Re: Pirfenidone - importing from Japan

[Guest guest]

Cameron

I would call that number and I don't know Canadian laws to know if they

can legally send it to you at that point.

I have to caution that this has not made it through trials and shown

itself to benefit now to be free of serious side effects. Now, I know

its an educated chance you're considering and in some ways not a lot

different than prednisone in that you're ready to take something because

its the only thing there to choose from. However, you might want to

check your current levels vs. those they have used to test the product.

The Capacity tests, like the ones in Japan, have been conducted on

patients in very early stages.

Other drugs currently being tested in one way or another if you could

get prescribed off label would be Sildenafil and Bosentan. These are

both in trials for PF and are not proven to help but both have been used

for Pulmonary Hypertension so their side effects are well known and

documented.

>

> Hello everyone,

>

> I am new to the group. I was diagnosed in early 2006 with IPF. I have

tried the combination drug therapy but it didn't help. Prednisone caused

fluid build-up in my lungs.

>

> Question: does anyone have any information about getting Pirfenidone

from Shionogi in Japan?

>

> I want to try Pirfenidone to avoid a lung transplant. My FVC and

Diffusion rates both below 50% predicted and I am on O2 24/7.

>

> Since I have failed the standard treatment and there is no other, I am

quite confident my doctor and I can get approval from the Canadian

government under its " Special Access Program " to use Pirfenidone. The US

has a similar program but I don't recall what it is called.

>

> My problem is getting the Pirfenidone. InterMune told me they will not

sell or release any until their CAPACITY trial results are available in

2009. The InterMune person told me to contact Shionogi in Japan, but was

only able to give me a phone number.

>

> Before reinventing the wheel by calling them, I am hoping someone has

already successfully done this, and can tell me how to do it.

>

> Anyone know anything?

>

> Thanks.

>

> Cameron

>

[Guest guest]

Thanks Irene.

Subject: Re: Re: Pirfenidone - importing from JapanTo: Breathe-Support Date: Wednesday, July 30, 2008, 9:51 PM

Hi Cameron,

Welcome to the group! I have PF.

I'm not familiar with the drug Pirfenidone, I know our Canadian laws, are different, from the US and other countries. You need to check both laws (Canadian & Japan) especially if you're thinking of importing drugs into Canada from another country, which their laws are very strict....

I'm not sure if you need to check out from the pharmaceuticals companies, I'm including the websites for you to check out

(Japan)

http://search. myway.com/ search/GGmain. jhtml?PG= SEASUSH & SEC=ABMANY & psa=DNH7QO1DqIW. i.2WenTfcA & ptnrS=DC & st=kwd & searchfor=Pharmaceu ticals+Companies +in+Japan

Canada

http://search. myway.com/ search/GGmain. jhtml?st= kwd & ptnrS=DC & ss=sub & searchfor=Pharmaceu ticals+Companies +in+Canada

Shionogi Pharmaceuticals

http://search. myway.com/ search/GGmain. jhtml?qid= 7811DB6A5CA5A2A1 17BFDCC7EF8DD6B7 & pg=GGmain & ord=25 & action=click & searchfor=Shionogi+ Pharmaceuticals & tpr=jrel3 & p=GGmain & ss=sub & st=kwd & ptnrS=DC & ct=RR & cb=DC

Importing or Bringing Medication into Japan for Personal Use

http://tokyo. usembassy. gov/e/acs/ tacs-medimport. html

http://www.mhlw. go.jp/english/ topics/import/ index.html

All the Best in your research about importing Pirfenidone from Japan!

IrenePF 03/07 Raynaud's Disease 09/07Crohn's Disease 03/95 Asthma 02/92

Re: Pirfenidone - importing from Japan

CameronI would call that number and I don't know Canadian laws to know if theycan legally send it to you at that point.I have to caution that this has not made it through trials and shownitself to benefit now to be free of serious side effects. Now, I knowits an educated chance you're considering and in some ways not a lotdifferent than prednisone in that you're ready to take something becauseits the only thing there to choose from. However, you might want tocheck your current levels vs. those they have used to test the product.The Capacity tests, like the ones in Japan, have been conducted onpatients in very early stages.Other drugs currently being tested in one way or another if you couldget prescribed off label would be Sildenafil and Bosentan. These areboth in trials for PF and are not proven to help but both have been usedfor Pulmonary Hypertension so their side effects are

