In re Biogen Securities Litigation

179 F.R.D. 25, 1997 U.S. Dist. LEXIS 22372, 1997 WL 878301
CourtDistrict Court, D. Massachusetts
DecidedSeptember 4, 1997
DocketNo. Civ. A. 94-12177-PBS
StatusPublished
Cited by16 cases

This text of 179 F.R.D. 25 (In re Biogen Securities Litigation) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Biogen Securities Litigation, 179 F.R.D. 25, 1997 U.S. Dist. LEXIS 22372, 1997 WL 878301 (D. Mass. 1997).

Opinion

MEMORANDUM AND ORDER

SARIS, District Judge.

INTRODUCTION

This case involves a class action alleging securities fraud in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, 15 U.S.C. § 78j(b), 78t(a), and Rule 10(b)-5, promulgated thereunder.1 The de[29]*29fendants are Biogen, Inc., a biopharmaceutieal company and its Chairman and Chief Executive Officer, James L. Vincent. Plaintiffs seek a class of all persons who purchased the common stock of Biogen during the period from January 11, 1994 through and including October 31, 1994, excluding the defendants and certain affiliated parties.

The ease is before this Court on both the defendants’ Motion for Summary Judgment (Docket No. 127) and the plaintiffs’ Motion for Class Certification (Docket No. 125).

After hearing, the Court ALLOWS in part and DENIES in part the defendants’ summary judgment motion. The Court also ALLOWS in part and DENIES in part the plaintiffs, motion to certify a class.

I. BACKGROUND

Drawing all inferences in favor of the non-moving party, the Court treats the following undisputed material facts as true for purposes of ruling on the motions for class certification and summary judgment.

A. Hirulog

Throughout the early 1990s, one of Biog-en’s leading new drug candidates was Hirulog, a blood thinner or anti-clotting agent, which Biogen hoped would replace the drug Heparin in the treatment of cardiovascular disease. As one of Biogen’s two key proprietary drug candidates, Hirulog was projected to serve a market worth hundreds of millions of dollars per year and, by all accounts, was key to the company’s strategy for future growth.

In an effort to obtain Food and Drug Administration (“FDA”) approval of Hirulog, Biogen conducted various tests of the drug, called Phase II and Phase III studies. Phase II studies are controlled clinical trials involving a limited population, usually no more than several hundred subjects, with the disease or condition for which the drugs would be preliminarily marketed. Phase II studies generally last from several months up to two years and are designed to determine the dose-response relationship of a drug for a given target population.

Phase III studies, often called “pivotal” trials, usually include from several hundred to several thousand subjects and provide additional information about effectiveness and safety, and an adequate basis for physician labelling. Phase III tests generally last from one to four years.2 At the time Hirulog was undergoing clinical trials, the FDA generally required two successful Phase III clinical trials as a condition for approving a new drug.

B. TIMI-7 Protocol

In May 1992, Biogen began TIMI-7, a Phase II clinical trial comparing four doses of Hirulog in patients with unstable angina. “TIMI” is the acronym for the Thrombolysis in Myocardial Infarction (TIMI) Trial. The study was conducted by the TIMI office of the National Heart, Lung and Blood Institute, not Biogen. The purpose of TIMI-7 was to identify an efficacious dose of Hirulog in the management of unstable angina, which could then be used in at least one larger Phase III trial (to be called “TIMI-8”) comparing Hirulog against Heparin in the treatment of unstable angina. Angina is chest pain caused by blood clots obstructing the flow of blood. When the frequency of angina becomes greater and more unpredictable, the condition worsens to unstable angina, which carries with it an increased risk of heart attack.

At the same time, Biogen began conducting two large Phase III trials testing Hirulog [30]*30in patients undergoing angioplasty (“angioplasty trial”).

To ensure against bias, the TIMI-7 protocol set forth prospectively-defined primary and secondary endpoints, using double-blinded, randomized data. The primary prospectively-defined endpoint was a composite endpoint called “unsatisfactory outcome,” defined to include any of four adverse events: (1) death, (2) myocardial infarction (“MI”), (3) failure-of-initial therapy, and (4) rapid clinical deterioration. Twenty-four secondary endpoints also were prospectively defined. Patients in the study were divided into four groups, each receiving a different dose of Hirulog. The data from the four groups were then compared at 72 hours following the start of treatment and at six weeks after the start of treatment.

