EPIX Pharmaceuticals (EPIX)

 

We outsource and plan to continue to outsource manufacturing responsibilities to third-parties for our existing and future therapeutic drug candidates for clinical development and commercial purposes. If one of our manufacturers for our therapeutic product candidates should become unavailable to us for any reason, we

 

We outsource and plan to continue to outsource manufacturing responsibilities to third-parties for our existing and future drug candidates for clinical development and commercial purposes. We are currently working with our contract manufacturers to produce sufficient quantities of the active pharmaceutical ingredient and drug product in each of our programs for our planned clinical trials in 2008. If one of our manufacturers for our therapeutic product candidates should become unavailable to us for any reason, we believe that there are a number of potential replacements as our processes are not manufacturer-specific, though we may incur some added cost and delay in identifying or qualifying such replacements, including delays associated with the need for FDA review and approval of the new manufacturer, as well as those associated with the new manufacturer’s ability to establish the manufacturing process.

 

Bayer Schering Pharma AG, Germany is responsible for the manufacture of Vasovist. Bayer Schering Pharma AG, Germany relies on Covidien as the sole manufacturer of Vasovist for human clinical trials and commercial use. Together with Bayer Schering Pharma AG, Germany, EPIX is considering alternative manufacturing arrangements for Vasovist for commercial use, including the potential transfer of manufacturing to Bayer Schering Pharma AG, Germany. In the event that Covidien fails to fulfill its manufacturing responsibilities satisfactorily, Bayer Schering Pharma AG, Germany has the right to purchase Vasovist from a third-party or to manufacture the compound itself.

 

We currently rely on Aptuit, Inc. and Thermo Fisher Scientific Inc. for our therapeutic drug product manufacturing and testing, and on Aptuit, Inc. (formerly Evotec, Ltd.) and Johnson Matthey Pharma Services for the manufacture and testing of our active therapeutic pharmaceutical ingredients. Our agreements with these suppliers generally operate on a work order basis, with no minimum purchase requirements and are generally terminable by us upon 60 days and 90 days prior written notice, respectively. Small amounts of material used for preclinical research and development purposes are synthesized in-house or with third-party contract laboratories. The production of our drug candidates PRX-08066, PRX-00023, PRX-03140 and PRX-07034 uses small-molecule synthetic organic chemistry procedures that are standard in the pharmaceutical industry. There are no complicated chemistries or unusual equipment required in the manufacturing process of these drug candidates. PRX-08066, PRX-00023, PRX-03140 and PRX-07034 are all currently administered as unformulated drug products. A commercially viable formulation will need to be developed, manufactured and certified for each of these drug candidates. The final commercial formulation may not prove to be bioequivalent to the current formulation. This may result in the need to initiate additional clinical trials to define new dosing regimes. Furthermore, the development and implementation of a new formulation and commercial process for cGMP manufacturing may add significant delays to additional clinical trials, regulatory filings and commercial launch.

 

 

We outsource and plan to continue to outsource manufacturing
responsibilities to third-parties for our existing and future
drug candidates for clinical development and commercial
purposes. We are currently working with our contract
manufacturers to produce sufficient quantities of the active
pharmaceutical ingredient and drug product in each of our
programs for our planned clinical trials in 2008. If one of our
manufacturers for our therapeutic product candidates should
become unavailable to us for any reason, we believe that there
are a number of potential replacements as our processes are not
manufacturer-specific, though we may incur some added cost and
delay in identifying or qualifying such replacements, including
delays associated with the need for FDA review and approval of
the new manufacturer, as well as those associated with the new
manufacturer’s ability to establish the manufacturing
process.

 

Bayer Schering Pharma AG, Germany is responsible for the
manufacture of Vasovist. Bayer Schering Pharma AG, Germany
relies on Covidien as the sole manufacturer of Vasovist for
human clinical trials and commercial use. Together with Bayer
Schering Pharma AG, Germany, EPIX is considering alternative
manufacturing arrangements for Vasovist for commercial use,
including the potential transfer of manufacturing to Bayer
Schering Pharma AG, Germany. In the event that Covidien fails to
fulfill its manufacturing responsibilities satisfactorily, Bayer
Schering Pharma AG, Germany has the right to purchase Vasovist
from a third-party or to manufacture the compound itself.