well known anddocumented.>> Hello everyone,>> I am new to the group. I was diagnosed in early 2006 with IPF. I havetried the combination drug therapy but it didn't help. Prednisone causedfluid build-up in my lungs.>> Question: does anyone have any information about getting Pirfenidonefrom Shionogi in Japan?>> I want to try Pirfenidone to avoid a lung transplant. My FVC andDiffusion rates both below 50% predicted and I am on O2 24/7.>> Since I have failed the standard treatment and there is no other, I amquite confident my doctor and I can get approval from the Canadiangovernment under its "Special Access Program" to use Pirfenidone. The UShas a similar program but I

don't recall what it is called.>> My problem is getting the Pirfenidone. InterMune told me they will notsell or release any until their CAPACITY trial results are available in2009. The InterMune person told me to contact Shionogi in Japan, but wasonly able to give me a phone number.>> Before reinventing the wheel by calling them, I am hoping someone hasalready successfully done this, and can tell me how to do it.>> Anyone know anything?>> Thanks.>> Cameron>

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[Guest guest]

Thanks Bruce.

Sildenafil looks promising as a way to aleviate symptoms, but there is no indication it will stop the progression of the disease. It seems to improve oxygen uptake, which can be a very good thing I would use it if I get to a point where the O2 is not enough and I don't yet have a transplant. One great potential side effect for me and my wife is that this drug is also known by another name: Viagra.

Bosentan, from what I have read, is quite an unknown at this point. The current studies are "early stages" and there is not a lot of hard evidence that it will be a successful drug. Perfenidone has had much more research and much more positive results in the trials conducted so far, both in the US (1999) and in Japan (2005 and the current Phase 3).

Cameron

Subject: Re: Pirfenidone - importing from JapanTo: Breathe-Support Date: Wednesday, July 30, 2008, 9:05 PM

CameronI would call that number and I don't know Canadian laws to know if theycan legally send it to you at that point.I have to caution that this has not made it through trials and shownitself to benefit now to be free of serious side effects. Now, I knowits an educated chance you're considering and in some ways not a lotdifferent than prednisone in that you're ready to take something becauseits the only thing there to choose from. However, you might want tocheck your current levels vs. those they have used to test the product.The Capacity tests, like the ones in Japan, have been conducted onpatients in very early stages.Other drugs currently being tested in one way or another if you couldget prescribed off label would be Sildenafil and Bosentan. These areboth in trials for PF and are not proven to help but both have been usedfor Pulmonary Hypertension so their side effects are

well known anddocumented.>> Hello everyone,>> I am new to the group. I was diagnosed in early 2006 with IPF. I havetried the combination drug therapy but it didn't help. Prednisone causedfluid build-up in my lungs.>> Question: does anyone have any information about getting Pirfenidonefrom Shionogi in Japan?>> I want to try Pirfenidone to avoid a lung transplant. My FVC andDiffusion rates both below 50% predicted and I am on O2 24/7.>> Since I have failed the standard treatment and there is no other, I amquite confident my doctor and I can get approval from the Canadiangovernment under its "Special Access Program" to use Pirfenidone. The UShas a similar program but I

don't recall what it is called.>> My problem is getting the Pirfenidone. InterMune told me they will notsell or release any until their CAPACITY trial results are available in2009. The InterMune person told me to contact Shionogi in Japan, but wasonly able to give me a phone number.>> Before reinventing the wheel by calling them, I am hoping someone hasalready successfully done this, and can tell me how to do it.>> Anyone know anything?>> Thanks.>> Cameron>

[Guest guest]

Cameron

To say any drug in trials has had positive results is unfortunately

investor relations talk and not scientifically based. Now, I'm hoping

pirfenidone will turn out positive but there is no result from the US

trials and no assumption can be made. As to the Japanese trials, many US

doctors dismiss the methodology of those studies and point to weaknesses

in them. Just please be careful of what you read from Intermune and

their releases. As to Sildenafil and Bosentan, their manufacturers have

chosen to wait until a product is either proven or not to make any

statements. Both are approved for PH and neither is proven for PF.

As to the Viagra side effect that is exactly how Viagra came to be. It

was a side effect found during trials. That was not what the medication

was originally developed for. However, once the side effect popped up,

Pfizer did realize there was much more money to be made on the side

effect than on the primary purpose.

Both Pirfenidone and Sildenafil were actually invented during the 90's

and have been tested for various conditions since then. Sildenafil was

first approved by the FDA in 98 for ED. It was approved for PH in 2005.

