22.06.2006 12:04:00
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Insmed Endocrine Society 2006 Update; Insmed Will Report Efficacy of IPLEX(TM) in Patients with Severe Insulin Resistance; Company Also to Present Data on the Unique Pharmacokinetics of IPLEX
-- rhIGF-1/rhIGFBP-3 Treatment of Patients with Severe Insulin Resistance Syndromes: Preliminary Data, Fiona Regan, Marc de Kerdanet, Mehul Dattani, Andreas Sommer, Kenneth M Attie, David B Dunger. (ENDO Abstract OR40-2)
Insmed also will be presenting additional data demonstrating thesafety and efficacy of IPLEX on patients with severe IGF-I deficiency.In addition, two posters will highlight the attributes of IPLEX'spharmacokinetic profile. Studies to be presented include:
-- Once Daily rhIGF-1/rhIGFBP-3 Treatment Improves Growth in Children with Severe Primary IGF-I Deficiency: Results of a Multicenter Clinical Trial (ENDO Abstract OR40-1, Tuesday, June 27, 11:15 a.m., room 206, Boston Convention and Exhibit Center)
-- Subcutaneous Administration of rhIGF-1/rhIGFBP-3 in Healthy Adult Volunteers Does Not Result in Supraphysiological Concentrations of Free IGF-I (ENDO Abstract P1-192, Saturday June 24, 11 a.m., poster session, Boston Convention and Exhibit Center)
-- Pharmacokinetics of Single Dose Subcutaneous Administration of rhIGF-1/rhIGFBP-3 in Healthy Adult Volunteers (ENDO Abstract P1-191, Saturday, June 24, 11 a.m., poster session, Boston Convention and Exhibit Center)
"We are extremely pleased to be presenting data at two poster andtwo podium presentations. We believe that IPLEX is a breakthrough drugthat is showing very promising results in patients with severe insulinresistance. The preliminary data that will be presented at ENDO 2006show that IPLEX may be beneficial for treating these patients, who aregenerally unresponsive to conventional therapies," remarked Kenneth M.Attie, M.D., Vice President, Medical Affairs, Insmed. "Additional databeing presented supports the rationale for developing a unique dualprotein therapeutic to closely mimic normal human physiology."
IPLEX is approved in the United States for the treatment of growthfailure in children with severe primary IGF-I deficiency (PrimaryIGFD).
About IPLEX
IPLEX is approved in the United States as the only once dailytreatment for the treatment of growth failure in children with severeprimary IGF-I deficiency (Primary IGFD). IPLEX, a complex ofrecombinant human IGF-I and its binding protein IGFBP-3(rhIGF-I/rhIGFBP-3), is the only FDA-approved IGF-I replacementtherapy that also replaces deficient IGFBP-3 in these patients. Thedrug, which was launched in the second quarter of 2006, is also beinginvestigated for various other indications with unmet medical needs,including severe insulin resistance, myotonic muscular dystrophy andHIV Associated Adipose Redistribution Syndrome (HARS). For moreinformation about IPLEX please go to www.go-IPLEX.com.
More on Severe Insulin Resistance
Syndromes of Severe Insulin Resistance appear to result fromgenetic defects in the insulin receptor or insulin action pathways. Inaddition to insulin resistance and glucose intolerance or overtdiabetes, these syndromes share a number of common features includingvariable degrees of hyperandrogenism, hirsutism, and dysmorphicfeatures. Individuals with Type A insulin resistance who develop frankdiabetes require large doses (>200 units/day) of subcutaneous insulin,oral hypoglycaemic agents and insulin sensitizers and despite thisintense regimen glycemic control remains poor and these patients areat high risk of the complications of diabetes, such as cardiovasculardisease, nephropathy, retinopathy and neuropathy. Phase II clinicaltrials completed with IPLEX in patients with diabetes have shownimproved glycemic control, improved insulin sensitivity as well as areduction in daily insulin consumption. IPLEX has Orphan DrugDesignation in both the United Sates and Europe for extreme insulinresistance.
About Insmed Incorporated
Insmed is a biopharmaceutical company focused on the developmentand commercialization of drug candidates for the treatment ofmetabolic diseases and endocrine disorders with unmet medical needs.For more information, please visit www.insmed.com. The Company'sleading product, IPLEX was approved as an orphan drug by the UnitedStates Food and Drug Administration in December 2005 for the treatmentof growth failure in children with severe primary IGF-I deficiency(Primary IGFD) or with growth hormone (GH) gene deletion who havedeveloped neutralizing antibodies to GH.
Statements included within this press release, which are nothistorical in nature, may constitute forward-looking statements forpurposes of the safe harbor provided by the Private SecuritiesLitigation Reform Act of 1995. Forward-looking statements in thispress release include, but are not limited to, statements regardingour IPLEX utilization program, regulatory and business strategies,manufacturing capabilities, product costs, plans and objectives ofmanagement and growth opportunities for existing or proposed products.Such forward-looking statements are subject to numerous risks anduncertainties, including risks that product candidates may fail in theclinic or may not be successfully launched, marketed, manufactured orreimbursed, we may lack financial resources to complete development ofproduct candidates, the FDA may interpret the results of our studiesdifferently than we have, competing products may be more successful,demand for new pharmaceutical products may decrease, thebiopharmaceutical industry may experience negative market trends andother risks detailed from time to time in our filings with theSecurities and Exchange Commission. As a result of these and otherrisks and uncertainties, actual results may differ materially fromthose described in this press release. For further information withrespect to factors that could cause actual results to differ fromexpectations, reference is made to our reports filed by the Companywith the Securities and Exchange Commission under the SecuritiesExchange Act of 1934, as amended. The forward-looking statements madein this release are made only as of the date hereof and Insmeddisclaims any intention or responsibility for updating predictions orfinancial guidance contained in this release.
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