Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 1 of 99
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MASSACHUSETTS
`
`
`
`OKLAHOMA FIREFIGHTERS PENSION
`AND RETIREMENT SYSTEM,
`
`
`
`
`
`BIOGEN INC., MICHEL VOUNATSOS,
`ALFRED SANDROCK, AND ALISHA
`ALAIMO,
`
`
`
`
`Civil Action No. 1:22-cv-10200-WGY
`
`
`CLASS ACTION COMPLAINT FOR
`VIOLATION OF THE FEDERAL
`SECURITIES LAWS
`
`
`Jury Trial Demanded
`
`Plaintiff,
`
`Defendants.
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`v.
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 2 of 99
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`I.
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`II.
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`III.
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`IV.
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` TABLE OF CONTENTS
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`Introduction ..........................................................................................................................3
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`Jurisdiction and Venue .......................................................................................................12
`
`Parties .................................................................................................................................13
`
`Substantive Allegations .....................................................................................................14
`
`Biogen’s Aging Line of Products and Need for a Blockbuster Replacement ........15
`
`The Development, Failure, and Resurrection of Aduhelm ....................................18
`
`Defendants’ Pre-Class Period Statements Primed the Market to Expect
`Sales of Aduhelm to Take Off Immediately Following FDA Approval ...............22
`
`The FDA’s Controversial Approval of Aduhelm ..................................................27
`
`Former Employees of Biogen and the
`Realities of Aduhelm’s Commercial Rollout .........................................................27
`
`Defendants’ False and Misleading Statements ......................................................48
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Defendants Falsely Claimed 900 Sites Were
`Ready to Implement Treatment After Aduhelm’s Approval .....................49
`
`Defendants Omitted Material Facts
`Concerning Logistical Bottlenecks Associated
`with Confirming Amyloid Beta in Potential Patients ................................51
`
`Defendants Falsely Characterized
`Medicare Coverage as Automatic Following FDA Approval ...................53
`
`Defendants Misleadingly Suggested that
`Third-Party Payors Approved Aduhelm’s
`$56,000 Per Patient, Per Year Price Point .................................................55
`
`Defendants Falsely Characterized the VA’s
`Willingness and Capacity to Cover and Administer Aduhelm ..................58
`
`The Market Slowly Learned that Aduhelm Was Not
`Being Readily Prescribed, That Third-Party Payors,
`Including Medicare, Would Not Pay For Coverage and
`The Entire Stock Price Increase from June 7 Was Eliminated ..............................60
`
`A.
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`B.
`
`C.
`
`D.
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`E.
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`F.
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`G.
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` i
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 3 of 99
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`H.
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`I.
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`J.
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`K.
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`Class Action Allegations........................................................................................81
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`Fraud on the Market ...............................................................................................82
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`No Safe Harbor ......................................................................................................84
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`Loss Causation .......................................................................................................86
`
`Count I
`Violation of § 10(b) of the Exchange Act
`and Rule 10b-5 Promulgated Thereunder ..........................................................................91
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`Count II
`Violation of § 20(a) of the Exchange Act ..........................................................................93
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`V.
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`VI.
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 4 of 99
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`1.
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`Lead Plaintiff, Oklahoma Firefighters Pension and Retirement System (“Lead
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`Plaintiff”), alleges the following based upon the investigation undertaken by Lead Counsel, which
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`included, but was not limited to, the review and analysis of: (i) public filings made by Biogen, Inc.
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`(“Biogen” or the “Company”) with the U.S. Securities and Exchange Commission (the “SEC”);
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`(ii) press releases and other public statements issued by Defendants; (iii) research reports issued
`
`by securities and financial analysts; (iv) media and news reports and other publicly available
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`information about Biogen and Defendants; (v) transcripts of Biogen’s earnings and other
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`conference calls with investors and analysts; (vi) publicly available presentations, press releases,
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`and interviews by Biogen and its employees; (vii) economic analyses of the movement and pricing
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`of Biogen’s publicly traded common stock; and (viii) interviews with former employees (“FEs”)
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`of Biogen.
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`2.
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`Lead Counsel’s investigation into the factual allegations continues, and many of
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`the relevant facts are known only to Defendants or are exclusively within their custody or control.
