Zaidi v. Adamas Pharmaceuticals, Inc.

CourtDistrict Court, N.D. California
DecidedJanuary 13, 2023
Docket4:19-cv-08051
StatusUnknown

This text of Zaidi v. Adamas Pharmaceuticals, Inc. (Zaidi v. Adamas Pharmaceuticals, 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
Zaidi v. Adamas Pharmaceuticals, Inc., (N.D. Cal. 2023).

Opinion

1 2 3 UNITED STATES DISTRICT COURT 4 NORTHERN DISTRICT OF CALIFORNIA 5 6 ALI ZAIDI, Case No. 19-cv-08051-JSW

7 Plaintiff, ORDER GRANTING, IN PART, AND 8 v. DENYING, IN PART, MOTION TO DISMISS AND SETTING CASE 9 ADAMAS PHARMACEUTICALS, INC., MANAGEMENT CONFERENCE et al., Re: Dkt. No. 85 10 Defendants.

12 Now before the Court for consideration is the motion to dismiss filed by Defendants 13 Adamas Pharmaceuticals, Inc. (“Adamas”), Gregory T. Went (“Went”), Alfred G. Merriweather 14 (“Merriweather”), and Richard A. King (“King”).1 The Court has considered the parties’ papers, 15 relevant legal authority, and the record in this case, and it HEREBY GRANTS, IN PART, AND 16 DENIES, IN PART, Defendants’ motion, with leave to amend as noted in this Order. 17 BACKGROUND 18 Lead Plaintiff Ralph Martinez (“Martinez”), on behalf of himself and other investors who 19 acquired Adamas securities between August 8, 2017 and March 4, 2019 (the “Class Period”), 20 alleges Defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and 21 Rule 10b-5 promulgated thereunder. 22 On October 8, 2021, the Court granted Defendants’ motion to dismiss Martinez’s first 23 amended complaint (“FAC”), with leave to amend.2 (Dkt. No. 79, “Order”.) As discussed in that 24 Order, Adamas is a pharmaceutical company that specializes in developing treatments for chronic 25

