Iplex

September 11, 2008

DePaul University College of Law

RE: URGENT APPEAL: Legal Assistance to the Disadvantaged legal aid/pro bono programs etc.

Re: Class-action lawsuit
Dean of the Law School

ALS

I am writing to you in hopes of bringing awareness to this insidious disease, as well as this insidious travesty of justice, perpetuated on People/patients with ALS (PALS). The Iplex saga is an excellent case study of how a dysfunctional political and economic system can stop the quest for knowledge dead in its tracks
There are approximately 35,000 people living with this disease in the U.S. Most have a life span of 2-5 years .At present; there is absolutely nothing that can be done for people with ALS except to treat their symptoms. Rilutek, the only FDA approved drug for ALS does absolutely nothing for symptoms, and possibly might help extend life by a mere 2-3 months, yes months. ALS is fast and cruel in its progression; it literally devastates the patient, devastates the family, and finally devastates the family's finances.

Every year, between 6000-7000 peoples are diagnosed with ALS (Lou Gehrig's disease) That may seem like a small number, unless of course you are one of the 7000, or a love one of those people. It is an awful disease that robs people of strength in their extremities and then relentlessly marches toward the center of the body, eventually causing paralysis of the throat muscles and diaphragm. There is no cure or a treatment, once diagnosed, the patient is essentially handed a death sentence.

Hope

With the arrival of Iplex, a drug, which was launched in the second quarter of 2006, there followed a number of very respectable studies (across the country/world) which went on to confirm efficacy in slowing down progression in ALS. As these very encouraging research results/data were being released to the public, PALS across the world were given reason for hope. Yet while these very encouraging studies have indeed given PALS great reason for hope, this hope is at present, lying just beyond our grasp.

The lawsuit

In the briefest possible summation, Iplex is a drug manufactured by Insmed. Iplex essentially is an improved version of a drug called Increlex, which is manufactured by Genentech/Tercica. Iplex has indeed been shown to reduce muscle atrophy. Iplex is IGF1 (insulin like growth factor) with a binding protein (BP3). The Binding protein is what gives IPLEX the added effect. It allows for higher dosing, greater specificity of action, and longer circulation in the blood stream. This is all well documented

Genentech/Tercica took Insmed to court, for patent infringement; the case was settled on March 7, 2007. The settlement winner Tercica shortly thereafter, began the process of having Iplex pulled off the market and replacing it with their own much inferior product Increlex, which has repeatedly failed to show efficacy in numerous clinical trials across the country.

The Italians

Almost two years ago years ago, Italian ALS patients sued Insmed and were successfully granted ‘Expanded Access to Iplex’’. They are being supported by the Italian government which is financing this program, providing millions of Euros each year for their patients’ medication. Therefore as a result of several Italian Court rulings ordering the Italian National Health System to provide the drug to 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/supply 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.
Although not a formal clinical trial, early reports have confirmed Iplex to be showing efficacy, in slowing the progression of ALS for their Italians patients. It's already being called a cure for Myotonic Muscular Dystrophy, (which is yet another muscle wasting disease.) Almost all of the respectable Italian medical journals have concurred the reason behind choosing Iplex over Increlex or any of the other IGF products that are lacking the very much needed binding protein (BP3) to be effective.

The Dilemma

Due to a patent infringement lawsuit, corporate greed, politics etc., Iplex has been taken off the market in the United States and is thus no longer available to any ALS patients in the United States. Because Italian ALS patients sued Insmed and were successfully granted ‘Expanded Access to Iplex’’ Iplex can now only be sold in Italy. While the Italian data is still being gathered from the Iplex studies, (expanded access program) ALS populations around the world desperately wait for validation . But even if this data reflects the best possible scenario, we will still be left with the fact that Insmed can not (per settlement with Genetech/Terricica) legally distribute/sell Iplex as a treatment for ALS anywhere but Italy.

Because the Italians forced Insmed's hand (Lawsuit), Iplex was made available to Italian patients with ALS under an expanded access program. To date over 100 Italian patients are enrolled in this trial, and according to recent updates, and none of the patients have dropped out and or stopped the drug. An educated guess suggests that Iplex is working. Any time a request for Iplex is made of Insmed their official response is that there is a suitable alternative available in the form of Increlex, manufactured by their competitor, and the victorious party in their lawsuit, Genentech.

Over the past 7 years, Increlex and various other drugs using different names but with similar chemical properties, have tested and repeatedly failed to halt disease progression in ALS. Genentech/Tercica has been especially determined to prove their drug Increlex works, but study after study has proven it does not help. In fact, Increlex has just failed yet another trial as a therapy against ALS in clinical testing. This is just another form of corporate deception masking the greed of the pharmaceutical industry. Meanwhile, the clock keeps ticking, and people are needlessly dying. While the pharmacy giants fulfill their obligations to their shareholders and their own pocketbooks, We (PALS) sit by wondering which one of us is next.

With regards to INSMED'S reasons for providing this drug to the Italians I have some suspicions as to their motivation... The fact that they seem to have no concrete plan to gather data and present it as a basis for the promotion of a formal trial smacks of a stall job to try and keep the income rolling in until they can develop their new business plans.

The Plea

At this point, Insmed holds our (PALS) fate in their hands. Instead of denying myself and my dying friends/comrades hope, they could, and morally should, provide Iplex to all PALS on an emergency use, individual basis. As stated previously, Insmed has repeatedly declined all requests to assist, patients/people living with ALS, in providing this life-saving drug.
Insmed could offer hope and life to me and to the 35,000 people courageously dying of this horrific disease today. I implore of Insmed, to do the right thing. I implore of the United States government or any body with power and influence, to intervene in this absurd patent fight, to give hope/ life to our dying brotherhood.

