Insmed Receives European Orphan Drug Designation for SomatoKine
2004-10-25 18:01 (New York)
for the
Treatment of Extreme Insulin Resistance;
Company to Initiate Clinial Trial in Type A Insulin Resistance
RICHMOND, Va., Oct. 25 /PRNewswire-FirstCall/ -- Insmed Incorporated
(Nasdaq: INSM) today announced that the Committee for Orphan Medicinal
Products of the European Agency for the Evaluation of Medicinal Products
(EMEA) has approved the Company's application for orphan drug designation in
Europe for SomatoKine(R), for the treatment of extreme insulin resistance. In
December 2003, Insmed reported that the Office of Orphan Products Development
of the Food and Drug Administration has approved the Company's application for
orphan drug designation in the United States for SomatoKine(R), for the
treatment of extreme insulin resistance. The European orphan drug designation
may provide Insmed ten years of market exclusivity in Europe upon
SomatoKine(R) approval for this indication. The United States orphan drug
designation may provide Insmed seven years of market exclusivity upon
SomatoKine(R) approval for this indication. There is currently no approved
treatment available for patients with extreme insulin resistance in Europe or
the United States. Insmed plans to initiate a Phase II clinical trial in
patients with Type A insulin resistance later this year.
Efficacy of SomatoKine in an Extreme Insulin Resistant Patient:
In September Insmed reported on results from a nine-month analysis of
therapy with SomatoKine(R) (rhIGF-I/rhIGFBP-3) (mecasermin rinfibate) for a
patient with Leprechaunism, the most extreme form of insulin resistance. The
nine-month analysis demonstrated substantial improvements in growth, metabolic
control, and neurological development. Of significant importance, the patient
surpassed the average expected life-span for Leprechaunism, and continues to
receive therapy to date.
More on Extreme Insulin Resistance
Syndromes of Extreme 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, and dysmorphic features.
More on rhIGF-I/rhIGFBP-3, SomatoKine(R)
Insmed's SomatoKine(R) is a proprietary delivery composition of insulin-
like growth factor-I (IGF-I). The novel compound is administered as a
subcutaneous injection, which can restore IGF levels to physiological relevant
levels. SomatoKine(R) is currently in a pivotal Phase III clinical trial for
the treatment of Growth Hormone Insensitivity Syndrome (GHIS). On July 20,
Insmed provided the results from a six-month data analysis of the ongoing
pivotal Phase III GHIS clinical trial showing a statistically significant
increase (p<0.0001) in height velocity in children receiving SomatoKine(R) as
a once-daily injection. In diabetic subjects, administration of SomatoKine(R)
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 SomatoKine(R) 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 SomatoKine(R) has demonstrated
a significant improvement in functional recovery and bone mineral density
About Insmed
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 insmed.com. |
