Re: Neuropharm Group Signs Collaboration Deal With Autism Speaks

[Guest guest]

Collaboration with Autism Speaks 05|07|07

NPL-2008 is Neuropharm's proprietary preparation of fluoxetine,

featuring autism-specific dosages in a melt-in-the-mouth formulation

designed specifically for those with autism. This new, rapidly

dissolving tablet benefits from the patented and proven Zydis® drug

delivery technology developed by Catalent Pharma Solutions (formerly

Cardinal Health Pharmaceutical Technologies).

The SOFIA trial, which is seeking to show a reduction in the core

symptomatology of autism, is a randomised, double-blind,

placebo-controlled trial comprising more than 100 children and

adolescents in approximately 12 centres throughout the US, where

NPL-2008 has Orphan Drug Designation. It is expected that the first

patients will be enrolled in Q3 2007 into the trial, which follows

positive results from an earlier single-centre Phase III study funded

by a grant from the US Food and Drug Administration's Office of Orphan

Product Development.

http://www.neuropharm.co.uk/pr_05_07_07.html

>

> Neuropharm Group Signs Collaboration Deal With Autism Speaks In

> Preparation For Planned Multi-centre Trial Of NPL-2008 [NHP.L]

>

> http://www.rttnews.com/sp/breakingnews.asp?item=37

>

> 7/5/2007 10:54:19 AM Neuropharm Group (NHP.L) announced that it has

> entered into a collaboration deal with the influential US charitable

> organisation Autism Speaks in preparation for a planned multi-centre

> trial of NPL-2008, its custom-designed product for the treatment of

> autism.

>

> The company stated that the deal, which gives it access to Autism

> Speaks' Clinical Trials Network of specialist paediatric centres and

> key opinion leaders, would expedite the enrolment of patients in this

> trial of NPL-2008, codenamed SOFIA. The company said, it would fund

> the trial and as per the terms of the deal, would fully reimburse

> Autism Speaks for its services.

>

> Mansfield, Neuropharm's Chief Executive Officer, said, " We are

> delighted to announce this collaboration with Autism Speaks and to be

> working with its established Clinical Trials Network. Our strategy is

> to work closely with patient organisations to maximise the

> effectiveness of our clinical programs and we are tremendously excited

> about the potential of NPL-2008. "

>

[Guest guest]

" Neuropharm believes that an estimated one million autistic patients

could potentially benefit from the use of fluoxetine. "

http://www.neuropharm.co.uk/pr_26_05_06.html

>

> Neuropharm Group Signs Collaboration Deal With Autism Speaks In

> Preparation For Planned Multi-centre Trial Of NPL-2008 [NHP.L]

>

> http://www.rttnews.com/sp/breakingnews.asp?item=37

>

> 7/5/2007 10:54:19 AM Neuropharm Group (NHP.L) announced that it has

> entered into a collaboration deal with the influential US charitable

> organisation Autism Speaks in preparation for a planned multi-centre

> trial of NPL-2008, its custom-designed product for the treatment of

> autism.

>

> The company stated that the deal, which gives it access to Autism

> Speaks' Clinical Trials Network of specialist paediatric centres and

> key opinion leaders, would expedite the enrolment of patients in this

> trial of NPL-2008, codenamed SOFIA. The company said, it would fund

> the trial and as per the terms of the deal, would fully reimburse

> Autism Speaks for its services.

>

> Mansfield, Neuropharm's Chief Executive Officer, said, " We are

> delighted to announce this collaboration with Autism Speaks and to be

> working with its established Clinical Trials Network. Our strategy is

> to work closely with patient organisations to maximise the

> effectiveness of our clinical programs and we are tremendously excited

> about the potential of NPL-2008. "

>

[Guest guest]

Whoo hoo! we are saved! Prozac for autism. We tried Prozac years

ago and it made him worse espically the tics.

> >

> > Neuropharm Group Signs Collaboration Deal With Autism Speaks In

> > Preparation For Planned Multi-centre Trial Of NPL-2008 [NHP.L]

> >

> > http://www.rttnews.com/sp/breakingnews.asp?item=37

> >

> > 7/5/2007 10:54:19 AM Neuropharm Group (NHP.L) announced that it

has

> > entered into a collaboration deal with the influential US

charitable

> > organisation Autism Speaks in preparation for a planned multi-

centre

> > trial of NPL-2008, its custom-designed product for the treatment

of

> > autism.

