"We believe this cell-based, differentiated medicine technology has the potential to transform the standard of treatment for wound healing," said Mark Trudeau, Chief Executive Officer and President of Mallinckrodt. "We're excited by these highly durable developmental pipeline additions to our hospital growth business, further diversifying our Specialty Brands portfolio and bringing value to patients with significant unmet medical needs."
StrataGraft is an investigational product in Phase 3 development for treatment of severe, deep partial thickness burns1, with a U.S. Food and Drug Administration (FDA) approval decision anticipated by 2020. Phase 2 development of StrataGraft is underway for treatment of severe, full thickness burns2. In 2012, the FDA granted StrataGraft orphan product status, and the product is being developed as a biologic to be filed under a biologic license application that would confer regulatory protection until 2032. In the U.S., approximately 10,000 patients annually are hospitalized for treatment of severe burns, and the U.S. market for skin graft products used in this application is estimated at approximately $300 million. Additional opportunities exist internationally, and the acquisition includes worldwide product rights.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical 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; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
Daniel J. Speciale, CPA
Director, Investor Relations
Senior Communications Manager
Senior Vice President, Communications and Public Affairs
1 Second-degree burns: Burns that impact the dermis
2 Third-degree burns: Burns that extend into subcutaneous tissue, muscle, or bone and often cause much scarring
Logo - http://photos.prnewswire.com/prnh/20150105/167103LOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mallinckrodt-completes-acquisition-of-stratatech-corporation-a-regenerative-medicine-company-focused-on-proprietary-therapeutic-human-skin-substitute-products-300320965.html
SOURCE Mallinckrodt plc