CuraGen Gets FDA Orphan Drug Designation For Kidney Drug (IGA Nephropathy)

[Guest guest]

Not sure if this has been posted before. They even use the

word " prevent " .

http://money.excite.com/jsp/nw/nwdt_rt.jsp?

section=news & cat=INDUSTRY & feed=dji & news_id=dji-

00085420041111 & date=20041111

CuraGen Gets FDA Orphan Drug Designation For Kidney Drug

Thursday November 11, 11:26 AM EST

NEW HAVEN, Conn. (Dow )--CuraGen Corp. (CRGN) said the U.S.

Food and Drug Administration granted orphan drug designation for

CuraGen's drug candidate used to potentially slow or prevent kidney

failure in patients affected by IgA nephropathy.

Currently, there is no FDA approved treatment of IgA nephropathy, a

kidney disorder that occurs in childhood and young adulthood. The

disease affects as many as 130,000 patients annually in the U.S.

In a press release Thursday, the genomics-based pharmaceutical

company said the orphan drug designation for CR002 typically results

in seven years of U.S. market exclusivity once approved by the FDA.

Other incentives provided by orphan designation include tax credits,

protocol assistance and eligibility for research and development

support.

The FDA's orphan drug program is intended to encourage research,

development and approval of products for diseases that affect fewer

than 200,000 patients a year in the U.S., provide a significant

therapeutic advantage over existing treatments or address an unmet

medical need.

CR002 will be evaluated in a Phase I trial to determine its safety

and tolerability, and what the body does with the drug.

CuraGen had 2003 revenue of $6.9 nillion.

[Guest guest]

Hi,

Thanks for sending this! Sounded interesting, although absent more

information, I'm reluctant to read too much into it without knowing more

about the drug. I don't know a whole lot about the orphan drug designation.

Cy

CuraGen Gets FDA Orphan Drug Designation For Kidney Drug

(IGA Nephropathy)

>

>

> Not sure if this has been posted before. They even use the

> word " prevent " .

>

> http://money.excite.com/jsp/nw/nwdt_rt.jsp?

> section=news & cat=INDUSTRY & feed=dji & news_id=dji-

> 00085420041111 & date=20041111

>

>

> CuraGen Gets FDA Orphan Drug Designation For Kidney Drug

>

> Thursday November 11, 11:26 AM EST

>

> NEW HAVEN, Conn. (Dow )--CuraGen Corp. (CRGN) said the U.S.

> Food and Drug Administration granted orphan drug designation for

> CuraGen's drug candidate used to potentially slow or prevent kidney

> failure in patients affected by IgA nephropathy.

>

> Currently, there is no FDA approved treatment of IgA nephropathy, a

> kidney disorder that occurs in childhood and young adulthood. The

> disease affects as many as 130,000 patients annually in the U.S.

>

> In a press release Thursday, the genomics-based pharmaceutical

> company said the orphan drug designation for CR002 typically results

> in seven years of U.S. market exclusivity once approved by the FDA.

>

> Other incentives provided by orphan designation include tax credits,

> protocol assistance and eligibility for research and development

> support.

>

> The FDA's orphan drug program is intended to encourage research,

> development and approval of products for diseases that affect fewer

> than 200,000 patients a year in the U.S., provide a significant

> therapeutic advantage over existing treatments or address an unmet

> medical need.

>

> CR002 will be evaluated in a Phase I trial to determine its safety

> and tolerability, and what the body does with the drug.

>

> CuraGen had 2003 revenue of $6.9 nillion.

>

>

>

>

>

>

>

>

> To edit your settings for the group, go to our Yahoo Group

> home page:

> http://groups.yahoo.com/group/iga-nephropathy/

>

> To unsubcribe via email,

> iga-nephropathy-unsubscribe

> Visit our companion website at www.igan.ca. The site is entirely supported

by donations. If you would like to help, go to:

> http://www.igan.ca/id62.htm

>

> Thank you

>

[Guest guest]

I sent an email to my neph today regarding this announcement. I

asked him if he knew about the trial. He thought that it might be

centered at Yale in New Haven, CT, but he was going to call down

there to see if anybody knew anything about it.

According to him, he said not to hold out too much hope, given the

recent Vioxx experience -- that the FDA and drug companies were

being much more cautious to make sure that they were not making the

situation worse -- in his words ... " first, do no harm... " .

