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In Re Nuvelo, Inc. Securities Litigation 07-CV-04056-Second

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In Re Nuvelo, Inc. Securities Litigation 07-CV-04056-Second 1 COUGHLIN STOIA GELLER RUDMAN & ROBBINS LLP 2 DENNIS J. HERMAN (220163) ELI R. GREENSTEIN 3 100 Pine Street, Suite 2600 4 San Francisco, CA 94111 Telephone : 415/288-4545 5 Fax: 415/288-4534 [email protected] 6 elig^a,csgrr.com 7 Liaison Counsel 8 BERGER & MONTAGE, P.C. IZARD NOBEL, LLP 9 SHERRIE R. SAVETT JEFFREY S. NOBEL CAROLE A. BRODERICK MARK P. KINDALL 10 BARBARA A. PODELL NANCY A. KULESA PHYLLIS M. PARKER SETH R. KLEIN 11 1622 Locust Street One Corporate Center 12 Philadelphia, PA 19103 One Church Street, Suite 1700 Telephone: 215/875-300 Hartford, CT 06103 13 Fax: 215/875-4604 Telephone: 860/493-6292 ssaveft@,,bm.net Fax: 860/493-6290 14 cbroderick@,bm.net [email protected] 15 bpodell@,,bm.et [email protected] pparker(&,,bm.net nkulesa(a,snilaw.com 16 [email protected] 17 Co-Lead Counsel for Plaintiffs 18 UNITED STATES DISTRICT COURT 19 NORTHERN DISTRICT OF CALIFORNIA 20 21 In re NUVELO, INC. SECURITIES Master File No. 3:07-cv-04056-VRW LITIGATION 22 CLASS ACTION 23 This Document Relates To: SECOND CONSOLIDATED COMPLAINT FOR VIOLATIONS OF THE FEDERAL 24 ALL ACTIONS. SECURITIES LAWS 25 26 27 28 1 TABLE OF CONTENTS 2 I. INTRODUCTION ...................................................................................................1 3 II. JURISDICTION AND VENUE ............................................................................ 15 4 III. PARTIES ............................................................................................................... 16 5 IV. CONFIDENTIAL WITNESSES ........................................................................... 18 6 V. BACKGROUND FACTS ...................................................................................... 19 7 A. Nuvelo Bets Its Future on the Commercialization of Alfimeprase ................................................................................................ 20 8 B. Amgen Refuses to Fund Further Efforts to Commercialize 9 Alfimeprase ................................................................................................ 22 10 VI. CLINICAL TRIALS OF ALFIMEPRASE ........................................................... 24 11 1. PAO Clinical Program ................................................................... 27 12 2. CO Clinical Program...................................................................... 32 13 3. Nuvelo Announces Failure of Both PAO and CO Phase 3 Trials ................................................................................. 3 5 14 VII. DEFENDANTS' SCHEME TO DEFRAUD ......................................................... 40 15 A. Defendants Falsely Represented the Significance and 16 Reliability of the Phase 2 Alfimeprase Trial Data, and Conceal Material Risks to FDA Approval and Commercial 17 Marketability for PAO and CO.................................................................. 40 18 B. Defendants ' Scheme Unravels ................................................................... 47 19 VIII. DEFENDANTS' FALSE AND MISLEADING STATEMENTS ........................ 50 20 A. Defendants False Statements In The May 26, 2005 Press Release ....................................................................................................... 50 21 B. Defendants False Statements In The November 1, 2005 22 Conference Call ......................................................................................... 51 23 C. Defendants' January 5, 2006 False and Misleading Statements .................................................................................................. 56 24 D. Defendants ' January 31 False And Misleading Statements ....................... 59 25 E. Defendants ' February 27 False And Misleading Statements ..................... 61 26 F. Defendants ' March 15 False And Misleading Statements ......................... 63 27 G. Defendants ' April 10, 2006 False and Misleading 28 Statements .................................................................................................. 63 1 H. Defendants ' April 24, 2006 False and Misleading Statements .................................................................................................. 64 2 I. Defendants ' May 5 , 2006 False and Misleading Statements ..................... 65 3 J. Defendants July 7, 2006 Misrepresentations ............................................. 67 4 K. Defendants ' August 3 , 2006 False and Misleading 5 Statements .................................................................................................. 70 6 IX. MISLEADING RISK WARNINGS PROVIDE NO SAFE HARBOR ............................................................................................................... 