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Stanford University Law School
- Securities Class Action Clearinghouse
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MILBERG WEISS BERSHAD
HYNES & LERACH LLP
ALAN SCHULMAN (128661)
600 West Broadway, Suite 1800
San Diego, CA 92101
Telephone: 619/231-1058
BERNSTEIN LITOWITZ BERGER &
GROSSMANN LLP
DANIEL L. BERGER
LISA K. BUCKSER
1285 Avenue of the Americas
33rd Floor
New York, NY 10019
Telephone: 212/554-1400
Attorneys for Plaintiff
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
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ROBERT LEFF, On Behalf of Himself Plaintiff, vs. COR THERAPEUTICS, INC. and
Defendants. |
Case No. C-98-20104-RMW CLASS ACTION COMPLAINT Plaintiff Demands |
1. All allegations made in this Complaint are based on information and belief, except those allegations that pertain to the named plaintiff and his counsel, which are based on personal knowledge. Plaintiff's information and belief is based, inter alia, on the investigation made by and through his attorneys.
2. This Court has jurisdiction over the subject matter of this action pursuant to §27 of the Securities Exchange Act of 1934 (the "Exchange Act"), 15 U.S.C. §78aa, and 28 U.S.C. §§1331 and 1337. The claims alleged herein arise under Sections 10(b) and 20(a) of the Exchange Act, 15 U.S.C. §§78j(b) and 78t(a), and Rule 10b-5 promulgated thereunder by the Securities and Exchange Commission ("SEC"), 17 C.F.R. §240.10b-5.
3. Venue is proper in this District pursuant to §27 of the Exchange Act and 28 U.S.C. §1391. Many of the acts and transactions giving rise to the violations of law complained of herein, including the dissemination to the public of materially false and misleading statements occurred in this District. In addition, at all times relevant hereto, defendant Cor Therapeutics, Inc. ("Cor" or the "Company") had its principal executive offices in this District at 256 East Grand Avenue, South San Francisco, California 94080.
4. In connection with the wrongful acts and conduct alleged herein, the defendants, directly and indirectly, used the means and instrumentalities of interstate commerce, including the United States mail and the facilities of a national securities market.
5. On or about January 28, 1998, plaintiff Robert Leff purchased 300 shares of Cor common stock on the open market, at a price of $20 per share, and suffered damages as a result of the violations of the federal securities laws alleged herein.
6. Defendant Cor is a Delaware corporation with its principal place of business located at 256 East Grand Avenue, South San Francisco, California 94080. Cor is primarily engaged in the business of discovering, developing and marketing biopharmaceutical products that are used to treat and prevent acute cardiovascular diseases such as acute myocardial infarction, unstable angina, abrupt closure following angioplasty, stroke and other diseases. On October 7, 1997, the Company completed a secondary offering by selling 2.9 million shares to the public at $19 per share (the "Offering").
7. At all times relevant hereto, defendant Vaughn M. Kailian ("Kailian") was President, Chief Executive Officer and Director of the Company. Moreover, as of April 29, 1997, Kailian was the largest individual shareholder of Cor common stock, with holdings of 450,225 shares. Throughout the Class Period, Kailian participated in the drafting, preparation and/or approval of various false and misleading statements concerning the results of the clinical trials of the Company's drug Integrilin. Because of Kailian's Board membership, executive and managerial positions, and extensive holdings of Cor common stock, Kailian was responsible for ensuring the truth and accuracy of the various public statements made throughout the Class Period.
8. Kailian had a duty to promptly disseminate accurate and truthful information with respect to the Company and to promptly correct any previously disseminated false or misleading information. As a result of his failure to do so with respect to the public statements of the Company, the market price of Cor common stock was artificially inflated, causing injury to the members of the Class.
9. Kailian, because of his position with the Company, membership on the Board of Cor and extensive ownership of Cor common stock, had the power and influence to direct the management and activities of Cor and its employees, and to cause Cor to engage in the unlawful conduct complained of herein. Accordingly, Kailian was able to, and did, control the Company's statements during the Class Period.
