- Original action filed in 2012, prior to Mallinckrodt's ownership
of Acthar Gel
- Company strongly disagrees with substance of complaints and sensational characterization of allegations
April 30, 2019
Recently a legacy legal matter stemming from allegations filed against the prior owner of Acthar® Gel became public, and recent news stories have conveyed those allegations. The company believes it is important to state its position on this matter.
The U.S. Department of Justice (DOJ) elected to join an existing civil False Claims Act case against the company, which has been unsealed by a court in the Eastern District of Pennsylvania. The original action was filed in 2012, prior to Mallinckrodt's ownership of Acthar Gel, and consists of two complaints filed by former Questcor employees. Questcor was the previous owner of Acthar Gel. The allegations pertain principally to legacy Questcor conduct.
Importantly, Mallinckrodt strongly disagrees with the substance of the complaints and the sensational characterization of the allegations.
Mallinckrodt has cooperated fully with the DOJ in its review of this historical conduct, voluntarily providing documents and information to the government. While we are disappointed the DOJ has elected to proceed with the lawsuit, we have been in advanced settlement talks with the government over the past several months.
The company believes these sales and marketing claims are likely to be resolved in the near term through ongoing negotiations, and further believes a resolution that is reasonable and manageable for all parties is achievable.
As the lawsuit principally concerns allegations of legacy conduct prior to Mallinckrodt's acquisition of Acthar Gel, the company does not envision any impact to how Mallinckrodt conducts business today.
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics. Its Specialty Generics and Amitiza® reportable segment includes specialty generic drugs, active pharmaceutical ingredients and AMITIZA (lubiprostone). To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel and related legal matters. The statements are based on assumptions about many important factors which could cause actual results to differ materially from those in the forward-looking statements, and such factors are identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2019 Mallinckrodt. 4/19