IPLEX for the rest of the world?

[rocmg]

This in earlier today... is it cause for excitement? trying to keep everything in check here...

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INSMED WILL CONTINUE TO MANAGE ALS EAP IN ITALY AND ALL IPLEX(TM) INITIATIVES IN THE U.S.

IDIS WILL HAVE RESPONSIBILITY FOR REST OF WORLD

RICHMOND, Va., March 30 /PRNewswire-FirstCall/ -- Insmed Inc. (NASDAQ: INSM) , a biopharmaceutical company, today announced the signing of an agreement with IDIS, a private, UK-based company specializing in the management of medicines on a named patient basis, also known as expanded access programs (EAPs) or named patient programs (NPPs), to manage such programs for the investigational drug IPLEX(TM) worldwide, excluding the U.S. and Italy. An EAP or NPP provides drug developers across the world with a legal and ethical way to make medicines available, where appropriate, in response to requests made by physicians, when those medicines are not yet approved in their country.

Under the agreement, Insmed will continue to be responsible for the IPLEX(TM) EAP for Amyotrophic Lateral Sclerosis (ALS) in Italy, as well as all IPLEX(TM)-related activities in the U.S., while IDIS will assume responsibility for the management of IPLEX(TM) for all other EAPs/NPPs worldwide. IDIS is expected to initiate the management of these EAPs/NPPs during the second quarter of 2009, and will be responsible for prescription, product and pharmacovigilance management.

"This agreement reflects Insmed's deep commitment to providing IPLEX(TM) to patients that are suffering from debilitating diseases, such as Amyotrophic Lateral Sclerosis, and have no other medical options," said Dr. Geoffrey Allan, President and CEO of Insmed. "IDIS is a world leader in the management of named patient programs, has significant knowledge of the various unique healthcare systems internationally and is the ideal partner to ensure that patients have appropriate access to IPLEX(TM)."

"We are pleased to be working with Insmed in order to expand access to IPLEX(TM), a drug that has shown significant potential in multiple important therapeutic categories," said John Lagus, Vice President of Business Development for IDIS.

About IPLEX(TM)

IPLEX(TM) was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency (Primary IGFD). IPLEX(TM) rhIGF-I/rhIGFBP-3), is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also being investigated for various other indications with unmet medical needs.

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein development experience and a proprietary protein platform aimed at niche markets with unmet medical needs.

About IDIS

IDIS is the world leader in the development and implementation of Named Patient Programs and has a proven track record of working in strategic partnership with U.S.-based companies to bring new medicines to Europe for the first time. IDIS supports its customers in over 100 countries worldwide, supplying more than 400 different medicines per month and responding to more than half a million requests on a named-patient basis to medical professionals worldwide. Headquartered near central London, IDIS has been a strategic partner to more than 40 pharmaceutical and biotech companies.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that closing conditions under our agreement with Merck & Co., Inc. may not be met, product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop IPLEX(TM) may be unsuccessful our common stock could be delisted from the Nasdaq Capital Market and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

 

[rocmg]

ah! perhaps i was jumping the gun a little here? for some reason i thought that this was evidence that IPLEX was going to be made available in other countries in the world. That the patent dispute had been sorted out basically and that they were going to allow another pharmaceutical group to manage similar expanded access programs worldwide.

looks like i was wrong?

 

[brendapals]

wow- lots of reading, hoping someone can put all of this in simpler terms maybe?...

 

[rocmg]

i don't know why... i assumed people would be more excited by this... perhaps IPLEX is just a flash in the pan afterall?

from my understanding, the implication is that ismed will continue to supply IPLEX to US and Italy, whereas a British company will now supply to the rest of the world -- those who specifically request the use of IPLEX and are granted the right to do so by a physician (as part of expanded access programs, similar to the one that the right to use IPLEX in the US was recently granted under.)

