Singh v. Schikan

106 F. Supp. 3d 439, 2015 U.S. Dist. LEXIS 58801, 2015 WL 2070222
CourtDistrict Court, S.D. New York
DecidedMay 5, 2015
DocketNo. 14 Civ. 5450(NRB)
StatusPublished
Cited by7 cases

This text of 106 F. Supp. 3d 439 (Singh v. Schikan) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Singh v. Schikan, 106 F. Supp. 3d 439, 2015 U.S. Dist. LEXIS 58801, 2015 WL 2070222 (S.D.N.Y. 2015).

Opinion

[442]*442MEMORANDUM AND ORDER

NAOMI REICE BUCHWALD, District Judge.

These actions are brought under Sections 11 and 15 of the Securities Exchange Act of 1933 against Prosensa Holding N.V. (“Prosensa”), its underwriters, and certain of its officers and directors (collectively, “defendants”), on behalf of a purported class of investors who purchased or otherwise acquired shares of Prosensa pursuant to the Registration Statement issued in connection with the company’s June 2013 initial public offering. Presently before the Court is defendants’ motion to dismiss the complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons stated herein, this motion is granted.

BACKGROUND

I. Factual Background

A. DMD and Drisapersen

Duchenne muscular dystrophy (“DMD”) is a rare neuromuscular disorder that causes progressive muscle loss, leading to severe disability and premature death. Id. ¶ 48. It is triggered by a genetic mutation that causes the dystrophin gene to produce inadequate amounts of dystrophin, a protein needed to keep muscles intact. Id. DMD primarily affects boys and young men, occurring in about one in 3500 boys worldwide. Id. ¶ 49. The main sign of DMD is worsening muscle weakness, with symptoms generally appearing between one and four years of age. Id. Affected children experience developmental delays and most require full-time wheelchair use by age twelve. Later in the disease’s progression, respiratory muscles weaken and cardiac function is impacted, making the disease “universally fatal.” The average life expectancy for one diagnosed with DMD is twenty-seven years. Id. ¶¶ 50-51. There are currently no approved DMD disease-modifying therapies. Id. ¶ 51.

Prosensa is a biotechnology company based in Leiden, Netherlands, that “engages in the discovery and development of RNA-modulating therapeutics for the treatment of genetic disorders.” Id. ¶¶ 2, 45. In 2003, it entered into an exclusive licensing agreement with the Leiden University Medical Center that allowed Prosensa use of the Center’s “proprietary RNA modulation exon-skipping technology” 1 in developing treatments for DMD. Id. “Drisapersen,” Prosensa’s lead product, is intended to treat DMD by skipping exon 51 for the dystrophin gene with the help of this technology. Id. ¶ 55.

In October 2009, Prosensa announced a development partnership with GlaxoSmithKline (“GSK”), under which GSK received exclusive rights to develop and license drisapersen. Id. As part of this collaboration, GSK was responsible for “fund[ing] and conducting] the clinical development and commercialization of drisapersen,” and had “complete control over such activities.” Reg. Stmt, at 10. See also id. at 11 (“GSK will fund all our costs and expenses associated with the further clinical development of, and has sole decision-making authority and is responsible for all research, development, regulatory, manufacturing, marketing, advertising, promotional, launch and sales and other commercial activities in connection with drisapersen.... GSK has the right to make decisions regarding the development [443]*443and commercialization of product candidates under the collaboration without consulting us.... ”).

B. The Drisapersen “DEMAND” Studies

In September 2010, GSK initiated a Phase II study of drisapersen (“DEMAND-II”), which would be completed in April 2013. Am. Cmplt. ¶¶ 7, 56. The 53-participant, 48-week trial compared two different doses of drisapersen with a placebo. Reg. Stmt. at 91. The trial’s primary endpoint was defined as “the distance walked in the six minute walk test (or ‘6MWD’) between the placebo group and the continuous active-treatment group at a dose of six mg/kg/week after twenty-four weeks.”2 Id.

In December 2010, GSK began a Phase III study (“DEMAND-III”), with results expected to be announced in the fourth quarter of 2013. Id. ¶ 8. The study was a randomized, double-blind, placebo-controlled trial, assessing drisapersen at a dose of six mg/kg/week in 186 boys with a primary endpoint of the 6MWD at forty-eight weeks. Id.

Notably, DEMAND-III had lessened enrollment criteria as compared to DEMAND-II.3 “For example, the DEMAND-II study only enrolled boys capable of standing up from the floor in seven seconds or less, whereas the DEMAND-III study had no maximum time for standing up. The lessening of the enrollment criteria resulted in the subject children being older and having more advanced DMD than those subjects in the DEMAND-II study.” Id. ¶ 9. See Reg. Stmt, at 93 (“A total of 53 DMD subjects aged 5 and above with a rise from the floor of less than 7 seconds were recruited [for DEMAND-II].”); id. at 94 (“The [DEMAND-III] study assesses ... drisapersen ... in 186 boys over five years of age and with a minimum 6MWD of 75 meters at enrollment.”). DEMAND-III also utilized a wider range of locations and new testing sites. “In fact, the DEMAND-III study was conducted at 44 centers in 19 countries (compared to the DEMAND-II study which was conducted at only 13 centers).” Am. Cmplt. ¶ 11.

In April 2013, following the completion of the DEMAND-II trial, Prosensa and GSK presented abbreviated results from the study. Id. ¶ 57. The companies announced that drisapersen had conferred a significant difference in walking distance compared to the placebo, specifically reporting a 117-foot difference in the distance walked in six minutes between those treated with drisapersen versus placebo. Id.

While undertaking these clinical trials, Prosensa faced increasing competition from Sarepta Therapeutic’s “eteplirsen,” which was also in clinical trials at the time of Prosensa’s IPO and was acknowledged in the Registration Statement as its key DMD competitor. Id. ¶ 64. In particular, on June 19, 2013, nine days before Prosensa’s planned initial public offering, Sarepta reported a continued sustained benefit in walking distance through eighty-four [444]*444weeks of its phase 2b, 12-person study. Id. ¶ 69.

C. The Registration Statement

In anticipation of its initial public offering, Prosensa filed a Registration Statement with the SEC on May 24, 2013, and filed six subsequent amendments, the last of which was filed on June 27, 2013. Id. ¶ 74. The Registration Statement provided investors with background on DMD, tracking “the natural history of the disease” (the progression of a disease process in an individual over time), and explaining the use of the 6MWD in assessing DMD’s natural history.4 Id. ¶¶ 59-61. It also included a graph, which served as a “[c]onceptual representation of 6-minute walking distance performance by DMD patients and healthy controls,” illustrating “the typical decline in 6MWD performance by boys with DMD over age 7.” Id. ¶ 63; Reg. Stmt. at 89.

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

Related

Cite This Page — Counsel Stack

Bluebook (online)
106 F. Supp. 3d 439, 2015 U.S. Dist. LEXIS 58801, 2015 WL 2070222, Counsel Stack Legal Research, https://law.counselstack.com/opinion/singh-v-schikan-nysd-2015.