VRUS » Topics » Delays in clinical trials could result in increased costs to us and delay our ability to obtain regulatory approval and commercialize our product candidates.

These excerpts taken from the VRUS 10-K filed Dec 11, 2008.

Delays in clinical trials could result in increased costs to us and delay our ability to obtain regulatory approval and commercialize our product candidates.

Significant delays in clinical trials could materially affect our product development costs and delay regulatory approval of our product candidates. We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including:

 

   

delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;

 

   

delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;

 

   

delays or failures in reaching agreement on acceptable terms with prospective study sites;

 

   

delays or failures in obtaining approval of our clinical trial protocol from an IRB to conduct a clinical trial at a prospective study site;

 

   

delays in recruiting patients/subjects to participate in a clinical trial;

 

   

failure of our clinical trials and/or clinical investigators to be in compliance with Good Clinical Practices;

 

   

unforeseen safety issues;

 

   

inability to monitor patients/subjects adequately during or after treatment;

 

   

difficulty monitoring multiple study sites;

 

   

failure of our third-party clinical trial managers to satisfy their contractual duties, comply with regulations or meet expected deadlines; and

 

   

determination by regulators that the clinical design of the trials is not adequate.

Delays in clinical trials could result in increased costs to us and delay our ability to obtain regulatory approval and
commercialize our product candidates.

Significant delays in clinical trials could materially affect our product development costs
and delay regulatory approval of our product candidates. We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all. Clinical trials can be delayed for a variety of
reasons, including:

 







  

delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar
product candidates of our competitors or failure to follow regulatory guidelines;

 







  

delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;


 







  

delays or failures in reaching agreement on acceptable terms with prospective study sites;

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delays or failures in obtaining approval of our clinical trial protocol from an IRB to conduct a clinical trial at a prospective study site;

 







  

delays in recruiting patients/subjects to participate in a clinical trial;

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

failure of our clinical trials and/or clinical investigators to be in compliance with Good Clinical Practices;

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

unforeseen safety issues;

 







  

inability to monitor patients/subjects adequately during or after treatment;

STYLE="font-size:6px;margin-top:0px;margin-bottom:0px"> 







  

difficulty monitoring multiple study sites;

 







  

failure of our third-party clinical trial managers to satisfy their contractual duties, comply with regulations or meet expected deadlines; and

 







  

determination by regulators that the clinical design of the trials is not adequate.

STYLE="margin-top:18px;margin-bottom:0px; text-indent:4%">Failure to recruit and enroll patients/subjects for clinical trials may cause the development of our product candidates to be delayed.

We have experienced, and expect to experience in the future, delays in patient/subject enrollment in our clinical trials for a variety of
reasons. The completion of clinical trials depends, among other things, on our ability to enroll a sufficient number of patients/subjects who remain in the study until its conclusion. The enrollment of patients/subjects depends on many factors,
including:

 







  

the patient/subject eligibility criteria defined in the protocol;

 








  

the size of the patient/subject population required for analysis of the trial’s therapeutic endpoints;

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the proximity of patients/subjects to study sites;

 







  

the design of the trial;

 







  

our ability to recruit clinical trial investigators with the appropriate competencies and experience;

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our ability to obtain and maintain patient/subject consents;

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the risk that patients/subjects enrolled in clinical trials will drop out of the trials before completion; and

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competition for patients/subjects by clinical trial programs for other treatments.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Our clinical trials compete with other clinical trials for drug candidates that are in the same therapeutic areas as our drug candidates, and this
competition reduces the number and types of patients/subjects available to us, because some patients/subjects who might have opted to enroll in our trials opt to enroll in a trial being conducted by one of our competitors. We conduct some of our
clinical trials at the same clinical trial sites that some of our competitors use, which reduces the number of patients/subjects who are available for our clinical trials in such clinical trial site. Delays in patient enrollment in the future as a
result of these and other factors may result in increased costs or may affect the timing or outcome of our clinical trials, which could prevent us from completing these trials and adversely affect our ability to advance the development of our
product candidates.

For example, in our Phase 2 study of Racivir, we anticipated that enrollment would take less than one year to
complete, but it actually took 20 months. The primary reasons for this unexpected delay in enrollment included competition for patients/subjects with other longer-term clinical studies, larger investigator budgets and greater payments to study
subjects for other clinical trials, very specific patient/subject enrollment criteria for our clinical study, and protocol modifications that were required to increase the duration of treatment. As a result of these delays, it took us longer to
complete this study than we had initially planned, and we had to commit staffing and resources to this project for an extended period that could have otherwise been allocated to other research programs.