10. Plaintiff brings this action on his own behalf and as a class action pursuant to Rule 23(a) and Rule 23(b)(3) of the Federal Rules of Civil Procedure on behalf of a class (the "Class") of all persons who purchased or otherwise acquired Cor common stock between August 25, 1997 and January 28, 1998, inclusive (the "Class Period"). Excluded from the Class are the defendants herein, members of the immediate family of the Individual Defendant, officers and/or directors of the Company, any person, firm, trust, corporation, officer, director or other individual or entity in which any defendant has a controlling interest or which is related to or affiliated with any of the defendants, and the legal representatives, agents, affiliates, heirs, successors-in-interest or assigns of any such excluded party.
11. The Class is so numerous that joinder of all members is impracticable. Approximately 23.8 million shares of Cor common stock were outstanding as of November 4, 1997. It is believed that thousands of persons purchased Cor common stock during the Class Period, rendering joinder of all such purchasers impracticable.
12. Plaintiff's claims are typical of the claims of the members of the Class. Plaintiff and all members of the Class sustained damages as a result of the wrongful conduct complained of herein.
13. Plaintiff will fairly and adequately protect the interests of the members of the Class and has retained counsel competent and experienced in class and securities litigation. Plaintiff has no interests that are contrary to or in conflict with those of the members of the Class which plaintiff seeks to represent.
14. A class action is superior to other available methods for the fair and efficient adjudication of this controversy. Because the damages suffered by individual Class members may be relatively small, the expense and burden of individual litigation make it virtually impossible for the plaintiff Class members individually to seek redress for the wrongful conduct alleged.
15. Common questions of law and fact exist as to all members of the Class and predominate over any questions solely affecting individual members of the Class. Among the questions of law and fact common to the Class are:
(a) Whether the federal securities laws were violated by defendants' acts as alleged herein;
(b) Whether the documents, releases and statements disseminated to the investing public and stockholders during the Class Period omitted and/or misrepresented material facts about the business affairs of Cor;
(c) Whether Cor's common stock during the Class Period was artificially inflated due to the non-disclosures and/or misstatements complained of herein;
(d) Whether defendants acted willfully, recklessly or with gross negligence in omitting to state and/or misrepresenting material facts; and
(e) Whether the members of the Class have sustained damages and, if so, the appropriate measure thereof.
16. Plaintiff knows of no difficulty that will be encountered in the management of this litigation that would preclude its maintenance as a class action.
17. The names and addresses of the record owners of Cor common stock purchased during the Class Period pursuant to the Offering are available from the Company's transfer agent(s). Notice can be provided to such record owners via first class mail using techniques and a form of notice similar to those customarily used in class actions.
18. Congress and the Food and Drug Administration ("FDA") have established a regulatory framework for testing and reviewing pharmaceutical products for safety and efficacy before they are permitted to be marketed in the United States. This regulatory framework includes procedures for laboratory evaluation of product chemistry and animal testing to preliminarily assess the safety and efficacy of a product.
19. If a company has a promising new drug on which it wishes to conduct further studies, it submits an Investigational New Drug Application ("IND") to the FDA for review prior to initiating testing of a drug. The ensuing clinical investigation of a previously untested drug is generally divided into three or four phases.
20. Clinical studies are conducted pursuant to an FDA approved protocol which sets forth the procedures for the clinical trial including: (a) a clear statement of objectives and methods for final data analysis; (b) a design that may permit comparisons of the test group with a control group to quantitatively determine the study drug's effectiveness and safety; (c) procedures for selecting subjects which include methods for verifying that they have the condition being studied; (d) a method of treatment assignment selected to minimize bias and assure comparability of subjects with respect to age, sex, severity and duration of disease, and uses of concomitant therapy; (e) sufficient blinding procedures to minimize bias on the part of the subjects and investigation team; and (f) outcome measures that are well-defined and reliable.
21. Phase I testing involves the closely monitored initial introduction of an investigational new drug in humans and is ordinarily an open-label or single-blind study designed to provide information about the drug's pharmacokinetics and pharmacological effects and to establish appropriate dosage schedules, dose tolerance and a preliminary side-effect profile of the drug.
22. Phase II studies are controlled clinical studies involving a limited population (typically 50-200 subjects) with the disease or condition for which the drug will be primarily marketed. This phase includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.
