Similar patents have been granted in the USA, Australia, New Zealand and Singapore; patent applications are pending in other jurisdictions.
• These patents provide protection until 2032.
• Administration of sildenafil, being the active pharmaceutical ingredient in SUD-003 and SUD-004, via an oral spray for the treatment of sexual dysfunction induced by Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants and for the treatment of pulmonary arterial hypertension (PAH).
• The global Erectile Dysfunction (ED) drugs market was valued at over US$ 4.4 billion in 2014. It affects about 150 million men worldwide and about 50% of men aged 40-88 suffer from the disorder.

Mr Stephen J Carter, SUDA’s CEO and Managing Director, commented: “We are delighted to have been issued this patent in Japan and to have had it approved in Russia. It reinforces our proprietary position covering the oral spray delivery of sildenafil for erectile dysfunction and pulmonary arterial hypertension. If we consider all countries where this patent or similar patents have been granted, then we have patent protection for SUD-003 and SUD-004 covering approximately 60% of the world’s healthcare market. We are finalising our new-generation formulation of SUD-003 with enhanced bioavailability and onset of action in preclinical models. In 2017, we anticipate continuing and furthering our discussions with prospective pharmaceutical partners globally who have shown interest in licensing our novel oral spray treatment for erectile dysfunction.”

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