 

We currently rely on Aptuit, Inc. and Thermo Fisher Scientific
Inc. for our therapeutic drug product manufacturing and testing,
and on Aptuit, Inc. (formerly Evotec, Ltd.) and Johnson Matthey
Pharma Services for the manufacture and testing of our active
therapeutic pharmaceutical ingredients. Our agreements with
these suppliers generally operate on a work order basis, with no
minimum purchase requirements and are generally terminable by us
upon 60 days and 90 days prior written notice,
respectively. Small amounts of material used for preclinical
research and development purposes are synthesized in-house or
with third-party contract laboratories. The production of our
drug candidates PRX-08066, PRX-00023, PRX-03140 and PRX-07034
uses small-molecule synthetic organic chemistry procedures that
are standard in the pharmaceutical industry. There are no
complicated chemistries or unusual equipment required in the
manufacturing process of these drug candidates. PRX-08066,
PRX-00023, PRX-03140 and PRX-07034 are all currently
administered as unformulated drug products. A commercially
viable formulation will need to be developed, manufactured and
certified for each of these drug candidates. The final
commercial formulation may not prove to be bioequivalent to the
current formulation. This may result in the need to initiate
additional clinical trials to define new dosing regimes.
Furthermore, the development and implementation of a new
formulation and commercial process for cGMP manufacturing may
add significant delays to additional clinical trials, regulatory
filings and commercial launch.

 

 

We outsource and plan to continue to outsource manufacturing responsibilities to third parties for our existing and future drug candidates for clinical development and commercial purposes. We are currently working with our contract manufacturers to produce sufficient quantities of the active pharmaceutical ingredient and drug product in each of our programs for our planned clinical trials in 2007. If one of our manufacturers for our therapeutic product candidates should become unavailable to it for any reason, we believe that there are a number of potential replacements as our processes are not manufacturer-specific, though we may incur some added cost and delay in identifying or qualifying such replacements, including delays associated with the need for FDA review and approval of the new manufacturer, as well as those associated with the new manufacturer’s ability to establish the manufacturing process.

 

Bayer Schering Pharma AG, Germany is responsible for the manufacture of Vasovist. Bayer Schering Pharma AG, Germany relies on Tyco as the sole manufacturer of Vasovist for human clinical trials and commercial use. Together with Bayer Schering Pharma AG, Germany, EPIX is considering alternative manufacturing arrangements for Vasovist for commercial use, including the potential transfer of manufacturing to Bayer Schering Pharma AG, Germany. In the event that Tyco fails to fulfill its manufacturing responsibilities satisfactorily, Bayer Schering Pharma AG, Germany has the right to purchase Vasovist from a third party or to manufacture the compound itself.

 

We currently rely on Aptuit, Inc. and Metrics, Inc. for our therapeutic drug product manufacturing and testing, and on Evotec, Ltd. and Johnson Matthey Pharma Services for the manufacture and testing of our active therapeutic pharmaceutical ingredients. Our agreements with these suppliers generally operate on a work order basis, with no minimum purchase requirements and are generally terminable by us upon 60 days and 90 days prior written notice, respectively. Small amounts of material used for pre-clinical research and development purposes are synthesized in-house. The production of our drug candidates PRX-08066, PRX-00023, PRX-03140 and PRX-07034 uses small-molecule synthetic organic chemistry procedures that are standard in the pharmaceutical industry. There are no complicated chemistries or unusual equipment required in the manufacturing process of these drug candidates. PRX-08066, PRX-00023, PRX-03140 and PRX-07034 are all currently administered as unformulated drug products. A commercially viable formulation will need to be developed, manufactured and certified for each of these drug candidates. The final commercial formulation may not prove to be bioequivalent to the current formulation. This may result in the need to initiate additional clinical trials to define new dosing regimes. Furthermore, the development and implementation of a new formulation and commercial process for cGMP manufacturing may add significant delays to additional clinical trials, regulatory filings and commercial launch.