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In Re Nuvelo, Inc. Securities Litigation 07-CV-04056-Declaration of Mark

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In Re Nuvelo, Inc. Securities Litigation 07-CV-04056-Declaration of Mark BERGER & MONTAGUE, P.C. Sherrie R. Savett Carole A. Broderick Phyllis M. Parker 1622 Locust Street Philadelphia, PA 19103 Tel: (215) 875-3000 Fax: (215) 875-4604 Email: [email protected] cbroderick@bm ,net [email protected] IZARD NOBEL LLP ROBBINS GELLER RUDMAN Jeffrey S. Nobel & DOWD LLP Mark P. Kindall, Bar No 138703 Darren J. Robbins Nancy A. Kulesa Dennis J. Herman 29 South Main Street Eli R. Greenstein Suite 215 S. Ashar Ahmed West Hartford, Ct 06107 Post-Montgomery Center Tel: (860) 493-6292 One Montgomery Street, Suite 1800 Fax: (860) 493-6290 San Francisco, CA 94104 Email: [email protected] Tel: (415) 288-4545 [email protected] Fax: (415) 288-4534 [email protected] Email: [email protected] dennisb@rgrdlaw,corn [email protected] aahmed@rgrdlaw com Co-Lead Counsel for Plaintiffs Liaison Counsel UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION In re NUVELO, INC. SECURITIES Master File No 07-CV-04056-VRW LITIGATION CLASS ACTION DECLARATION OF MARK P. KINDALL IN SUPPORT OF PLAINTIFFS' MOTION FOR CLASS CERTIFICATION DATE: March .3, 2011 I TIME: 10:00 a.rn. I COURTROOM: 6 DECLARATION OF MARK P KINDALL IN SUPPORT OF PLArNTIFFS' MOTION FOR CLASS CERTIFICATION - 07-CV-04056-VRW DECLARATION OF MARK P. KINDALL IN SUPPORT OF PLAINTIFFS' MOTION FOR CLASS CERTIFICATION 2 3 I, Mark P. Kindall, hereby declare as follows: 4 1. I am a partner at the law firm of Izard Nobel LLP, which was appointed Co-Lead 5 Counsel for Plaintiffs in this litigation on September 19, 2007. I have personal knowledge of the 6 facts set forth herein. 7 2. Attached hereto as Exhibit 1 is a true and correct copy of a powerpoint presentation 8 presented at the 13th Annual Midwestern Institute for Interventional Therapy's Interventional 9 Radiology and Endovascular Therapy Seminar by Jacob Cynamon, M.D., a member of the Nuvelo 10 Advisory Board, entitled, "Alfimaprase: Phase 2 Multi-center Trial (NAPA-1) (Nov. 7, 2004), and 11 which document was obtained from a webpage of the Midwestern Institute for Interventional 12 Therapy at www.milt.com/2004/fri2004/AlfimepraseCynamon.pdf 13 .3, Attached hereto as Exhibit 2 is a true and correct copy of an article authored by 14 Sukgu M. Han, MD, Fred A. Weaver, MD, MMM, Anthony J. Comerota, MD, Bruce A. Perler, MD, 15 MBA and Mark Joing, MBA, which appeared in Volume 51, No. 3 of the Journal of Vascular 16 Surgery entitled, "Efficacy and Safety of Alfimeprase in Patients with Acute Peripheral Arterial 17 Occlusion (PAO)." 18 4. Attached hereto as Exhibit 3 is a true and correct copy of the Declaration of Juan 19 Pablo Cabrera in Support of Plaintiffs' Motion for Class Certification, dated December 10, 2010. 5, Attached hereto as Exhibit 4 is a true and correct copy of the Declaration of Frank C. 21 Petronis in Support of Plaintiffs' Motion for Class Certification, dated December 10, 2010. 22 6. Attached hereto as Exhibit 5 is a true and correct copy of the Declaration of Patricia .23 A. Petronis in Support of Plaintiffs' Motion for Class Certification, dated December 10, 2010. 24 7. Attached hereto as Exhibit 6 is a true and correct copy of the Declaration of Todd A. .25 Stephens in Support of Plaintiffs' Motion for Class Certification, dated December 13, 2010. 26 8. Attached hereto as Exhibit 7 is a true and correct copy of the Declaration of Amy A. .27 Stephens in Support of Plaintiffs' Motion for Class Certification, dated December 13, 2010. 28 DECLARATION OF MARK P KINDALL IN SUPPORT OF PLAINTIFFS' MOTION FOR CLASS CERTIFICATION - 07-CV-04056-VRW - 1 - 1 9. Attached hereto as Exhibit 8 is a true and correct copy of the firm resume of Izard 2 Nobel LLP, 3 10. Attached hereto as Exhibit 9 is a true and correct copy of the firm resume of Berger & 4 Montague, RC, 5 11, Attached hereto as Exhibit 10 is a true and correct copy of the firm resume of 6 Robbins Geller Rudman & Dowd, LEP_ 7 12. Attached hereto as Exhibit 11 is a true and correct copy of the Declaration of Dr, 8 Scott D. Hakala, Ph.D., CF.A.,, Regarding Market Efficiency, dated December 14, 2010, together 9 with Exhibits A — D3 attached thereto. 10 I declare, pursuant to the laws of the United States of America, that the foregoing is true and 11 correct to the best of my knowledge and belief. 12 13 14 XP.445.&644 I 5 .-2.010 ,A1 Date - ark P. Kin ii' 1 15 16 17 18 19 20 21 2? -).3 ',4 25 `,6 27 28 DECLARATION OF MARK P. KINDALL IN SUPPORT OF PLAINTIFFS' MOTION FOR CLASS CERTIFICATION - 07-CV-04056-VRW 2 _._ I CERTIFICATE OF SERVICE 2 I hereby certify that on December 15, 2010, I electronically filed the foregoing with the Clerk 3 of the Court using the CM/ECF system which will send notification of such filing to the e-mail 4 addresses denoted on the attached Electronic Mail Notice List, and I hereby certify that I have 5 mailed the foregoing document or paper via the United States Postal Service to the non-CM/ECF 6 participants indicated on the attached Manual Notice List. 7 I further certify that I caused this document to be forwarded to the following Designated 8 Internet Site at: http://securities,stanford,edu. 9 I certify under penalty of perjury under the laws of the United States of America that the 10 foregoing is true and correct. Executed on December 15, 2010. 