In re Biosante Pharmaceuticals, Inc.

968 F. Supp. 2d 940, 2013 WL 4829122, 2013 U.S. Dist. LEXIS 129334
CourtDistrict Court, N.D. Illinois
DecidedSeptember 11, 2013
DocketCase No. 12 C 3480
StatusPublished

This text of 968 F. Supp. 2d 940 (In re Biosante Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Biosante Pharmaceuticals, Inc., 968 F. Supp. 2d 940, 2013 WL 4829122, 2013 U.S. Dist. LEXIS 129334 (N.D. Ill. 2013).

Opinion

MEMORANDUM OPINION AND ORDER

JOAN B. GOTTSCHALL, District Judge.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante developed LibiGel, a low-dose transdermal testosterone gel. LibiGel was meant to treat women with hypoactive sexual desire disorder (“HSDD”), which is a form of female sexual dysfunction (“FSD”). This shareholder derivative action against BioSante’s board of directors (Louis Sullivan, Steven Simes, Fred Holubow, Ross Mangano, Edward Rosenow, Stephen Sherwin, and John Potts) is based on many of the same events underlying a direct putative class action securities case captioned Lauria v. BioSante, et al., 12 C 772, also assigned to this court. LibiGel’s failure to perform well in Phase III efficacy trials caused BioSante’s stock price to drop and is at the heart of both actions. The defendants seek to dismiss the complaint in its entirety.1 For the following reasons, the motion to dismiss is granted, and the plaintiffs are given 28 days to amend their complaint if they choose to do so.

I. Background 2

BioSante, a Delaware corporation, is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. At all times relevant to this action, BioSante’s primary product in development was LibiGel, a transdermal testosterone gel for the treatment of HSDD.

The plaintiffs contend that the defendants “breached their fiduciary duty of loyalty by making or causing to be made false and misleading statements about the commercial viability, efficacy, and market potential for LibiGel.” Compl. at ¶ 2. They also allege that the defendants breached their duties of oversight by [944]*944“recklessly and/or negligently disregarding] the wrongs complained of----” Id. at ¶ 91. Specifically, the plaintiffs assert that the defendants failed to inform shareholders that the “placebo effect” would prevent LibiGel from being approved for sale.

The placebo effect, in this context, is a function of psychological factors related to female sexual desire. Generally, women who enroll in sexual dysfunction studies are already interested in improving their sex lives. In most cases, the studies reinforce this desire by requiring participants to record their sexual experiences. As a result, placebos often perform as well as medication, and, the plaintiffs argue, a common result is that drugs designed to treat HSDD do not meaningfully outperform placebos in the treatment of female sexual dysfunction.

The plaintiffs assert that BioSante failed to structure the LibiGel trials in a manner that would minimize the placebo effect, or to inform shareholders that the manner in which the trials were conducted was likely to enhance the placebo effect. Claiming that the placebo effect destroyed the prospects of every previous effort to bring to market a drug to treat female sexual dysfunction, the plaintiffs take issue with BioSante’s representations that it expected LibiGel to be the first drug approved to treat HSDD and criticize the lack of disclosures about the placebo effect.

The plaintiffs also stress that during LibiGel’s Phase III clinical trials, the FDA recommended against approving Flibanserin (another treatment for female sexual dysfunction) because the placebo effect prevented Flibanserin’s manufacturer from demonstrating that its medication worked. In response to the FDA’s announcement about Flibanserin, BioSante issued a press release stating that “[g]iven the recommendation of the Advisory Committee [about Flibanserin], we believe that LibiGel is positioned to be the first product approved for the treatment of HSDD.” Id. at 143.

Next, the plaintiffs point to the fact that during LibiGel’s clinical trials, the American Psychological Association (“APA”) revised the diagnostic manual used by psychiatrists by narrowing the definition of HSDD and its symptoms. Specifically, the APA removed “hypo” from the definition of HSDD because it incorrectly implied that “a biological deficiency of testosterone” caused HSDD. Id. at 170. According to the plaintiffs, the revision undermined LibiGel, which is a testosterone supplement.

The defendants knew that these changes would negatively affect doctors’ ability to diagnose patients with female sexual dysfunction which, in turn, would severely limit the market for LibiGel. Thus, the defendants repeatedly explained that they were attempting to structure LibiGel’s development in a way that would cause the FDA to state “that in fact female sexual dysfunction is a diagnosable condition with measurable endpoints and that women deserve an option, a therapeutic option.” Id. at ¶¶ 71-72. They did not, however, publicly address the impact that the changes would likely have on LibiGel’s market potential.

On December 14, 2011, BioSante announced that LibiGel had failed to outperform a placebo in its Phase III efficacy tests. This news caused BioSante’s share price to plummet. Shareholders filed a putative class action securities case against BioSante and Simes (BioSante’s Vice Chairman, President and Chief Executive Officer). See Lauria v. BioSante Pharm., et al., No. 12 C 772 (N.D.Ill.). Shareholders also filed the instant action, which is a derivative action against BioSante’s board of directors.

[945]*945The plaintiffs did not serve a pre-suit demand on BioSante’s board prior to filing this action. They assert that a pre-suit demand would have been futile because:

(1) The defendants are unwilling or unable to meet their duties as fiduciaries by filing suit themselves because they “have professional relationships with, are friends with, and have entangling financial alliances, interests and dependencies with the other defendants”;
(2) The defendants had access to “the information, reports, and clinical data about LibiGel and its prospects” and nevertheless approved false and misleading statements about LibiGel’s performance in clinical trials and its chances of success;
(3) “[N]one of the director defendants can exercise independent business judgment in deciding whether or not to bring and vigorously prosecute this action because they each face [a] substantial likelihood of personal liability for breaching their fiduciary duty of loyalty” and either participated in the wrongdoing or are interdependent with other defendants who acted wrongfully;
(4) As members of the Audit and Finance Committee, defendants Sullivan, Holubow, and Mangano were privy to material information not disclosed to the investing public and were responsible for BioSante’s financial and legal affairs, so are directly responsible for the breaches of fiduciary duty alleged in the complaint;
(5) Simes was privy to materially adverse information withheld from shareholders and was personally responsible for disseminating misleading information in announcements and public filings and acted “to preserve his position of control and the prerequisites thereof,” including nearly $2M in compensation and will not initiate litigation that will cause him financial harm; and
(6)Any action brought by the board would expose them all to civil and potentially criminal liability so the board members all have a conflict of interest.

Id. at ¶¶ 87-102.

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Bluebook (online)
968 F. Supp. 2d 940, 2013 WL 4829122, 2013 U.S. Dist. LEXIS 129334, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-biosante-pharmaceuticals-inc-ilnd-2013.