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Mallinckrodt Provides Synacthen® Depot and Synacthen Update

Mallinckrodt acquired rights to market and sell Synacthen Depot and Synacthen in certain countries as part of its acquisition of Questcor Pharmaceuticals in August 2014. Both products have regulatory approval in a number of countries, though not in the U.S., and both have an important role in treating small patient populations suffering from a variety of serious and rare diseases. The approved indications vary by country.

At the time Mallinckrodt made the acquisition, the company understood that to assure Synacthen would remain available for patients in our markets around the world and, by obtaining U.S. Food and Drug Administration approval, become available to U.S. patients, significant investment would be required. Part of this investment is to assure the manufacturing of Synacthen. In the spring of 2014 the existing European manufacturer of the products announced it would cease manufacturing the product in April 2016 – requiring Mallinckrodt to identify and initiate production with a new manufacturer.

Mallinckrodt is committed to supporting continued and broader availability of Synacthen and Synacthen Depot, and committed to investing the more than $US50 million required to support continued manufacturing, regulatory, research and market access for the products. Importantly, though adjusting the price of the products will contribute to long-term sustainability, the company does not expect the Synacthen products to be profitable in the near-term, even with the new pricing model.

Mallinckrodt is also committed to communicating the value that its medicines provide – not only to appropriate patients -- but to healthcare systems in the countries where our products are approved. The company collaborates with governments around the world to ensure they understand the health benefits as well as the economics of retaining continued Synacthen Depot and Synacthen availability for patients in need. In nearly all those markets, these products are currently the only synthetic ACTH-based drugs that remain available; today other previously available products having long since been discontinued or removed by their manufacturers.

In Canada, Synacthen Depot is used in treatment of only a few hundred patients per year, and at a fraction of the annual cost per patient reported in a recent news story. Contract prices for the products were set following dialogue with and approval by certain Canadian provincial authorities, who agreed to a price increase to ensure the drug would remain an option for those small numbers of patients it benefits. Other provincial authorities have chosen to remove the product from their public formulary plans. Even in those provinces where the product will not be readily reimbursed on the public plan, consideration is allowed on a case-by-case basis for public reimbursement, and there may be alternative options for patient assistance as well.

November 17, 2015