Singapore - Specialty pharmaceutical company iX Biopharma Ltd (SGX: 42C) ('iX Biopharma' or, together with its subsidiaries, 'the Group') is pleased to announce that Silcap, a sildenafil drug used in the treatment of male erectile dysfunction ('ED'), has obtained approval and registration by the Health Sciences Authority (HSA) in Singapore.
While patients suffering from ED have access to a variety of generic treatment options, iX Biopharma's Silcap has been designed as a novel small capsule, unlike existing alternatives which are typically delivered in tablet form. Silcap is the first capsule sildenafil product to obtain marketing approval in Singapore.
Silcap is iX Biopharma's second drug for the treatment of male erectile dysfunction after Wafesil, a novel dose form of sildenafil delivered using iX Biopharma's proprietary WaferiX drug delivery technology, a sublingual wafer that delivers drug actives safely, conveniently and rapidly into the blood stream. iX Biopharma also supplies Silcap and Wafesil in Australia since obtaining approval and registration in 2018 from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia.
Ms Eva Tan, Director, Corporate and Commercial Strategy of iX Biopharma said: 'We are delighted with the approval and registration of Silcap in Singapore. Apart from offering a unique value proposition when compared to existing sildenafil products in the market, Silcap's approval continues to reaffirm our ability to bring products successfully from clinical development to registration and launch.'
Silcap is available in dosage strengths of 25 mg and 50 mg in pack sizes of 4, 8 and 12 capsules. Following the approval, the Group will be preparing for marketing launch of Silcap in Singapore. As sildenafil drugs are classed as prescription medication in Singapore, Silcap will be supplied to the local market via licensed medical practitioners.
About male erectile dysfunction
Erectile dysfunction is a common condition affecting one in five men over the age of 40 years1. In a population-based survey conducted in Singapore on men greater than 30 years old, a prevalence rate of male erectile dysfunction of 51.3% was observed, whereas another study on the ageing population in the country reported a prevalence rate of 73.0%2.
Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance, and these problems may be related to a wide variety of factors. Erectile dysfunction is common among older men and is often associated with chronic illnesses including atherosclerosis, diabetes and depression. It is also associated with certain prescription medications and alcohol consumption.
About iX Biopharma Ltd
iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia. The Group is focused on the development and commercialisation of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.
iX Biopharma's pipeline of products under development includes Wafermine (ketamine wafer) and BnoX (buprenorphine wafer) for pain management. iX Biopharma's drugs for the treatment of erectile dysfunction, Wafesil, a sublingual sildenafil wafer, and Silcap, have been registered in Australia and Singapore. iX Biopharma has developed Xativa, the world's first freeze-dried sublingual medicinal cannabis wafer.
The Group's nutraceuticals division, Entity Health Limited, is engaged in the development and commercialisation of nutraceutical products that address specific conditions and improve quality of life. It distributes its Entity line of nutraceutical products in Australia through more than 250 pharmacies and health food shops, in China through its flagship stores on Tmall Global and JD Worldwide, and globally through its online store.
Contact:
Dr Janakan Krishnarajah
Tel: +65 6235 2270
Email: j.krishnarajah@ixbiopharma.com
This announcement has been reviewed by the Company's sponsor, CIMB Bank Berhad, Singapore Branch ('Sponsor') in accordance with Rule 226(2)(b) of the Catalist Rules. This announcement has not been examined or approved by the SGX-ST and the SGX-ST assumes no responsibility for the contents of this announcement, including the correctness of any of the statements or opinions made or reports contained in this announcement. The contact person for the Sponsor is Mr. Yee Chia Hsing, Head, Catalist. The contact particulars are 50 Raffles Place, #09-01 Singapore Land Tower, Singapore 048623, telephone: (65) 6337-5115.
IX BIOPHARMA LTD. 