Earlier I explained what ALS is doing to us physically, but what people can't really see is the devastating impact the disease has on our families, and our financial situation. We all want to be able to watch our children graduate from college. We all want to be able to walk to our daughters down the aisle on their wedding days. We all want to grow old with our spouses and enjoy some golden years playing with our grandchildren. But to do any of these, we need the powers that be at Genentech/ Tercica/ Insmed to come to their moral senses and release this life-saving treatment. Up till the creation of Iplex there were absolutely no treatments, no cure, and absolutely no hope. I truly believe that Iplex greatly improves my chances in the fight against this monster disease. I don’t have time to wait.

I hope that I have given you a good/ better understanding of why Iplex is so important to people like me. It is also my hope that you will view this from my perspective – it may be a matter of policy for you, but it’s a matter of life and death for me.
The Mission/ Request

As part of an international group of ALS patients and their caregivers, who are on a quest (win, lose, or draw) to access Iplex, we have exhausted all means, to appeal to (Tercica/ Insmed's) moral sensibilities to no avail. The Italian government has successfully sued and won access to Iplex for their citizens. At this point we've tried everything (except litigation); therefore we would like to petitioned your help in this David versus Goliath battle, of corporate profits versus human life. Iplex has shown great promise in slowing ALS, yet is out of our reach due to a patent infringement suit

We have contacted your firm/law school and requested that you evaluate whether you will undertake this matter (represent us in this class-action lawsuit) that we wish to pursue against (Tercica/ Insmed). We will provide you with any and all sensitive documents that we have it our possession, web sites, etc. Our hope is that you and your staff, after reviewing all heard the documentation, will be able to consider the urgency in this matter, and thus represent us in this matter

In the event that we are fortunate enough to retain your services to represent our international group of patients/people with ALS, we hope you will understand that as a direct result of the ravaging effects that this disease has had on our employment/ financial status most of us are presently on very fix incomes. Therefore it would be extremely hard, (almost impossible) for any of us to pay standard legal fees. What we are essentially looking for is lawyers and or law students that could possibly offer services through Legal Assistance to the Disadvantaged legal aid/pro bono programs etc., law firms and other legal entities interested in providing free legal representation.

The passage of time may bar us from pursuing whatever, if any, claim we may have against (Tercica/ Insmed). Because time is always important, and could be critically short in our case, could you find it in the kindness of your heart to expedite your decision back to us as soon as possible? If declining to undertake this matter, we respectfully thank you for your time. With that said, we would like to express that we feel RIGHT IS ON OUR SIDE and if a complaint is filed, we (PALS) will eventually prevail. But as you now know, time is short for people/patients with ALS.

It is our hope that you will listen to our story and that you and your staff take time to investigate the matter further. We are taking this one day at a time, but feel trepidation about what awaits us. Close your eyes and picture yourself in our shoes. Please help us bring this travesty of justice to the forefront and at least secure a treatment so that we can hold out till someone finds a cure. Please Help Us.

Edward W. Esparza
4248 North Atlantic
Schiller Park 60176

847-678-1874
847-530-1477-cell phone
e.esparza@comcast.net

Please also see our web pages http://give-us-iplex.blog.com/3741691/#cmts and http://als.over-blog.de/ lose.

This is one of many researchers that put together a power point showing the benefit of IGF and IPLEX, with the improved benefit of IPLEX in myotonic muscular dystrophy. This is the first I have been able to find of actual findings out of the MMD trials. This researcher also believes, per her power point, that IPLEX can be of therapeutic value to ALS patients; amongst others... this is a good link...

http://www.parentprojectmd.org/site/DocServer/barton_igf-1_2006.pdf?docID=1 246

7:23 am PDT, Aug 20, Name not displayed, Maryland
In the interest of full disclosure, I am an Insmed stockholder. It should be noted that Insmed has no legal limitations on its ability to market and sell Iplex. They simply choose not to so that they will not have to pay the steep royalties. Insmed and TRCA/Ipsen BOTH need to come to their senses and reach a deal that will allow ALS sufferers to at least try this treatment off-label


1) The patients seeking Iplex placed a legal challenge to gain access to Iplex for their usage. No one has proposed any attempt to have a trial as that is not what they want, they just want the drug.

2) There are 100 patients who are currently receiving this drug who are reporting similar results that are being monitored by over 22 Doctors/ Neurologists.

3) The fact that each person has to individually apply every 12 months (the program has been running for nearly 2 years) to continue access to the drug proves that there must be a therapeutic value in the drug as they have all (that's 100 patient) been granted continued use.

4) Genentech/Tercica are in a legal stalemate due to argument over who owns the patent of the drug which means who actually owns it that’s why there has been a hold on it's release, this includes the release for any potential trials, so if no one can get it then no one can trial it, get it?


Although a double-blind clinical trial is ideal, a non-blinded trial is also possible if the data is strong enough.
As to the binding protein as it pertains to changing the effect of IGF-1.

It has been reported to:

1. Reduce the hypoglycemic effect
2. Allow for a larger dose with fewer side effects
3. Allow for a longer active phase of the IGF-1 in the body. Something on the order of many hours as opposed to minutes.
4. Potentially help the IGF-1 to cross the Blood Brain Barrier.