Insmed, Genentech, and Ipsen/Tercica issue statement about IPLEX for ALS
Tuesday November 18, 2008
The medication IPLEX (mecasermin rinfabate), manufactured by Insmed, has since January 2007 been used on an experimental basis in Italy to treat people with amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease), a neurodegenerative disease. On November 10, 2008, Insmed and its partners Genentech and Ipsen/Tercica issued a statement about making IPLEX available to people with ALS in other countries. The statement says in part: "Genentech, Ipsen/Tercica, and Insmed have been contacted by people living with Amyotrophic Lateral Sclerosis (ALS) and their loved ones seeking access to IPLEX™ . . . We understand the devastation a disease like ALS causes and that there are a lack of available therapies that provide meaningful clinical benefit. Although IPLEX™ has not been rigorously tested in people with ALS, nor received regulatory approval for use in ALS, all the companies involved appreciate the urgency and desperation for new treatments in the ALS community. We are all working diligently to determine how best to respond to that need.
The availability of IPLEX™ is subject to a Court-Ordered Settlement Agreement. On November 8, 2008, Genentech and Ipsen/Tercica signed a letter of intent whereby they have consented to amend the Court-Ordered Settlement Agreement to permit Insmed to supply IPLEX™ in connection with named-patient ALS programs worldwide on a royalty-free basis."
What it all means: Insmed is going to seek approval to use IPLEX in other countries based on the results of the treatment of people with ALS in Italy. The drug won't be free, but Genentech and Ipsen/Tercica won't collect royalties on it. IPLEX is the first drug of any kind to show effectiveness in reducing the symptoms of ALS.
Comments
Your wrong about not collecting royalties.
Insmed will receive revenue from the named patient program. From the Insmed 10Q:
We continue to provide IPLEX to named patients with amyloid lateral sclerosis (“ALS’) in Italy under our Expanded Access Program. We pay a royalty under our settlement agreement for all cost-recovery that we receive under the Expanded Access Program. (p.10)
and
Revenues for the third quarter ended September 30, 2008 were $4.1 million, up from $1.4 million for the corresponding period in 2007. The increase was primarily attributable to a $1.6 million increase in cost recovery revenue from our EAP to treat patients with ALS in Italy and the grant receipt of $1.0 million from the Muscular Dystrophy Association supporting the IPLEX™ Phase 2 Myotonic Muscular Dystrophy (“MMD”) trial.
The Veterans Administration (VA) announced on September 29, 2008 that it will treat veterans with ALS.
http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/11105
According to the New York Times, that means 416 new cases a year, an average of 700 veterans treated annually.
http://www.nytimes.com/2008/09/24/health/24disease.html?partner=rssnyt&emc=rss
Yeah, it just means Insmed won’t be PAYING royalties to the two other companies.
To this lady’s defense, she probably just mis-spoke.
IPLEX has the potential to be huge, in my opinion.
http://vfcsstockhouse.blogspot.com
You are correct, thanks for pointing out the typo–I fixed it in the post.
ALS really isn’t a “rare” disease–every year ALS strikes almost as many people as does MS. You do not meet many ALS pattients though because the disease kills so quickly (avg 3-5 years) that there are few of us living at any point in time. Also, the crippling paralysis means we don’t get out much.
A few ALS patients in the U.S. tried Iplex for a few weeks before the court order–they’ve reported significant improvement. Three years ago I was a software developer and an amature athlete, now I can barely type, have trouble breathing and the likelihood of being alive when my daughter graduates high school in 1-1/2 years is doubtful. Iplex is our hope to once again be contributing members of society instead of paralyzed cripples.
Anyone ever heard of Chyluria? It is a very rare kidney disease common in Asia but rare in the U.S. I live in GA and was diagnosed with chyluria after eight months of going to several different doctors. One morning I got up and could not use the bathroom, when I did my pee was white, like milk. Yea….wierd! Doctors told me everthing from it was depression(seriously) to an unidentified bacteria. Finally I was referred to Emery University in Atlanta, GA. Didn’t find out much. In Asian countries it is usually due to filarysis, caused from a mosquito bite and eggs travel through the blood stream and hatch in the lymph nodes. In the U.S. it is caused by chronic inflammatory diseases, trauma and a few other things. There is no cure for it the only treatment is a low fat diet and believe me, I follow a low fat diet if I don’t I pay for it. Fat collects in my bladder and I pass it through my urine. That is why the urine is white. I would like to know if there is anyone out there who knows about this disease or anyone who has it. In 2004 when I was diagnosed, according to the research I did there were only eight cases in the U.S.