Insmed Sues Tercica for False Advertising.RICHMOND, Va. -- Insmed Incorporated (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 ) announced today that it has sued Tercica, Inc. for allegedly false and misleading statements Tercica has made in advertising and promoting Increlex[TM], Tercica's Severe Primary IGFD treatment. In a counterclaim filed in the United States District Court for the Eastern District of Virginia The United States District Court for the Eastern District of Virginia is one of two United States district courts serving the Commonwealth of Virginia. History During the 1960s, Judge Albert V. Bryan Jr. , Insmed charges that Tercica has made numerous unlawful, false and misleading statements Increlex and/or IPLEX[TM], the only once daily treatment for children with short stature 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). At issue are statements made by Tercica that Insmed believes are likely to mislead customers into believing that Increlex is a superior choice in Primary IGFD treatments. Those statements include misrepresentations that Increlex is the most convenient, stable and easy-to-handle Primary IGFD treatment; false statements that IPLEX requires "special equipment" or "elaborate thawing" procedures; statements that falsely minimize concerns about the incidence of severe hypoglycaemia Noun 1. hypoglycaemia - abnormally low blood sugar usually resulting from excessive insulin or a poor diet hypoglycemia insulin reaction, insulin shock - hypoglycemia produced by excessive insulin in the system causing coma during treatment with an IGF-1 drug (in contrast to Tercica's admissions to 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. ); and unfair and misleading price comparisons, which misrepresent the relative costs of using Increlex and IPLEX. Insmed seeks an injunction barring Tercica from making these misrepresentations, an order compelling Tercica to recall its false advertisements and issue corrections, and an award of profits, damages, and attorney's fees and costs. Insmed's counterclaim is part of its response to false advertising claims that Tercica brought against Insmed in June. Portions of those claims were dismissed by the Court earlier this month. The matter is scheduled for trial in March. About IPLEX IPLEX is approved in the United States as the only once daily treatment for children with short stature associated 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). For more information about IPLEX please go to www.go-IPLEX.com. About Insmed Insmed is a biopharmaceutical company focused on the development and commercialization of drugs for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com. Forward Looking Statements Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for the 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 the pending litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and or future ability to conduct our business as now conducted and as it is currently proposed to be conducted. Such forward-looking statements are subject to numerous risks and uncertainties, including but not limited to the uncertainty of the outcome of any litigation with Tercica, the risk 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 or the FDA or other regulatory agencies may interpret the results of our studies differently than we have. We can give no assurances that we would be successful in any litigation or that such litigation would not have a material adverse effect on our business, financial condition and results of operation. Furthermore, we may not be able to afford the expense of defending against such a claim. 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. |
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