> >

> > The company stated that the deal, which gives it access to Autism

> > Speaks' Clinical Trials Network of specialist paediatric centres

and

> > key opinion leaders, would expedite the enrolment of patients in

this

> > trial of NPL-2008, codenamed SOFIA. The company said, it would

fund

> > the trial and as per the terms of the deal, would fully reimburse

> > Autism Speaks for its services.

> >

> > Mansfield, Neuropharm's Chief Executive Officer,

said, " We are

> > delighted to announce this collaboration with Autism Speaks and

to be

> > working with its established Clinical Trials Network. Our

strategy is

> > to work closely with patient organisations to maximise the

> > effectiveness of our clinical programs and we are tremendously

excited

> > about the potential of NPL-2008. "

> >

>

[Guest guest]

Some of this can be helpful when used in conjunction with other methods.

When it is used to the exclusion of all else, that is where problems may arise.

Neuropharm Group Signs Collaboration Deal With Autism Speaks

Neuropharm Group Signs Collaboration Deal With Autism Speaks InPreparation For Planned Multi-centre Trial Of NPL-2008 [NHP.L]http://www.rttnews.com/sp/breakingnews.asp?item=377/5/2007 10:54:19 AM Neuropharm Group (NHP.L) announced that it hasentered into a collaboration deal with the influential US charitableorganisation Autism Speaks in preparation for a planned multi-centretrial of NPL-2008, its custom-designed product for the treatment ofautism.The company stated that the deal, which gives it access to AutismSpeaks' Clinical Trials Network of specialist paediatric centres andkey opinion leaders, would expedite the enrolment of patients in thistrial of NPL-2008, codenamed SOFIA. The company said, it would fundthe trial and as per the terms of the deal, would fully reimburseAutism Speaks for its services. Mansfield, Neuropharm's Chief Executive Officer, said, "We aredelighted to announce this collaboration with Autism Speaks and to beworking with its established Clinical Trials Network. Our strategy isto work closely with patient organisations to maximise theeffectiveness of our clinical programs and we are tremendously excitedabout the potential of NPL-2008."

[Guest guest]

From flu shot to fluoxetine in one easy step.

About fifteen years ago, I was involved in a very interesting

project: helping a friend to mop up the blood from the floors, walls

and bathtub as a result of his wife being on Prozac for five weeks.

We had to use a ladder to clean the wall in the stairwell eighteen

feet above the ground floor. She survived and is apparently very

anti-pharma.

http://www.ssristories.com

http://www.breggin.com/bulletinprozac5.html

http://www.breggin.com/31-49.pdf

> >

> > Neuropharm Group Signs Collaboration Deal With Autism Speaks In

> > Preparation For Planned Multi-centre Trial Of NPL-2008 [NHP.L]

> >

> > http://www.rttnews.com/sp/breakingnews.asp?item=37

> >

> > 7/5/2007 10:54:19 AM Neuropharm Group (NHP.L) announced that it

has

> > entered into a collaboration deal with the influential US

charitable

> > organisation Autism Speaks in preparation for a planned multi-

centre

> > trial of NPL-2008, its custom-designed product for the treatment

of

> > autism.

> >

> > The company stated that the deal, which gives it access to Autism

> > Speaks' Clinical Trials Network of specialist paediatric centres

and

> > key opinion leaders, would expedite the enrolment of patients in

this

> > trial of NPL-2008, codenamed SOFIA. The company said, it would

fund

> > the trial and as per the terms of the deal, would fully reimburse

> > Autism Speaks for its services.

> >

> > Mansfield, Neuropharm's Chief Executive Officer,

said, " We are

> > delighted to announce this collaboration with Autism Speaks and

to be

> > working with its established Clinical Trials Network. Our

strategy is

> > to work closely with patient organisations to maximise the

> > effectiveness of our clinical programs and we are tremendously

excited

> > about the potential of NPL-2008. "

> >

>

[Guest guest]

Please tell me this is a joke!!!!!!

--- markautismcharge

<mark.connolly.cgb5@...> wrote:

> Whoo hoo! we are saved! Prozac for autism. We tried

> Prozac years

> ago and it made him worse espically the tics.

