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

London, New York and Hamilton, Bermuda, April 30, 2010 (ots/PRNewswire)
-- 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
http://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

ots Originaltext: Celtic Pharmaceutical Holdings L.P.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: 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; IrmaGomez-Dib, Tel: +1(212)850-5761