Category: Uncategorized
December 18, 2003

News Release: Theratechnologies and ALZA Corporation launch a clinical study for transdermal parathyroid hormone (PTH) in osteoporosis

Theratechnologies (TSX: TH) announced today that a first subject has been dosed in a Phase I clinical study for ThPTH, its transdermal formulation of parathyroid hormone (PTH) being developed in collaboration with ALZA Corporation of Mountain View, California for the treatment of osteoporosis. This trial, which is being conducted in the United Kingdom, was designed for the initial development of a patch formulation as an alternative to injectable PTH. The product under development incorporates ALZA's Macroflux(R) technology. 'Based on the positive results obtained in our preclinical feasibility study in 2002, we are moving forward with the clinical development of a transdermal product using PTH for the treatment of osteoporosis', said Dr. Thierry Abribat, Vice President and Chief Scientific Officer of Theratechnologies. 'PTH is the only approved therapy that has shown efficacy in promoting bone formation and, given that it has already been approved in an injectable form in this indication, we consider that this project carries less clinical risk than would be the case with a novel compound,'he added.

About the study

This Phase I study will be conducted in healthy volunteers. Preliminary information will be obtained on safety as well as on the pharmacokinetic profile and biological activity of ThPTH in comparison with the marketed form of PTH.

About osteoporosis

It is estimated that osteoporosis affects approximately 30 million people in the United States, Europe and Japan. Osteoporosis is a bone disorder characterized by progressive bone loss predisposing to an increased risk of fracture, typically in the hip, spine and wrist. The progressive bone loss, which begins between the ages of 30 and 40, is mainly asymptomatic until a bone fracture occurs, leading to a high degree of patient morbidity and mortality. Eighty percent of those affected by osteoporosis are women and, during the six years following the onset of menopause, women lose one third of their bone mass. In the United-States alone, osteoporosis is responsible for more than 1.5 million fractures annually and the estimated direct expenditures (hospitals and nursing homes) for osteoporosis and associated fractures were $17 billion in 2001 or $47 million per day.

About ThPTH

Theratechnologies'ThPTH is a transdermal formulation of PTH, a hormone secreted by the parathyroid glands that regulates the metabolism of calcium and phosphate in the body. PTH has stirred great interest in the treatment of osteoporosis for its ability to promote bone formation, hence dramatically reducing the incidence of fractures. Large-scale clinical trials have shown that PTH, administered by injection, effectively and safely reduces the percentage of vertebral and non-vertebral fractures in women with osteoporosis. Theratechnologies and ALZA achieved excellent preclinical feasibility study results when combining parathyroid hormone (PTH) with ALZA's Macroflux(R) transdermal technology. This study showed that PTH can be administered transdermally in animals with a pharmacokinetic profile similar to subcutaneous injection.

About Macroflux(R) transdermal technology

Macroflux(R) transdermal technology incorporates a thin titanium screen with precision microprojections that, when applied to the skin, creates superficial pathways through the skin's dead barrier layer allowing transport of macromolecules. The creation of Macroflux(R) pathways allows for better control of drug distribution throughout the skin patch treatment area and potential reduction in skin irritation.

About Theratechnologies

Theratechnologies (TSX:TH) is a Canadian biotechnology company engaged in the discovery and development of therapeutic products in the field of endocrinology and metabolism. The Company has and is developing a portfolio of peptides at various stages of development for the treatment of catabolic (loss of the body's synthesis and regeneration capacity) and metabolic disorders, as well as osteoporosis and type II diabetes. In addition, Theratechnologies is expanding its peptide portfolio through proven, proprietary technologies. Its subsidiary, Celmed BioSciences, develops cell-based therapies for the treatment of hematological, immune and neurodegenerative disorders.

Theratechnologies'website is located at www.theratech.com. The Company is listed on the Toronto Stock Exchange under the symbol TH.

This press release contains forward-looking statements regarding the clinical development of ThPTH and its future commercialization in the indication described above. Such statements inherently involve numerous risks and uncertainties, including the availability of funds and resources, the success and timely completion of clinical trials and the granting of the necessary authorizations. Actual future results may differ materially from the anticipated results. Investors are cautioned against placing undue importance on forward-looking information contained herein and should consult the Company's 2002 Annual Report, which contains a more exhaustive analysis of risks and uncertainties connected to the businesses of the Company.

For further information: Peter McBride, Vice President, InvestorRelations and Public Affairs, (514) 336-4804, ext.215,pmcbride(at)theratech.com; Patricia Delaney Lussier, Communications Director,(514) 336-4804, ext. 234, pdelaney(at)theratech.com

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