Healthcare Industry News: surgical sealant
News Release - February 1, 2016
Mallinckrodt Completes Acquisition Of Three Commercial-Stage, Global Specialty Hemostasis Brands From The Medicines CompanyCHESTERFIELD, United Kingdom, Feb. 1, 2016 -- (Healthcare Sales & Marketing Network) -- Mallinckrodt plc (MNK), a leading specialty biopharmaceutical company, today announced it closed the acquisition of the global portfolio of three commercial-stage topical hemostasis drugs from The Medicines Company. The portfolio includes RECOTHROM® Thrombin topical (Recombinant), PreveLeak™ surgical sealant, and RAPLIXA™ (Fibrin Sealant (Human)).
Under Mallinckrodt's acquire to invest operating model, the company will invest in market development of RECOTHROM, PreveLeak and RAPLIXA, all innovative, highly durable hemostasis products that increase surgeons' choices. The addition of these global hemostasis assets to the company's Specialty Brands segment will expand Mallinckrodt's growing hospital portfolio, including INOmax® (nitric oxide) for inhalation and THERAKOS® immunotherapy systems, and specifically augments its current OFIRMEV® (acetaminophen) injection surgical pain management offering. Products that help control bleeding are essential to surgical practice, and the market is estimated at $750 million annually in the U.S. and at least $1 billion globally.
"Acquiring and promoting leading hemostasis brand RECOTHROM alongside OFIRMEV broadens Mallinckrodt's impact in the surgical suite for patients and physicians, and creates a strong framework to broadly commercialize innovative, highly durable agents PreveLeak and RAPLIXA, which carry intellectual property protection to 2028 and 2031, respectively," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt.
Ron Lloyd, Senior Vice President and President, Hospital Therapies, said, "As we continue to further diversify our portfolio, we're excited about the volume growth opportunity these products offer, which can expand access to patients in the hospital setting for years to come."
RECOTHROM is widely used in the U.S., and is the first and only recombinant topical thrombin approved for use in adult and pediatric patients. PreveLeak provides an ideal balance of strength and flexibility, and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. RAPLIXA is the first biologically active powdered hemostat which contains both thrombin and fibrinogen. The RAPLIXASpray™ device allows for greater versatility in administering RAPLIXA.
Each of the acquired products is approved for use in the U.S. and certain European countries, with long-range market exclusivity through intellectual property protection – RECOTHROM to 2026, PreveLeak to 2028 and RAPLIXA to 2031. Only RECOTHROM is currently marketed in the U.S.
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.
Full instructions for use are available here.
RAPLIXA is a fibrin sealant (human) indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and is applied directly or using the RAPLIXASpray device.
Important Risk Information
Contraindications: Do not use intravascularly. Do not use for the treatment of severe or brisk arterial bleeding. Do not use in patients known to have anaphylactic or severe systemic reactions to human blood products.
Warnings and precautions: Thromboembolic events may result from intravascular application of RAPLIXA. Air or gas embolism can occur using air- or gas-pressurized sprayers to administer fibrin sealants. Operate the device according to the manufacturer's instructions. RAPLIXA may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission. Allergic type hypersensitivity reactions may occur. If allergic type hypersensitivity symptoms occur, discontinue administration immediately.
The most commonly reported adverse reactions (> 5% subjects) were procedural pain, nausea, constipation, pyrexia, and hypotension.
Full prescribing information is available here.
OFIRMEV (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.
Important Risk Information
RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
Take care when prescribing, preparing, and administering OFIRMEV injection to avoid dosing errors which could result in accidental overdose and death.
OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.
OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur, or at the first appearance of skin rash. Do not use in patients with acetaminophen allergy.
The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. The antipyretic effects of OFIRMEV may mask fever in patients treated with postsurgical pain. OFIRMEV is approved for use in patients > 2 years of age. Do not exceed the recommended maximum daily dose of OFIRMEV. OFIRMEV should be administered only as a 15-minute infusion.
For additional Important Risk Information, including complete boxed warning, see Full Prescribing Information.
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 and pulmonology; 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; deep regulatory expertise; 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.
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Cautionary Statements Related to Forward-Looking Statements
Statements in this document that are not strictly historical, including statements regarding 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 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: general economic conditions and conditions affecting the industries in which Mallinckrodt operates; 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 identify, acquire or close future acquisitions; 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 ability to successfully develop or commercialize new products; Mallinckrodt's 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; limited clinical trial data for H.P. Acthar® Gel; complex reporting and payment obligations under healthcare rebate programs; Mallinckrodt's ability to achieve anticipated benefits of price changes; 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; and the effectiveness of information technology infrastructure.
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 September 25, 2015. 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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