Guo v. Mahaffy

CourtDistrict Court, D. Colorado
DecidedSeptember 29, 2020
Docket1:17-cv-00706
StatusUnknown

This text of Guo v. Mahaffy (Guo v. Mahaffy) is published on Counsel Stack Legal Research, covering District Court, D. Colorado primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Guo v. Mahaffy, (D. Colo. 2020).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLORADO Judge R. Brooke Jackson Civil Action No 17-cv-00706-RBJ WENDUO GUO, derivatively on behalf of Clovis Oncology Inc., Plaintiff, v. PATRICK J. MAHAFFY, DANIEL W. MUEHL, GILLIAN C. IVERS-READ, M.JAMES BARRETT, BRIAN G. ATWOOD, JAMES C. BLAIR, PAUL H. KLINGENSTEIN, EDWARD J. MCKINLEY, THORLEF SPICKSCHEN, KEITH FLAHERTY, GINGER L. GRAHAM, ERLE T. MAST, and ANDREW R. ALLEN, Defendants, and CLOVIS ONCOLOGY, INC., a Delaware corporation, Nominal Defendant. ORDER ON DEFENDANT’S MOTION TO DISMISS This matter is before the Court on defendants’ motion to dismiss. ECF No. 40. For the reasons discussed below, the motion is GRANTED. I. FACTS Nominal Defendant Clovis Oncology, Inc. (“Clovis”) is a biopharmaceutical company. ECF No. 35 at ¶2. Clovis acquires, develops, and commercializes anti-cancer products across the United States, Europe, and other international markets. Id. Individual defendants Patrick J. Mahaffy, Daniel H. Muehl, Gillian C. Ivers-Read, M. James Barrett, Brian G. Atwood, James C. Blair, Paul H. Klingenstein, Edward J. McKinley, Thorleff Spickschen, Keith Flaherty, Ginger L. Graham, Erle T. Mast, and Andrew R. Allen (collectively “individual defendants”) are current and former officers and directors of Clovis. Id. at ¶1. Plaintiff Wenduo Guo is a stockholder of Clovis. Id. at ¶19. He was also a stockholder at the time of the alleged wrongdoing in this case and has maintained his stockholder status continuously since that time. Id.

During the period relevant to this case, Clovis had no marketed products but did have three oncology products under development. Id. at ¶3, 47. One of them, rociletinib, is the focus of this litigation. Id. at ¶3. Rociletinib was intended for the treatment of lung cancer patients resistant to front-line therapies. Id. These patients represented an estimated $3 billion untapped market. Id. at ¶48. Beginning in or about 2013, Clovis began a series of clinical tests to attempt to receive FDA approval for a new drug application (“NDA”) for rociletinib. Id. at ¶4. These tests included “TIGER-X”, a multi-year safety and efficacy trial, and “TIGER-2”, an additional efficacy trial. Both trials were “open label” which meant the trial data was available to defendants throughout the time of the studies. Id. at ¶50.

Plaintiff alleges that, according to defendant Clovis, the “primary endpoint” of these trials was to determine the “objective response rate” (“ORR”) of rociletinib under “Response Evaluation Criteria in Solid Tumors” (“RECIST”) standards. Id. at ¶4. ORR represents the percentage of patients in the trials who experience clinically meaningful tumor shrinkage when being treated with the drug. RECIST standards require that each tumor shrinkage instance be “confirmed” in an additional scan occurring weeks after the first scan. Id. This requirement aims to avoid overestimating response rates. As plaintiff explains, the tumor shrinkage rate cannot be included in the ORR calculation unless it is confirmed through this second scan. Id. In late 2013 pharmaceutical company AstraZeneca disclosed that it was developing a new cancer treatment drug, called Tagrisso. Id. at ¶49. Tagrisso was targeted at the same $3 billion market of treatment-resistant cancer patients. Clovis was thus racing AstraZeneca to develop rociletinib and bring it to market first. Id. In mid-2014 AstraZeneca reported a confirmed ORR for Tagrisso of 54%. Id. at ¶55. A

