Sutent Clinical Development

<table cellspacing="1" cellpadding="7" width="672" border="1"> <tbody> <tr> <td valign="top" colspan="3" height="16"> <br /> <br /> <p> <b><font face="Times" color="#ff0000" size="5">Sutent Clinical Development</font></b> </p> </td> </tr> <tr> <td valign="top" width="13%" height="15"> <p> <b><font face="Helvetica Condensed" size="2">Date</font></b> </p> </td> <td valign="top" width="88%" colspan="2" height="15"> <p> <b><font face="Helvetica Condensed" size="2">Action</font></b> </p> </td> </tr> <tr> <td valign="top" bgcolor="#ffffff" colspan="3" height="16"> <p> <b><font face="Times" size="4">IND Chronology (62,382)</font></b> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">4/16/2001</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">IND submission</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">5/14/2001</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">FDA requests monitoring of study patients for adrenal toxicity based on preclinical evidence of adrenal hemorrhage</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">2/2002</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Sponsor switches from free-base to L-malate salt of study drug substance</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">8/22/2002</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Meeting to discuss potential adrenal toxicity; medical officer recommends study investigators perform stimulation tests to screen for adrenal functional reserve</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">5/13/2003</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Type A meeting regarding GIST <i>Phase III</i> trial design; FDA recommends time to progression as sole primary endpoint</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">6/24/2003</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Fast track designation for imatinib-resistant GIST</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">8/13/2003</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Special protocol assessment (SPA) request for GIST indication</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">11/10/2003</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">End-of-<i>Phase II</i> meeting to discuss metastatic renal cell carcinoma (mRCC) indication</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">1/12/2004</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Teleconference to discuss potential for QTc prolongation; FDA recommends positive control study to detect prolongation of at least 5 msec</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">1/23/2004</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">End-of-<i>Phase II</i> meeting</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">4/13/2004</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">SPA request for first-line treatment of mRCC</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">5/27/2004</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Teleconference to discuss RCC</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">5/28/2004</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Treatment protocol for pivotal GIST study submitted</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">9/23/2004</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Pre-NDA meeting</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">1/19/2005</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Pre-NDA meeting</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">2/23/2005</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">End-of-<i>Phase II</i> meeting</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">4/19/2005</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Pre-NDA meeting regarding audit of digitized images</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">8/1/2005</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Meeting to discuss adrenal stimulation test results</font> </p> </td> </tr> <tr> <td valign="top" bgcolor="#ffffff" colspan="3" height="16"> <p> <b><font face="Times" size="4">NDA Chronology (21-938, 21-968)</font></b> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">8/10/2005</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">NDA submission (21-968: RCC; 21-938: GIST)</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">1/26/2006</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">Approval</font> </p> </td> </tr> <tr> <td valign="top" width="13%" colspan="2" height="15"> <p> <font face="Helvetica Condensed" size="3">2/11/2006</font> </p> </td> <td valign="top" width="87%" height="15"> <p> <font face="Helvetica Condensed" size="3">PDUFA date (priority review)</font> </p> </td> </tr> </tbody> </table>