TPTX » Topics » NGX267 and NGX292 are being developed to treat xerostomia, or dry mouth. There are currently two muscarinic receptor agonists approved to treat xerostomia. We do not know if NGX267 and NGX292 will yield commercially viable products or receive regulatory a

These excerpts taken from the TPTX 10-K filed Mar 31, 2008.

NGX267 and NGX292 are being developed to treat xerostomia, or dry mouth. There are currently two muscarinic receptor agonists approved to treat xerostomia. We do not know if NGX267 and NGX292 will yield commercially viable products or receive regulatory approval.

        NGX267 and NGX292 are muscarinic receptor agonists with functionally specific M1 receptor activity that we intend to develop for the treatment of xerostomia, or dry mouth. There are currently two muscarinic receptor agonists marketed in the United States for the treatment of xerostomia. We do not know whether or not NGX267 and NGX292 will have any advantages over the currently marketed products or will be safe and efficacious. Failure to demonstrate an advantage over the currently marketed products or a failure to be safe and efficacious will prevent us from commercializing NGX267 and NGX292 or generating significant revenue.

NGX267 and NGX292 may be developed in the future for Alzheimer's disease or CIAS, indications for which there are no products approved by the FDA, and for which no regulatory precedents have been established. Therefore, we do not know whether our product candidates will yield commercially viable products or receive regulatory approval.

        NGX267 and NGX292 are muscarinic receptor agonists with functionally specific M1 receptor activity that we may develop in the future for the treatment of Alzheimer's disease or CIAS. There are currently no approved therapies for the treatment of Alzheimer's disease or CIAS. Therefore, in order to successfully commercialize NGX267 and NGX292, we will need to agree with the FDA and other applicable regulatory agencies on clinical trial endpoints regarding safety and efficacy. Given the lack of current treatments for each of these indications, we may be unable to agree on the endpoints or successfully complete clinical trials that demonstrate that such endpoints, if agreed to, have been met. Any delay in agreeing to clinical trial endpoints or in achieving those endpoints could delay commercialization thereby damaging our ability to generate significant revenue from NGX267 and NGX292, or prevent us from commercializing NGX267 and NGX292 altogether.

NGX267 and NGX292 are being developed to treat xerostomia, or dry mouth. There are currently two muscarinic receptor agonists approved to treat
xerostomia. We do not know if NGX267 and NGX292 will yield commercially viable products or receive regulatory approval.




        NGX267
and NGX292 are muscarinic receptor agonists with functionally specific M1 receptor activity that we intend to develop for the treatment of xerostomia, or dry mouth. There are
currently two muscarinic receptor agonists marketed in the United States for the treatment of xerostomia. We do not know whether or not NGX267 and NGX292 will have any advantages over the currently
marketed products or will be safe and efficacious. Failure to demonstrate an advantage over the currently marketed products or a failure to be safe and efficacious will prevent us from commercializing
NGX267 and NGX292 or generating significant revenue.



NGX267 and NGX292 may be developed in the future for Alzheimer's disease or CIAS, indications for which there are no products approved by the FDA, and
for which no regulatory precedents have been established. Therefore, we do not know whether our product candidates will yield commercially viable products or receive regulatory
approval.



        NGX267
and NGX292 are muscarinic receptor agonists with functionally specific M1 receptor activity that we may develop in the future for the treatment of Alzheimer's disease or CIAS.
There are currently no approved therapies for the treatment of Alzheimer's disease or CIAS. Therefore, in order to successfully commercialize NGX267 and NGX292, we will need to agree with the FDA and
other applicable regulatory agencies on clinical trial endpoints regarding safety and efficacy. Given the lack of current treatments for each of these indications, we may be unable to agree on the
endpoints or successfully complete clinical trials that demonstrate that such endpoints, if agreed to, have been met. Any delay in agreeing to clinical trial endpoints or in achieving those endpoints
could delay commercialization thereby damaging our ability to generate significant revenue from NGX267 and NGX292, or prevent us from commercializing NGX267 and NGX292 altogether.



EXCERPTS ON THIS PAGE:

10-K (2 sections)
Mar 31, 2008
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