Negotiated settlement between Insmed Corporation and Tercica(and Tercica's associated licensing companies Genentech and Cephalon) has devastating impact on ALS Patients worldwide. Iplex, (an IGF-1 medication with an IGF-3 binding protein component), produced by Insmed, has been taken off the market. This drug, given by injection once daily, is the first to show benefit for ALS, HIV-Aids, Myotonic Muscular Dystrophy and burn victims. Because of a patent infringement, the settlement winner Tercica, is pulling all Iplex off the market and replacing it with their own inferior product, Increlex, which offers little or no benefit for these patients. Even at an astronomical cost to patients, ( $9500 a month) the demand is great, the supply unavailable. In fact, Tercica is recommending that all remaining supplies be destroyed rather than providing it to those in dire need. The bottom line is money over life-the obvious 21st century mantra for the pharmaceutical industry.

Increlex is IGF-1 only and the protein is distributed throughout the body and does not attach to the muscles affected by ALS or other conditions. Consequently more of it must be administered (twice a day injections) and less of it is delivered to the areas most in need. By contrast, Iplex (IGF-1 with binding protein IGF-3) attaches to the muscles most needing IGF-1 and is delivered far more rapidly (requiring one injection daily).

Increlex is the same drug as its earlier incarnation, Myotrophin, which showed limited success, if any, for ALS. That is the drug now being tested (again) at Mayo Clinic in Rochester and has been tested on again/off again for 13 years. It fails for the reason stated above.

There is clear evidence from previously completed clinical test studies demonstrating the superiority of Iplex over the less effective Increlex for severe short stature syndrome. There is clear and overwhelming evidence of the ability of Iplex to benefit those with Myotonic Muscular Dystrophy per the recently completed University of Rochester test study. There is no evidence yet published to suggest that Tercica's lesser product Increlex will benefit any of these conditions: ALS, HIV-AIDS, severe burn, fractured hip, Myotonic Muscular Dystrophy. And there is clear evidence that Increlex is less capable than Iplex for those with severe short stature syndrome.

We need your help in placing pressure upon Tercica to stop ignoring requests for Iplex, begin distribution immediately and continue to provide the Iplex product to the ALS and other communities who have already experienced positive affects.


INSMED Contact:
Administrative office
Phone: 804-565-3000, Fax: 804-565-3500
Ronald Gunn, Chief Operating Officer
Dr Kenneth Attie, Medical Affairs
Dr Geoffrey Allan, President, CEO

TERCICA Contact:
Administrative Office 866-837-2422
Dr. George Bright, Pediatric Endocrinologist
Dr. Sandra Blethen, Pediatric Endocrinologist
Thorsten von Stein, Senior VP, CMO
Fredik Wiklund, Investor Relations/Media
John Scarlett, President, CEO
_________________

Thelma,

I could say nothing here and you would still know that I sympathize with the people in this situation 100%. This is a sick person's worst nightmare and I'm living it personally. As more evidence emerges of the importance of GDNF, it remains unavailable. I wonder if any of the people involved in this deal have ever met a person with ALS?

paula

I hope everyone who visits this message board will call today. We must stand united with the ALS community.

TERCICA Contact:
Administrative Office 866-837-2422
Dr. George Bright, Pediatric Endocrinologist
Dr. Sandra Blethen, Pediatric Endocrinologist
Thorsten von Stein, Senior VP, CMO
Fredik Wiklund, Investor Relations/Media
John Scarlett, President, CEO

fredrik.wiklund@tercica.com
650-624-4992




thank you, Thelma

Jean B

RICHMOND, Va.--(BUSINESS WIRE)--Insmed Incorporated (NASDAQ: INSM) has been requested by the Italian Ministry of Health, to make its drug, IPLEX™ (rhIGFI/rhIGFBP-3), available to physicians in Italy to treat patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease.

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 disease,” said Geoffrey Allan, President and CEO 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.

http://www.equitygroups.com/nasd/ins...ges/95493.html

john.scarlett@tercica.com
sandra.blethen@tercica.com
george.bright@tercica.com

All,

There is no evidence yet published to suggest that Tercica's product Increlex will benefit any of these conditions: ALS, HIV-AIDS, severe burn, fractured hip, Myotonic Muscular Dystrophy.

PLEASE stop ignoring requests for Iplex, begin distribution immediately and continue to provide the Iplex product to the ALS and other communities who have already experienced positive affects.

Thank you,

Jean B

I just finished a clinical trial out of the University of Rochester. I have myotonic dystrophy and found great success using IPLEX. My terrible gastro-intestinal problems disappeared, my fatigue decreased, the myotonia effecting my face and hands decreased as well. I had no side effects whatsoever.

According to Dr. Moxley, none of the other test patients had side effects, and most found great benefits, including increased focus, strength and decrease in depression.

I've been attempting to find any way to continue using IPLEX. There is no other treatment for MMD. My sister has a congential form and I'm certain Iplex could help her. My father has a severe form of the disease and won't leave his house because of his horrible gasto-intestinal problems and of course his loss of almost all muscle tone in his body.

Fortunately for me, I haven't been severely effected yet, and I hoped to keep it that way, possibly even improve and Iplex gave me great hope. This news is devastating to me and my family. Please, anything anyone can do to keep this drug from being destroyed or taken off the market would be so much appreciated.

B. Pratt

Thanks Jean,

I just e-mailed them!

Faye

A Iplex Availability Advocacy Group is currently bing formed to pursue all avenues to make Iplex available to those who so badly need it it.

If you are interested in this group, contact me at my email address.

Norske

Jean,

I just emailed them too.

I'll spread the word through the grass-roots organizations such as Care2 Petition Site by starting a petition.

www.thepetitionsite.com

If Jean doesn't mind, I'll copy her letter because it suits the purpose greatly.

John

Dear John,

Thank you!