Insmed Provides Update on IPLEX(TM) Launch; Company Shares Details on Payer Usage Program and Pricing.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 provided an update on the launch of IPLEX (mecasermin rinfabate (rDNA origin) injection) and the Company's payer Utilization Program for the treatment of patients with severe short stature Short stature refers to a height of a human being which is below expected. Shortness is a vague term without a precise definition and with significant relativity to context. associated with severe primary 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 (Primary IGFD). On May 23, 2006, Insmed announced the IPLEX Utilization Program to approximately 800 national payers as part of its comprehensive launch communications. In a letter to payers, Insmed informed them of the availability and pricing of IPLEX. Prominent in the announcement was a statement specifically detailing Insmed's pricing commitment to this market. Insmed proactively created the utilization program, and informed the payer universe that the annual charge for therapy is limited to actual milligrams prescribed and used. The utilization program assures that there is no charge for unused product remaining after the prescribed dose is extracted. Any remaining product discarded as waste is accounted for, and replaced by the company at no charge to the payer or patient, to assure that the payer or patient pays only for the amount dosed and administered. The utilization program, and other distribution activities, is managed by Insmed's single point of contact system, PlexPoint(TM). "Insmed is committed to the Primary IGFD market place. Everything we've done during launch was designed to increase patient access to this important once-a-day therapy," remarked Philip J. Young, Chief Business Officer. "We made the decision to bring IPLEX to the market as rapidly as possible after receiving 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. approval and Orphan Designation in December 2005. As part of our launch we proactively announced the IPLEX Utilization Program, the first of its kind in the industry, guaranteeing payers and patients they would only pay for IPLEX that is prescribed and used." Insmed is aware that price comparisons between the available IGF-I replacement therapies have been attempted. However, the company believes that it would be inappropriate to draw conclusions from unbalanced pricing comparisons as the assumptions are not based in fact, nor reinforced by market practices and physician prescribing trends. The therapeutic dose range for IPLEX is 1 mg/kg to 2 mg/kg taken once daily. A comparison using only the 2 mg/kg dose is inappropriate in light of the fact that the patients with the best growth response in the pivotal study, (efficacy which was similar to published studies with rhIGF-I), received approximately 1.4 mg/kg, once daily. "We believe we have a competitively priced product with an excellent safety and efficacy profile. We are pleased with how well the market is responding to IPLEX at this early stage and believe that the attributes of IPLEX will continue to prove attractive to prescribing physicians, payers and patients," Young added. Insmed is committed to this utilization program until the release of a shelf stable, multi-dose vial and delivery system, which is planned to be available in 2007. We believe our manufacturing facility in Boulder, Colorado The City of Boulder (, Mountain Time Zone) is a home rule municipality located in Boulder County, Colorado, United States. Boulder is the 11th most populous city in the State of Colorado, as well as the most populous city and the county provides us with the capability to manage the cost of IPLEX within a reasonable range while we continue the development of a new product formulation. The Insmed Sales and Managed Care teams are working to ensure that the target audiences are aware of the Utilization Program and the attributes of IPLEX therapy. Pricing for IPLEX, the only FDA approved once-daily IGF-I replacement therapy, is available on all of the standard pharmaceutical databases. Further information about IPLEX is available at www.go-IPLEX.com or by calling 1-866-go-IPLEX (1-866-464-7539). 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 orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the 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 growth hormone or somatotropin (sōmăt'ətrō`pən), glycoprotein hormone released by the anterior pituitary gland that is necessary for normal skeletal growth in humans (see protein). (GH) gene deletion who have developed neutralizing antibodies to GH. About IPLEX IPLEX, a complex of recombinant human IGF-I and its binding protein IGFBP-3 (rhIGF-I/rhIGFBP-3), is the only once-daily IGF-I replacement therapy. It is also the only FDA-approved therapy that provides both IGF-I and IGFBP-3 to treat children with severe primary IGFD. The drug which was launched in the second quarter of 2006, is also being investigated for various other indications with unmet medical needs, including extreme insulin resistance Insulin Resistance Definition Insulin resistance is not a disease as such but rather a state or condition in which a person's body tissues have a lowered level of response to insulin, a hormone secreted by the pancreas that helps to regulate the level , 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 ). About the Condition Severe primary IGFD is a genetic or acquired condition in which patients do not generate sufficient quantities of insulin-like growth factor-I (IGF-I) due to a defect in the growth hormone (GH) receptor/IGF-I pathway. Gene mutations leading to growth failure due to IGF-I deficiency have been identified in the growth hormone receptor Growth hormone receptor is a protein which acts as a receptor for somatotropin. Defects in the gene are associated with Laron syndrome. External links
Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 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. |
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