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Italian Ministry of Health Requests IPLEX(TM) for Treatment of ALS (Lou Gehrig's Disease).


Insmed and Cephalon Ceph´a`lon

n. 1. (Zool.) The head.
 Sign License Agreement Allowing Insmed to Distribute under Cephalon Patent Rights

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
) has been requested by the Italian Ministry of Health, to make its drug, IPLEX[TM] (rhIGFI/rhIGFBP-3), available to physicians in Italy to treat patients with Amyotrophic Lateral Sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease,  (ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. ), also known as Lou Gehrig's Disease Lou Geh·rig's disease
n.
See amyotrophic lateral sclerosis.
.

The request comes as a result of several Italian Court rulings ordering the Italian National Health System to provide the drug to specific ALS patients who have petitioned the Court. Through an agreement with Cephalon, which holds European patent rights to IGF-1 pertaining to the treatment of ALS, Insmed will be able to provide IPLEX to physicians in Italy. IPLEX will be distributed through an expanded access program, with Insmed receiving payment for drug from the Italian Health Authorities.

ALS is a neurodegenerative disorder that causes progressive muscle weakness and loss of motor neurons. IGF-1 is a neurotrophic factor essential for normal development of the nervous system. In animal models and cell culture systems IGF-1 protects motor neurons and promotes muscle and nerve regeneration.

"We are very pleased that the Italian ministry has approached us to help in treating this devastating dev·as·tate  
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.

2. To overwhelm; confound; stun: was devastated by the rude remark.
 disease," said Geoffrey Allan, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Insmed. "We greatly appreciate the fact that Cephalon has collaborated with us in this effort. We hope that data collected from this expanded access program will be useful for the further clinical development of IPLEX for this indication," he added.

In Italy, there are an estimated 1000 new cases of ALS per year. The Ministry of Health has tried for several years to provide IGF-1 to these patients and in doing so has contacted several pharmaceutical companies worldwide.

"We are very pleased that Insmed responded to our request and are willing to provide IPLEX," said Carlo Tomino of the Italian Ministry of Health/AIFA.

About ALS

Amyotrophic lateral sclerosis (ALS), often referred to 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 par·a·lyze  
tr.v. par·a·lyzed, par·a·lyz·ing, par·a·lyz·es
1. To affect with paralysis; cause to be paralytic.

2. To make unable to move or act: paralyzed by fear.
. Yet, through it all, for the vast majority of people, their minds remain unaffected. While there is no cure or treatment today that halts or reverses ALS, there are several drugs in clinical trials that hold promise. The most recent study involving IGF-1is being conducted by Dr. Eric Sorenson, of the Mayo Medical Center, in Rochester, Minnesota.

About IPLEX[TM]

IPLEX is approved in the United States as 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). IPLEX (rhIGF-I/rhIGFBP-3), a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (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-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
). For more information about IPLEX please visit 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 Company's product plans. Such forward-looking statements are subject to numerous risks and uncertainties, including but not limited to the uncertainty of the ultimate outcome of any 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.
 with Tercica and Genentech, including litigation that resulted in a jury verdict finding that Insmed infringed three patents owned by Genentech and exclusively licensed by Tercica and awarding Genentech and Tercica past damages of $7.5 million dollars as an upfront payment and a royalty of 15% for past sales under $100 million and 20% for past sales over $100 million, 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 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.
 or other regulatory agencies may interpret the results of our studies differently than we have. We can give no assurances that we will be successful in overturning the jury verdict either at the district court or on appeal or in avoiding an injunction that Genentech and Tercica have requested to stop the manufacture and sale of IPLEX or in avoiding the enhancement of damages and award of attorney fees and costs that Genentech and Tercica have also indicated they will seek 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, or paying the damages awarded by the jury, as well as any enhanced damages or attorney's fees that may be awarded by the Court. We may also not be able to continue to operate should an injunction issue. 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Jan 10, 2007
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