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In Re Delcath Systems, Inc. Securities Litigation 13-CV-03116-Amended

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In Re Delcath Systems, Inc. Securities Litigation 13-CV-03116-Amended Case 1:13-cv-03116-LGS Document 53 Filed 10/01/13 Page 1 of 40 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK ) ) l3Civ.3116(LGS) IN RE DELCATH SYSTEMS, INC. SECURITIES ) CoccecA. LITIGATION ) AMENDED CLASS ACTION ) COMPLAINT ) JURY TRIAL DEMANDED Lead Plaintiff the Delcath Systems Group, Inc. ("Plaintiff'), individually and on behalf of all other persons similarly situated, by its undersigned attorneys, for its Amended Class Action Complaint against defendants, alleges upon personal knowledge as to itself and its own acts, and upon information and belief as to all other matters, based on, inter alia, the investigation conducted by and through its attorneys, which included, among other things: a review of the defendants' public documents; conference calls and announcements made by defendants; Securities and Exchange Commission ("SEC") filings; wire and press releases published by and regarding Delcath Systems Inc. ("Delcath" or the "Company"); securities analysts' reports and advisories about the Company; and information readily obtainable believes that substantial additional evidentiary support will exist for the after a reasonable opportunity for discovery. NATURE OF THE ACTION 1. This is a securities fraud class action on behalf of a] purchased or otherwise acquired the securities of Delcath during the period from April 21, 2010 through and including September 13, 2013 (the "Class Period"), seeking to pursue remedies under the Securities Exchange Act of 1934 (the "Exchange Act"). This class action is brought under Sections 10(b) and 20(a) of the Exchange Act, 15 U.S.C. §§ 78j(b) and 78t(a); and SEC Rule lOb-S promulgated thereunder by the SEC, 17 C.F.R. § 240.1Ob-5. Case 1:13-cv-03116-LGS Document 53 Filed 10/01/13 Page 2 of 40 under Sections 10(b) and 20(a) of the Exchange Act, 15 U.S.C. §§ 78j(b) and 78t(a); and SEC Rule 10b-5 promulgated thereunder by the SEC, 17 C.F.R. § 240.10b-5. 2. At the outset of the Class Period, Defendants sought approval from the FDA of Delcath’s New Drug Application (“NDA”) for a chemosaturation system with melphalan (the “Melblez Kit”) intended for the treatment of patients with cancer of the eye or skin that causes metastases in the liver (referred to as “unresectable ocular or cutaneous melanoma metastatic to the liver”). This was Delcath’s sole potential drug product, and the Company’s fortunes were inexorably linked to obtaining timely approval for its sale. 3. Throughout the Class Period, Defendants issued materially false and misleading statements regarding the Melblez Kit, which misled investors. In particular, Defendants: 1) failed to disclose the severe toxicity caused by treatment with the Melblez Kit which resulted in the deaths of 7% of the patients treated versus zero deaths in the non-drug group during the study; 2) failed to disclose that nearly 24% of the patients treated with the Melblez Kit suffered Serious Adverse Events; 3) failed to disclose that, after the FDA initially rejected the filing of the Melblez Kit NDA, the Company refiled the NDA with a different filter (critical to reducing toxicities) without having performed clinical trials thereon; and 4) therefore misled investors regarding the “strength” of the clinical results and severity of the side effects as compared to other treatment options given the foregoing. 4. On February 22, 2011, the Company announced that it had received a “Refusal to File” letter from the U.S. Food & Drug Administration (“FDA”) for its Melblez Kit NDA. According to the Company, the letter “requested information involving manufacturing plant inspection timing, product and sterilization validations and additional safety information ... as well as additional statistical analysis clarification.” 2 Case 1:13-cv-03116-LGS Document 53 Filed 10/01/13 Page 3 of 40 5. Nevertheless, the Company continued to tout the strength of the clinical trial data and express its confidence in the future of the Melblez Kit even with the substitution of the new filter, untested on humans, in the resubmitted NDA in 2012. 6. On April 30, 2013, FDA staff published briefing documents ahead of a meeting by the Oncologic Drugs Advisory Committee (“ODAC”) on May 2, 2013. The briefing documents concluded, among other things, that “substantial evidence of effectiveness in adequate and well controlled clinical trials utilizing the proposed drug-device combination product and a favorable benefit risk profile is required for approval.” Moreover, the briefing documents revealed that a staggering 7% of the 122 patients treated with the Melblez Kit died as a result of the treatment. 7. On this news, Delcath shares declined $0.558 per share or over 40%, to close at $0.832 per share on April 30, 2013. 