70 7 X. ADDITIONAL SCIENTER ALLEGATIONS ...................................................... 75 8 A. Individual Defendants' Compensation Was Tied to 9 Financial Performance ............................................................................... 75 10 B. Defendants Were Motivated to Commit Fraud to Gain Access to Capital through the Follow-On Offering ................................... 76 11 XI. PRESUMPTION OF RELIANCE AND PROXIMATE LOSS 12 CAUSATION/ECONOMIC LOSS ....................................................................... 78 13 A. Applicability of Presumption of Reliance: Fraud on the Market Doctrine ......................................................................................... 79 14 B. Defendants' False and Misleading Statements Proximately 15 Caused Economic Loss to Nuvelo's Investors ........................................... 81 16 XII. GROUP PLEADING ALLEGATIONS ................................................................ 84 17 XIII. CLASS ACTION ALLEGATIONS ...................................................................... 86 18 19 20 21 22 23 24 25 26 27 28 1 I I. INTRODUCTION 2 1. This is a securities fraud class action against Nuvelo, Inc. ("Nuvelo 3 or the "Company ) and certain of the Company's senior officers and directors for 4 violations of the Securities Exchange Act of 1934 (the "Exchange Act ) and Rule 5 IOb-5 promulgated thereunder, 17 C.F.R. §240. 10b-5. This action is brought on 6 behalf of all purchasers ofthe publicly traded securities ofNuvelo between January 7 5, 2006 and December 8, 2006, inclusive (the "Class Period ), including purchasers 8 in Nuvelo's January 31 , 2006 $119 million follow-on offering ("Follow-On 9 Offering ). 10 2. Nuvelo is a biopharmaceutical company that, in the relevant time 11 period, was engaged in the preclinical and clinical testing of acute cardiovascular 12 and cancer therapies which had been developed by other companies. During the 13 Class Period, the Company's drug development pipeline included three drugs under 14 development: (a) alfimeprase, a thrombolytic drug which dissolved blood clots and 15 which the Company described as its "lead product, (b) rNAP62, an anticoagulant 16 which the Company claimed had potential utility as a treatment for heart disease and 17 which had just begun to be tested for efficacy, and (3) NU206, which the Company 18 was intending to, but had not begun testing to treat certain side effects of 19 chemotherapy and radiation therapy for cancer. However, the Company's lead 20 cardiovascular development program - to which the market attributed at least 80% 21 of the Company's value and which the Company touted as its path to profitably - 22 was alfimeprase, which the Company claimed was faster and safer than other 23 thrombolytic drugs, and had multiple uses for markets that could, in the aggregate, 24 yield billions of dollars of annual sales. 25 3. Nuvelo obtained the rights to alfimeprase from Amgen, Inc. 26 ("Amgen ), a pharmaceutical company whose co-founder, George Rathmann 27 ("Rathmann ), sat on Nuvelo's board. Amgen had previously tried unsuccessfully 28 to develop alfimeprase. Nevertheless, Nuvelo, which had never successfully SECOND CONSOLIDATED COMPLAINT FOR VIOLATIONS OF THE FEDERAL SECURITIES LAWS - 3:07-cv-04056-VRW -1- 1 brought a drug to market, sought to capitalize on alfimeprase's purported 2 I commercial potential, using it as a lever to raise money to keep the Company afloat, 3 I as well as to line defendants' pockets. 4 4. At the time Nuvelo obtained the rights to alfimeprase in 2002, it was 5 1 running out of cash and in danger ofbecoming insolvent. After obtaining the rights 6 I to alfimeprase, Nuvelo merged with Variagenics, Inc. ("Variagenics ) - another 7 drug company that, like Nuvelo, had no products with any near term revenue 8 potential in the pipeline but, unlike Nuvelo, had $55.9 million in the bank. 9 Following the merger, Nuvelo jumped into clinical trials ofalfimeprase, repeatedly 10 boasting of the purported results of the trials and the potential commercial success 11 of drug. Before and during the Class Period, the Company repeatedly used the 12 alleged success of the alfimeprase trials to access the market and obtain much 13 needed cash to continue in operation, test its drug candidates and highly compensate 14 its executives, raising over $291 million in four public and private offerings, while 15 paying over $4.7 million in salary and cash bonuses to its top officers and directors, 16 the defendants here. 17 5. Defendants told investors that the Company was conducting the final 18 1 Phase 3 clinical trials needed to obtain FDA approval of alfimeprase for two uses 19 with a combined U.S. market of $500 million in annual sales , uses for which 20 Defendants asserted the efficacy of the drug had been shown in earlier Phase 2 21 clinical studies,
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