Pirfenidone has not been approved for the treatment of any condition.

Now, I'm not saying that if someone walked up and offered me Pirfenidone

today I wouldn't try it. I'm just trying to make it clear that the

evidence isn't in. Unfortunately, many other medications have made it to

Phase 3 and then killed. Unfortunately, Intermune, the manufacturer of

Pirfenidone, touted the last drug they had just as strongly in Phase 3.

> >

> > Hello everyone,

> >

> > I am new to the group. I was diagnosed in early 2006 with IPF. I

have

> tried the combination drug therapy but it didn't help. Prednisone

caused

> fluid build-up in my lungs.

> >

> > Question: does anyone have any information about getting Pirfenidone

> from Shionogi in Japan?

> >

> > I want to try Pirfenidone to avoid a lung transplant. My FVC and

> Diffusion rates both below 50% predicted and I am on O2 24/7.

> >

> > Since I have failed the standard treatment and there is no other, I

am

> quite confident my doctor and I can get approval from the Canadian

> government under its " Special Access Program " to use Pirfenidone. The

US

> has a similar program but I don't recall what it is called.

> >

> > My problem is getting the Pirfenidone. InterMune told me they will

not

> sell or release any until their CAPACITY trial results are available

in

> 2009. The InterMune person told me to contact Shionogi in Japan, but

was

> only able to give me a phone number.

> >

> > Before reinventing the wheel by calling them, I am hoping someone

has

> already successfully done this, and can tell me how to do it.

> >

> > Anyone know anything?

> >

> > Thanks.

> >

> > Cameron

> >

>

[Guest guest]

Bruce,

Everything in your email is consistent with what I have read.

Also, some scientists have pointed out that a) there could be a genetic difference between Japanese and Caucasian responses to Pirfenidone (or any drug), and the formulation used by Shionogi is slghtly different than the formulation used by InterMune. Why they would be using different formulas, I don't know.

Anyway, only time will tell if Pirfenidone helps me or anyone else.

Cameron

Subject: Re: Pirfenidone - importing from JapanTo: Breathe-Support Date: Thursday, July 31, 2008, 3:22 AM

CameronTo say any drug in trials has had positive results is unfortunatelyinvestor relations talk and not scientifically based. Now, I'm hopingpirfenidone will turn out positive but there is no result from the UStrials and no assumption can be made. As to the Japanese trials, many USdoctors dismiss the methodology of those studies and point to weaknessesin them. Just please be careful of what you read from Intermune andtheir releases. As to Sildenafil and Bosentan, their manufacturers havechosen to wait until a product is either proven or not to make anystatements. Both are approved for PH and neither is proven for PF.As to the Viagra side effect that is exactly how Viagra came to be. Itwas a side effect found during trials. That was not what the medicationwas originally developed for. However, once the side effect popped up,Pfizer did realize there was much more money to be made on the

sideeffect than on the primary purpose.Both Pirfenidone and Sildenafil were actually invented during the 90'sand have been tested for various conditions since then. Sildenafil wasfirst approved by the FDA in 98 for ED. It was approved for PH in 2005.Pirfenidone has not been approved for the treatment of any condition.Now, I'm not saying that if someone walked up and offered me Pirfenidonetoday I wouldn't try it. I'm just trying to make it clear that theevidence isn't in. Unfortunately, many other medications have made it toPhase 3 and then killed. Unfortunately, Intermune, the manufacturer ofPirfenidone, touted the last drug they had just as strongly in Phase 3.> >> > Hello everyone,> >> > I am new to the group. I was diagnosed in early 2006 with IPF. Ihave> tried the combination drug therapy but it didn't help. Prednisonecaused> fluid build-up in my lungs.> >> > Question: does anyone have any information about getting Pirfenidone> from Shionogi in Japan?>

>> > I want to try Pirfenidone to avoid a lung transplant. My FVC and> Diffusion rates both below 50% predicted and I am on O2 24/7.> >> > Since I have failed the standard treatment and there is no other, Iam> quite confident my doctor and I can get approval from the Canadian> government under its "Special Access Program" to use Pirfenidone. TheUS> has a similar program but I don't recall what it is called.> >> > My problem is getting the Pirfenidone. InterMune told me they willnot> sell or release any until their CAPACITY trial results are availablein> 2009. The InterMune person told me to contact Shionogi in Japan, butwas> only able to give me a phone number.> >> > Before reinventing the wheel by calling them, I am hoping someonehas> already successfully done this, and can tell me how to do

it.> >> > Anyone know anything?> >> > Thanks.> >> > Cameron> >>

[Guest guest]