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`Lead Plaintiff believes that substantial additional evidentiary support will exist for the Complaint’s
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`allegations after a reasonable opportunity for discovery, including access to the materials that
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`Defendants and third parties have produced to, among others, the U.S. Food and Drug
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`Administration (“FDA”), the U.S. Securities and Exchange Commission (“SEC”), the Federal
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`Trade Commission (“FTC”), the U.S. House of Representatives Committee on Oversight and
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`Reform, other federal agencies, and third-parties.
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`3.
`
`This matter is a securities class action brought against Biogen and three of its
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`executives (collectively “Defendants”) for false and misleading statements made to investors in
`
` 1
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 5 of 99
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`connection with the Company’s rollout of aducanumab, branded as Aduhelm1, a monoclonal
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`antibody treatment for Alzheimer’s disease. The putative class is comprised of investors who
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`purchased or otherwise acquired Biogen stock between June 7, 2021, and January 11, 2022,
`
`inclusive (the “Class Period”). Defendants false and misleading statements made in connection
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`with the rollout of Aduhelm violated Sections 10(b) and 20(a) of the Securities Exchange Act of
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`1934 (the “Exchange Act”), 15 U.S.C. §§ 78j(b) and 78t(a) and Rule 10b-5 promulgated
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`thereunder by the SEC, 17 C.F.R. § 240.10b-5.
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`4.
`
`Defendants misled investors as to the commercial readiness for its new drug,
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`Aduhelm through five categories of false and misleading statements concerning the following: (i)
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`the number of sites ready, willing, and able to administer Aduhelm immediately after approval;
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`(ii) the significance of logistical constraints on diagnosing patients; (iii) the degree to which
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`Medicare’s coverage of the treatment was independent of the FDA’s approval of the treatment;
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`(iv) the willingness of third-party payors to cover Aduhelm at a premium price point, or, indeed,
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`at any price point absent peer-reviewed data supporting a determination of the treatment’s clinical
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`effectiveness; and (v)
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`the Veterans Health Administration (the “VA” or “Veterans
`
`Administration”) willingness and capacity to cover and administer Aduhelm for its beneficiaries.
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`In addition to these categories of false and misleading statements, throughout the Class Period,
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`Defendants misled investors as to their irregular interactions with the FDA prior to Aduhelm’s
`
`approval, which later became the subject of investigations by the Inspector General of the
`
`Department of Health and Human Services, and Congress, and contributed to a significant portion
`
`
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`1 For ease of reference, this complaint uses Aduhlem throughout, though prior to FDA approval
`both internal and public documents referring to the treatment routinely refer to the compound’s
`unbranded name, Aducanumab.
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` 2
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 6 of 99
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`of the medical community questioning Aduhelm’s efficacy, driving provider hesitancy to prescribe
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`it. Fueled by Defendants false and misleading statements, Biogen’s stock price skyrocketed
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`following the FDA’s approval of Aduhelm, increasing from $286.14 per share to close at $395.85
`
`on June 7, 2021, a $14.6 billion one day price increase in the Company’s market capitalization. By
`
`the end of the Class Period, after the market came to learn that there was a fraction of the sites
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`actually ready to treat patients, that sales of Aduhelm were significantly slower than expected, that
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`Medicare would not cover most patients, and that most third-party payers balked at Adhulem’s
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`hefty price tag, Biogen’s stock price fell to $225 per share, well-below its pre-FDA approval price,
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`removing all the inflation in Biogen’s stock.
`
`I.
`
`INTRODUCTION
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`5.
`
`Biogen is multinational biotechnology company headquartered in Cambridge,
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`Massachusetts. Since its founding in 1978, the Company has become well known within the
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`biotechnology industry for its focus on the research and development of treatments for multiple
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`sclerosis, Alzheimer’s disease and other chronic neurological diseases and conditions.
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`6.
`
`Biogen’s work developing Aduhelm dates to at least 2007. In 2015, the Company
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`announced positive results from a Phase I trial of the treatment. The prospect of developing and
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`bringing to market the first FDA approved treatment for Alzheimer’s disease had potentially
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`immense implications for the Company as well as the millions of people suffering from the disease
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`and those caring for them. Biogen moved aggressively to pursue this opportunity. In August 2015,
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`Biogen began two simultaneous Phase III efficacy trials for Aduhelm.
