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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.


RICHMOND, Va. -- Insmed, Inc (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: INSM INSM Initiative Neue Soziale Marktwirtschaft (German)
INSM Integrated Network and Systems Management
) today announced that investigators from the University of Cambridge, UK, will be presenting new results on the safety and efficacy of its insulin-like growth factor insulin-like growth factor

one of the twenty or so substances, additional to the classic bone-regulating hormones, which exert an effect on bone cell metabolism. See also somatomedin C.
 drug, IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection), in patients with severe insulin resistance syndromes at the annual meeting of the Endocrine Society in Boston, MA. This platform presentation will be given on Tuesday, June 27 at 11:30 a.m., Room 206 of the Boston Convention and Exhibit Center. The title of the talk is:

--rhIGF-1/rhIGFBP-3 Treatment of Patients with Severe Insulin Resistance Syndromes: Preliminary Data, Fiona Regan, Marc de Kerdanet, Mehul Dattani, Andreas Sommer Sommer is a surname, from the German and Danish word for the season "summer".

It may refer to:
  • Alfred Sommer (ophthalmologist) (born 1943), American academic
  • António de Sommer Champalimaud
  • Barbara Sommer (born 1948), German politician (CDU)
, Kenneth M Attie, David B Dunger. (ENDO ENDO Endometriosis  Abstract OR40-2)

Insmed also will be presenting additional data demonstrating the safety and efficacy of IPLEX on patients with severe IGF-I IGF-I

see somatomedin C.

IGF-I Insulin-like growth factor I, somatomedin-C A polypeptide hormone structurally similar to proinsulin, synthesized in the liver and fibroblasts, giving fibroblasts a paracrine function; serum levels correlate with
 deficiency. In addition, two posters will highlight the attributes of IPLEX's pharmacokinetic 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 and two podium presentations. We believe that IPLEX is a breakthrough drug that is showing very promising results in patients with severe insulin resistance. The preliminary data that will be presented at ENDO 2006 show that IPLEX may be beneficial for treating these patients, who are generally unresponsive to conventional therapies," remarked Kenneth M. Attie, M.D., Vice President, Medical Affairs, Insmed. "Additional data being presented supports the rationale for developing a unique dual protein therapeutic to closely mimic normal human physiology."

IPLEX is approved in the United States for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD).

About IPLEX

IPLEX is approved in the United States as the only once daily treatment for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD). IPLEX, a complex of recombinant human IGF-I and its binding protein IGFBP-3 (rhIGF-I/rhIGFBP-3), is the only FDA-approved IGF-I replacement therapy that also replaces deficient IGFBP-3 in these patients. The drug, which was launched in the second quarter of 2006, is also being investigated for various other indications with unmet medical needs, including severe insulin resistance, myotonic muscular dystrophy Noun 1. myotonic muscular dystrophy - a severe form of muscular dystrophy marked by generalized weakness and muscular wasting that affects the face and feet and hands and neck; difficult speech and difficulty with the hands that spreads to the arms and shoulders and  and HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  Associated Adipose adipose /ad·i·pose/ (ad´i-pos)
1. fatty.

2. the fat present in the cells of adipose tissue.


ad·i·pose
adj.
Of, relating to, or composed of animal fat; fatty.
 Redistribution Syndrome (HARS HARS Historical Aircraft Restoration Society
HARS HIV/AIDS Reporting System
HARS Historic Area Remediation Site
HARS Highway Advisory Radio System (public service announcements)
HARS High Altitude Route System
). For more information about IPLEX please go to www.go-IPLEX.com.

More on Severe Insulin Resistance

Syndromes of Severe Insulin Resistance appear to result from genetic defects in the insulin receptor or insulin action pathways. In addition to insulin resistance and glucose intolerance or overt diabetes, these syndromes share a number of common features including variable degrees of hyperandrogenism, hirsutism Hirsutism Definition

Excessive growth of facial or body hair in women is called hirsutism.
Description

Hirsutism is not a disease. The condition usually develops during puberty and becomes more pronounced as the years go by.
, and dysmorphic features. Individuals with Type A insulin resistance who develop frank diabetes require large doses (>200 units/day) of subcutaneous insulin, oral hypoglycaemic agents and insulin sensitizers and despite this intense regimen glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


glycemic

pertaining to the level of glucose in the blood.
 control remains poor and these patients are at high risk of the complications of diabetes, such as cardiovascular disease, nephropathy nephropathy /ne·phrop·a·thy/ (ne-frop´ah-the) disease of the kidneys.nephropath´ic

analgesic nephropathy
, retinopathy and neuropathy. Phase II clinical trials completed with IPLEX in patients with diabetes have shown improved glycemic control, improved insulin sensitivity as well as a reduction in daily insulin consumption. IPLEX has Orphan Drug Designation in both the United Sates and Europe for extreme insulin resistance.

About Insmed Incorporated

Insmed is a biopharmaceutical company focused on the development and commercialization of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com. The Company's leading product, IPLEX was approved as an orphan drug by the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our IPLEX utilization program, regulatory and business strategies, manufacturing capabilities, product costs, plans and objectives of management 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 launched, marketed, manufactured or reimbursed, we may lack financial resources to complete development of product candidates, the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 our 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 our 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Geographic Code:1USA
Date:Jun 22, 2006
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