>

>

> > >

> > > Neuropharm Group Signs Collaboration Deal With

> Autism Speaks In

> > > Preparation For Planned Multi-centre Trial Of

> NPL-2008 [NHP.L]

> > >

> > >

> http://www.rttnews.com/sp/breakingnews.asp?item=37

> > >

> > > 7/5/2007 10:54:19 AM Neuropharm Group (NHP.L)

> announced that it

> has

> > > entered into a collaboration deal with the

> influential US

> charitable

> > > organisation Autism Speaks in preparation for a

> planned multi-

> centre

> > > trial of NPL-2008, its custom-designed product

> for the treatment

> of

> > > autism.

> > >

> > > The company stated that the deal, which gives it

> access to Autism

> > > Speaks' Clinical Trials Network of specialist

> paediatric centres

> and

> > > key opinion leaders, would expedite the

> enrolment of patients in

> this

> > > trial of NPL-2008, codenamed SOFIA. The company

> said, it would

> fund

> > > the trial and as per the terms of the deal,

> would fully reimburse

> > > Autism Speaks for its services.

> > >

> > > Mansfield, Neuropharm's Chief Executive

> Officer,

> said, " We are

> > > delighted to announce this collaboration with

> Autism Speaks and

> to be

> > > working with its established Clinical Trials

> Network. Our

> strategy is

> > > to work closely with patient organisations to

> maximise the

> > > effectiveness of our clinical programs and we

> are tremendously

> excited

> > > about the potential of NPL-2008. "

> > >

> >

>

>

>

________________________________________________________________________________\

____

Boardwalk for $500? In 2007? Ha! Play Monopoly Here and Now (it's updated for

today's economy) at Games.

http://get.games./proddesc?gamekey=monopolyherenow

[Guest guest]

I agree with you and also only a stop gap measure to help for some until

appropriate reseach is done into all causes. Hoepfully one day there

will not be a need for any of thse drugs.

Marty

>

> Some of this can be helpful when used in conjunction with other

methods.

>

> When it is used to the exclusion of all else, that is where problems

may arise.

>

>

> Neuropharm Group Signs Collaboration Deal With

Autism Speaks

>

>

> Neuropharm Group Signs Collaboration Deal With Autism Speaks In

> Preparation For Planned Multi-centre Trial Of NPL-2008 [NHP.L]

>

> http://www.rttnews.com/sp/breakingnews.asp?item=37

>

> 7/5/2007 10:54:19 AM Neuropharm Group (NHP.L) announced that it has

> entered into a collaboration deal with the influential US charitable

> organisation Autism Speaks in preparation for a planned multi-centre

> trial of NPL-2008, its custom-designed product for the treatment of

> autism.

>

> The company stated that the deal, which gives it access to Autism

> Speaks' Clinical Trials Network of specialist paediatric centres and

> key opinion leaders, would expedite the enrolment of patients in this

> trial of NPL-2008, codenamed SOFIA. The company said, it would fund

> the trial and as per the terms of the deal, would fully reimburse

> Autism Speaks for its services.

>

> Mansfield, Neuropharm's Chief Executive Officer, said, " We are

> delighted to announce this collaboration with Autism Speaks and to be

> working with its established Clinical Trials Network. Our strategy is

> to work closely with patient organisations to maximise the

> effectiveness of our clinical programs and we are tremendously excited

> about the potential of NPL-2008. "

>

[Guest guest]

Why is a pharma clinical trial even being advertised here? For reference, who

is " searchingforserenity111 " ?

Eichenberger

[Guest guest]

This clinical trial is NOT being "advertised" here. I believe most of us are appalled that Autism Speaks would choose to collaborate in such a trial. It was posted as "information" about what Autism Speaks is getting involved in. IMO, Aasatracy_eichenberger@... wrote: Why is a pharma clinical trial even being advertised here? For reference, who is "searchingforserenity111"? Eichenberger

[Guest guest]

Yes, precisely. It is exposing Autism Speaks for the big pharma front

that it is. This is just the beginning of the pharma drugs that will

be rolled out now that AS has " the system " in place. These are the

types of treatments that AS espouses as " biomedical treatments " .