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`7.
`
`By 2019, Biogen faced declining sales, increasing competition, or both, for a range
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`of its other products, and it became increasingly clear both within the Company and to investors
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`that the financial trajectory of the Company was intertwined with, if not dependent on, Aduhelm’s
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 7 of 99
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`prospects for regulatory approval and commercialization. There was immense pressure on the
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`Company and its executives to ensure that Aduhelm proved to be both a clinical and commercial
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`success. Indeed, on the day Biogen announced the FDA approved Aduhelm, June 7, 2021, stock
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`market analyst Steven Seedhouse, of CIMB, wrote that Aduhelm “may have saved the company
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`actually given the myriad franchise and competitive risk throughout the rest of their commercial
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`businesses . . ..”
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`8.
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`In March 2019, Biogen, in consultation with a group of outside advisors brought in
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`to conduct a “futility analysis,” determined that there was insufficient evidence of a clinical benefit
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`in patients to justify the submission of Aduhelm for FDA approval. Biogen discontinued
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`Aduhelm’s Phase III trials and announced the disappointing results to investors on March 21, 2019.
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`Biogen’s CEO, Defendant Vounatsos, referred to the failure as “evidence of the complexity of
`
`treating Alzheimer’s Disease and the need to further advance knowledge of neuroscience.” On this
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`news Biogen stock plummeted almost 30%, from $320.59 to $226.88 per share.
`
`9.
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`Some of Biogen’s executives were not prepared to accept this outcome. According
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`to news reports, as early as April 2019, Biogen’s Chief Medical Officer Alfred Sandrock decided
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`to reach out to the FDA to determine if there was any path forward for approval, notwithstanding
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`the results of Aduhelm’s Phase III trials. The head of the FDA’s Division of Neuroscience, Billy
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`Dunn, was a former colleague of Sandrock, and, allegedly, became an internal advocate at the
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`FDA for Aduhelm’s approval.
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`10.
`
`Internally, Biogen’s lobbying campaign with the FDA was called “Project Onyx,”
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`and these efforts are presently the subject Congressional investigations, as well an investigation
`
`by the Office of the Inspector General of U.S. Health and Human Services. The SEC and FTC are
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`also investigating Biogen in connection with Aduhelm’s approval and marketing. Both STAT
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 8 of 99
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`News and the New York Times, in June and July 2021 respectively, wrote exposés on Biogen’s
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`irregular contacts with the FDA to get Aduhelm approved and thereafter, on July 9, 2021, the then
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`Acting Commissioner of the FDA requested the Inspector General of the Department of Human
`
`Services to investigate how Aduhelm received FDA approval noting there was contact between
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`the FDA and Biogen outside the normal course.
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`11.
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`On October 22, 2019, merely half a year after announcing it would not submit
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`Aduhelm for FDA approval, Biogen completely changed course and announced it would be
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`submitting Aduhelm to the FDA for approval as a result of a “new analysis” of the data from the
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`treatment’s Phase III trials. Biogen completed the submission of Aduhelm for FDA approval in
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`July 2020, and, looking ahead to the treatment’s commercial rollout, announced that it had begun
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`efforts to identify potential treatment sites across the country and engage with stakeholders to price
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`the treatment.
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`12.
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`Securing FDA approval for Aduhelm proved to be an uphill battle. On November
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`6, 2020, the FDA’s Peripheral and Central Nervous System Drug Advisory Committee (the “PCNS
`
`Advisory Committee”) unanimously recommended against approving Aduhelm to treat
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`Alzheimer’s disease, based largely on a lack of demonstrable clinical benefit. The Company was
`
`undeterred as Biogen was reportedly informed by Dunn that the FDA would approve Aduhelm.
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`Indeed, by spring of 2021, Biogen had substantially ramped up its nationwide campaign to identify
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`potential treatment sites and “educate” healthcare providers and other stakeholders about
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`Aduhelm’s benefits to prepare for Aduhelm’s rollout following the FDA’s anticipated approval of
`
`the treatment.
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`13.