Cameron

Note the Japanese trial was not Phase III but Phase II and only 107 patients and stopped at nine months. The selection of patients was quite random so that the groups were not controlled double blind. One last note relative to that trial:

Pirfenidone, however, was not without adverse effects; in fact, about half of the patients were taking a reduced dose at nine months due to side effects. The most common of these were photosensitivity, vomiting, fever, and hepatic dysfunction. Most of these symptoms disappeared once the medication was decreased or stopped.

Now, I'm not saying Pirfenidone does or doesn't work, just that we don't know now do we have real knowledge of side effects. I'm also saying that we do know more than enough to not trust any information released by Intermune.

> > >> > > Hello everyone,> > >> > > I am new to the group. I was diagnosed in early 2006 with IPF. I> have> > tried the combination drug therapy but it didn't help. Prednisone> caused> > fluid build-up in my lungs.> > >> > > Question: does anyone have any information about getting Pirfenidone> > from Shionogi in Japan?> > >> > > I want to try Pirfenidone to avoid a lung transplant. My FVC and> > Diffusion rates both below 50% predicted and I am on O2 24/7.> > >> > > Since I have failed the standard treatment and there is no other, I> am> > quite confident my doctor and I can get approval from the Canadian> > government under its "Special Access Program" to use Pirfenidone. The> US> > has a similar program but I don't recall what it is called.> > >> > > My problem is getting the Pirfenidone. InterMune told me they will> not> > sell or release any until their CAPACITY trial results are available> in> > 2009. The InterMune person told me to contact Shionogi in Japan, but> was> > only able to give me a phone number.> > >> > > Before reinventing the wheel by calling them, I am hoping someone> has> > already successfully done this, and can tell me how to do it.> > >> > > Anyone know anything?> > >> > > Thanks.> > >> > > Cameron> > >> >>

[Guest guest]

Cameron

One correction....the issue wasn't the randomization but the fact it was done before determining the eligible people. Doctors can better word it so here is a brief section of the scientific concern over the study:

First, selection of the subjects was clearly biased. Randomization occurred before identification of an eligible population. By excluding the 27 subjects who were unable to complete the six minute exercise test (6MET) at baseline, the investigators lost the benefits of randomization, including prevention of confounding (2). Second, using an unvalidated test (the 6MET) as a primary outcome limited the assessment of the intervention. More troubling from a methodologic view, however, was the differential assessment of the 6MET. Every subject had a walking speed "tailored to their comfort," ranging from 40 to 80 m/min, and was monitored for desaturation until a nadir SpO2 was reached. Clearly, the work required to reach a nadir while walking at a speed of 80 m/min is different from the work required to reach a nadir while walking at 40 m/min. Thus, even the trivial (but statistically significant) difference in lowest SpO2 attained in the subgroup analysis is questionable. Third, the early stopping of the trial was based upon adverse events in the placebo arm.

> > > >> > > > Hello everyone,> > > >> > > > I am new to the group. I was diagnosed in early 2006 with IPF. I> > have> > > tried the combination drug therapy but it didn't help. Prednisone> > caused> > > fluid build-up in my lungs.> > > >> > > > Question: does anyone have any information about getting> Pirfenidone> > > from Shionogi in Japan?> > > >> > > > I want to try Pirfenidone to avoid a lung transplant. My FVC and> > > Diffusion rates both below 50% predicted and I am on O2 24/7.> > > >> > > > Since I have failed the standard treatment and there is no other,> I> > am> > > quite confident my doctor and I can get approval from the Canadian> > > government under its "Special Access Program" to use Pirfenidone.> The> > US> > > has a similar program but I don't recall what it is called.> > > >> > > > My problem is getting the Pirfenidone. InterMune told me they will> > not> > > sell or release any until their CAPACITY trial results are available> > in> > > 2009. The InterMune person told me to contact Shionogi in Japan, but> > was> > > only able to give me a phone number.> > > >> > > > Before reinventing the wheel by calling them, I am hoping someone> > has> > > already successfully done this, and can tell me how to do it.> > > >> > > > Anyone know anything?> > > >> > > > Thanks.> > > >> > > > Cameron> > > >> > >> >>