Healthcare Industry News: Auxilium Pharmaceuticals
News Release - June 12, 2006
Data Presented at American Diabetes Association Annual Meeting Suggest Testosterone Levels Correlate with Insulin Resistance and Insulin Sensitivity in Type 2 Diabetes PatientsFindings from this analysis of diabetic patients call for more research to evaluate benefits of testosterone replacement therapy in Type 2 diabetes patients
MALVERN, Pa., June 12 (HSMN NewsFeed) -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL ), a specialty pharmaceutical company, announced that new findings presented today at the American Diabetes Association's 66th Annual Scientific Sessions suggest that abnormally low testosterone levels may be linked to progression of Type 2 diabetes. The data are obtained from patient screening for a prospective study and include 568 men with Type 2 diabetes. Researchers found a general increase in insulin resistance in patients with Type 2 diabetes who have low total testosterone levels, compared to Type 2 diabetes patients with normal total testosterone levels. Recent studies have highlighted the potential importance of androgen concentrations in relation to insulin sensitivity. This latest cohort analysis provides evidence of the need for additional investigation into the effects that testosterone replacement therapy has on insulin resistance, glucose regulation and progression of Type 2 diabetes. Data were presented today in a poster titled, "Comparison of Indices of Insulin Resistance and Insulin Secretion between Hypogonadal and Non-Hypogonadal Type II Diabetic Patients" (Abstract #606-P), at the American Diabetes Association's 66th Annual Scientific Sessions in Washington, DC. The study was sponsored by Auxilium Pharmaceuticals, Inc.
The objective of the analysis was to characterize possible differences in insulin resistance (IR) and insulin secretion (IS) between hypogonadal (total testosterone < 300 ng/dL) and non-hypogonadal Type 2 diabetic participants. Of the subjects in the analysis, 252 (44.4%) were classified as hypogonadal and 316 subjects (55.6%) were classified non-hypogonadal. The homeostatic model assessment (HOMA) method was used in this study to assess beta cell function and insulin resistance from basal (fasting) glucose and insulin or C-peptide concentrations. The HOMA IR for hypogonadal subjects was 7.6 and 5.1 for the non-hypogonadal subjects (P < 0.0001). The HOMA IS was 113.3 and 93.3 for hypogonadal and non-hypogonadal subjects, respectively (P = 0.018). The comparison of these index values suggests a generalized increase in insulin resistance in Type 2 diabetes patients with low total testosterone levels.
"Given that insulin resistance is an important indicator for diabetes progression and a common cause of mortality in diabetic patients, these findings naturally raise the question of the effect that testosterone supplementation has on insulin resistance and whether it may help counter the progression of Type 2 diabetes," said Marc S. Rendell, M.D., Creighton Diabetes Center, an Investigator in this study. "Our data suggest that it is important to assess testosterone levels in male patients with diabetes and to treat low levels as part of the overall plan of therapy"
Testosterone is an androgen hormone that is primarily responsible for normal growth and development of male sex organs. The normal range for total testosterone in men is generally 300 to 1,000 nanograms per deciliter (ng/dL), depending on the lab performing the test and the methodology used.
A decrease in testosterone production, when testosterone levels drop below the normal range, is known medically as hypogonadism. A simple blood test conducted by a physician can determine if a man has low testosterone.
Researchers are accumulating clinical evidence that links low testosterone levels to long-term medical conditions such as metabolic syndrome, Type 2 diabetes, coronary heart disease, osteoporosis and depression. Additionally, studies have shown that men who suffer from obesity, diabetes or hypertension may be twice as likely to have low testosterone levels. Several published studies have shown the beneficial effects on men's health by normalizing testosterone levels with testosterone replacement therapy.
About Auxilium Pharmaceuticals
Auxilium Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on developing and marketing products for urology, sexual health and other indications within specialty markets. Auxilium markets Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 130-person sales and marketing team. Auxilium has five projects in clinical development. Auxilium believes that AA4500, an injectable enzyme, has completed Phase II of development for the treatment of Dupuytren's Disease and is in Phase II of development for the treatment of Peyronie's Disease and Frozen Shoulder Syndrome (Adhesive Capsulitis). Auxilium's testosterone replacement transmucosal film product candidate for the treatment of hypogonadism (AA2600) has commenced Phase III of development and should commence pivotal Phase III trials later in the second quarter. Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in Phase I of development. Auxilium has two pain products using its transmucosal film delivery system in pre-clinical development. Auxilium has rights to six additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system, options to all indications using AA4500 for non-topical formulations, and other products for urology and sexual health. For additional information, visit http://www.auxilium.com .
Safe Harbor Statement
This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the results of the prospective study and the timing for the commencement of various clinical trials for Auxilium's product candidates during 2006, if at all, and products in development for pain, urology and sexual health. All statements other than statements of historical facts contained in this release, including but not limited to, statements regarding future expectations, plans and prospects for the Company, statements regarding forward-looking financial information and other statements containing the words "believe," "may," "could," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," and similar expressions, as they relate to the Company, constitute forward-looking statements. Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in the Company's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2006 under the heading "Risk Factors", which is on file with the Securities and Exchange Commission (the "SEC") and may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "Investor Relations - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.
In addition, forward-looking statements provide the Company's expectations, plans or forecasts of future events and views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's assessments as of any date subsequent to the date of this release.
Source: Auxilium Pharmaceuticals
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