An optimistic claim that the drug could benefit 1 million people is

very appealing to the pharmaceutical company's stock holders, as well.

FYI - I am a parent of a child with an ASD.

> Why is a pharma clinical trial even being advertised here?

For reference, who is " searchingforserenity111 " ?

>

> Eichenberger

>

[Guest guest]

This research, which actually may not be bad (or good) is precisely the reason AS has such a bad reputation.

If this were a minor study amidst larger studies on toxicity and immune dysfunction/dysregulation, people might not be so pissed off.

From a public relations perspective (regardless of the merits of the research), it is so typical of AS and why so many object.

In a larger regimen of therapeutic approaches, this may have its place, the fact that AS appears to be doing this research to the exclusion of other research lends further credence to the criticism of bias.

They need to get their shit together.

Re: Neuropharm Group Signs Collaboration Deal With Autism Speaks

Yes, precisely. It is exposing Autism Speaks for the big pharma frontthat it is. This is just the beginning of the pharma drugs that willbe rolled out now that AS has "the system" in place. These are thetypes of treatments that AS espouses as "biomedical treatments". An optimistic claim that the drug could benefit 1 million people isvery appealing to the pharmaceutical company's stock holders, as well.FYI - I am a parent of a child with an ASD. > Why is a pharma clinical trial even being advertised here?For reference, who is "searchingforserenity111"?> > Eichenberger>

[Guest guest]

Just a couple of observations.

1. I don't think Autism Speaks sees it necessarily a bad thing to be

a pharma front group, or perceived as being such a group. PHarma

sponsorships are readily found on the Autism Speaks million dollar

baby website. From their point of view, what's the big deal being

associated?

2. With the exception of apparently a few loud mouths on this list, I

don't think AS, just yet, has such a bad reputation in the community

as Henry mentioned.

So you want to raise awareness about the true purpose of AS? Who is

there on our side to back up your efforts? Despite thousands of

parents who use DAN! alternatives, nobody at DAN! or at ARI or at ASA

-- on their websites or in their newsletters -- has very much negative

to say about Autism Speaks. Perhaps there is good reason not to " go

negative " . Yet, the community needs to hear the truth somehow. What

to do? Who ya gonna call? Or do you?

Lenny

> Why is a pharma clinical trial even being advertised here?

For reference, who is " searchingforserenity111 " ?

>

> Eichenberger

>

[Guest guest]

Lenny, you're like a flag blowing in the wind. Which way is the wind

blowing today?? The only time you refer to people as " loud mouths "

is when they don't agree with you.

Loud mouths out there? *raises hand*

......and proud.

-- In EOHarm , " schaferatsprynet " <schafer@...> wrote:

>

>

> Just a couple of observations.

>

> 1. I don't think Autism Speaks sees it necessarily a bad thing to be

> a pharma front group, or perceived as being such a group. PHarma

> sponsorships are readily found on the Autism Speaks million dollar

> baby website. From their point of view, what's the big deal being

> associated?

>

> 2. With the exception of apparently a few loud mouths on this list, I

> don't think AS, just yet, has such a bad reputation in the community

> as Henry mentioned.

>

> So you want to raise awareness about the true purpose of AS? Who is

> there on our side to back up your efforts? Despite thousands of

> parents who use DAN! alternatives, nobody at DAN! or at ARI or at ASA

> -- on their websites or in their newsletters -- has very much negative

> to say about Autism Speaks. Perhaps there is good reason not to " go

> negative " . Yet, the community needs to hear the truth somehow. What

> to do? Who ya gonna call? Or do you?

>

> Lenny

>

>

>

> > Why is a pharma clinical trial even being advertised here?

> For reference, who is " searchingforserenity111 " ?

> >

> > Eichenberger

> >

>

[Guest guest]

But medications will be in a quick release delivery system like the

Listerine breath strips. They could even make each tablet into fun

shapes for the youngsters like the autism puzzle piece, the awareness

ribbon or even the shape of Bob s head. The possibilities are

endless.

> > > Why is a pharma clinical trial even being advertised here?

> > For reference, who is " searchingforserenity111 " ?

> > >

> > > Eichenberger

> > >

> >

>

[Guest guest]

LOL. I was actually thinking about this a few hours ago. I was

thinking that the drugs could be made into the shape of an umbrella

that everyone is supposed to be standing under with AS.