23. Phase III studies, which usually include from several hundred to several thousand subjects, begin after the conclusion of Phase II testing which suggests potential effectiveness of the drug, and are intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug, and to provide an adequate basis for physician labeling.
24. After the conclusion of a successful Phase III study or studies, the applicant files a New Drug Application ("NDA") for marketing approval, which provides complete data on the drug's pharmacology, animal toxicology, clinical study results and manufacturing and labeling information. The NDA is reviewed by a team of FDA personnel, usually consisting of a physician, a pharmacologist, a chemist, a pharmacokineticist, and where appropriate, a biometrician or microbiologist. The FDA generally requires an NDA to contain two well-controlled Phase III studies demonstrating the effectiveness of a drug to a statistically significant level (p-value <.05) in order to gain marketing approval.
25. Prior to the FDA's final determination on the approvability of an NDA, an FDA advisory committee reviews the data submitted and makes a recommendation as to whether the NDA should be approved. Although the FDA is not bound by the determination of the advisory committee, it is a rare case in which the FDA will approve the use of a drug after an advisory committee has recommended against it.
26. The development of a pharmaceutical product takes many years and requires companies to invest millions of dollars for research and development. However, if approval is obtained, the rewards are great. FDA approval to market the drug frequently gives the company a large market share, especially where the approval is obtained for a disease for which there are not many treatment options. Moreover, FDA approval, because of its rigorous requirements, usually ensures many other regulatory bodies outside the Untied States will also approve the product for sale.
27. Since its inception, Cor has focused on the discovery and development of pharmaceutical products for the treatment and prevention of severe cardiovascular diseases. However, the Company has not generated any product revenues and, in fact, has been unprofitable since inception and, as of June 30, 1997, had an accumulated deficit of $155,695,000. The key to the Company's future, and the only product in its pipeline, is Integrilin, which is a small synthetic peptide derived from the venom of southeastern Pygmy rattlesnakes that was developed by the Company for use of patients with certain acute cardiovascular indications.
28. In 1995, the Company completed a clinical trial which studied the use of Integrilin in the treatment of elective and urgent coronary angioplasty. Based on the data from this one trial, known as the Impact II trial, Cor submitted an NDA to the FDA in April 1996 seeking approval for the use of Integrilin as an adjunct therapy in helping to prevent acute cardiac ischemic complications in patients undergoing percutaneous transluminal coronary angioplasty.
29. On February 28, 1997, the Company announced in a press release that the FDA's Cardiovascular and Renal Drugs Advisory Committee had recommended against approval of Integrilin because the results of the Impact II trial alone were not sufficiently compelling to forego the FDA's customary requirement of two positive clinical trials prior the approval of a new drug. The Company did not disclose in the press release that in recommending against approval, the advisory committee criticized certain statistical mistakes in Cor's NDA. Unfazed, defendant Kailian was quoted in the press release as stating that "we believe INTEGRILIN (TM) provides real benefit to patients and should be approved."
30. Despite the clear set back to Cor, who had never shown a profit in its entire history, analysts remained hopeful about Integrilin's prospects since the use of Integrilin as an adjunctive therapy in angioplasty was not the drug's most promising indication. According to a March 4, 1997 article in BioWorld Today, "some analysts said the key indication for the drug is unstable angina, currently the focus of a Phase III clinical trial expected to conclude in July." Oppenheimer & Co. ("Oppenheimer") analyst Matthew Geller stated in the article that "'[t]he key indication is unstable angina, which is a potential billion-dollar indication.'"
31. The Company announced on March 25, 1997 that it had received a "not-approvable" letter from the FDA which concurred in the advisory panel's conclusion that the Impact II study was not sufficiently robust as a single study to support approval.
32. As reported on March 27, 1997, defendant Kailian told BioWorld Today that the information that the FDA was seeking would be made available when Cor unblinds its Phase III Pursuit clinical trial for Integrilin for use in connection with unstable angina. Thus, the Company intended to add the results from its clinical trials which tested Integrilin for use in angina patients to its NDA, seeking approval for use of the drug in connection with angioplasty treatment, a completely different indication.
