- Proposed acquisition includes two
pioneering hemostat and sealant products, including the first and
only stand-alone recombinant thrombin and a surgical sealant
- Products expand Baxter’s portfolio of
surgical solutions to address intraoperative bleeding and increase
surgeons’ options
Baxter International Inc. (NYSE: BAX), a global medical products
company, is committed to advancing surgical innovation and today
announced an agreement to acquire two hemostat and sealant products
from Mallinckrodt plc: RECOTHROM Thrombin topical (Recombinant),
the first and only stand-alone recombinant thrombin, and PREVELEAK
Surgical Sealant, which is used in vascular reconstruction.
“Uncontrolled intraoperative bleeding can lead to a wide variety
of clinical and economic complications for patients and hospitals.
As a leading provider of advanced hemostats and sealants, Baxter is
focused on continually identifying solutions to help meet surgeons’
varying needs,” said Wil Boren, president of Baxter’s Advanced
Surgery business. “We are excited about the addition of RECOTHROM
to help surgeons address less severe intraoperative bleeding and
PREVELEAK to complement Baxter’s existing portfolio of sealants for
cardiovascular and other surgical specialties.”
Thrombin is a proven blood coagulation agent – used on its own
or in combination with other hemostats – that has been estimated to
be used in more than one million patients per year in the United
States to help surgeons address intraoperative bleeding1. RECOTHROM
is a thrombin-based product indicated as an aid to hemostasis
whenever oozing blood and minor bleeding from capillaries and small
venules is accessible and control of bleeding by standard surgical
techniques is ineffective or impractical in adults and pediatric
populations greater than or equal to one month of age. As the only
topical hemostat from recombinant DNA origin approved in the United
States and Canada, RECOTHROM can be used in pediatric and adult
patients with or without antibodies to bovine-derived thrombin.
The acquisition also includes PREVELEAK, a surgical sealant
designed to seal suture holes formed during surgical repair of the
circulatory system and to reinforce sutured connections between
blood vessels. PREVELEAK augments Baxter’s portfolio of
complementary hemostats, sealants and tissue products used in
cardiovascular and other surgeries, offering surgeons additional
clinically differentiated products to address patients’ varying
needs. PREVELEAK is approved in the United States and European
Union.
Sales of the proposed acquired products totaled approximately
$56 million in the twelve months preceding September 29, 2017. Upon
closing, the deal is expected to be modestly accretive to Baxter’s
2018 adjusted earnings and increasingly accretive thereafter. Under
the terms of the agreement, Baxter will acquire RECOTHROM and
PREVELEAK for an upfront payment of approximately $153 million and
potential contingent payments in the future.
The transaction is expected to close in the first half of 2018,
subject to the expiration of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act and other customary
closing conditions.
About Baxter’s Surgery Portfolio
Baxter is committed to advancing surgical innovation with a
variety of products and delivery devices used for hemostasis
(addressing bleeding), tissue sealing, and hard tissue
regeneration, as well as soft tissue repair and microsurgery. With
products available in nearly 60 countries, Baxter is at the
forefront of providing surgeons and hospitals with innovative
products that improve patient outcomes, are convenient to use and
are cost-effective. Baxter’s surgical portfolio includes FLOSEAL
Hemostatic Matrix, TISSEEL Fibrin Sealant, COSEAL Surgical Sealant
and VASCU-GUARD Patch among others.
About Baxter
Baxter International Inc. provides a broad portfolio of
essential renal and hospital products, including home, acute and
in-center dialysis; sterile IV solutions; infusion systems and
devices; parenteral nutrition; surgery products and anesthetics;
and pharmacy automation, software and services. The company’s
global footprint and the critical nature of its products and
services play a key role in expanding access to healthcare in
emerging and developed countries. Baxter’s employees worldwide are
building upon the company’s rich heritage of medical breakthroughs
to advance the next generation of healthcare innovations that
enable patient care.
IMPORTANT SAFETY INFORMATION
RECOTHROM Thrombin topical (Recombinant) Indication
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.
RECOTHROM may be used in conjunction with an absorbable gelatin
sponge, USP.
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 or any components of
RECOTHROM.
- Do not use in patients with known
hypersensitivity to hamster proteins.
Warnings and Precautions
- For topical use only. DO NOT
INJECT.
- RECOTHROM may cause thrombosis if it
enters the circulatory system.
- Hypersensitivity reactions, including
anaphylaxis, may occur. RECOTHROM is produced in a genetically
modified Chinese Hamster Ovary (CHO) cell line and may contain
hamster or snake proteins.
