Applestein v. Medivation, Inc.

861 F. Supp. 2d 1030, 2012 WL 986276, 2012 U.S. Dist. LEXIS 39360
CourtDistrict Court, N.D. California
DecidedMarch 22, 2012
DocketNo. C-10-0998 EMC
StatusPublished
Cited by9 cases

This text of 861 F. Supp. 2d 1030 (Applestein v. Medivation, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Applestein v. Medivation, Inc., 861 F. Supp. 2d 1030, 2012 WL 986276, 2012 U.S. Dist. LEXIS 39360 (N.D. Cal. 2012).

Opinion

ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS PLAINTIFFS’ THIRD AMENDED COMPLAINT

EDWARD M. CHEN, District Judge.

Defendants’ motion to dismiss Plaintiffs’ third amended complaint came on for [1033]*1033hearing before the Court on March 16, 2012. Docket No. 147. For the reasons set forth below, the Court GRANTS Defendants’ motion to dismiss.

I. FACTUAL & PROCEDURAL HISTORY

Lead Plaintiff Catoosa Fund LP filed this securities class action against Defendants Medivation, Inc. and Medivation senior officers David T. Hung, C. Patrick Machado, Lynn Seely, and Gregory Bailey.

Plaintiffs’ case concerns the clinical testing of Dimebon for use in treating Alzheimer’s disease. Docket No. 147 ¶ 3 (“TAC”). In general, to receive approval by the Food and Drug Administration (“FDA”), a manufacturer must demonstrate the drug’s safety and effectiveness. TAC ¶ 35. Approval by the FDA involves three phases of clinical trials on humans. TAC ¶ 38. Phase 1 is a preliminary test that assesses “whether small doses of the drug causes any immediate safety problems that could make continuation of the trial impossible.” TAC ¶39. Phase 2 tests the effectiveness of the drug and is often a double-blind test where neither the investigators nor the patients know which group of patients is receiving the active drug or the placebo. TAC ¶ 40. Approximately 33% of drugs are successful at Phase 2. TAC ¶41. Phase 3 primarily focuses on confirming that the drug is effective and safe, and involves thousands of patients to produce additional information about the effectiveness and safety of the drug. TAC ¶ 42. Plaintiffs allege that 90% of drugs that reach a Phase 3 trial are successful in confirming the effectiveness and safety of the drug. TAC ¶ 43.

Dimebon was originally approved in Russia as an over-the-counter oral antihistamine for the treatment of allergies. TAC ¶ 46. Testing of Dimebon for the treatment of Alzheimer’s disease began in Russia in the early 1990s. TAC ¶ 47. In 2001, Dimebon passed the Phase 1 study based on a clinical study involving 14 patients in Russia. TAC ¶¶ 52, 53.

In October 2003, Defendant Medivation bought the rights to Dimebon. TAC ¶ 54. Defendants then conducted a 6-month Phase 2 Dimebon Alzheimer’s study that involved 183 patients at 11 different sites in Russia. TAC ¶¶ 55, 56, 64. Plaintiffs allege that Defendants did not, contrary to their public representations, conduct a double-blind test. The test was not double-blind because the Dimebon pills used were distinguishable from the placebo by taste and appearance. TAC ¶ 65.

In support of this allegation, Plaintiffs offer the statements of three confidential witnesses who are employed by Orgánica, the Russian pharmaceutical company which produced the Dimebon pills for Defendants’ Phase 2 study. TAC ¶ 66. CW-1 is a Senior Technology Engineer who informed CW-2 that Orgánica supplied uncoated Dimebon pills for Defendants’ Phase 2 study. TAC ¶¶ 67, 68. As a result, the Dimebon pills were distinctly bitter. TAC ¶ 68. CW-3 is a longtime Orgánica employee responsible for testing new medicines, who informed CW-2 that Orgánica supplied both the Dimebon pills and placebos for Defendants’ Phase 2 studies and that Orgánica failed to produce placebo tablets that matched the Dimebon pills. TAC ¶ 70. This failure allegedly resulted in Dimebon pills and placebos that were distinguishable by taste and appearance. TAC ¶ 70. Finally, CW-2 is a member of Organica’s board, who after consulting with CW-1 and CW-3, verified that Orgánica provided uncoated Dimebon pills and unmatched placebos for Defendants’ Phase 2 studies. TAC ¶ 69. Plaintiffs also offer Dr. Lon S. Schneider’s statement as corroboration of the statements by the confidential witnesses. Dr. Schneider believes that the active Dimebon [1034]*1034and placebos were distinguishable for two reasons. TAC ¶ 73. First, Dr. Schneider cites Defendants’ failure to describe in detail the pills used in the study in their clinical trial paper as suspicious. TAC ¶ 75. Second, Dr. Schneider states that his unnamed colleague attended a presentation where Defendants Hung and Seely admitted that the Phase 2 studies were not identical. TAC ¶ 76.