33. Accordingly, the market was anxiously awaiting the results of Cor's Phase III Pursuit trial to see whether the results would be enough to get approval of the drug for patients undergoing angioplasty and, more importantly, whether the drug would prove to be effective for use in the far bigger indication of unstable angina.
34. On August 25, 1997, the first day of the Class Period, the Company announced the results of its Phase III Pursuit trials which were trumpeted as a huge success:
[I]nitial results of the 10,948 patient PURSUIT trial demonstrated that its investigational new drug INTEGRILIN (TM) (eptifibatide) significantly reduced the occurrence of death or heart attack in patients with the serious heart conditions of unstable angina and non-Q-wave myocardial infarction (MI).
The PURSUIT trial, the largest clinical study ever conducted in this patient population, was designed to determine the effect of treatment with INTEGRILIN as an adjunct to current medical and interventional strategies in the treatment of unstable angina and non-Q-wave MI.
* * *
The primary efficacy endpoint of the trial was the prevention of death or myocardial infarction within 30 days following treatment, as adjudicated by the Clinical Events Committee. INTEGRILIN produced a statistically significant reduction in the incidence of death or MI from 15.7% to 14.2% (P=0.04) within 30 days. An absolute reduction of 1.5 percentage points in the rate of death or MI was demonstrated at 96 hours (P=0.011) and 7 days (P=0.016), and this reduction was maintained to 30 days. In addition, treatment with INTEGRILIN resulted in a significant reduction in the combined incidence of death or major MI (as measured by cardiac enzyme levels) from 8.5% to 7.3% (P=0.03) and reduced the incidence of Q-wave myocardial infarction from 1.7% to 1.1% (P=0.02), each within 30 days.
35. The Company's press release also quoted Dr. Robert M. Califf, Professor of Medicine at Duke University Medical Center and Director of the Duke Clinical Research Institute which coordinated the trial in conjunction with the Cleveland Clinic and Cardialysis in Rotterdam, The Netherlands, as stating "'[t]he PURSUIT results demonstrate that this class of agents improves clinical outcomes in the treatment of unstable angina.'"
36. The market was encouraged by the positive results of the Pursuit trial as announced by the Company. Accordingly, the price of Cor common stock increased 11.9% on August 25, 1997 to $12.9375, up from $11.5625 on August 22, 1997, the previous trading day, on extraordinarily high volume of 6,460,800.
37. Analysts also responded favorably to the results. Oppenheimer analyst, Matt Geller, was quoted in BioWorld Today on August 26, 1997 as stating "[w]e believe, based on the size of the trial, the clean primary endpoint and clear statistical significance of an intent-to-treat analysis, that the drug has an extremely high chance of being approved in the United States and abroad." Further, analysts at Oppenheimer, Goldman, Sachs & Co. and Lehman Brothers Inc. all upgraded their ratings on Cor stock based on the results of the Pursuit clinical trials.
38. The Company's stock continued to rise further in the ensuing days with the stock closing at $16.50, an increase of 14.4% on heavy volume on August 29, 1997. An August 29, 1997 article on the Dow Jones News Service stated that analysts attributed the increase in price to the fact that "the positive results from the company's pursuit trial of the heart drug, Integrilin - or eptifibatide - finally sunk in with investors."
39. A September 1, 1997 article in Biotechnology Newswatch stated that "Vaughn Kailian, Cor's President and CEO, said he was 'absolutely delighted' with the results, and the company is currently putting together an amendment to the earlier New Drug Application."
40. Capitalizing on the unbridled optimism surrounding Cor's prospects of obtaining approval of Integrilin for the treatment of angina and non-Q-wave myocardial infarction ("NQMI"), the Company announced on September 8, 1997 that it filed a registration statement with the SEC for a public offering of 2.5 million newly issued shares of Cor common stock.