26 1 The Court refers to Went, Merriweather, and King as the “Individual Defendants.” 27 2 Martinez amended the Class Period, which originally ran through September 30, 2019 and 1 neurological disorders, including Parkinson’s disease. Went acted as Adamas’ Chief Executive 2 Officer and its Chairman of the Board of Directors from its founding in 2000 to September 16, 3 2019, when he transitioned to a strategic advisory role. Merriweather acted as Adamas’ Chief 4 Financial Officer from June 2017 until December 31, 2019, when he retired. King acted as 5 Adamas’ Chief Operating Officer from April 27, 2017 to September 15, 2018, when he resigned 6 for personal reasons. (Order at 1:24-2:5; see also Second Amended Class Action Complaint 7 (“SAC”) ¶¶ 28, 30, 32.) 8 One treatment for Parkinson’s is levodopa therapy, which “replaces lost dopamine in 9 patients.” (SAC ¶ 2.) Martinez alleges that a primary side effect of levodopa therapy is 10 dyskinesia: the “involuntary and uncontrolled movements that occur when there is too much 11 dopamine.” (Id.) On August 24, 2017, the Food and Drug Administration (“FDA”) approved 12 Adamas’ drug GOCOVRI for treatment of levodopa-induced-dyskinesia (“LID”). (Id. ¶ 8.) 13 GOCOVRI was the “first drug treatment Adamas … developed and … market[ed] entirely on its 14 own” and was Adamas’ primary source of revenue during the Class Period. (Id. ¶¶ 2, 55.) The 15 drug is an extended release formulation of amantadine, which Martinez alleges had been used to 16 treat LID for decades even though it had not been approved by the FDA for that purpose. (Id. ¶¶ 17 3-4.) Adamas designed GOCOVRI to be administered at night and in a single dose. That dosage 18 would permit maximum concentration of the drug during the day, when dyskinesia would be most 19 bothersome, and would permit a lower concentration at night, when amantadine might impact 20 sleep. These facts purportedly differentiated GOCOVRI from generic immediate-release versions 21 of amantadine (“amantadine IR”), which was designed to be taken in multiple doses throughout 22 the day. (Id. ¶¶ 3-4; see also id. ¶¶ 48-52.) 23 Martinez challenges statements that fall into three categories: (1) payer feedback about 24 GOCOVRI and their decisions about coverage and reimbursement; (2) physicians’ and patients’ 25 responses to GOCOVRI; and (3) the effectiveness of Adamas’ specialty pharmacy (“Onboard”) 26 for distribution and the Onboard process in general. Adamas publicly stated that its success as a 27 company depended upon GOCOVRI’s commercial success. It also made public statements that 1 liability is that the Individual Defendants knew that many – if not all – of these risks had come to 2 fruition by the time they made the challenged statements. 3 For example, Martinez alleges that amantadine IR was significantly cheaper than 4 GOCOVRI and had been used for decades to treat LID. As a result, Adamas needed payers and 5 physicians to differentiate GOCOVRI from amantadine IR. Martinez alleges that before it 6 launched GOCOVRI, Adamas performed surveys of payers to “understand whether and how 7 GOCOVRI would be covered at different price points.” (Id. ¶ 74.) According to Martinez, the 8 survey results “showed payers favored the lowest price range” and that regardless of price, 9 “certain payers indicated that they would impose” access restrictions, including step-through 10 therapy. (Id.) 11 Martinez also alleges that Adamas conducted a survey of physicians in 2017. The results 12 of those surveys allegedly showed physicians did not see a difference between GOCOVRI and 13 amantadine IR. (See, e.g., id. ¶¶ 72-73.) Thus, Martinez alleges that because of GOCOVRI’s cost 14 and the alleged similarity to amantadine IR, Defendants knew from the outset that payers would 15 place restrictions on reimbursements, which would affect the likelihood that physicians would be 16 willing to prescribe and the likelihood that patients would be willing to use GOCOVRI. (See 17 generally SAC ¶¶ 56-60, 86-91.) 18 Martinez also alleges that Adamas’ decision to distribute GOCOVRI through Onboard and 19 its decision not to provide free samples to physicians negatively impacted GOCOVRI’s success. 20 (See, e.g., id. ¶¶ 61-65, 112-113) According to Martinez, despite representations that the Onboard 21 process was “seamless” and that prescriptions were being reimbursed quickly, this was not the 22 case. Those problems with the Onboard program allegedly diminished demand for GOCOVRI. 23 (Id. ¶¶ 111-113.) In addition, on February 20, 2018, the FDA approved OSMOLEX ER, another 24 extended release version of amantadine, for the same indication as amantadine IR. (Id. ¶¶ 92-95.) 25 According to Martinez, OSMOLEX ER posed competition to and further weakened demand for 26 GOCOVRI. 27 The Court will address additional facts as necessary in the analysis. 1 ANALYSIS 2 A. Applicable Pleading Standards. 3 Under Federal Rule of Civil Procedure (“FRCP”) 12(b)(6), the Court generally “is limited 4 to the allegations in the complaint, which are accepted as true and construed in the light most 5 favorable to the plaintiff.” Lazy Y Ranch LTD v. Behrens, 546 F.3d 580, 588 (9th Cir. 2008). 6 However, the Court may consider “documents incorporated into the complaint by reference, and 7 matters of which [the Court] may take judicial notice.” Tellabs, Inc. v. Makor Issues & Rights, 8 Ltd., 551 U.S. 308, 322-23 (2007) (“Tellabs”). Even under the liberal pleadings standard of FRCP 9 8(a)(2), “a plaintiff’s obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’ requires 10 more than labels and conclusions, and a formulaic recitation of the elements of a claim for relief 11 will not do.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citing Papasan v. Allain, 12 478 U.S. 265, 286 (1986)). Pursuant to Twombly, a plaintiff must allege conduct that is not just 13 conceivable; they must allege “enough facts to state a claim to relief that is plausible on its face.” 14 Id. at 570.

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Zaidi v. Adamas Pharmaceuticals, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/zaidi-v-adamas-pharmaceuticals-inc-cand-2023.