`
`Before the Class Period, Defendants began to tell investors that Biogen would be
`
`ready to immediately begin commercial sales of Aduhelm after its approval by the FDA. For
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 9 of 99
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`example, on an earnings conference call on February 3, 2020, Defendant Vounatsos said that
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`Biogen was “ready to launch [Aduhelm] in the U.S., if and when it is approved. . . . We believe
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`there are several hundred sites in the U.S. that are ready to start treating patients should [Aduhelm]
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`be approved.” On the same call, in discussing the price for Aduhelm, Vounatsos said “we are
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`getting there. We had very large engagements with many stakeholders.” On an April 22, 2021
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`earnings call Vounatsos said that “[w]e anticipate approximately 600 ready-to-treat [Aduhelm
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`sites], but many more in the works.” And, he said, in response to an analysts’ question, that
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`“[c]oncerning price, I think that we are there, Mike. We have done a thorough engagement with
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`different stakeholders, considering the burden of the disease and the clinical meaningfulness that
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`[Aduhelm] will bring.”
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`14.
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`On June 7, 2021, the FDA approved Aduhelm through its Accelerated Approval
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`process for the treatment of Alzheimer’s disease. In public statements the same day, Biogen
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`announced it would price Aduhelm at approximately $56,000 per person, per year. That day, in
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`various interviews, Vounatsos told investors that there were 900 sites ready to start treating patients
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`and Biogen was ready to ship millions of doses of the treatment. Investors also knew from
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`Vounatsos’ prior statements that Biogen had done a “thorough engagement” on price with
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`stakeholders, including private and public payers – a point he emphasized in interviews the same
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`day. And investors knew from Vounatsos’ prior statements that that at least 600 sites were ready
`
`to start treatment. Investors believed Aduhelm was primed to be a blockbuster drug for Biogen.
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`Biogen’s stock skyrocketed by over $100 per share, representing an increase in market
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`capitalization of approximately $14.6 billion on June 7, 2021.
`
`15.
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`Stock market analysts reacted positively to the news. For example, CIMB’s
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`Seedhouse wrote “Upgrade to Market Perform; [wide-eyed emoji]; Bring on the ~$330B Market
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 10 of 99
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`Opportunity.” Guggenheim’s Yatin Suneja and Eddie Hickman wrote “[Biogen] – Adu Priced at
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`$56k/Year vs. our $50k Est; [Biogen] Est 1-2MM Addressable Patients With Amyloid Pathology,
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`Implying a $50-100B TAM.” Analysts from BTIG wrote “We have probably been more positive
`
`on the chances for approval than consensus but fairly skeptical on commercialization due to
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`possible scan requirements and the potential for serious [adverse effects]. . . . The three required.
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`. . scans seem a moderate requirement relative to the numbers in most trials and could aid in the
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`rollout.”
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`16.
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`The next day, June 8, 2021, in both press releases and during a conference call with
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`investors, Defendants focused their comments on Aduhelm’s commercial rollout – and made false
`
`and misleading statements about five topics: (i) the number of sites ready, willing and able to
`
`administer Aduhelm in the near-term; (ii) the significance of logistical constraints on diagnosing
`
`potential patients; (iii) the degree to which Medicare’s coverage of the treatment was independent
`
`of the FDA’s approval of the treatment; (iv) the willingness of third-party payors to cover Aduhelm
`
`at a premium price-point, or, indeed, at any price-point absent peer-reviewed data supporting a
`
`determination of the treatment’s clinical effectiveness; and (v) the VA’s willingness and capacity
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`to cover and administer Aduhelm for its beneficiaries. Defendants also omitted to reveal the
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`unusual relationship between Biogen and the FDA that led to Accelerated Approval of Aduhelm.
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`Among other reasons, as it became known during the Class Period, this unusual relationship
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`contributed to skepticism among the medical community in deciding whether to prescribe
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`Aduhelm to their patients and was one reason many members of the medical community decided
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`to wait for Biogen to publish peer reviewed data before they would prescribe the treatment. These
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`false and misleading statements and material omissions all created the picture that Aduhelm was
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`ready to be administered in the United States at hundreds of sites, that pricing would not be an
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 11 of 99
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`obstacle, and that Medicare coverage after FDA approval was “automatic.” Biogen’s stock price
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`rose again on June 8, 2021 to close at $406.14 per share.
`
`17.
