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Insmed Obtains Patent Rights for Extreme Insulin Resistance From Fujisawa.

Business Editors/Health/Medical Writers


RICHMOND, Va.--(BUSINESS WIRE)--Jan. 26, 2004

Insmed Incorporated (Insmed) (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 Insmed has been granted a non-exclusive license to patent rights pertaining to the use of an 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.

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
) therapy for the treatment of extreme or severe insulin resistant diabetes from Fujisawa Pharmaceutical Co., Ltd. (Fujisawa). Under the terms of the agreement, Insmed will obtain worldwide rights in territories (excluding Japan) where a valid patent claim exists, including the United States and Europe. Financial terms were not disclosed.

Seiji Hashimoto, Ph.D., Director, Product Planning, Global Corporate Strategic Planning of Fujisawa stated, "Severe 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
 can be a life threatening and severely debilitating de·bil·i·tat·ing
Causing a loss of strength or energy.

Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 condition. We are pleased to be working with Insmed in their pursuit to address this worldwide unmet medical need. "

Geoffrey Allan, Ph.D., President and chief executive officer of Insmed commented, "Severe Insulin Resistance is a very important indication for Insmed. This licence is a significant strategic achievement for our company in our pursuit for an effective treatment of these severe diseases."

On December 15, 2003, Insmed announced it had received Orphan Drug Designation for SomatoKine(R), an IGF-I therapy, for the treatment of extreme insulin resistance. In human clinical studies in patients with extreme insulin resistance syndromes, IGF-I therapy effectively reduced blood glucose and enhanced insulin sensitivity (1, 2, 3).

1. Morrow LA, O'Brien MB, Moller DE, Flier JS, Moses AC.

Recombinant Human Insulin-Like Growth Factor-I Therapy

Improves Glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


pertaining to the level of glucose in the blood.
 Control and Insulin Action in the Type A

Syndrome of Severe Insulin Resistance. J Clin Endocrinol

Metab. 79: 205-210, 1994.

2. Kuzuya H, Matsuura N, Sakamoto M, Makino H, Sakamoto Y,

Kadowaki T, Suzuki Y, Kobayashi M, Akazawa Y, Nomura M,

Yoshimasa Y, Kasuga M, Goji K, Nagataki S, Oyasu H, Imura

H. Trial of Insulin-Like Growth Factor-I Therapy for

patients With Extreme Insulin Resistance Syndromes.

Diabetes. 42:696-705, 1993.

3. Nakae J, Kato M, Murashita M, Shinohara N, Tajima T,

Fujieda K. Long-Term Effect of Recombinant Human

Insulin-Like Growth Factor I on Metabolic and Growth

Control in a Patient with Leprechaunism. J Clin Endocrinol

Metab. 83:542-549, 1998.

More on rhIGF-I/rhIGFBP-3 (SomatoKine(R))

Insmed's rhIGF-I/rhIGFBP-3 is a proprietary delivery composition of insulin-like growth factor-I (IGF-I). The novel compound is administered as a once-daily subcutaneous injection, which can restore IGF (Internet Governance Forum) An international organization of governments and U.N. agencies that was founded to discuss Internet issues such as security and spam. It was created at the United Nations Summit in 2005 after the U.S.  levels to physiological relevant levels. In diabetic subjects, administration of rhIGF-I/rhIGFBP-3 demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use. Following severe burn injury, in both children and adults, administration of rhIGF-I/rhIGFBP-3 demonstrated a significant improvement in muscle protein synthesis and a significant reduction in the inflammatory response associated with the trauma. In recovery from hip fractures, administration of rhIGF-I/rhIGFBP-3 has demonstrated a significant improvement in functional recovery and bone mineral density bone mineral density
See bone density.

bone mineral density A measurement of bone mass, expressed as the amount of mineral–in grams divided by the area scanned in cm2. See Bone densitometry.
. rhIGF-I/rhIGFBP-3 is currently in a pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  for the treatment of Growth Hormone Insensitivity Syndrome growth hormone insensitivity syndrome Laron dwarfism, pituitary dwarfism II An AR condition characterized by severe growth retardation, delayed bone age, occasionally blue sclerae, and physical manifestations of GH deficiency, due to a defect in the GH receptor  (GHIS GHIS Growth Hormone Insensitivity Syndrome
GHIS Geosynchronous High-Resolution Interferometer Sounder
), a severe growth disorder.

About Insmed Incorporated

Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit

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 include all statements regarding expected financial position, results of operations, cash flows, dividends, financing plans, business strategies, operating efficiencies or synergies, budgets, capital and other expenditures, competitive positions, growth opportunities for existing or proposed products or services, plans and objectives of management, demand for new pharmaceutical products, market trends in the pharmaceutical business, inflation and various economic and business trends. 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 marketed, the company may lack financial resources to complete development of product candidates, 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 the company's 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.
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Publication:Business Wire
Geographic Code:1USA
Date:Jan 26, 2004
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