41. The Company filed an amendment to the registration statement on or about September 16, 1997. The prospectus included in the registration statement reiterated the same positive results of the Pursuit trial as were reported in the Company's August 25, 1997 press release:
In the PURSUIT trial, treatment with INTEGRILIN reduced the occurrence of death or heart attack in patients with unstable angina or non-Q-wave myocardial infarction ("NQMI"). The primary efficacy endpoint of the trial was the prevention of death or myocardial infarction ("MI") within 30 days following randomization. The occurrence of such adverse events was measured by both a Clinical Events Committee ("CEC") and by the individual clinical investigators in the trial. Treatment with INTEGRILIN produced a statistically significant reduction in the incidence of death or MI from 15.7% to 14.2% (p=0.04) within 30 days, which represents 15 fewer adverse events per 1,000 patients, as measured by the CEC. The trial, as assessed by the clinical investigators, also showed positive results, with a reduction in the incidence of adverse events from 10.0% to 8.0% (p=0.0007) within 30 days, which represents 20 fewer adverse events per 1,000 patients.
42. The prospectus also stated that "[b]ased on the positive data from the PURSUIT trial, the Company currently plans to file an amendment to its NDA prior to the end of 1997 to seek marketing approval for unstable angina and NQMI."
43. On October 1, 1997, the Company announced in a press release that it had submitted an amendment to its original NDA that "addresses issues raised in the FDA's action letter of March 1997, and includes clinical data from the PURSUIT trial, which studied the effect of INTEGRILIN(TM) in the treatment of patients with unstable angina and non-Q-wave myocardial infarction."
44. As a result of the Company's dissemination of positive results from the Pursuit clinical trials, the Company was able to drive up the price of its stock from the pre-August 25, 1997 announcement price of $11.5625 and complete a public offering of 3,335,000 shares of common stock at $19 per share -- only seven weeks later. The completion of the offering, which resulted in proceeds of more than $59 million, was announced by the Company on October 13, 1997.
45. Defendants continued to tout Integrilin's prospects at a Company symposium on November 8, 1997. At the symposium, defendant Kailian stated that "'[t]here's a very dramatic reduction in the incidence of death or heart attack in the U.S.'" for patients taking Integrilin. "'It really shows that in the U.S., no matter how these patients were treated, they were getting a benefit.'" Bloomberg reported that Kailian also stated at the symposium that "Integrilin should win U.S. approval based on the overall results of the worldwide study."
46. On January 28, 1998, Cor announced that, contrary to the Company's positive statements throughout the Class Period, the FDA advisory committee concluded that the Pursuit trial was not a sufficient basis for approval of Integrilin in the treatment of unstable angina and NQMI.
47. As reported in Medical Industry Today, on January 29, 1998, during the advisory committee's review of the NDA, panel members questioned Cor's efficacy claims regarding Integrilin's ability to benefit patients undergoing angioplasty. "Specifically, the panel questioned the Company's statistical assumptions and analysis and chided the company for making some of the same statistical mistakes as occurred at the February 1997 [advisory committee] meeting." "The importance of very minor changes in statistical analysis was apparent as neither of Cor's clinical trials definitely reached statistical significance."
48. Reuters also reported on January 29, 1998 that analyst Akhtar Samad said that "the panel took issue with COR's data showing that in its so-called PURSUIT study of almost 11,000 patients with unstable angina, Integrilin reduced the rate of death or serious heart attack from 15.7 percent to 14.2 percent." Samad added that "[t]he panel felt the way COR did its statistical analysis was not done properly" and the results "thus failed to show statistically significant efficacy for the angina patients."
49. Although the FDA advisory committee did recommend that Integrilin be approved for use in the setting of coronary angioplasty, the market was devastated by the news that it would not be approved for the indications that had much greater revenue potential (i.e., unstable angina and NQMI). As a result, trading of the Company's stock was halted on January 28, 1998 and when the stock reopened on January 29, 1998, the stock plummeted to $9.4375, a decline of almost 53% from its closing price of $20 on January 27, 1998.
50. Plaintiff repeats and realleges the allegations set forth above as though fully set forth herein.
51. During the Class Period, defendants carried out a plan, scheme and course of conduct which was intended to and, throughout the Class Period, did: (a) deceive the investing public, including plaintiff and other Class members, as alleged herein; (b) artificially inflate and maintain the market price of Cor securities; (c) cause plaintiff and other members of the Class to purchase Cor securities at inflated prices; and (d) enable the Company to complete a public offering and raise more than $59 million at artificially inflated prices. In furtherance of this unlawful scheme, plan and course of conduct, defendants took the actions set forth herein.
