SOURCE: Celtic Pharma

October 15, 2007 08:36 ET

Celtic Pharma - Research Update

Hamilton, Bermuda--(Marketwire - October 15, 2007) -

   Celtic Pharma Announces Initiation of Phase II Clinical Trial for 
                   TDT-067, a Treatment for Onychomycosis

LONDON, NEW YORK and HAMILTON, BERMUDA, 15 October 2007 -- Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma"), the global private equity firm focused on the biotechnology and pharmaceutical industries, announced today the enrollment of the first patient into the Phase II trial of TDT-067, terbinafine in Transfersomes®, for the treatment of onychomycosis. This is an open-label study to explore the efficacy and safety of topically applied terbinafine delivered through the Transfersome® targeted delivery technology. Celtic Pharma acquired an exclusive global licence to IDEA AG's Transfersome® technology in February 2006.

Onychomycosis is a fungal infection of the fingernails and 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, especially among older individuals, (in the US it is estimated that Onychomycosis occurs in 7-10% of adults). Present treatment options include both oral and topical drugs, with oral therapies giving better outcomes.

Innovative drug carriers called Transfersomes® have been developed for the non-invasive 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 Transfersomes®) is a novel, epicutaneously applied (applied directly to the skin) carrier-based dosage form of terbinafine for the treatment of onychomycosis of the toenail and fingernail.

Commenting on today's announcement, Dr. Bob Milsted, Head of European Drug Development of Celtic Pharma said, "We are delighted to see this exciting drug/ carrier combination enter Phase II of its development, in which we endeavour to achieve proof of principle that this novel therapeutic approach will be efficacious. It is well established that current topical products for onychomycosis do not work well, as it is difficult to penetrate the nail to the site of the infection in the nail bed. However, many patients still choose topical treatments over systemic treatments due to the side effects associated with these systemic medications. We believe the epicutaneous application of terbinafine will benefit patients through improved delivery of terbinafine to the site of infection and consequently, TDT-067 represents a significant opportunity."

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 programmes and drives these programmes 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


Celtic Pharma

Kathy Armstrong

Tel:  +1 212 616-4042

John Mayo

Tel:  +44 (0)20 7291-5400

Financial Dynamics

David Yates

Tel:  +44 (0)20 7831-3113

Jonathan Birt

Tel:   +1 (212) 850-5634

Forward-Looking Statements

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Celtic Pharma disclaims any intent or obligation to update these forward-looking statements.

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