And who knows about future approved drugs for ASDs using other drug

delivery systems. Transdermal patches in the shape of the Train?

>

> But medications will be in a quick release delivery system like the

> Listerine breath strips. They could even make each tablet into fun

> shapes for the youngsters like the autism puzzle piece, the awareness

> ribbon or even the shape of Bob s head. The possibilities are

> endless.

>

[Guest guest]

Perhaps it will be a suppository so they can really stick our kids in

the ass......

, who has NOT had her evening cocktail....yet.

> >

> > But medications will be in a quick release delivery system like

the

> > Listerine breath strips. They could even make each tablet into fun

> > shapes for the youngsters like the autism puzzle piece, the

awareness

> > ribbon or even the shape of Bob s head. The possibilities

are

> > endless.

> >

>

[Guest guest]

" Why is a pharma clinical trial even being advertised here? "

It's called being aware of what's going on around you.

>

> Why is a pharma clinical trial even being advertised here? For

reference, who is " searchingforserenity111 " ?

>

>

> Eichenberger

>

[Guest guest]

Some people prefer the mushroom theory. (Oooo damn, there goes my

loud mouth again.)

> >

> > Why is a pharma clinical trial even being advertised here? For

> reference, who is " searchingforserenity111 " ?

> >

> >

> > Eichenberger

> >

>

[Guest guest]

> > > Why is a pharma clinical trial even being advertised here?

> > For reference, who is " searchingforserenity111 " ?

> > >

> > > Eichenberger

> > >

> >

>

[Guest guest]

You mean a Sponge Bob cherry flavored " fluox-let " like the

Risperdal " Quicklet " lozenge? ROTFL. Make sure it has a

gluten/dairy/soy base with a little melamine and aspartame.

>

> But medications will be in a quick release delivery system like the

> Listerine breath strips. They could even make each tablet into fun

> shapes for the youngsters like the autism puzzle piece, the awareness

> ribbon or even the shape of Bob s head. The possibilities are

> endless.

>

>

[Guest guest]

"Autism may be 80% genetically determined. The genetic basis of the

disorder is likely to involve several genes. Previous research has

implicated the gene coding for the serotonin transporter."http://www.neuropharm.co.uk/autism.htmlAnyone know where neuropharm pulled this number from? Does it start with an "a" and end with an "s"?> >> > But medications will be in a quick release delivery system like the> > Listerine breath strips. They could even make each tablet into fun> > shapes for the youngsters like the autism puzzle piece, the awareness> > ribbon or even the shape of Bob s head. The possibilities are> > endless.> > > >>

[Guest guest]

I'd go with NAA. I don't know their model, but I like what they're

doing as an org & I'd trust that they'd support good research.

Debi

>

> Who do we know organizationally that is willing to send both messages,

> comparing a better model of funding research than AS? So far, I

> haven't seen much already out there. I would like to see Autism United

> get off the ground. But they'll need a community willing to support

> their efforts.

>

>

> Lenny

>

>

[Guest guest]

I believe that AS was formed and takes the positions that they take in order to manage the potential breakdown in our public health system and medical institutions from a complete collapse in faith, the catalyst of which was the vaccine program which increased the number of vaccines containing highly toxic concentrations of mercury which was injected into neonates, the resulting damage which was caused on a generational scale by same and the ensuing circus which inevitably followed (and follows most government screwups), with which we presently deal.

At the same time, AS is trying to help.

As the establishment organization, AS must continue to support a medical model which, at least in significant part and likely in major part, works in contravention to what common sense and, in a broader context, good medical practice would support. To wit, you don't cure a disease or condition, which can be cured with the right intervention, by managing symptoms through pharmacological intervention. Pharmacological intervention has its place, its just that it should not be the be all, end all, that AS appears to have made it to the exclusion of all else. Their emphasis is misplaced. Clear evidence of that is the rift between the s. But the s' disagreement is also a significant disagreement/ongoing battle that pervades the medical community- allopathic intervention vs. alternative medicine.

I believe that members of AS (in their own minds) mean well, but operate within guidelines which are establishment guidelines (more historical than justifiable) and can only help to a certain point.

They have been excellent on awareness. A day doesn't go by when I don't see one of their commercials indicating the impact autism has on our society.