C. TIMI-7 Results

By early September, 1993, Biogen officials learned that the TIMI-7 trial had failed to show efficacy at its primary and secondary endpoints. That is, there was no statistical difference in outcomes across doses, as measured by the pre-determined primary and 24 secondary endpoints.

Nonetheless, the principal investigators, including Dr. Eugene Braunwald, the chair, “scrubbed” the TIMI-7 data looking at it from every possible angle to see how it could help Biogen take the next step. Braunwald is a well known cardiologist at Brigham & Women’s Hospital, who is chair of the Department of Medicine of the Harvard Medical School. This retroactive analysis showed that death or nonfatal myocardial infarction (“MI”) was less in the group of patients who received the higher three doses of Hirulog when compared with those who received the lowest dose.

On December 23, 1993, Biogen reported the results of TIMI-7 to Dr. Stephen Fredd, Director of the FDA’s Gastrointestinal & Coagulation Drugs Division, in a confidential letter explaining that TIMI-7 had failed to show statistically significant evidence that increased doses of Hirulog achieved improved results over Heparin as measured by the primary endpoint of the study. Biogen also submitted to the FDA a protocol for TIMI-8, a proposed Phase III trial to compare the efficacy of Hirulog to Heparin “by the occurrence of death or non-fatal MI from randomization to hospital discharge.” By December 1993, Biogen was considering not proceeding with TIMI-8 if the FDA did not agree at a meeting to occur in February that TIMI-8 could be used as the basis for registration for a NDA without a second Phase III trial.

On February 4, 1994, Biogen representatives met with Dr. Fredd, of the FDA, to discuss the results of TIMI-7 and the proposed TIMI-8 protocol.3 Dr. Fredd warned that the lack of a statistical difference between the various dose groups with respect to the primary endpoint of the TIMI-7 study “raises concern regarding the efficacy of [Hirulog].” Nonetheless, the FDA encouraged Biogen to embark on TIMI-8, a larger, $25 million Phase III follow-up clinical trial, designed to compare Hirulog against Heparin in the treatment of unstable angina. The FDA never actually promised that TIMI-8 would suffice for an NDA application. At $25 million, TIMI-8 was to be the most expensive clinical trial in the company’s history.

D. Biogen’s Public Statements Regarding TIMI-7 Results

1. January 11, 1991 Statement

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

Related

Courter v. CytoDyn Inc
W.D. Washington, 2025
Sec. & Exch. Comm'n v. Johnston
310 F. Supp. 3d 265 (District of Columbia, 2018)
AG Funds, L.P. v. Sanofi
87 F. Supp. 3d 510 (S.D. New York, 2015)
In Re Boston Scientific Corp. Securities Litigation
708 F. Supp. 2d 110 (D. Massachusetts, 2010)
In Re the First Marblehead Corp. Securities Litigation
639 F. Supp. 2d 145 (D. Massachusetts, 2009)
Freeland v. Iridium World Communications Ltd.
545 F. Supp. 2d 59 (District of Columbia, 2008)
In Re Entropin, Inc. Securities Litigation
487 F. Supp. 2d 1141 (C.D. California, 2007)
In Re Vertex Pharmaceuticals, Inc., Securities Litigation
357 F. Supp. 2d 343 (D. Massachusetts, 2005)
Swack v. Credit Suisse First Boston
383 F. Supp. 2d 223 (D. Massachusetts, 2004)
In Re Transkaryotic Therapies, Inc. Securities Litigation
319 F. Supp. 2d 152 (D. Massachusetts, 2004)
Nathenson v. Zonagen Inc.
267 F.3d 400 (Fifth Circuit, 2001)
Reisman v. KPMG Peat Marwick L.L.P.
11 Mass. L. Rptr. 351 (Massachusetts Superior Court, 2000)
Lirette v. Shiva Corp.
27 F. Supp. 2d 268 (D. Massachusetts, 1998)

Cite This Page — Counsel Stack

Bluebook (online)
179 F.R.D. 25, 1997 U.S. Dist. LEXIS 22372, 1997 WL 878301, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-biogen-securities-litigation-mad-1997.