Celtic Pharma Announces Presentation of Preclinical Data at the 69th Annual Meeting of the AAD in New Orleans

By Celtic Pharmaceutical Holdings L.p., PRNE
Sunday, February 6, 2011

LONDON, NEW YORK and HAMILTON, Bermuda, February 7, 2011 - — Transfersome(R) Trans-Dermal Delivery System potentiates terbinafine's
anti-fungal activity in TDT 067 –

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(R), 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(R) 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(R) targeted delivery technology over 48 weeks. Transfersomes(R)
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(R) have been developed for
the non-invasive delivery of agents into or through the skin.
Transfersome(R) 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(R))
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(R)
technology in February 2006. 'Transfersome' is a registered trademark owned

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

Enquiries, Celtic Pharma, John Mayo, Tel: +44 (0)20 7291-5400; or Financial Dynamics, UK: Jonathan Birt, Tel: +44 (0)20 7269 7205, Jonathan.Birt at FD.com, or John Dineen, Tel: +44 (0) 20 7269 7193, John.Dineen at FD.com, or US: Robert Stanislaro, Tel: +1-212-850-5657, Robert.Stanislaro at FD.com, or Irma Gomez-Dib, Tel: +1-212-850-5761, Irma.Gomez-Dib at FD.com

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