More opportunities for PALS to try IPLEX assuming they can get a doctor to get them on to one of these "expanded access" programs. the details of how, when and where to get involved in the expanded access programs might be the real news. my neuro seems to think it might be a bit of a commercial venture for persons involved... which took the fizz out of my sails until i realized people have been &^**ing other people over for centuries to make money, why should the situation be any different for PALS.

 

[SavoringLife]

We spoke to our neuro about this and he quite vehemently declined to support Iplex for a variety of reasons, most notably that he doesn't approve of INSMED's business practices, so absolutely will not allow it in his clinic. Does anyone know of any neuro's who are willing to prescribe Iplex as part of a potential Expended Access Program? As with a lot of other PALS, we are pretty much willing to try anything that much offer some relief.

 

[Al]

One of my Neuro's thinks this could be another Lithium type fiasco where initially it sounds promising but on digging deeper it turns out to be more hype than substance. Strange that they both come out of Italy. I"m trying not to be negative here but just going on what I've read and heard.

AL.

 

[hopingforcure]

My Neuro basically said what Al's said, that it was a growth hormone, just packaged different. I have been researching and waiting for it, and was so excited about the FDA passing of compassionate use. Some people will be starting it, and some in a lottery type fda trial will then get acess. Andrea, Cals for Jim was instrumental in getting this this to happen, Jim has since passed, and will not get to take part in the trial.. I pray that those who get it have a miracle, and it works... Not counting on it though. It is a very exspensive medicine.. Hope they give it to the pals for free or a huge discount. I believe it to be five thousand or more a month..

 

[joelc]

I read volumes about this and everything I read, once you get past the hype, says it does not work. So I guess I am agreeing with what Al and hopingforcure have just written. Also, to get in on the trials you have to be almost unaffected by ALS which excludes most of us!

 

[SavoringLife]

Thanks for the feedback. We have also read mixed things about Iplex. Is there anyone out there who is taking it as part of the initial compassionate use approval? Would be interesting to hear from them and see their response.

 

[clewbcg]

Pals getting iplex on Monday

I just posted on another thread, but wanted to reply to your question. my pals is starting on iplex on Monday as part of the compassionate use. he signed up for it before the march deadline and is getting it for very low cost through his respiratory doctor. his neuro was not big on it and isn't getting involved. I'm worried that this is another lithium type bust that will just get his hopes up for nothing and might have bad side effects.

 

[rocmg]

clew -- i've said this before, but frustrated PALS are being forced to play a game of Russian Roulette where experimental new treatments are concerned.

"hope" means different things to different people -- hope for some is that the medical establishment has a major breakthrough in treatment, hope for others lies in the fight, the risk-taking... to tell someone to shut up and stop taking risks might be every bit as harmful as taking an experimental drug. if you take away the fight, the possibility, you take away the hope and maybe even the will and desire to live.

there's simply no way of knowing. everyone is different and everyone has the right to do what they wish at the end of the day. i doubt you will find anyone here who will tell you it was the right decision to try iplex, but you and your PALS made a personal choice. all i can say is i sincerely hope it works out for you. really and truly.

be skeptical, be realistic, but don't allow anyone to steal away your hope.

 

[Markbreton]

rocmq - Well said!
Mark

 

[clewbcg]

update on iplex use

I posted on another iplex thread as well, but wanted to update on my pals. He has been on iplex several weeks now, and no improvement. Sorry-but wanted to let people know. We did the lithium as well(no improvement), and I realize that people are frustrated about the difficulty getting iplex. I wish I could say that there has been a big change, but my pals has gotten worse since he started taking iplex. Not blaming the iplex, but I don't think it is doing anything to slow things down either. We have a six month supply so I guess we'll keep going. My poor pals has bruises from the injections. I'm pretty good at shots, but he still seems to bruise. Not much left to put the needle into. Has anyone else been on iplex?

 

[SavoringLife]

Clew, thank you so much for the update. As everyone else, we are desperate to hear any news -- whether good or bad -- on possible treatments. My PALS started Ceftriaxone last week, but went off it today as his liver enzymes were too high.