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Legal Proceedings
9 Months Ended
Sep. 30, 2019
Legal Proceedings  
Legal Proceedings

18. Legal Proceedings

 

Securities Class Actions

 

On July 30, 2019, plaintiff Linda Rosi (“Rosi”) filed a putative class action complaint captioned Rosi v. Aclaris Therapeutics, Inc., et al., in the U.S. District Court for the Southern District of New York against the Company and certain of its executive officers (“Defendants”).  The complaint alleges that Defendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA and find that the materials minimized the risks or overstated the efficacy of the product.  The complaint seeks unspecified compensatory damages on behalf of Rosi and all other persons and entities that purchased or otherwise acquired the Company’s securities between May 8, 2018 and June 20, 2019. 

 

On September 9, 2019, an additional plaintiff, Robert Fulcher (“Fulcher”), filed a substantially identical putative class action complaint captioned Fulcher v. Aclaris Therapeutics, Inc., et al., in the same court against the same Defendants.

 

On September 30, 2019, Rosi and Fulcher each filed separate motions to consolidate the cases and to be appointed “lead plaintiff” for the putative class.  On October 15, 2019, Rosi filed a “notice of non-opposition” to Fulcher’s motion to consolidate cases and to serve as lead plaintiff.    The court has not yet appointed a lead plaintiff and no consolidated complaint has been filed.

 

Defendants dispute plaintiffs’ claims and intend to defend the matter vigorously.

 

Patent Infringement

 

On October 8, 2019, the Company, together with Allergan, Inc., filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Taro Pharmaceuticals, Inc. (“Taro”), related to an Abbreviated New Drug Application (“ANDA”) that Taro filed with the FDA to market a generic version of RHOFADE.    The lawsuit claims infringement of U.S. Patent Nos. 7,812,049, 8,420,688, 8,815,929, 9,974,773 and 10,335,391, which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for RHOFADE. The Company received a Paragraph IV Notice Letter from Taro dated August 28, 2019, advising that Taro had submitted an ANDA to the FDA seeking approval from the FDA to manufacture and market a generic version of RHOFADE prior to the expiration of the Orange Book-listed patents. Under the Asset Purchase Agreement (the “APA”) with EPI Health, EPI Health agreed to file a motion to be substituted for the Company as a plaintiff party and has agreed to reimburse the Company for its reasonable fees and expenses so long as it remains a plaintiff party.