SOURCE: Celtic Pharma

April 30, 2007 02:22 ET

Celtic Pharma - Research Update

Hamilton, Bermuda -- (MARKET WIRE) -- April 30, 2007 --CELTIC PHARMA RECEIVES IND APPROVAL TO INITIATE A LARGE RANDOMIZED STUDY IN THE US FOR TA-NIC, ITS IMMUNOTHERAPY VACCINE FOR THE TREATMENT OF SMOKING CESSATION

New York, London, Bermuda, April 30, 2007 - Celtic Pharmaceuticals Holdings L.P. ("Celtic Pharma") today announced it has received IND approval for TA-NIC, a vaccine being developed for the treatment of nicotine addiction. TA-NIC is designed to induce nicotine-specific antibodies. When nicotine enters the bloodstream of a TA-NIC-dosed patient it will encounter and bind to these antibodies. The antibody-nicotine complex is too large to cross the blood-brain barrier, so the pleasurable stimulus which typically accompanies smoking should be absent or reduced. The prior owners of TA-NIC completed two phase I/II studies in the United Kingdom in 120 patients who were smokers. These vaccination studies were not associated with any unexpected adverse events and there were indications of efficacy in the treated group compared to placebo.

These studies are the basis for a large randomized study Phase IIB, which will be conducted in the US under the IND. This placebo controlled study, designed to assess the efficacy and safety of TA-NIC in managing smoking cessation when given in conjunction with current standard support treatments is scheduled to begin in the coming weeks. The study is a double-blind, multi-center dose-ranging trial, enrolling up to 200 patients in each of three treatment arms. The primary endpoint of the study is the abstinence rate at six months. Standard supportive elements of smoking cessation programs such as counseling and behavioral modification are incorporated into all three treatment arms.

Michael Earl, Commercial Director at Celtic Pharma Development Services, said:

"There is an urgent need for a more effective treatment for nicotine addiction with nearly 5 million people dying each year from tobacco use, according to the World Health Organization. With more than 1.2 billion people globally still smoking, the WHO predicts half of those will eventually be killed by tobacco. TA-NIC has the potential to be a key driver in the treatment of nicotine addiction. Given the potential of this product, we are already seeing considerable interest from pharmaceutical companies who may want to acquire this product when the results of this study are available."

Stephen Evans-Freke and John Mayo, Managing General Partners of Celtic Pharma, added:

"This is a significant milestone in the development of an effective treatment for all smokers wanting to quit. There are several nicotine addiction vaccines in development, but TA-NIC is the first to enter a robust randomized study to evaluate the effectiveness of TA-NIC as a treatment for nicotine addiction."

Celtic is also developing a vaccine against Cocaine addiction, TA-CD, which shares a common technical platform with TA-NIC.

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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For more information, please contact:


Celtic Pharma


Michael Earl

Managing Director - Commercial

Tel: +44 (0)207 291 5458

michael.earl@dev.celticpharma.com



Kathy Armstrong

Investor Relations

Tel: +1 (212) 616-4042

kathy@celticpharma.com


Media Contacts:


FD


US:

Matt Dallas

Tel: +1 (212) 850-5627

Matt.Dallas@fd.com



UK:

David Yates or Anna Keeble

Tel: +44 (0) 207 267 3113

David.Yates@fd.com

Anna.Keeble@fd.com



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