LAKE FOREST, Ill., July 16, 2015 /PRNewswire/ -- Hospira, Inc.
(NYSE: HSP), the world's leading provider of injectable drugs and
infusion technologies, and a global leader in biosimilars, today
announced it had obtained U.S. Food and Drug Administration (FDA)
approval for the launch of bivalirudin for injection, a generic
version of The Medicines Company's Angiomax™. Branded sales of
Angiomax in 2014 in the United
States were approximately $500
million.
Hospira's bivalirudin for injection is available in a
single-dose flip-top vial, which matches the current branded
offering available. In addition, the company plans to launch a
differentiated presentation of the 250 mg bivalirudin for injection
in Hospira's unique ADD-Vantage™ vial.
"Hospira is excited to launch the first generic of bivalirudin
based on a successful challenge of the originator's patents," said
Philippe Drouet, president, U.S.
Commercial, Hospira. "This approval further demonstrates our
commitment to bringing safe, lower-cost generic versions of
important medications to the market as soon as possible."
Available as a lyophilized (powder) format, Hospira's
bivalirudin for injection is a direct thrombin inhibitor indicated
for use as an anticoagulant in patients:
- With unstable angina undergoing percutaneous transluminal
coronary angioplasty (PTCA);
- Undergoing percutaneous coronary intervention (PCI) with
provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the
REPLACE-2 study;
- With, or at risk of, heparin-induced thrombocytopenia (HIT) or
heparin-induced thrombocytopenia and thrombosis syndrome (HITTS),
undergoing PCI.
Bivalirudin is intended for use with aspirin.
Hospira's specialty injectable pharmaceuticals (SIP) offering
includes approximately 200 generic injectable drugs in many dosages
and formulations. In addition, many of its products are available
in popular differentiated presentations, several of which are
proprietary, such as the ADD-Vantage™ drug delivery system and
Carpuject™ prefilled syringes. Therapeutic segments include
analgesia, anesthesia, anti-infectives, cardiovascular, oncology,
emergency and other areas. Hospira also has robust pipelines of
both generic and biosimilar drugs.
Important Safety Information
Contraindications
- Active major bleeding.
- Hypersensitivity to bivalirudin or any product components.
Warnings and Precautions
- Bleeding events: Hemorrhage can occur at any site. Discontinue
bivalirudin for an unexplained fall in blood pressure or
hematocrit.
- Coronary artery brachytherapy: Risk of thrombus formation,
including fatal outcomes, in gamma brachytherapy.
Adverse Reactions
Most common adverse reaction was bleeding (28 percent). Other
adverse reactions (incidence >0.5 percent) were headache,
thrombocytopenia and fever.
Limitation of use
Safety and effectiveness has not
been established in patients with acute coronary syndromes who are
not undergoing PTCA or PCI.
About Hospira
Hospira, Inc. is the world's leading provider of injectable
drugs and infusion technologies, and a global leader in
biosimilars. Through its broad, integrated
portfolio, Hospira is uniquely positioned to Advance
Wellness™ by improving patient and caregiver safety while reducing
healthcare costs. The company is headquartered in Lake Forest,
Ill. Learn more at www.hospira.com.
-- Private Securities Litigation Reform Act of
1995 --
A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements generally relate to future events or Hospira's future
financial or operating performance. In some cases, you can identify
forward-looking statements because they contain words such as
"may," "will," "should," "expects," "plans," "anticipates,"
"could," "intends," "target," "projects," "contemplates,"
"believes," "estimates," "predicts," "potential" or "continue" or
the negative of these words or other similar terms or expressions
that concern Hospira's expectations, strategy, plans or intentions.
Forward-looking statements in this press release include Hospira's
expectations regarding regulatory approvals, clinical trials and
the actions of competitors. Hospira's expectations and beliefs
regarding these matters may not materialize, and actual results in
future periods are subject to risks and uncertainties that could
cause actual results to differ materially from those projected.
Actual results may differ materially from those indicated by these
forward-looking statements as a result of various important
factors, including, without limitation, challenges inherent in
creating and developing compounds and product candidates and
economic, competitive, governmental, regulatory, legal, supply and
other factors. Information on these and additional risks affecting
Hospira's business and operating results are more fully discussed
in the section entitled "Risk Factors" in Hospira's most recently
filed annual report on Form 10-K and any subsequently filed
quarterly report on Form 10-Q. The forward-looking statements in
this press release are based on information available as of the
date hereof, and Hospira disclaims any obligation to update any
forward-looking statements, except as required by law.
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SOURCE Hospira, Inc.