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Altea Therapeutics Commences Phase 1 Clinical Trials of a Novel Fentanyl Citrate Transdermal Patch Designed for the Safe and Rapid Management of Moderate to Severe Chronic Pain

Posted on: Thursday, 25 May 2006, 09:01 CDT

Altea Therapeutics announced today that it has commenced Phase 1 clinical trials in the U.S. for AT3022, the Company's fentanyl citrate transdermal patch designed to provide safe and rapid management of moderate to severe chronic pain. AT3022 utilizes the Company's proprietary PassPort(TM) Transdermal System, developed to deliver water-soluble small molecules, proteins, carbohydrates and oligonucleotides across the skin.

AT3022 is designed to provide a safer and more efficacious alternative to the currently marketed fentanyl patches that can only deliver the highly lipid-soluble base form of fentanyl. In July 2005, the FDA issued a Public Health Advisory in response to safety-related events in patients using marketed fentanyl patches to manage their pain. Primary safety concerns with marketed fentanyl patches include the formation of depots of fentanyl base in the skin leading to slow elimination after patch removal, and long times to reach steady state, both of which combine to make accurate dose titration lengthy and difficult. Further, the presence of a large amount of fentanyl base in the patch after removal can lead to drug abuse, and patch leakage or application of a heat source can lead to dose-dumping that may have life-threatening consequences. The use of the PassPort Transdermal System to deliver the highly water-soluble fentanyl salt is intended to mitigate each of these concerns.

"The current safety of opioids for treatment of severe pain is a pressing issue for clinicians and regulatory agencies," stated Dr. Eric Tomlinson, President and Chief Executive Officer of Altea Therapeutics. "AT3022 incorporates layers of potential deterrents against product abuse, misuse, and diversion and provides rapid and sustained delivery of a highly effective opioid, fentanyl citrate. The product is intended to lead to safe and accurate dose titration while offering rapid discontinuation of treatment if required."

Approximately 50 million Americans suffer from chronic pain. Pain impacts daily functioning, quality of life and accounts for more than $100 billion annually in health care expenditures and productivity loss in the U.S. The total U.S. market for analgesics, not including over-the-counter products, totaled $18.9 billion in 2004. The opioid analgesic market segment accounted for $6.3 billion of that market.

About Altea Therapeutics

Altea Therapeutics is an emerging private pharmaceutical company focused on developing and commercializing a broad portfolio of pharmaceutical products based on a new class of advanced transdermal patches that deliver sustained therapeutic levels of highly water-soluble drugs, peptides, proteins, and vaccines in a convenient, painless, and cost-effective manner.

Altea Therapeutics has demonstrated in several clinical studies that its patented PassPort(TM) transdermal system achieves what existing patches are unable to do, namely the continuous delivery through the skin of proteins and highly water-soluble drugs - compounds typically administered by painful needle injections or unsafe extended-release oral formulations.

The Company has completed initial Phase 2 clinical trials in the U.S. with a daily hydromorphone hydrochloride patch for the rapid management of moderate to severe pain, and is conducting Phase 1 clinical trials in the U.S. with insulin patches that provide continuous delivery of basal levels of insulin for people with diabetes.

Additional information about Altea Therapeutics can be found at www.alteatherapeutics.com.

NOTE: Altea Therapeutics, PassPort, Medicines Made Better are either registered trademarks or trademarks of Altea Therapeutics Corporation, in the USA and/or other countries. All other brand names, product names, or trademarks belong to their respective holders.

The statements in this press release regarding the products of Altea Therapeutics in development, product development plans, and projected financial results, are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the ability of Altea Therapeutics to both complete the design, development, and manufacturing process development of its products, manufacture and commercialize its products, obtain product and manufacturing approvals from regulatory agencies, manage its growth and expenses, finance its activities and operations, as well as marketplace acceptance of its products.

Source: Business Wire

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