Daval International Announces the Granting of Orphan Drug Designation by the FDA for AIMSPRO®

February 25, 2014

EASTBOURNE, England, February 25, 2014 /PRNewswire/ –

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(R) 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

To view the abstract of the publication, please click on this link.


and the poster is available on the Daval website at


Notes to Editors


AIMSPRO(R) (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.

SOURCE Daval International

Source: PR Newswire

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