Healthcare Industry News: PREVELEAK
News Release - March 19, 2018
Mallinckrodt Completes Sale Of RECOTHROM(R) And PREVELEAK(R) To BaxterTransaction supports Mallinckrodt's transformation to an innovation-driven specialty pharmaceutical growth company focused on improving outcomes for patients with severe and critical conditions
STAINES-UPON-THAMES, United Kingdom, March 19, 2018 -- (Healthcare Sales & Marketing Network) -- Mallinckrodt plc (NYSE: MNK), a leading specialty pharmaceutical company, announced today it has closed the sale of RECOTHROM® Thrombin topical (Recombinant) and PREVELEAK® Surgical Sealant to Baxter International Inc. (NYSE: BAX).
"This action further illustrates the strategic evolution of our portfolio, and will free resources for investing in treatments for seriously ill infants and adults," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. "We believe these products are an excellent fit for Baxter, and this transaction is the best solution to meet patient needs."
The approximately $185 million transaction consists of a base payment of $153 million, inclusive of existing inventory and subject to a closing inventory adjustment, and the remainder in potential future milestones. Baxter will assume other expenses, including contingent liabilities associated with PREVELEAK.
RECOTHROM Thrombin topical (Recombinant) and PREVELEAK Surgical Sealant, both products for use in the control of bleeding in the surgical suite, are included in the transaction, as well as the manufacturing operation for PREVELEAK.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. 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 gastrointestinal products. 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 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 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.
RECOTHROM, Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age.
Important Risk Information
Contraindications: Do not inject directly into the circulatory system. Do not use for the treatment of massive or brisk arterial bleeding. Do not administer to patients with a history of hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.
Warnings and precautions: RECOTHROM may cause thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT. Hypersensitivity reactions, including anaphylaxis, may occur.
The most common adverse reaction (incidence 6%) was thromboembolic events. Antibody formation to RECOTHROM occurred in < 1% of patients. None of the antibodies detected neutralized native human thrombin.
PREVELEAK Surgical Sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Important Risk Information
Contraindications: PREVELEAK is not for use in patients with known allergies to materials of bovine or shellfish origin. PREVELEAK is not for intravascular use. PREVELEAK is not for cerebrovascular repair or cerebrospinal leak repair.
Warnings: Do not use PREVELEAK as a substitute for sutures or staples. Avoid exposure of PREVELEAK to nerves. Do not use PREVELEAK in the presence of obvious infection and use it with caution in contaminated areas of the body. Do not allow either the uncured or polymerized form of PREVELEAK to contact circulating blood. PREVELEAK contains a material of animal origin that may be capable of transmitting infectious agents. Repeated use of PREVELEAK in subsequent surgeries has not been studied. Hypersensitivity reactions were not seen using PREVELEAK, but hypersensitivity of bovine serum albumin has been reported.
Cautionary Statements Related to Forward-Looking Statements
Statements in this document that are not strictly historical, including statements regarding the future financial condition and operating results, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses and any other statements regarding events or developments that the company believes or anticipates 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: general economic conditions and conditions affecting the industries in which Mallinckrodt operates; Mallinckrodt's ability to obtain regulatory approval to market its products or the timing of such approval process; the commercial success of Mallinckrodt's products; Mallinckrodt's ability to realize anticipated growth, synergies and cost savings from acquisitions; conditions that could necessitate an evaluation of Mallinckrodt's goodwill and/or intangible assets for possible impairment; changes in laws and regulations; Mallinckrodt's ability to successfully integrate acquisitions of operations, technology, products and businesses generally and to realize anticipated growth, synergies and cost savings; Mallinckrodt's and Mallinckrodt's licensers' ability to successfully develop or commercialize new products; Mallinckrodt's and Mallinckrodt's licensers' ability to protect intellectual property rights; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; the reimbursement practices of a small number of public or private insurers; pricing pressure on certain of Mallinckrodt's products due to legal changes or changes in insurers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; limited clinical trial data for H.P. Acthar Gel; complex reporting and payment obligations under healthcare rebate programs; Mallinckrodt's ability to navigate price fluctuations; future changes to U.S. and foreign tax laws; Mallinckrodt's ability to achieve expected benefits from restructuring activities; complex manufacturing processes; competition; product liability losses and other litigation liability; ongoing governmental investigations; material health, safety and environmental liabilities; retention of key personnel; conducting business internationally; the effectiveness of information technology infrastructure; and cybersecurity and data leakage risks.
These and other factors are identified and described in more detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 29, 2017. 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.
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