52. Defendants, directly and indirectly, using the means and instrumentalities of interstate commerce, the United States mails and the facilities of the national securities markets, engaged and participated in a continuous course of conduct to purposely misrepresent the results of the Company's Pursuit clinical trials in order to convince the investing public that Cor's Integrilin would be approved for the treatment of angina and non-Q-wave myocardial infarction which would, in turn, lead to tremendous profits for the Company. The defendants are sued either as primary participants in the wrongful and illegal conduct charged herein or as controlling persons as alleged below.
53. As alleged herein, defendants acted with scienter in that they knew, or were reckless in not knowing, that the results of the Pursuit clinical trials were not statistically significant and, therefore, Integrilin could not possibly be approved by the FDA. As alleged herein, the problems with Cor's statistical analysis were the same problems that the advisory committee had criticized a year earlier, putting defendants on notice of the flaws in their statistical analysis. Moreover, defendants knew or should have known that their statistical analysis was flawed because a very small change in the numbers led to a change in the results from statistically significant to statistically insignificant.
54. Defendants were motivated to mislead the public about the prospects for Integrilin's approval so that they could complete the Offering and raise over $59 million for the Company that they could not otherwise have raised.
55. As a result of the dissemination of the materially false and misleading information and failure to disclose material facts, as set forth above, the market price of Cor common stock was artificially inflated during the Class Period. In ignorance of the fact that market prices of Cor's publicly-traded securities were artificially inflated, and relying directly or indirectly on the false and misleading statements made by defendants, or upon the integrity of the market, plaintiff and the other members of the Class acquired Cor's common stock during the Class Period at artificially high prices and were damaged thereby.
56. Had plaintiff and the other members of the Class known the truth concerning the misrepresented and omitted facts described above, they would not have purchased or otherwise acquired their Cor securities during the Class Period, or, if they had acquired such securities during the Class Period, they would not have done so at the artificially inflated prices which they paid.
57. By virtue of the foregoing, defendants have violated Section 10(b) of the Exchange Act, and Rule 10b-5 promulgated thereunder.
58. Plaintiff repeats and realleges the allegations set forth above as if set forth fully herein.
59. Defendant Kailian was a control person of Cor within the meaning of §20(a) of the Exchange Act by virtue of his positions as President, Chief Executive Officer and director of the Company. Accordingly, Kailian had the power to influence and control, and did influence and control, directly or indirectly, the decision-making of the Company, including the content and dissemination of the various statements which plaintiff contends are false and misleading.
60. Defendant Kailian was provided with or had unlimited access to copies of the Company's press releases, public filings and other statements alleged by plaintiff to be misleading prior to and/or shortly after these statements were issued and had the ability to prevent the issuance of the statements or cause the statements to be corrected.
61. As set forth above, defendant Kailian violated §10(b) and Rule 10b-5 by his acts and omissions as alleged in this Complaint. By virtue of his position as a controlling person, t of defendants' wrongful conduct, plaintiff and other members of the Class suffered damages in connection with their purchases of the Company's securities during the Class Period.
WHEREFORE, plaintiff, on his own behalf and on behalf of the Class, prays for judgment as follows:
1. Declaring this action to be a class action properly maintainable pursuant to Rule 23(a) and Rule 23(b)(3) of the Federal Rules of Civil Procedure on behalf of the Class, and declaring plaintiff to be a proper Class representative;
2. Awarding plaintiff and the other members of the Class compensatory damages as a result of the wrongs complained of herein;
3. Awarding plaintiff and the other members of the Class their costs and expenses of this litigation, including reasonable attorneys' and experts' witness fees and other costs and disbursements; and
4. Awarding plaintiff and the other members of the Class such other and further relief as the Court may deem just and proper.
Plaintiff hereby demands a trial by jury.
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DATED: January 30, 1998 |
MILBERG WEISS BERSHAD ______________________________ 600 West Broadway, Suite 1800 BERNSTEIN LITOWITZ BERGER & Attorneys for Plaintiff |
COMPLNTS\CORTHERAP.CPT
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