Adverse Reactions
- Thromboembolic adverse reactions were
reported in 6% of surgical patients treated with RECOTHROM in all
completed clinical trials.
- Antibody formation to RECOTHROM
occurred in <1% of patients. None of the antibodies detected
neutralized native human thrombin.
Use in Specific Populations
- Pregnancy Category C. RECOTHROM should
be given to a pregnant woman only if clearly needed.
- Pediatric Use: Safety and efficacy have
not been established in neonates.
- Geriatric Use: Of 644 patients in
clinical studies of RECOTHROM, 36% (n=232/644) were ≥65 years old
and 15% (n=95/644) were ≥75 years old. No differences in safety or
effectiveness were observed between these patients and younger
patients, and other reported clinical experience has not identified
differences in responses between the elderly and younger patients,
but greater sensitivity of some older individuals cannot be ruled
out.
Please see additional important risk information and Full
Prescribing Information.
PREVELEAK Surgical Sealant Indications
PREVELEAK Surgical Sealant is indicated for use in vascular
reconstructions to achieve adjunctive hemostasis by mechanically
sealing areas of leakage.
IMPORTANT RISK INFORMATION
Contraindications
Not for use in patients with known allergies to materials of
bovine or shellfish origin.
• Not for intravascular use.
• Not for cerebrovascular repair or cerebrospinal leak
repair.
Warnings and Precautions
• Do not use as a substitute for sutures or staples.
• Avoid exposure to nerves.
• Do not use in the presence of obvious infection and use with
caution in contaminated areas of the body.
• Do not allow either the uncured or polymerized form 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 BSA has been reported.
• Avoid contact with skin or other tissue not intended for
application.
• Safety and effectiveness of PREVELEAK in minimally invasive
procedures or coronary artery bypass grafting (CABG) have not been
established.
• Do not use blood saving devices when suctioning excess
PREVELEAK.
• PREVELEAK syringe and delivery tips are for single patient use
only. Do not resterilize.
• Do not use if packages have been opened or damaged.
• Take care not to spill contents of syringe. Avoid tissue
contact with material expelled from delivery tip during
priming.
• Avoid pausing more than 10-15 seconds between priming and
application to prevent polymerization within the delivery tip.
• Minimize use in patients with abnormal calcium metabolism
(e.g. chronic renal failure, hyperparathyroidism).
Polyaldehyde treated tissue can have an enhanced propensity for
mineralization.
• Evidence of cytotoxicity was observed during cell culturebased
laboratory assays and is believed to be due to the polyaldehyde
component of the product. No evidence of cytotoxicity was observed
in animal or clinical studies.
Adverse Reactions
• Potential adverse effects associated with the use of this
class of surgical sealants include application of the sealant to
tissue not targeted for the procedure, failure of the sealant to
adhere to the tissue, hypersensitivity reaction such as swelling or
edema at the application site, possible transmission of infectious
agents from materials of animal origin, thrombosis and
thromboembolism.
• Serious adverse events that occurred in clinical studies
included death, hypotension, thrombosis/ thromboembolism, ischemia,
respiratory failure/dysfunction, steal syndrome, and myocardial
infarction.
Use in Specific Populations
• Use of PREVELEAK in pediatric or pregnant patients has not
been studied.
This release includes forward-looking statements concerning a
definitive agreement entered into by the company to acquire two
hemostat and sealant products from Mallinckrodt plc. The
statements are based on assumptions about many important factors,
including the following, which could cause actual results to differ
materially from those in the forward-looking statements: the
ability of the company and Mallinckrodt plc to obtain required
regulatory approvals and satisfy closing conditions; the company’s
ability to close the transaction, successfully integrate the
products into its hemostat and sealant portfolio and realize the
anticipated benefits of the acquisition; demand for and market
acceptance of risks for new and existing products, and the impact
of those products on quality or patient safety concerns; actions of
regulatory bodies and other governmental authorities; changes in
laws and regulations; and other risks identified in Baxter’s most
recent filing on Form 10-K and other SEC filings, all of which are
available on its website. Baxter does not undertake to update its
forward-looking statements.
1 Lawson JH. The clinical use and immunologic impact of thrombin
in surgery. Semin Thromb Hemost. 2006;32(Suppl 1):98–110.
https://www.ncbi.nlm.nih.gov/pubmed/16673271
Baxter, FLOSEAL, TISSEEL, COSEAL and VASCU-GUARD are registered
trademarks of Baxter International Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20180108005996/en/
Baxter International Inc.Media Contact:Beth Mueller,
224-948-5353media@baxter.comorInvestor Contact:Clare
Trachtman, 224-948-3085
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