Mallinckrodt And Federal Trade Commission Resolve Questcor Matter
Under the agreement,
Since acquiring Questcor,
Synthetic ACTH products are relatively common – Synacthen Depot and others have been on the market outside of the U.S. for years, if not decades – and in
However, history has borne out the FTC's view that there are "high barriers to entry2" for a synthetic ACTH in the U.S. market. Synacthen Depot has never been
The Commission further states that U.S. market entry would require a sponsor to successfully conduct "clinical trials necessary for
In addition, recent market experience demonstrates that the time and resources required even to explore development of a synthetic ACTH for IS and NS can be prohibitive. In 2013, another publicly traded company developed its own synthetic ACTH product and announced plans to enter the U.S. market in IS and NS. Subsequently, in a 2016 call with investors, the company communicated that it would seek to partner with or sublicense the product to a larger company to avoid the "time, effort and resources" required for internal development.
INVESTOR CONFERENCE CALL
- At the
- By telephone: For both listen-only participants and those who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is (877) 359-9508. For participants outside the U.S., the dial-in number is (224) 357-2393. Callers will need to provide the Conference ID of 50844751.
- Through an audio replay: A replay of the call will be available beginning at
11:30 a.m. Eastern Timeon Thursday, January 19, and ending at 11:59 p.m. Eastern Timeon February 2. Dial-in numbers for U.S.-based participants are (855) 859-2056. Participants outside the U.S. should use the replay dial-in number of (404) 537-3406. All callers will be required to provide the Conference ID of 50844751.
About Synacthen Depot
Synacthen Depot is a synthetic melanocortin peptide with 24 amino acids known as tetracosactide that is used for the treatment of a number of conditions outside the U.S., and Synacthen is a diagnostic formulation of the drug. Synacthen Depot, as formulated, contains benzyl alcohol, which can be toxic to infants.
About Duchenne Muscular Dystrophy
DMD is a genetic disorder characterized by progressive muscle degeneration and weakness. It is one of nine types of muscular dystrophy.
DMD is caused by an absence of dystrophin, a protein that helps keep muscle cells intact. Symptom onset is in early childhood, usually between ages 3 and 5. The disease primarily affects boys, but in rare cases it can affect girls. Symptoms include muscle weakness, which can begin as early as age 3, first affecting the muscles of the hips, pelvic area, thighs and shoulders, and later the skeletal (voluntary) muscles in the arms, legs and trunk.4 Boys with DMD are typically wheelchair bound by age 12 and do not survive past their mid-20s, when their heart and breathing muscles begin to fail.5
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies, as well as nuclear imaging products. 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; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about
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Cautionary Statements Related to Forward-Looking Statements
Statements in this document that are not strictly historical, including statements regarding the terms of the agreement with the FTC and the expected payment and license, future operating results, and any other statements regarding events or developments that we believe or anticipate will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: any legal or regulatory challenges to the settlement; the ability of
These and other factors are identified and described in more detail in the "Risk Factors" section of
Senior Vice President, Investor Strategy and IRO
Director, Investor Relations
2 Complaint, FTC, the States of
4 https://www.mda.org/disease/duchenne-muscular-dystrophy (Accessed August 21, 2016)
5 http://www.cureduchenne.org/aboutduchenne.html (Accessed
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