But they have fallen down elsewhere. They have fallen down primarily because of institutional bias which evolved from the historically changing biomedical understanding of autism from the purely absurd (refrigerator moms) to the somewhat correct, but rather limited, genetics model. And because of institutional bias, they are stuck there. If you look at the scientific expertise at AS, you see a lot of molecular biology and genetics, some psychology/psychiatry and some neurology. For dealing with a disease state or set of conditions which we now know is essentially immunogical in origin and nature. You also see a clear emphasis on allopathic technologies, to the apparent exclusion of alternative approaches, broadly reflecting medical bias in the country at large.

Given the history of the biomedical understanding of autism, it is perhaps not suprising that AS is where it is. It is also not surprising, given the nature of organizations and the incrementalism that naturally flows from those organizations, that an organization that evolved from an earlier understanding that has now experienced a paradigm shift, would be ill suited for dealing with the rapidly changing biomedical landscape.

Throw into that mix potential liability issues (donors), a threat to a fundamental tenet of public health approaches to treating/avoiding disease, and an emphasis by establishment medicine on exclusive allopathic remedies and you see that AS is not so far off from where it should be and what it is capable of being. Good on awareness, misinformed (because of the historical evolution of understanding) on biomedical issues, incapable of maximally responding because of ill suited scientific expertise and institutional bias and an adoption of allopathic pharmacological remedies to the exclusion of all else.

A mix of good and bad. A mix of competent and incompetent. But not evil.

The question is how/where do you go from here.

Can we trust the organization to change from within, to adapt to the changing landscape?

Or is the creation of alternatives a better approach.

Re: Neuropharm Group Signs Collaboration Deal With Autism Speaks

Lenny, you're like a flag blowing in the wind. Which way is the windblowing today?? The only time you refer to people as "loud mouths"is when they don't agree with you.Loud mouths out there? *raises hand*.....and proud.-- In EOHarm , "schaferatsprynet" <schafer@...> wrote:>> > Just a couple of observations.> > 1. I don't think Autism Speaks sees it necessarily a bad thing to be> a pharma front group, or perceived as being such a group. PHarma> sponsorships are readily found on the Autism Speaks million dollar> baby website. From their point of view, what's the big deal being> associated?> > 2. With the exception of apparently a few loud mouths on this list, I> don't think AS, just yet, has such a bad reputation in the community> as Henry mentioned. > > So you want to raise awareness about the true purpose of AS? Who is> there on our side to back up your efforts? Despite thousands of> parents who use DAN! alternatives, nobody at DAN! or at ARI or at ASA> -- on their websites or in their newsletters -- has very much negative> to say about Autism Speaks. Perhaps there is good reason not to "go> negative". Yet, the community needs to hear the truth somehow. What> to do? Who ya gonna call? Or do you?> > Lenny> > > > > Why is a pharma clinical trial even being advertised here?> For reference, who is "searchingforserenity111"?> > > > Eichenberger> >>

[Guest guest]

I written a piece today for The Rescue Post that discusses AS Treatment

Chair's long standing relationship with Neuropharm and his receiving

Orphan Drug Status for Prozoc back in 1999. It ties Harry Potter,

Dark Magic and AS together.

This announcement by AS about " SOFIA " (such a pretty name, almost makes

me want to have another baby girl) must be the his baby. Mazel tov....

Head over to www.rescuepost.com

KIM

[Guest guest]

The intersection of an Eli Lilly drug, prozac, and its putative use to treat autism and Lilly's involvement in thimerosal poisoning of children makes this testing ab initio extremely disturbing at best.

It is also the reason why AS is so heavily criticized as a Pharma front.

Do we know if Neuropharm is a sub of Eli Lilly or Lilly has substantial investment in Neuropharm?

That would be much, much worse.

Re: Neuropharm Group Signs Collaboration Deal With Autism Speaks

But medications will be in a quick release delivery system like theListerine breath strips. They could even make each tablet into funshapes for the youngsters like the autism puzzle piece, the awarenessribbon or even the shape of Bob s head. The possibilities areendless.> > > Why is a pharma clinical trial even being advertised here?> > For reference, who is "searchingforserenity111"?> > > > > > Eichenberger> > >> >>