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`First, Defendants statements that there were “900 sites ready to implement
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`treatment with Aduhelm” in the United States at the time of FDA approval was false and materially
`
`misleading when made. Multiple former employees of Biogen have confirmed this claim was false
`
`and that the actual number of treatment sites ready, willing, and able to administer Aduhelm was,
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`far lower, and that Biogen’s executives either knew or recklessly disregarded the truth that the
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`number of sites ready to administer Aduhelm was significantly lower than 900. Indeed,
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`approximately 6 weeks later, Vounatsos admitted that of the 900 sites, only 325 were actually
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`ready to treat as only 325 had completed an internal “pharmacy and therapeutics committee
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`reviews” also called “P&T” - which required review of the FDA’s approval of the drug, label, cost
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`and whether the treatment would be covered by third-party payers – none of which could have
`
`occurred prior to June 7, 2021. By September 2021, Vounatsos and Alaimo admitted that only 50
`
`sites were actually administering Aduhelm, .055% of the number investors were told were “ready
`
`to treat” on day one.
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`18.
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`Second, Defendants mislead investors by downplaying the significance of logistical
`
`constraints on identifying the presence of amyloid beta in potential Aduhelm patients. Defendants
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`stated that most physicians would want to determine the presence of amyloid beta in a patient
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`before prescribing Aduhelm to treat that patient. There are two methods to test for amyloid beta in
`
`an individual: securing brain imaging via positron-emission tomography (a “PET scan”) or a
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`lumbar puncture via a spinal tap to test the cerebrospinal fluid (CSF) of the patient. Defendants
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`acknowledged that PET scans were not covered by Medicare and were quite expensive, so most
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`patients would not use a PET scan to test for amyloid beta. During the clinical trials, PET scans,
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 12 of 99
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`paid for by Biogen, were used to determine the presence of amyloid beta. As for CSFs, Defendants
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`touted a partnership with Labcorp and Mayo Clinic Laboratories to test the cerebrospinal fluid of
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`potential patients for evidence of amyloid beta, suggesting they had created a relatively simple
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`pathway for patients to be tested for the presence of amyloid beta, which would lead to the patient
`
`being prescribed Aduhelm. Defendants omitted to reveal, however, that Biogen’s sales force had
`
`encountered tremendous resistance, if not downright hostility, from doctors when they suggested
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`CSF analysis as a means to test for amyloid beta. Many healthcare providers opposed referring
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`elderly patients with dementia or Alzheimer’s for a lumbar puncture, more commonly known as a
`
`spinal tap. A lumbar puncture was simply not an option for a significant portion of the population
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`described by Defendants as potential Aduhelm patients, whether because of age, infirmity, other
`
`complicating health factors, or simply because of their healthcare provider’s unwillingness to
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`recommend a painful, exhausting, and sometimes dangerous procedure as a prerequisite to
`
`receiving a treatment of doubtful clinical benefit. Plus, many of the sites at which the lumbar
`
`puncture was required to be performed were reluctant to perform them as the reimbursement rates
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`were quite low and the sites would make more money performing other procedures. Importantly,
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`Biogen’s former employees repeatedly emphasized these logistical and economic constraints
`
`during their evaluations of potential treatment sites. Defendants knew or recklessly disregarded
`
`the truth that there was a major bottleneck preventing most patients from even receiving a
`
`diagnosis sufficient to warrant them to begin receiving Aduhelm to treat dementia, cognitive
`
`decline, or Alzheimers disease.
`
`19.
`
`Third, Defendants characterized Medicare’s coverage of Aduhelm as
`
`“automatically presumed” following FDA approval – a point emphasized by several influential
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`market analysts. These characterizations were false and misrepresented that Medicare coverage
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 13 of 99
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`was “automatically presumed” once the FDA approved Aduhelm. Ultimately, as described below,
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`the U.S. Centers for Medicare and Medicaid Services (“CMS”) engaged in a National Coverage
`
`Determination (“NCD”) with respect to Aduhelm and eventually determined that Medicare
`
`coverage for Aduhelm would be limited to reimbursement for treatments administered to patients
`
`enrolled in CMS-approved randomized clinical trials. Coverage was not “automatic.”
`
`20.
