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Connetics Announces Completion of Patient Enrollment for Scleroderma Pivotal Trial.

Business Editors/Health & Medical Writers

PALO ALTO, Calif.--(BW HealthWire)--Dec. 20, 1999

Connetics Corporation (Nasdaq:CNCT) today announced it has completed patient enrollment for its Phase II/III pivotal trial with ConXn(R) (recombinant human relaxin, H2) for the treatment of scleroderma. Sixteen study centers nationwide enrolled 239 scleroderma patients. The purpose of the trial is to evaluate the efficacy of ConXn in treating diffuse scleroderma, as well as to obtain additional safety and dose ranging data. Results are expected to be announced in late 2000.

"We are very pleased with the speed and efficiency demonstrated by the study investigators in conjunction with our clinical team in screening and enrolling patients for this study. Likewise, we are encouraged by the patient community's interest in participating in what has become one of the largest clinical trials ever conducted in scleroderma," said Thomas G. Wiggans, President and CEO of Connetics. "Our objectives for this pivotal trial are to replicate the results of the earlier Phase II study, which demonstrated statistically significant improvement in skin score and positive trends in a panel of secondary endpoints. Upon achievement of our study objectives, we anticipate filing a BLA in 2001."

In the earlier Phase II study with ConXn, patients treated with 25 ug/kg/day demonstrated statistically significant improvement in skin score and positive trends in 11 secondary parameters, including lung function, oral aperture, hand extension, and disability parameters, such as eating, gripping, reaching and personal hygiene.

Scleroderma is a serious and sometimes life-threatening disease characterized by thickening and hardening of the skin and, in severe cases, the internal organs, including the heart, lungs, kidneys and the organs of the gastrointestinal tract. Scleroderma can cause extensive disfigurement and quality of life impairment, often making it impossible for afflicted patients to carry out the most routine daily functions.

The Scleroderma Research Foundation estimates that between 300,000 and 500,000 individuals in the United States suffer from various forms of this disease, and 80% of those afflicted are women. Approximately 70,000 in the United States have progressive systemic sclerosis, the most serious form of the disease. No effective therapies exist today to treat the hardening of the skin and internal organs in this disease.

For more information on scleroderma, please call the Scleroderma Foundation at 800/722-HOPE or the Scleroderma Research Foundation at 800/441-CURE.

About Connetics

Connetics Corporation, headquartered in Palo Alto, California, is a pharmaceutical company focused on late-stage product development and commercialization for dermatology and other specialty medical markets. For more information about Connetics or the Connetics relaxin development program, please visit Connetics' Web Site at, send e-mail to or call 888/969-CNCT.

This news release may contain forward-looking statements or predictions. These statements represent our judgement as of this date and are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed in such forward-looking statements. Potential risks and uncertainties include, without limitation, those associated with product development, clinical trials, future revenues and profitability, and obtaining marketing approval. These and other factors are discussed in more depth in Connetics' Form S-3 dated October 5, 1999 for the Company's recently completed public offering and in the Company's other filings with the SEC. These documents contain and identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.
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Publication:Business Wire
Date:Dec 20, 1999
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