Celtic Pharma Announces Initiation of Phase III Trial of TDT 067 for the Treatment of Onychomycosis

By Celtic Pharmaceutical Holdings L.p., PRNE
Thursday, April 29, 2010

LONDON, NEW YORK and HAMILTON, Bermuda, April 30, 2010 - Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma"), the
global private equity firm focused on the biotechnology and pharmaceutical
industries, announced today the enrolment of the first patient into its Phase
III trial of TDT 067, terbinafine in Transfersomes(R), for the topical
treatment of onychomycosis (also known as a fungal nail infection).

This Phase III trial is a three-arm, double-blind study to be
conducted in approximately 40 centers around the world. It is powered to
provide potentially registrational data on the efficacy, tolerability and
safety of topically applied terbinafine delivered through the Transfersome(R)
targeted delivery technology over 48 weeks. PPD Inc., a leading global
contract research organization, has been appointed to conduct the study.

Dr. Phoebe Rich of Oregon Dermatology and Research Center,
Oregon Health and Sciences University, the Principal Investigator for North
America
said, "This important trial uses exciting new technology to deliver
antifungal drug deep into the site of infection in the nail. This drug could
potentially address the huge unmet need for topical therapy for
onychomycosis."

Dr. Bardur Sigurgeirsson, Department of Dermatology,
University of Iceland, the Prinicipal Investigator for Europe added, "I am
delighted to be involved in the trial of this innovative new product, which I
believe to be an important advance in this therapy area. There is a huge
demand for a safe and effective treatment for onychomycosis. Whilst oral
therapies can be successful in treating the disease, they carry the risk of
side-effects, notably hepatotoxicity. This results in physicians not being
able to treat a large percentage of the people suffering from this disease.
There is a great opportunity for a safe and effective topical treatment and I
believe that TDT 067 could be just that."

John Mayo and Stephen Evans Freke, Managing General Partners,
Celtic Pharma said: "We are delighted to progress to Phase III clinical
development of TDT 067, where we anticipate confirmation that this is a
medically and commercially important advance in the treatment of this common
disease. Based on what we have seen in Phase II development, we believe that
we have a product candidate that is comparable in efficacy to currently
available oral therapy but without the potential for serious safety issues."

During Phase II development, TDT 067 achieved two orders of
magnitude lower plasma terbinafine concentrations compared to oral
terbinafine in a pharmacokinetic study conducted under conditions of maximal
use. In contrast, terbinafine levels measured in affected nails were three
orders of magnitude higher than those reported for oral terbinafine. This
illustrates the targeted delivery of terbinafine. In a Phase II efficacy and
safety study, patients treated for only 12 weeks with a primary endpoint of
mycological cure at 14 weeks and follow up to 48 weeks, a 90% mycological
cure rate (as defined by negative culture and negative microscopic
examination) was observed at 14 weeks. At 48 weeks the mycological cure rate
was still 38% despite no active treatment for the preceding 36 weeks. TDT 067
was well tolerated with negligible systemic exposure and no serious local
side effects, confirming the maximal use study findings, suggesting that
patients can be treated for longer durations which should enable improved
efficacy.

About Onychomyosis (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 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 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 Transfersomes(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
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.

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.

    Enquiries

    Celtic Pharma
    John Mayo
    Tel: +44(0)207-291-5400

    Financial Dynamics
    UK:
    Jonathan Birt / John Dineen
    Tel: +44(0)207-269-7205

    US:
    Robert Stanislaro
    Tel: +1(212)850-5657

    Irma Gomez-Dib
    Tel: +1(212)850-5761

Enquiries: Celtic Pharma, John Mayo, Tel: +44(0)207-291-5400; Financial Dynamics - UK: Jonathan Birt / John Dineen, Tel: +44(0)207-269-7205; US: Robert Stanislaro, Tel: +1(212)850-5657; Irma Gomez-Dib, Tel: +1(212)850-5761

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