SUDA PHARMACEUTICALS LTD ACN 090 987 250
ASX Release SUDA LTD ESTABLISHES CLINICAL ADVISORY BOARD FOR SUD-‐001 MIGRAINE ORAL SPRAY PERTH, AUSTRALIA - 21 April 2015: SUDA LTD (ASX: SUD), a leader in oro-‐mucosal drug delivery, today announces the appointment of two leading headache specialists to its Clinical Advisory Board (CAB) for SUD-‐001, the Company's first-‐in-‐class oral spray of sumatriptan for the treatment of migraine headache. These experts are providing advice and guidance to SUDA on the pivotal development plan, which will be presented to the US FDA. The two appointments to the CAB are Professor Anthony Fox and Dr Roger Cady.
Professor Fox is a physician with over 25 years' experience in the pharmaceutical industry with both large and small companies. His industrial positions with large pharma included Glaxo Inc in North Carolina, where he led the US clinical development of oral, intranasal and subcutaneous sumatriptan (Imitrex®; Imigran®) for migraine and cluster headache. He is now a Visiting Professor at King's College London. He is a chartered biologist and a Fellow of the Royal College of Physicians as well as its Faculty of Pharmaceutical Medicine; he is also an Adjunct Associate Clinical Professor at the University of California, San Diego. He is on the editorial boards of several journals, and co-‐edits Principles and Practice of Pharmaceutical Medicine. Professor Fox has published many research papers concerning migraine therapies, pharmacokinetics, and other relevant topics.
Dr Roger Cady is a graduate of the Mayo Medical School and holds board certification in Headache Medicine by the United Council for Neurologic Subspecialties. Dr Cady founded the US-‐based Headache Care Centre, which comprises a team of specialists in the integrated treatment and care of patients with headache. In particular, Dr Cady has been instrumental in developing the early intervention paradigm for the treatment of acute migraine. He has authored/co-‐authored over 250 peer-‐reviewed articles, and in particular, he was the leading author on the paper in JAMA that was the first to describe the therapeutic properties of sumatriptan in a sound, large-‐scale clinical trial. Dr Cady has written and contributed to numerous books, and co-‐edited Treating the Headache Patient. He is a member of the Board of Directors for the US National Headache Foundation.
SUDA's CEO, Mr Stephen Carter, commented: "We are thrilled to have attracted two of the world's leading experts with unparalleled clinical and medical experience in migraine to advise SUDA on the development of SUD-‐001. The involvement of these key opinion
ASX Release No. 768 21 April 2015 Page 1 of 2
leaders provides further endorsement of the merits of our unique oral spray formulation of sumatriptan for migraine and will also support our objective to out-‐license the product to pharmaceutical companies."
Further information: STEPHEN CARTER
Tel: +61 8 6142 5555
sjcarter@sudaltd.com.au
SUDA LTD (ASX: SUD) is a drug delivery company focused on oro-‐mucosal administration, headquartered in Perth, Western Australia. The Company is developing novel oral spray formulations of existing off-‐patent pharmaceuticals using its proprietary OroMist® drug delivery technology platform. The many potential benefits of administering drugs through the oral mucosa (ie: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist®, a first-‐in-‐class oral spray of zolpidem for insomnia. ZolpiMist® has been approved in the USA and SUDA has rights to the product outside of the Americas and South Africa. SUDA's most advanced development-‐stage product, ArTiMist™, is a novel sublingual malaria treatment for children. In a Phase III trial, ArTiMist™ was shown to be superior to intravenous quinine. Other products in development include oral sprays for the treatment of migraine headache, chemotherapy-‐induced nausea and vomiting, erectile dysfunction and pre-‐procedural anxiety. For more information, visit www.sudaltd.com.au
About SUD-‐001SUD-‐001 is a first-‐in-‐class oro-‐mucosal spray formulation of sumatriptan (marketed in tablet form and in a nasal spray by GlaxoSmithKline under the brand name Imitrex®). Sumatriptan is one of the most widely used drugs for the treatment of acute migraine in adults. Clinical studies conducted to date indicate that a SUD-‐001 dose of 20mg may be more effective than the standard 50mg sumatriptan tablet in reducing pain and other symptoms associated with migraine headaches. Migraine is a painful and debilitating condition that disrupts lives, impacts careers and costs employers in lost work and diminished productivity. According to a 2011 WHO report, migraine affects about 11% of the global adult population and the market value for the same year was estimated to be around US$3.2bn and is forecast to reach US$4.4bn by
2020.
ASX Release No. 768 21 April 2015 Page 2 of 2
|
distributed by
|
