RICHMOND, Va., Sep 24, 2004 (BUSINESS WIRE) -- Insmed Incorporated (Nasdaq:INSM) today announced the appointment of Kenneth Attie, M.D. as Medical Director. Dr. Attie, a highly regarded authority in the field of pediatric endocrinology and growth disorders, will lead Insmed's clinical team as the company continues to prepare upcoming regulatory filings and plans future clinical trials for its Phase III drug candidate, SomatoKine(R).
"We are delighted to add Ken to the Insmed team during this critical time as we prepare our NDA filing and advance additional indications through clinical trials. He has been intimately involved with the successful filing of multiple NDAs, and subsequent presentations and negotiations with the FDA. We will certainly rely on this extensive regulatory and clinical experience to assist us as we move forward," said Geoffrey Allan, Ph.D., President and Chief Executive Officer of Insmed. "Ken is also a primary author of several key publications regarding the therapeutic use of growth hormone, and played a key role in the development of Genentech's endocrine clinical program. We are very pleased that he has chosen to bring his expertise to Insmed to help us bring our IGF-I replacement therapy, SomatoKine(R), to market."
For over 10 years, Dr. Attie was a senior clinical scientist at Genentech (NYSE: DNA) where he played a crucial role in the development and commercial expansion of growth hormone. He was directly involved in the efforts that led to approval of growth hormone use in children with Turner syndrome and chronic renal insufficiency. Dr Attie has authored nearly 40 publications related to growth disorders, growth hormone deficiency in adults, and growth hormone insensitivity. He has also worked extensively on alternative delivery formulations of growth hormone.
"After working on the clinical development and commercialization of growth hormone while at Genentech, I am excited to be joining the Insmed team and to help further the development of SomatoKine for the safe replacement of IGF-I," stated Dr. Attie. "I believe Insmed's approach to delivering IGF-I with IGFBP-3 as a therapy for various indications will be a valuable and preferred addition to endocrine and metabolic medicine, and I am looking forward to advancing SomatoKine(R) through clinical development and into multiple commercial markets."
More on SomatoKine(R) (rhIGF-I/rhIGFBP-3)
Insmed's rhIGF-I/rhIGFBP-3 is a proprietary delivery composition of insulin-like growth factor-I (IGF-I). The novel compound is administered as a subcutaneous injection, which can restore IGF levels to physiological relevant levels. rhIGF-I/rhIGFBP-3 is currently in a pivotal Phase III clinical trial for the treatment of Growth Hormone Insensitivity Syndrome (GHIS).On July 20, Insmed provided the results from a six-month data analysis of the ongoing pivotal Phase III GHIS clinical trial showing a statistically significant increase (p
About Insmed
Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.
Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding clinical trials and goals, our regulatory and business strategies and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.