8. On May 2, 2013, the Company announced that the ODAC voted 16 to 0 against approval finding that benefits of treatment with Delcath’s Melblez Kit did not outweigh the risks associated with the procedure. 9. On this news, Delcath shares declined $0.3326 per share or nearly 42%, to close at $0.46 per share on May 3, 2013. 10. On September 13, 2013 the Company announced that it had received a Complete Response Letter (“CRL”) from the FDA declining to approve the Melblez Kit and requesting a new trial to using overall survival as the primary efficacy outcome measure and which demonstrates that the clinical benefits of Melblez Kit outweigh its risks. The CRL also required the Company to conduct a new trial to test the product “the Company intends to market,” i.e., the Melblez Kit with the new filter, previously untested on humans. 3 Case 1:13-cv-03116-LGS Document 53 Filed 10/01/13 Page 4 of 40 11. That same day, the Company also announced the termination of Delcath Chief Executive Officer, Defendant Eamonn P. Hobbs. 12. Delcath shares continued their decline from $0.37 per share to $0.34 cents, a drop of 8.1%. 13. As a result of Defendants’ wrongful acts and omissions, and the precipitous declines in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages. JURISDICTION AND VENUE 14. The claims asserted herein arise under Sections 10(b) and 20(a) of the Exchange Act, 15 U.S.C. §§ 78j(b) and 78t(a), and SEC Rule 10b-5 promulgated thereunder by the SEC, 17 C.F.R. § 240.10b-5. 15. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331 and 1337 and Section 27 of the Exchange Act, 15 U.S.C. § 78aa. 16. Venue is proper in this District pursuant to Section 27 of the Exchange Act, 15 U.S.C. § 78aa and 28 U.S.C. § 1391(b). Many of the acts and transactions alleged herein, including the preparation and dissemination of materially false and misleading information, occurred in substantial part in this District. 17. In connection with the challenged conduct, defendants, directly or indirectly, used the means and instrumentalities of interstate commerce, including, but not limited to, the United States mails, interstate telephone communications and the facilities of the national securities markets. 4 Case 1:13-cv-03116-LGS Document 53 Filed 10/01/13 Page 5 of 40 PARTIES 18. Plaintiffs purchased Delcath securities during the Class Period, and suffered damages as a result of the federal securities law violations and false and/or misleading statements and/or material omissions alleged herein. 19. Defendant Delcath is a Delaware corporation with its principal executive offices located at 600 Fifth Avenue, 23 rd Floor, New York, New York 10020. Delcath claims to have developed a system to isolate the liver from the circulatory system and to administer chemotherapy and other therapeutic agents directly to the liver. This system filters patients’ blood removing most of the harmful chemotherapy agents lessening the side-effects of the treatment. The aggregate number of shares of Delcath securities outstanding as of March 7, 2011 is approximately 43 million shares. Delcath common stock is listed on the NASDAQ Stock Market (“Nasdaq”) under the ticker “DCTH.” 20. Defendant Eamonn P. Hobbs (“Hobbs”) was at all relevant times the Company’s President, Chief Executive Officer (“CEO”) and a director on the Company’s Board of Directors. SUBSTANTIVE ALLEGATIONS Background 21. Delcath is a specialty pharmaceutical and medical device company focused on oncology. According to the Company’s 10-Ks, from inception, the Company has directed its research efforts solely towards the development and clinical study of the Melblez Kit. This drug delivery device is designed to administer high dose chemotherapy and other therapeutic agents to the liver to treat two types of cancer causing metastases in the liver -- unresectable metastatic ocular or cutaneous melanoma occurring exclusively or predominantly in the liver -- while 5 Case 1:13-cv-03116-LGS Document 53 Filed 10/01/13 Page 6 of 40 controlling the systemic exposure of those agents through use of a filter. The device is designed to first isolate the circulatory system of the liver, infuse the liver with chemotherapeutic agent, and then filter the highly toxic melphalan from the blood prior to returning it to the patient’s bloodstream. The Melblez Kit system is intended to address many of the limitations of traditional treatments by permitting the delivery of much higher doses of chemotherapeutic drugs directly to the liver while minimizing the systemic exposure of such drugs. 22. The device portion of the Melblez Kit consists of clamps, tubes and most importantly a filter that isolates a patient's liver from rest of the bloodstream. Once the liver is blocked off, it is bathed in very high doses of the chemotherapy melphalan to kill tumors.
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