Plaintiffs allege that because the Dimebon pill was easily distinguishable from the placebo and thus the Phase-2 test was unblinded (TAC ¶ 77), the test results were biased; patients would know they were receiving Dimebon and would be more likely to report favorable outcomes because they expected a benefit. TAC ¶ 62. In addition, investigators would be less likely to identify and report treatment responses in the no-treatment group while being more sensitive to favorable outcomes in patients in the treatment group. TAC ¶ 62.

In September 2006, Defendant Medivation announced that the Phase 2 test was a success, and that Dimebon “met all efficacy endpoints in a ‘randomized, double-blinded placebo-controlled Phase 2 study of 183 patients with mild to moderate Alzheimer’s disease conducted in 11 sites in Russia.” TAC ¶ 90. The reported results were so strong that some scientists believed Dimebon would win FDA approval even if the Phase 3 results were “only half as good as the original.” TAC ¶ 93. According to Plaintiffs, Defendants misrepresented facts about the validity of the Phase 2 study and concealed the fact that the study was not double-blind and was hence flawed.

After the results were reported, Defendant Medivation’s stock surged to a 52-week high with a price increase of 38.84%. TAC ¶ 12. Plaintiffs allege that Individual Defendants subsequently sold almost 1 million shares of Medivation common stock for proceeds of almost $22 million. TAC ¶ 182. Two years after announcing the Phase 2 study results, Medivation entered into an agreement with Pfizer, Inc., giving Medivation an up-front cash payment of $225 million. TAC ¶ 12.

Defendants entered into the Phase 3 study for Dimebon. Plaintiffs allege that unlike the Phase 2 study, the Phase 3 study was conducted largely in the United States and was actually double-blinded because the Dimebon pills were coated. TAC ¶¶ 100, 102. The double-blind Phase 3 test “failed miserably — patients treated with Dimebon had no statistically significant improvements.... Defendants reported that the Dimebon patients and the placebo patients were essentially unimproved.” TAC ¶ 103. After Defendants announced the disappointing Phase 3 results on March 3, 2010, Medivation’s shares dropped 67% from $50.25 to $13.10, for a total loss of $923,217,234. TAC ¶¶ 14,165.

Based on these allegations, Plaintiffs assert two class claims: (1) a claim for securities fraud pursuant to Securities Exchange Act § 10(b) and Rule 10b-5, and (2) a derivative claim under Securities Exchange Act § 20(a). In August 2011, 2011 WL 3651149, the Court dismissed Plaintiffs’ Consolidated Amended Complaint (“CAC”) on the ground that Plaintiffs failed to plead allegations giving rise to a strong inference of scienter. Docket No. 129 at 16 (“Dismissal Order”). Plaintiffs were given leave to file an amended complaint to add additional factual allegations. Dismissal Order at 16. In November 2011, Plaintiffs filed a Second Amended Complaint (“SAC”), including statements by CW-1 and CW-2 that Orgánica produced uncoated Dimebon pills for the Phase 2 study but did not produce the placebo pills. Docket No. 138 ¶¶ 68, 69 (“SAC”). Shortly after filing the SAC, [1035]

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
861 F. Supp. 2d 1030, 2012 WL 986276, 2012 U.S. Dist. LEXIS 39360, Counsel Stack Legal Research, https://law.counselstack.com/opinion/applestein-v-medivation-inc-cand-2012.