IPLEX

IPLEX (mecasermin rinfabate [rDNA origin] injection) is a drug developed by INSMED corporation 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.

Due to a patent settlement, IPLEX is being taken off the market for shortstature related indications. However, IPLEX is being studied as a treatment for other several serious medical conditions.

Potential treatment of Myotonic Muscular Dystrophy
IPLEX is being investigated in a Phase II clinical study at the University of Rochester School of Medicine, with funding provided by the Muscular Dystrophy Association and the National Institutes of Health. This Phase II program is studying the safety and tolerability of once-daily, subcutaneous injection of IPLEX in patients with MMD. Initial data from this trial will be available in the second quarter of 2007.

Potential treatment of HIV-Associated Adipose Redistribution Syndrome
IPLEX is also being explored as a possible therapy for HIV- Associated Adipose Redistribution Syndrome (HARS). Data is being collected from a Phase II open-label clinical study directed by Morris Schambelan, M.D., a professor of medicine at University of California San Francisco. Dr Shambelan serves as Chief of Endocrinology and Director of the General Clinical Research Center at San Francisco General Hospital. This study is designed to evaluate the safety and efficacy of IPLEX treatment with the primary goal of determining the effects of IPLEX on visceral fat distribution and glucose and lipid metabolism. Initial data from this trial is to be available in 2007, with Phase III trials initiating in 2009.

Potential treatment of Retinopathy of Prematurity
Clinical work is at an earlier stage in the development of IPLEX to treat Retinopathy of Prematurity (ROP). This disease, affecting an estimated 14,000 to 16,000 premature infants each year, causes the lack of development of the small blood vessels in the back of the eye leading to blindness in the majority of cases. A Phase I clinical study investigating IPLEX as a treatment for ROP has been initiated at the University of Gothenburg in Sweden, in collaboration with scientists at the Harvard Medical School in the U.S. results of this study are expected by the end of 2007.

Potential treatment of ALS
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.

In January 2007, INSMED announced that the Italian Ministry of Health requested INSMED corporation to make IPLEX available to treat Italian patients sufferings from ALS.