`
`Fourth, Defendants misleadingly suggested that third-party payors had expressed
`
`support, approval, or, at a minimum, a willingness to accept Aduhelm’s initial annual price point
`
`of $56,000 per patient. Defendants attributed their confidence in the treatment’s pricing to
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`“engagement” with both public and private “stakeholders, including clinical experts, health
`
`economics, policymakers and payers. . .” and claimed that the price “reflected the overall value
`
`the treatment” would bring to “patients, caregivers and society.” In truth, many third-party payors
`
`balked at Aduhelm’s price point.
`
`21.
`
`Defendants also omitted to reveal that many healthcare providers were unwilling to
`
`provide the treatment at any price until they could see peer-reviewed data supporting the
`
`treatment’s clinical benefit – a problem repeatedly identified to Biogen’s executives according to
`
`former employees. Defendants Vounatsos and Alaimo admitted as much at a September 9, 2021,
`
`Morgan Stanley HealthCare Conference. Plus, Bloomberg news published a survey on November
`
`18, 2021 that “[n]one of the 25 large insurers that responded to a Bloomberg News survey judged
`
`the $56,000-a-year drug “medically necessary. . . . Insurers cited uncertainty about benefits and
`
`side effects for their denials.” By late December 2021, Biogen announced that it would cut the
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`annual price of Aduhelm in half, down to $28,200, effectively acknowledging that its initial
`
`representations about the treatment’s pricing being the result of constructive engagement with
`
`payers and other stakeholders were untrue.
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 14 of 99
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`22.
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`Fifth, Defendants made false and misleading statements about the Veterans
`
`Administration’s willingness and capacity to cover and administer the treatment of Aduhelm for
`
`eligible beneficiaries. A number of Biogen’s former employees have confirmed that VA sites first
`
`coded by Biogen as “ready” to administer Aduhelm were, in fact, either known to be lacking the
`
`requisite medical infrastructure to provide the treatment or had not been evaluated at all because
`
`of the VA’s unwillingness to provide access to such sites during the Covid-19 pandemic. At least
`
`one former employee of Biogen has stated that a leading VA advisor, Dr. Andrew Budson,
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`conveyed to Biogen’s medical science liaison, Johannah Venturini, prior to the start of the Class
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`Period, that he did not support the VA covering Aduhelm.
`
`23.
`
`Finally, Healthcare providers were aware of the controversy surrounding FDA
`
`approval of Aduhelm and wanted to see peer-reviewed data to confirm the drug’s benefits. The
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`controversial nature of the approval led many healthcare providers to take a skeptical and dim view
`
`of the drug and wait to see the peer reviewed data, which led to limited sales of Aduhelm.
`
`24.
`
`As the truth about Aduhelm emerged, Biogen’s share price declined. During and
`
`by the end of the Class Period, Defendants acknowledged that the treatment was not actually
`
`available at 900 sites, bottlenecks relating to confirming the presence of amyloid beta had
`
`substantially curtailed sales, Biogen cut the price of the treatment in half in response to objections
`
`raised by the same stakeholders it had claimed to have engaged with on the issue of price, the VA
`
`had refused to include Aduhelm in its formulary, and the FDA’s approval of Aduhelm was the
`
`subject of multiple governmental investigations.
`
`25.
`
`On January 11, 2022, after the close of stock trading, CMS released its draft
`
`opinion, limiting Medicare reimbursement for Aduhelm to patients enrolled in ongoing clinical
`
`trials – effectively contradicting Biogen’s claim that Medicare coverage was automatic following
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 15 of 99
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`FDA approval. On January 12, 2022, Biogen’s stock price fell by $16.18 per share to close at $225
`
`per share.
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`26.
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`After the Class Period, Biogen replaced Vounatsos as CEO, terminated its entire
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`Aduhelm sales force, and effectively abandoned Aduhelm as a commercial drug.
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`II.
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`JURISDICTION AND VENUE
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`27.
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` The federal law claims asserted herein arise under §§ 10(b) and 20(a) of the
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`Exchange Act, 15 U.S.C. § 78j(b) and 78t(a), and Rule 10b-5 promulgated thereunder by the SEC,
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`17 C.F.R. § 240.10b-5, as well as under the common law.
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`28.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
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`§1331 and § 27 of the Exchange Act, 15 U.S.C. § 78aa and 28 U.S.C. § 1331.
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`29.
