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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.


TSX:TH - Post by User

Post by PinnacleXon Dec 30, 2022 4:06pm
182 Views
Post# 35197674

Lets not all forget this company been here before .....

Lets not all forget this company been here before .....https://scc-csc.lexum.com/scc-csc/scc-csc/en/item/15290/index.do


SUPREME COURT OF CANADA
 
Citation: Theratechnologies inc. v. 121851 Canada inc., 2015 SCC 18, [2015] 2 S.C.R. 106 Date: 20150417
Docket: 35550
 
Between:
Theratechnologies inc., Yves Rosconi and Paul Pommier
Appellants
and
121851 Canada inc.
Respondent
- and -
Mouvement d’ducation et de dfense des actionnaires
Intervener
 
 
Coram: McLachlin C.J. and Abella, Rothstein, Cromwell, Moldaver, Karakatsanis and Wagner JJ.
 
Reasons for Judgment:
(paras. 1 to 56)
Abella J. (McLachlin C.J. and Rothstein, Cromwell, Moldaver, Karakatsanis and Wagner JJ. concurring)
 

 
 
 
 

Theratechnologies inc. v. 121851 Canada inc., 2015 SCC 18, [2015] 2 S.C.R. 106
Theratechnologies inc.,
Yves Rosconi and Paul Pommier                                                                 Appellants
v.
121851 Canada inc.                                                                                     Respondent
and
Mouvement d’ducation et de dfense des actionnaires                             Intervener
Indexed as: Theratechnologies inc. v. 121851 Canada inc.
2015 SCC 18
File No.: 35550.
2014: December 1; 2015: April 17.
Present: McLachlin C.J. and Abella, Rothstein, Cromwell, Moldaver, Karakatsanis and Wagner JJ.
on appeal from the court of appeal for quebec
                    Securities — Statutory disclosure obligations — Action for damages — Prior judicial authorization — Pharmaceutical company in process of obtaining approval to market new drug — Questions on drug’s potential side effects raised as part of approval process — Questions publicized by stock quotation enterprises resulting in drop of pharmaceutical company’s share price — Corporate shareholder seeking to institute class action for breach of company’s disclosure obligation — Action requiring prior judicial authorization based on whether there is a “reasonable possibility that it will be resolved in plaintiff’s favour” — Securities Act, CQLR, c. V-1.1, ss. 5.3, 73, 225.4.
                    In the spring of 2010, Theratechnologies inc. (Thera) was awaiting the approval of the United States Food and Drug Administration (FDA) for a new drug to reduce excess abdominal fat among HIV patients. As its application proceeded, Thera regularly updated its shareholders and the Commission des valeurs mobilires du Qubec about developments in the FDA process. It also regularly informed its shareholders about the results of its clinical trials measuring the safety and efficacy of the drug, including potential side effects. The trials indicated that the benefits of the drug could be “achieved without significant side effects”.
                    As is common during the new drug approval process, the FDA referred a number of questions about this drug to an expert Advisory Committee, including questions about its potential side effects. The FDA also made these questions public as part of a package of briefing materials on its website. Thera believed the briefing documents it had already provided to the FDA and the clinical results it had already made public to its investors offered a comprehensive response to the specific questions the FDA had posed. When the questions were publicized by stock quotation enterprises, the price of the company’s shares dropped. 121851 Canada inc., a holding company, sold its shares in Thera during this period. Ultimately, the drug was approved by the FDA and Thera’s share price recovered.
                    121851 sought authorization under s. 225.4 of the Securities Act to bring a class action for damages against Thera, claiming that the information about the potential side effects of the drug and the FDA’s questions about those side effects amounted to a material change in Thera’s business, operations or capital, triggering timely disclosure obligations under s. 73 of the Securities Act.
                    Under s. 225.4, the court is a gatekeeper, and grants authorization “if it deems that the action is in good faith and there is a reasonable possibility that it will be resolved in favour of the plaintiff”. The Motions Judge concluded that the authorization mechanism in s. 225.4 of the Securities Act imposed a higher threshold than art. 1003 of the Code of Civil Procedure, which deals with the authorization of class actions generally, but found sufficient evidence to support the conclusion that 121851’s action had a reasonable possibility of success. The Court of Appeal agreed with the Motions Judge that the screening mechanism under s. 225.4 was more stringent than for the authorization of a class action under art. 1003 of the Code of Civil Procedure and required more than a mere possibility of success. It also agreed that the threshold was met in this case.
                    Held: The appeal should be allowed.
                    Section 225.4 of the Securities Act is part of a new regime to address breaches of continuous disclosure obligations in the secondary market, the market in which a company’s shares are traded publicly after they have been issued or distributed by the company. The reforms were inspired by the recommendations of the Allen Committee, suggested after a number of high profile misrepresentations at publicly traded companies. The Committee concluded that the remedies available to investors injured by misleading disclosure in the secondary trading market were so difficult to pursue, that they were largely illusory. As a result, it recommended the creation of a statutory civil liability regime that would help investors sue issuers, directors, and officers who violated statutory disclosure obligations.