few weeks later, on May 31, 2014, Clovis reported at the 2014 American Society of Clinical Oncology medical conference that rociletinib exhibited a “58% objective response rate” in its Phase II TIGER-X trial. Clovis also reported that the ORR was evaluated “per RECIST v1.1” standards. Id. That same day Clovis issued a press release, also filed with the Securities and Exchange Commission (“SEC”), which repeated the 58% ORR number. Id. at ¶56. The press release included a statement that Clovis was “extremely pleased with the consistency of the efficacy demonstrated to date, the growing evidence of a lengthy duration of benefit and that [rociletinib] is so well-tolerated with a manageable side effect profile.” Id. This number misrepresented the true ORR of rociletinib because it was not confirmed, as required under

RECIST standards. Nonetheless Clovis’ representatives continued to tout this 58% number and other unconfirmed ORR rates. Id. at ¶¶58–62. According to plaintiff, individual defendants continued to misrepresent the efficacy and safety of rociletinib during and after these trials over a period of years. Through a series of press releases, conference and symposium presentations, investor calls, investor conferences, and a publication in the New England Journal of Medicine, defendants misrepresented the following: that rociletinib trials strictly adhered to RECIST standards; that rociletinib was performing “extremely well” in trials; that rociletinib had an “impressive” and “highly compelling” efficacy profile; that rociletinib had a strong safety profile including minimal and “easily managed” side effects; that rociletinib was “well tolerated;” and that rociletinib would “compete very effectively” with a similar drug called Tagrisso being developed by AstraZeneca. Id. at ¶¶5, 56–74. Clovis held its 2015 Annual Meeting of Stockholders on June 11, 2015. Id. at ¶14. On

April 30, 2015 Clovis filed a proxy statement on Schedule DEF 14A with the Securities and Exchange Commission (“SEC”). This was done upon the directive of individual defendants Mahaffy, Atwood, Barrett, Blair, Flaherty, Graham, Klingenstein, McKinley, and Spickschen. Id. At the time, Mahaffy, Barrett, and Spickschen were members of Clovis’ board of directors. The proxy statement elicited stockholder votes in part to approve their reelection to the board. Id. The proxy statement contained language on the board’s role in risk management and oversight; the audit committee, whose responsibilities included overseeing compliance with legal and regulatory requirements; the corporate governance committee; and the company’s adoption of a Code of Business Ethics. Id. at ¶80.

According to the information defendants provided in the proxy statement and more broadly, things with rociletinib were going well. But on November 16, 2015 Clovis issued a press released titled Clovis Oncology Announces Regulatory Update for Rociletinib NDA Filing, which announced that the 60% ORR it had originally reported was actually “based primarily on unconfirmed responses.” Id. at ¶6, 83. The confirmed response ORR was instead only 28% for patients receiving 500mg doses and 34% for patients receiving 625mg doses. Id. at ¶83. Plaintiff alleges that, as a result of this announcement, Clovis’ stock price decreased nearly 70% from the previous trading day’s closing price of $99.43 to the announcement day’s closing price of $30.24. Id. at ¶7. This represented a loss of $2.6 billion in market capitalization in one day. Id. Nonetheless, after this announcement the individual defendants assured investors that rociletinib had a favorable safety profile and could still be a commercial success. Id. at ¶8, 86. However, rociletinib’s situation got worse, not better. On April 8, 2016 the Food & Drug Administration (“FDA”) publicly disclosed that rociletinib significantly increased the risk of

“serious” and “life threatening” cardiovascular events in patients taking the drug. Id. at ¶9, 87. Among the patients taking rociletinib, 56% interrupted treatment, 51% reduced their doses, and 12% discontinued treatment due to the drug’s adverse side effects. Id. at ¶87. The FDA announcement also stated that rociletinib would need to display the strongest safety warning if ever approved for commercial use. Id. at ¶9. That same day, Clovis’ stock price decreased an additional 17.7%, resulting in a loss of $130.4 million in market capitalization. Id. at ¶10.

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Guo v. Mahaffy, Counsel Stack Legal Research, https://law.counselstack.com/opinion/guo-v-mahaffy-cod-2020.