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Celtic Pharma Announces Presentation of Preclinical Data at the 69th Annual Meeting of the AAD in New Orleans
Date:2/7/2011

LONDON, NEW YORK and HAMILTON, Bermuda, Feb. 7, 2011 /PRNewswire/ -- Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma"), the global private equity firm focused on the biotechnology and pharmaceutical industries, announced today the presentation of key in-vitro data at the American Academy of Dermatology (AAD) 69th annual meeting in New Orleans (4-8 February, 2011) for TDT 067, terbinafine in Transfersomes®, for the topical treatment of onychomycosis (also known as a fungal nail infection).  

The first of the two in-vitro studies presented by the lead investigator, Professor Mahmoud Ghannoum, Director of the Centre for Medical Mycology at Case Western Reserve University in Cleveland, Ohio, investigates the activity of TDT 067 against the common causative agents of onychomycosis as measured by minimum inhibitory and fungicidal concentrations. The data demonstrate that TDT 067 has potent inhibitory and fungicidal activity against dermatophyte strains, and that the fungicidal activity of TDT 067 is shown to be more potent than conventional terbinafine preparations.  

In a second in-vitro study, presented by Professor Ghannoum, the morphology and ultrastructure of dermatophyte hyphae were investigated following exposure to TDT 067 using scanning electron microscopy (SEM) and transmission electron microscopy (TEM). The data show that terbinafine formulated in Transfersomes® in Celtic Pharma's TDT 067 drug candidate potentiates the action of terbinafine by enabling it to penetrate more effectively to its site of action inside the fungus, where it disrupts the intracellular matrix leading to eventual death of hyphae.

Michael Earl, co-CEO of Celtic Pharma Development Services, said: "The in-vitro data presented at the AAD demonstrate that TDT 067 potentiates the anti-fungal effects of terbinafine and the entry of the drug into dermatophyte hyphae, which we believe will provide a significant clinical benefit for the treatment of onychomycosis.  We hope to see confirmation of this benefit through the on-going pivotal clinical trial."

TDT 067 is currently in Phase III development.  A 42 center global trial is currently in progress and has fully enrolled the planned 776 patients.  The study is powered to provide  registrational data on the efficacy, tolerability and safety of topically applied terbinafine delivered through the Transfersome® targeted delivery technology over 48 weeks. Transfersomes® are a trans-dermal drug delivery system that enables delivery of high concentrations of drug to deep tissue without significant systemic exposure to the drug, so TDT 067 is designed to obviate the hepatotoxicity issues associated with oral administration of terbafine.

About Onychomycosis (Fungal Nail Infection)

Onychomycosis is a fungal infection, generally of the toenails, that results in thickening, discoloration, splitting of the nails and lifting of the nail from the nail bed.  The disease has a high incidence within the general population -- estimated to be as high as 13% in the US -- especially among older individuals, with only a small percentage of diagnosed patients being treated.  Present treatment options include both oral and topical drugs, with oral therapies giving better outcomes. However, these oral therapies have a black box warning and carry the risk of systemic side-effects, notably hepatotoxicity, that may be considered disproportionate to the disease being treated. This risk results in a large percentage of those affected by the condition  not being given the most effective treatments available.

Notes for Editors

Innovative drug carriers called Transfersomes® have been developed for the noninvasive delivery of agents into or through the skin. Transfersome® preparations consist of complex lipid vesicles, which are able to cross the skin permeability barrier, the stratum corneum, driven by the transcutaneous water gradient. TDT 067 (terbinafine in Transfersome®) is a novel, epicutaneously applied carrier-based dosage form of terbinafine for the treatment of onychomycosis of the toenail and fingernail.  Celtic Pharma acquired an exclusive global licence to IDEA AG's Transfersome® technology in February 2006. 'Transfersome' is a registered trademark owned by IDEA AG.

About Celtic Pharmaceutical Holdings L.P.

Celtic Pharmaceutical Holdings L.P. is a global private equity investment firm focused on the biotechnology and pharmaceutical industries.  Celtic Pharma was founded by Stephen Evans-Freke and John Mayo, CBE, and is based in Bermuda, with offices in New York and London. Celtic Pharma acquires and invests in late stage pharmaceutical programs and drives these programs through the final stages of regulatory approval. Celtic Pharma's aim is to bridge the gap between the established pharmaceutical companies' new product pipeline crisis and the biotech industry's capital drought.  For further information, please visit Celtic Pharma's website at www.celticpharma.com.


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SOURCE Celtic Pharmaceutical Holdings L.P.
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