11 /5/ JEFFREY S. NOBEL 1.3 IZARD NOBEL LLP 14 29 South Main Street, Suite 215 West Hartford, CT 06107 15 Telephone: 860/493-6292 860/493-6290 (fax) 16 [email protected] 17 18 19 20 21 2? 23 24 25 26 27 28 589609_1 DECLARATION OF MARK P KTNDALL EN SUPPORT OF PLAINTIFFS' MOTION FOR CLASS CERTIFICATION - 07-CV-04056-VRW 07-CV-04056-VRW Efficacy and safety of alfinieprase in patients with acute peripheral arterial occlusion (PAO) Sulrgu M. Han, MD, Fred A. Weaver, MD, MAIM,' Anthony J. Conaerota, MD," Bruce A. Perler, MD, MBA,' and Mark iroing, MRA;'t Los Angeles Calif; Toledo, Ohio; Baltimore, Md; and Broomfiel4 Colo Purina= To investigate the safety and effectiveness of a novel thrombolytic, aifimeprase, in catheter-directed thromb olysis (CDT) of acute peripheral arterial occlusions (PAO). • • Methods: Between April 2005 and March 2007, patients with acute PAO (Rutherford class I or Ila) of a lower extremity and onset of symptoms within 14 days prior to randomization were included. Studies HA004 and HA007 enrolled respectively 300 and 102 patients. Both studies HA004 and HA007 were placebo-controlled. 1-1A004 had two placebo arms, intrathrombus and perithrombus, while HA007 had intrathrombus placebo arm. HA004 was partially double- blind (perithrombus group was not blinded) and HA007 was double-blind. Patients were randomized to intrathroxnbus alfimeprase (0.3 mg/kg), intrathrombus (IT) placebo, or peritbrorribus (PT) placebo (1-IA004 only) in two divided weight-based infusions 2 hours apart. Depending on arteriographie results after treatment, patients received no farther intervention or underwent endovascular therapy or open vascular surgery. The primary endpoint of both studies was efficacy of alfuncprase compared with placebo as measured by avoidance of an open vascular surgeryprocedure at 30 days. Results:The avoidance of open_ vascala.r surgery at 30 days was seen in 52(34.9%), 42(37.2%), and 7 patients (18.4%) with • alfinacprase, IT placebo, and PT placebo in HA004 and 15 (29,4%) and 9 patients (17.6%) with alfimeprase and IT placebo in 1-1A007; differences between alfimeprase and IT placebo were not statistically significant. Results were similar for secondary endpoints, including arterial flow restoration in 4 hours, 30-day ankle-brachial index, index limb pain severity, and hospital slaw duration. The overall rate of adverse events was higher with alfimeprase than placebo, 'Hemorrhagic and peripheral embolic event rates with alfuncprase were 23% (34 patients) and 10.1% (15 patients) in HA.004, and 9.4% (5 patients) and 9.8% (5 patients) in I-IA007; rates with IT placebo were 11% (12 patients, P = .107) and 5% (5 patients, P = .148) in 1-1A004 and 10% (5 patients, P .982) and 0% in HA007 (P = .07). No deaths were related to study drug administration. Conclusions: CDT for acutePAO with alfuneprase was as sec as placebo. However, alfimeprase was no more effective than placebo in increasing 30-day surgery-free survival. The surprising effectiveness of placebo alone demonstrates that the inclusion of a placebo arm is essential to the design of future lytic trials. (J Vase Surg 2010;51:600-9.) • • Current treatment options for acute peripheral arterial extremity arterial and graft occlusions have confirmed these and graft occlusion (PAO) include open surgical therapy theoretic advantages. The Surgery vs Thrombolysis for and endovaseular treatments, often involving catheter- Ischenaia of the Lower Extremity (STILE) trial showed that directed thrornbolysis. In addition to restoring arterial flow in patients with acute (symptoms less than 14 days) lower by dissolving an occluding thombus, thrombolysis can extremity ischemia, catheter-directed thrombolysis with unmask the underlying lesion, which can be treated with a recombinant tissue plasminogen activator (rt-PA) or uro.ki- • less invasive percutaneous procedure and potentially con- nase (UK) was associated with improved amputation-free vert an emergent intervention to an elective procedure with survival and shorter hospital stays in comparison to sur- less risk to the patient. Several randomized controlled trials gery.1 '2 The Thrornbolysis or Peripheral Arterial Surgery comparing safety and efficacy of thrombolydc therapy to (TOPAS) trial showed equivalent 1-year amputation-free surgery as the initial therapy in patients with acute lower survival rates in the UK-mediated thrombolysis group and surgery group, but both studies showed that the need for From the Division of Vascular Surgery and fmdovascular Therapy, and magnitude of open surgery were significantly reduced CardioVaseular Thoracic Institute, Universityof Southern California, Los with the thromhdysis group Angeles,' Toledo Vascular Institute, Toledo,' Division of Vascular Sur- gay, Johns Hopkins Medical Center, Baltimore,' and ARCA biopharnia, Conventional thrombolytic agents act indirectly to Inc, Broomfielti.d cause dissolution of fibrin by activation of plasminogen.
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