STYLE="margin-top:18px;margin-bottom:0px; text-indent:4%">Our product candidates may have undesirable side effects when used alone or in combination with other products that prevent their regulatory
approval or limit their use if approved.

We must demonstrate the safety of our product candidates to obtain regulatory approval.
Although in clinical trials to date, clevudine, Racivir, PSI-6130 and R7128 were generally well tolerated, these trials involved a small number of patients/subjects and we may observe significant adverse events for these product candidates in the
future. With respect to DFC, on April 3, 2006, Incyte announced its decision to discontinue its development of DFC after observing an increased incidence of grade 4 hyperlipasemia in the rollover portion of a Phase 2b clinical trial. It is
possible that any side effects associated with our product candidates may outweigh the benefits of our product candidates and prevent regulatory approval or limit their market acceptance if they are approved. Recent developments in the
pharmaceutical industry have prompted heightened government focus on safety reporting and pharmacovigilance. Global health authorities may impose regulatory requirements to monitor safety that may burden our ability to commercialize our drug
products.

This excerpt taken from the VRUS 10-K filed Dec 31, 2007.

Delays in clinical trials could result in increased costs to us and delay our ability to obtain regulatory approval and commercialize our product candidates.

Significant delays in clinical trials could materially affect our product development costs and delay regulatory approval of our product candidates. We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including:

 

   

delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;

 

   

delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;

 

   

delays or failures in reaching agreement on acceptable terms with prospective study sites;

 

   

delays or failures in obtaining approval of our clinical trial protocol from an IRB to conduct a clinical trial at a prospective study site;

 

   

delays in recruiting patients to participate in a clinical trial;

 

   

failure of our clinical trials and clinical investigators to be in compliance with the FDA’s Good Clinical Practices;

 

   

unforeseen safety issues;

 

   

inability to monitor patients adequately during or after treatment;

 

   

difficulty monitoring multiple study sites;

 

   

failure of our third-party clinical trial managers to satisfy their contractual duties, comply with regulations or meet expected deadlines; and

 

   

determination by regulators that the clinical design of the trials is not adequate.

This excerpt taken from the VRUS 10-Q filed Aug 9, 2007.

Delays in clinical trials could result in increased costs to us and delay our ability to obtain regulatory approval and commercialize our product candidates.

Significant delays in clinical trials could materially affect our product development costs and delay regulatory approval of our product candidates. We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including:

 

   

delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;

 

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delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;

 

   

delays or failures in reaching agreement on acceptable terms with prospective study sites;

 

   

delays or failures in obtaining approval of our clinical trial protocol from an IRB to conduct a clinical trial at a prospective study site;

 

   

delays in recruiting patients to participate in a clinical trial;

 

   

failure of our clinical trials and clinical investigators to be in compliance with the FDA’s Good Clinical Practices;

 

   

unforeseen safety issues;

 

   

inability to monitor patients adequately during or after treatment;

 

   

difficulty monitoring multiple study sites;

 

   

failure of our third-party clinical trial managers to satisfy their contractual duties, comply with regulations or meet expected deadlines; and

 

   

determination by regulators that the clinical design of the trials is not adequate.

This excerpt taken from the VRUS 10-Q filed Jun 11, 2007.

Delays in clinical trials could result in increased costs to us and delay our ability to obtain regulatory approval and commercialize our product candidates.

Significant delays in clinical trials could materially affect our product development costs and delay regulatory approval of our product candidates. We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including:

 

   

delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;

 

   

delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;

 

   

delays or failures in reaching agreement on acceptable terms with prospective study sites;

 

   

delays or failures in obtaining approval of our clinical trial protocol from an institutional review board to conduct a clinical trial at a prospective study site;

 

   

delays in recruiting patients to participate in a clinical trial;

 

   

failure of our clinical trials and clinical investigators to be in compliance with the FDA’s Good Clinical Practices;

 

   

unforeseen safety issues;

 

   

inability to monitor patients adequately during or after treatment;

 

   

difficulty monitoring multiple study sites;

 

   

failure of our third-party clinical trial managers to satisfy their contractual duties, comply with regulations or meet expected deadlines; and

 

   

determination by regulators that the clinical design of the trials is not adequate.

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