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`In connection with the acts and conduct alleged in this Complaint, Defendants,
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`directly or indirectly, used the means and instrumentalities of interstate commerce including, but
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`not limited to, the mails, interstate telephone communications, and the facilities of the NASDAQ
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`Stock Market, a national securities exchange. In connection with the acts and omissions at issue in
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`this action, this Court has jurisdiction over each Defendant named herein because each Defendant
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`is an individual or corporation with sufficient minimum contacts with this District so as to render
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`the exercise of jurisdiction by the District Court permissible under traditional notions of fair play
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`and substantial justice.
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`30.
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`Venue is proper in this judicial district pursuant to Section 27 of the Exchange Act,
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`15 U.S.C. § 78aa and 28 U.S.C. § 1931(b). Biogen maintains its corporate headquarters in this
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`district, and did so at all relevant times, and many of the acts and conduct that constitute the
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`violation of law complained of herein, including dissemination to the public of materially false or
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`misleading information, occurred in and/or were issued from this District.
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 16 of 99
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`III. PARTIES
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`31.
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`Lead Plaintiff, Oklahoma Firefighters Pension and Retirement System, is the state
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`agency responsible for administering the public pension system for all firefighters in Oklahoma.
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`Created in 1980, it oversees over $3.52 billion of assets, as of June 30, 2021, and manages the
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`retirement benefits, disability benefits, surviving spouse benefits, and death benefits.
`
`32.
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`Defendant Biogen, Inc, is incorporated in the State of Delaware and has its
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`headquartered in Cambridge, Massachusetts. The Company’s stock trades on the NASDAQ under
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`the ticker symbol “BIIB.”
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`33.
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`Defendant Michel Vounatsos is and was at all relevant times the Chief Executive
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`Officer of Biogen.
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`34.
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`Defendant Alfred Sandrock was the Chief Medical Officer of Biogen throughout
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`the class period until December 31, 2021.
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`35.
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`Defendant Alisha Alaimo is and was at all relevant times the President of Biogen
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`U.S.
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`36.
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`Collectively, Defendant Vounatsos, Sandrock, and Alaimo, are referred throughout
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`this complaint as the “Individual Defendants.”
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`37.
`
`The Individual Defendants, because of their positions at the Company, possessed
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`the power and authority to control the content and form of the Company’s annual reports, quarterly
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`reports, press releases, investor presentations, and other materials provided to the SEC, securities
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`analysts, money and portfolio managers, and investors. Each of the Individual Defendants
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`authorized the publication of the documents, presentations, and materials alleged herein to be
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`misleading prior to its issuance and had the ability and opportunity to prevent the issuance of these
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`false statements or to cause them to be corrected. Additionally, the Individual Defendants were
`
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`Case 1:22-cv-10200-WGY Document 30 Filed 06/27/22 Page 17 of 99
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`responsible for strategic decisions at the Company that resulted in all allegations. Because of their
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`positions with the Company and access to material non-public information available to them, but
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`not to the public, the Individual Defendants knew that the adverse facts specified herein had not
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`been disclosed to and were being concealed from the public and that the positive representations
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`being made were false and misleading.
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`IV.
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`SUBSTANTIVE ALLEGATIONS
`
`38.
`
`Biogen is a global biopharmaceutical company focused on the research,
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`development, production, and sale of pharmaceutical treatments for serious neurological and
`
`neurodegenerative diseases. As noted above, Biogen’s work developing Aduhelm dates to at least
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`2007.
`
`39.
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`Aduhelm is a monoclonal antibody treatment that purports to reduce the build-up
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`of amyloid beta in the brain. Amyloid beta is correlated with Alzheimer’s disease and some
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`research suggests that reduction of amyloid beta could be an avenue for the prevention and
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`treatment of neurological decline from Alzheimer’s disease and dementia. However, a significant
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`percentage of the population of individuals diagnosed with Alzheimer’s disease will test negative
`
`for the presence of amyloid beta in the brain.
`
`40.
`
`During the Class Period, confirming the presence of amyloid beta in a patient,
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`required either a PET scan, costing typically cost around $5,000 and ordinarily not covered by
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`insurance, or an analysis of sample cerebrospinal fluid (“CSF”) drawn from a lumbar puncture,
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`also called a spinal tap, usually costing between $800 to $1,00