He thought that it was going to take a long Phase I trial to really

tell if the drug was viable or not, which may have been the reason

for the orphan drug assignment -- basically they may be looking at

the vast majority of the patent period being used by trials.

Keep in mind the general slow progression that most IGaN patients

experience -- sometimes it takes many years to slowly lose the

kidney function that we have. How are they going to show that they

have slowed the progression even more when many have slow

progression to begin with?

Some of us may have been told that we have a particularly virulent

version of the disease. I was, because I lost more than 50% kidney

function in the first couple of months. On the other hand, I've

lost essentially no function in the last 4 years...

Walt

>

> Not sure if this has been posted before. They even use the

> word " prevent " .

>

> http://money.excite.com/jsp/nw/nwdt_rt.jsp?

> section=news & cat=INDUSTRY & feed=dji & news_id=dji-

> 00085420041111 & date=20041111

>

>

> CuraGen Gets FDA Orphan Drug Designation For Kidney Drug

>

> Thursday November 11, 11:26 AM EST

>

> NEW HAVEN, Conn. (Dow )--CuraGen Corp. (CRGN) said the U.S.

> Food and Drug Administration granted orphan drug designation for

> CuraGen's drug candidate used to potentially slow or prevent

kidney

> failure in patients affected by IgA nephropathy.

>

> Currently, there is no FDA approved treatment of IgA nephropathy,

a

> kidney disorder that occurs in childhood and young adulthood. The

> disease affects as many as 130,000 patients annually in the U.S.

>

> In a press release Thursday, the genomics-based pharmaceutical

> company said the orphan drug designation for CR002 typically

results

> in seven years of U.S. market exclusivity once approved by the FDA.

>

> Other incentives provided by orphan designation include tax

credits,

> protocol assistance and eligibility for research and development

> support.

>

> The FDA's orphan drug program is intended to encourage research,

> development and approval of products for diseases that affect

fewer

> than 200,000 patients a year in the U.S., provide a significant

> therapeutic advantage over existing treatments or address an unmet

> medical need.

>

> CR002 will be evaluated in a Phase I trial to determine its safety

> and tolerability, and what the body does with the drug.

>

> CuraGen had 2003 revenue of $6.9 nillion.

[Guest guest]

Hi Walt, Glad to hear that you contacted Dr. Denker about CuraGen.

I printed out the article and intended to show it to him when I meet

with him on Wednesday. I hope he can help me - I sure need someone

to sort things out!

Gloria

> >

> > Not sure if this has been posted before. They even use the

> > word " prevent " .

> >

> > http://money.excite.com/jsp/nw/nwdt_rt.jsp?

> > section=news & cat=INDUSTRY & feed=dji & news_id=dji-

> > 00085420041111 & date=20041111

> >

> >

> > CuraGen Gets FDA Orphan Drug Designation For Kidney Drug

> >

> > Thursday November 11, 11:26 AM EST

> >

> > NEW HAVEN, Conn. (Dow )--CuraGen Corp. (CRGN) said the U.S.

> > Food and Drug Administration granted orphan drug designation for

> > CuraGen's drug candidate used to potentially slow or prevent

> kidney

> > failure in patients affected by IgA nephropathy.

> >

> > Currently, there is no FDA approved treatment of IgA nephropathy,

> a

> > kidney disorder that occurs in childhood and young adulthood. The

> > disease affects as many as 130,000 patients annually in the U.S.

> >

> > In a press release Thursday, the genomics-based pharmaceutical

> > company said the orphan drug designation for CR002 typically

> results

> > in seven years of U.S. market exclusivity once approved by the

FDA.

> >

> > Other incentives provided by orphan designation include tax

> credits,

> > protocol assistance and eligibility for research and development

> > support.

> >

> > The FDA's orphan drug program is intended to encourage research,

> > development and approval of products for diseases that affect

> fewer

> > than 200,000 patients a year in the U.S., provide a significant

> > therapeutic advantage over existing treatments or address an

unmet

> > medical need.

> >

> > CR002 will be evaluated in a Phase I trial to determine its

safety

> > and tolerability, and what the body does with the drug.

> >

> > CuraGen had 2003 revenue of $6.9 nillion.