                    Under Quebec’s new regime, when a security is acquired or transferred at the time of a false declaration or omission of information that should have been disclosed, the fluctuation in the value of the security is presumed to be attributable to that fault. Investors are thereby released from the burden of demonstrating that the variation in the market price of the security was linked to the misinformation or omission, and from demonstrating that they personally relied on that misinformation or omission in buying or transferring the security. In order to discourage the kind of strike suits that had become common in the United States under more investor-friendly regimes, the Quebec scheme established an authorization mechanism — s. 225.4 — to permit only actions in good faith and with a “reasonable possibility” that the claim would be resolved “in favour of the plaintiff”. The regime reflected an attempt to strike a balance between preventing unmeritorious litigation and strike suits and, at the same time, ensuring that investors have a meaningful remedy when issuers breach disclosure obligations.
                    The “reasonable possibility” that the claim would be resolved in favour of the plaintiff required under s. 225.4 sets out a different and higher standard than the general threshold for the authorization of a class action under art. 1003 of the Code of Civil Procedure. Under art. 1003, the court seeks only to identify whether “the facts alleged seem to justify the conclusions sought”, that is, whether the applicant has established “a good colour of right”. The Quebec legislature used different language in s. 225.4 to create a more meaningful screening mechanism in the securities context so that costly strike suits and unmeritorious claims would be prevented. The threshold requires that there be a reasonable or realistic chance that the action will succeed.
                    A case with a realistic chance of success requires the claimant to offer some credible evidence in support of the claim. Courts must therefore undertake a reasoned consideration of the evidence to ensure that the action has some merit, but the authorization stage under s. 225.4 should not be treated as a mini-trial. If the goal of the screening mechanism is to prevent costly strike suits and litigation with little chance of success, it follows that the evidentiary requirements should not be so onerous as to essentially replicate the demands of a trial. A full analysis of the evidence is unnecessary. What is required is sufficient evidence to persuade the court that there is a realistic chance that the action will be resolved in the claimant’s favour.
                    121851 claims that Thera breached s. 73 of the Securities Act, which requires issuers to provide timely disclosure of material changes to investors. A material change has two components. There must be a change in the business, operations or capital of the issuer and the change must be material, which means it would reasonably be expected to have a significant effect on the market price or value of the securities of the issuer. 121851 argues that when Thera received the FDA briefing materials for the Advisory Committee, it should have issued a responsive press release. But 121851 has not pointed to any evidence that could qualify as a change in Thera’s operations, capital or business as described in s. 5.3 of the Securities Act. The results of the clinical trials, including potential side effects, were disclosed to shareholders as they became available. There was no new information about the side effects of the drug that required timely disclosure when the FDA mentioned those side effects in the briefing materials.
                    Nor has 121851 pointed to any evidence to suggest that the questions the FDA posed to its advisory committee about these side effects, or the contents of its briefing package more generally, departed in any way from the regular and routine process through which the FDA assesses whether a drug should be approved. Rather, they are a routine step in the FDA’s work to determine whether a drug’s benefits outweigh its risks. It is difficult to characterize these questions as any kind of change to Thera’s business, operations, or capital requiring a reassuring public response from Thera.
                    Because the evidence does not credibly point to a material change that could have triggered disclosure obligations, there is no reasonable possibility that 121851’s action under s. 73 of the Securities Act could succeed.
Cases Cited
                    Distinguished: Pezim v. British Columbia (Superintendent of Brokers), [1994] 2 S.C.R. 557; referred to: Cartaway Resources Corp. (Re), 2000 BCSECCOM 88, [2000] B.C.S.C.D. No. 92 (QL); Cornish v. Ontario Securities Commission, 2013 ONSC 1310, 306 O.A.C. 107; Infineon Technologies AG v. Option consommateurs, 2013 SCC 59, [2013] 3 S.C.R. 600; Guimond v. Quebec (Attorney General), [1996] 3 S.C.R. 347; Marcotte v. Longueuil (City), 2009 SCC 43, [2009] 3 S.C.R. 65; Ironworkers Ontario Pension Fund (Trustee of) v. Manulife Financial Corp., 2013 ONSC 4083, 44 C.P.C. (7th) 80; Silver v. Imax Corp. (2009), 66 B.L.R. (4th) 222, leave to appeal refused, 2011 ONSC 1035, 105 O.R. (3d) 212; Dobbie v. Arctic Glacier Income Fund, 2011 ONSC 25, 3 C.P.C. (7th) 261; Round v. MacDonald, Dettwiler and Associates Ltd., 2011 BCSC 1416, aff’d 2012 BCCA 456, 39 B.C.L.R. (5th) 44; Millwright Regional Council of Ontario Pension Trust Fund (Trustees of) v. Celestica Inc., 2014 ONSC 1057, 49 C.P.C. (7th) 12; Millwright Regional Council of Ontario Pension Trust Fund (Trustees of) v. Celestica Inc., 2014 ONCA 90, 118 O.R. (3d) 641; Kerr v. Danier Leather Inc., 2007 SCC 44, [2007] 3 S.C.R. 331; TSC Industries, Inc. v. Northway, Inc., 426 U.S. 438 (1976).
Statutes and Regulations Cited
Act to amend the Securities Act and other legislative provisions, S.Q. 2007, c. 15 [Bill 19].
Civil Code of Qubec, arts. 1457, 1607.
Code of Civil Procedure, CQLR, c. C-25, art. 1003.
Securities Act, CQLR, c. V-1.1, ss. 5 “material fact”, 5.3, 73, 225.4.
Securities Act, R.S.A. 2000, c. S-4, s. 147.
Securities Act, R.S.B.C. 1996, c. 418, s. 85.
Securities Act, R.S.N.S. 1989, c. 418, s. 81.
Securities Act, R.S.O. 1990, c. S.5, ss. 75, 138.8(1).
Securities Act, S.N.B. 2004, c. S-5.5, s. 89(1).
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