Tuesday, March 13, 2007

INDESTRUCTIBLE WINS BEST DOCUMENTARY AT CINEQUEST FILM FESTIVAL!
CHOCOLATE SUPREME!
Ben and Rebeccah received a standing ovation Sunday evening from an audience of nearly a thousand people when the announcement was made that INDESTRUCTIBLE had won. Truly a most delectable event in all of our lives. (For more about the Awards Ceremony, see previous post.)

BURNT!
JUST THREE WEEKS AGO, BEN STARTED ON A NEW MEDICATION, WHILE CONTINUING ON BUNAOGAO, THAT IMPROVED HIS SYMPTOMS EVEN AT AN INITIAL REDUCED DOSAGE. THE SAME DAY OF INDESTRUCTIBLE’S PREMIERE, WE LEARNED THE DRUG WILL NO LONGER BE AVAILABLE. PLEASE READ THE PRESS RELEASE BELOW TO LEARN SPECIFIC DETAILS OF THIS UNCONSCIONABLE ACTION. PLEASE CONTACT ANYONE YOU KNOW WHO CAN BE OF HELP TO STOP THIS CALLOUS ACTION AND GET THE DRUG INTO THE HANDS OF THOSE WHO NEED IT TODAY!


FOR IMMEDIATE RELEASE

BACKGROUND: ALS (Lou Gehrig’s Disease), an always fatal neurological disease, has been untreatable for 150 years and claims the lives of more than 6000 persons each year in the US alone. It is equally prevalent in most other countries. Through networking, several dozen ALS patients have recently started using Iplex off-label. Iplex is a growth hormone developed and FDA-approved for children with severe growth stature syndrome associated with IGF-1 (primary growth hormone) deficiency. Recently published test studies also show IGF-1 deficiency among persons with ALS.

IPLEX: Developed by Insmed Incorporated, Richmond, VA. Delivers positive benefits for ALS, HIV-AIDS, Myotonic muscular dystrophy, fractured hip, severe short stature syndrome and burn victims.

INCRELEX: Developed by Tercica, Inc, Brisbane, CA. Provides inferior or non-existent benefits for the conditions listed above.

THE PROBLEM: Insmed lost a law suit to Tercica in Dec, 2006 for patent infringement and, in a recent settlement to avoid further litigation, has withdrawn IPlex from the market. Tercica claims its product Increlex, is exactly the same as IPlex. Not so. Tercica has already acknowledged they forced the removal of IPlex from the market to give their (inferior) Increlex a better sales opportunity. Both Insmed and Tercica press releases are contradictory (to one another) and therefore untruthful and in violation of SEC regulations. Each company states they are willing and/or able to distribute Iplex to ALS and other markets, but both companies refuse to do so (citing the settlement agreement).

THE FACTS: Increlex is NOT the same as IPlex in the following ways: IPlex is IGF-1 with a binding protein IGF-3 that helps deliver the needed IGF-1 to muscles most damaged, achieves results more rapidly, allows for higher dosages without adverse side effects, and requires only one injection daily. Increlex is a new name of an old product, Myotrophin (developed by Genentech and licensed to Tercica), that contains only IGF-1 and has been tested repeatedly over the last 10 years with no positive results. It is “free” IGF-1, does not attach to muscles most in need, does not deliver rapid results, allows only for limited dosages without adverse side effects, and requires 2 injections daily.

THE EVIDENCE: Clinical test studies demonstrated the superiority of IPlex over the less effective Increlex for severe short stature syndrome and Myotonic muscular dystrophy (per recently completed University of Rochester test study). Physicians have been regularly converting their severe growth stature syndrome patients from Increlex to Iplex (until it was withdrawn under the agreement forced on Insmed by Tercica). Empirical data and anecdotal evidence not yet published both in Italy and US clearly suggests that IPlex will benefit the following conditions: ALS, HIV-AIDS, severe burn, fractured hip. Benefits shown for ALS patients (even under low dosage, short-term usage of IPlex) include increased limb strength, respiration capacity, chewing, swallowing, musculature, functional strength.

THE SOLUTION: Tercica and/or Insmed should provide IPlex to those who desperately need the medication immediately, even though the cost was up to $9500 per month for adults before IPlex was withdrawn. Patients already on IPlex were told to destroy what they had left or return it to the company.

Begin immediately an open-label clinical test trial of IPlex for those with ALS and HIV-AIDS on a “compassionate use” basis. Supply IPlex free of charge for those who participate.

Examine those patients who have used Iplex for ALS to confirm initial results if necessary.

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

For Additional Information or to Offer Ideas and Suggestions Contact:

Stephen Byer
Patient Advocate for Rare and Orphan Diseases
bsbyer@mhtc.net
608-698-4200

3 comments:

Anonymous said...

I wish everyone would call and let both Insmed and Tricicia know that this is not about making a buck but about helping, and saving lives....great post..

Anonymous said...

Sooner than later iPLEX will be available to everyone who needs it !

Anonymous said...

Insmed is not the bad guy here. They tried to negotiate over and over with Tercica, but Tercica, backed by GENENTECH wanted to crush them and get Insmed's surperior drug out of their way so they could make more money.

Iplex is being shown, in clinical trials in Italy, to definately benefit ALS patients greatly.

Write the FDA, write your congressman and write Insmed. Tercica will NOT help you at all. Patients of this terrible disease have rights!