February 20, 2014
Daval International Announces the Granting of Orphan Drug Designation by the FDA for AIMSPRO®
Eastbourne, UK – Daval International, the emerging life sciences company focused on the development of novel treatments for serious unmet medical needs, today announced receipt of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA), Office of Orphan Products Development, for AIMSPRO® for the treatment of systemic sclerosis (scleroderma).
"The granting of Daval’s request for Orphan Drug Designation represents a significant milestone in the development of AIMSPRO," said James Shotton, Daval’s Chief Executive Officer "and should prove helpful in our dialogue with the FDA as the compound's development progresses. It is Daval’s intention to find ways to continue the development of AIMSPRO using the benefits conferred by gaining Orphan Drug designation. Further, this designation alerts the FDA that we are dedicated to bringing a better therapy to patients suffering with scleroderma. "
The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor and if the disease or condition for which the drug is intended affects fewer than 200,000 people in the United States. In addition, the combination of the product to treat the rare disease or condition must meet strict certain criteria. The granting of Orphan designation qualifies the sponsor of the product for a tax credit during the course of the development of the product, waiver of the prescription drug user fee and seven years of marketing exclusivity in the US for the drug or biologic upon FDA approval.
AIMSPRO recently completed a Double-Blind Placebo-Controlled Phase II Clinical Study evaluating its safety and tolerability given as a monotherapy to patients with Late Stage Established Diffuse Cutaneous Systemic Sclerosis (diffuse scleroderma) and which was published in the globally renowned Annals of the Rheumatic Diseases journal, the EULAR journal.
To view the abstract of the publication, please click on this link.
http://ard.bmj.com/content/early/2013/09/25/annrheumdis-2013-203674.abstract and the poster is available for download if you click ARD Publication.
For further information please contact:
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Notes to Editors
AIMSPRO® (Hyperimmune Caprine Sera, HICS) is a proprietary, purified, protein–multi-peptide conjugate com-plex being developed as a novel, first-in-class biological treatment for a number of immune diseases where regulation and stabilisation of the immune system is required. It is believed that the drug has a unique mechanism of action that supports its broad potential application in neuro-degenerative diseases. AIMSPRO has been granted a Specials License by the UK's MHRA and is also available in Australia under Categories A and B of the TGA's Special Access Scheme.
About Daval International Limited
DAVAL INTERNATIONAL LIMITED is an emerging life sciences company focused on the development and delivery of novel and distinctive treatments for serious unmet medical needs through a combination of innovation, dedication, entrepreneurship, skilled science and partnership. From its inception in 2000, the founder and management team of Daval have had a vision of bringing effective treatments that noticeably improves the quality of life of patients suffering from the most serious debilitating neuro-degenerative, inflammatory and autoimmune diseases and to offer a choice over and above some of the disease modifying treatments available currently.