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| [April 09, 2012] |
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Pacira Pharmaceuticals, Inc. Announces Commercial Availability of EXPAREL®
PARSIPPANY, N.J. --(Business Wire)--
Pacira
Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced the commercial
launch of EXPAREL®
(bupivacaine liposome injectable suspension) in the United States.
Starting today, EXPAREL will begin shipping to hospital and ambulatory
care customers through their normal wholesaler and distributor channels.
EXPAREL was approved by the U.S. Food and Drug Administration (FDA) in
October 2011 for administration into the surgical site to produce
postsurgical analgesia.
Strong pre-launch commercialization efforts including more than 40 data
publications and more than 1,700 interactions with potential customers
have laid the groundwork for what Pacira believes will be the successful
introduction of EXPAREL into the hospital marketplace.
"For Pacira, today is the culmination of several important
organizational milestones that span the last several years, with the
most significant being the FDA approval of EXPAREL," said Dave Stack,
president and CEO of Pacira Pharmaceuticals. "For the millions of
patients undergoing surgical procedures in the U.S. each year, the
introduction of EXPAREL-a single-dose, non-opioid local analgesic given
at the close of surgery-represents a significant addition to the
armamentarium of currently available options to manage postsurgical
pain."
The Pacira sales force, which consists of 63 hospital specialists who
cover more than 81 percent of the market Pacira is targeting for
EXPAREL, was launched in January 2012. Since that time, this team has
been executing a formulary access strategy, working closely with key
hospital and surgical customers to initiate the formulary review process
to obtain access for EXPAREL.
"Through the work of our field force and the commercialization
activities executed to date, awareness and anticipated demand for
EXPAREL has continued to grow among our target markets," said Taunia
Markvicka, PharmD, vice president, commercial. "We intend to build off
that momentum through a targeted strategy in 2012 that encompasses Phase
4 clinical research, partnerships with key hospital customers and robust
publication and medical education plans."
About Pacira
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) is an emerging specialty
pharmaceutical company focused on the clinical and commercial
developmentof new products that meet the needs of acute care
practitioners and their patients. The company's current emphasis is the
development of non-opioid products for postsurgical pain control, and
its lead product, EXPAREL® (bupivacaine liposome injectable
suspension), was approved for administration into the surgical site to
produce postsurgical analgesia by the U.S. Food and Drug Administration
in October 2011. EXPAREL and two other commercially available products
utilize the Pacira proprietary product delivery technology DepoFoam®,
a unique platform that encapsulates drugs without altering their
molecular structure and then releases them over a desired period of
time. Additional information about Pacira is available at www.pacira.com.
About EXPAREL®
EXPAREL® (bupivacaine liposome injectable suspension) is
indicated for administration into the surgical site to produce
postsurgical analgesia. The product combines bupivacaine with DepoFoam®,
a proven product delivery technology that delivers medication over a
desired time period. EXPAREL represents the first and only
multivesicular liposome local anesthetic that can be utilized in the
peri- or postsurgical setting in the same fashion as current local
anesthetics. By utilizing the DepoFoam platform, a single dose of
EXPAREL delivers bupivacaine over time, providing analgesia with reduced
opioid requirements for up to 72 hours. Pivotal studies have
demonstrated the safety and efficacy of EXPAREL in patients undergoing
bunionectomy or hemorrhoidectomy procedures and additional studies are
underway to further demonstrate the safety and efficacy in other
procedures. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
EXPAREL has not been studied for use in patients younger than 18 years
of age. Non-bupivacaine-based local anesthetics, including lidocaine,
may cause an immediate release of bupivacaine from EXPAREL if
administered together locally. The administration of EXPAREL may follow
the administration of lidocaine after a delay of 20 minutes or more.
Other formulations of bupivacaine should not be administered within 96
hours following administration of EXPAREL. Monitoring of cardiovascular
and neurological status, as well as vital signs should be performed
during and after injection of EXPAREL as with other local anesthetic
products. Because amide-type local anesthetics, such as bupivacaine, are
metabolized by the liver, EXPAREL should be used cautiously in patients
with hepatic disease. Patients with severe hepatic disease, because of
their inability to metabolize local anesthetics normally, are at a
greater risk of developing toxic plasma concentrations. In clinical
trials, the most common adverse reactions (incidence greater-than or
equal to 10%) following EXPAREL administration were nausea,
constipation, and vomiting.
Please see the full Prescribing Information for more details available
at www.EXPAREL.com.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about EXPAREL's potential and
the expected timing of commercial launch, expected 2012 revenues and
other statements containing the words "believes," "anticipates,"
"plans," "expects," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including risks relating to: the success of our sales
and manufacturing efforts in support of the commercial launch of
EXPAREL; the rate and degree of market acceptance of EXPAREL; the size
and growth of the potential markets for EXPAREL and our ability to serve
those markets; our commercialization and marketing capabilities; and
other factors discussed in the "Risk Factors" section of our Annual
Report on Form 10-K for the fiscal year ended December 31, 2011 as filed
with the Securities and Exchange Commission on March 27, 2012, and in
other filings that we periodically make with the SEC (News - Alert). In addition, the
forward-looking statements included in this press release represent our
views as of the date of this press release. We anticipate that
subsequent events and developments will cause our views to change.
However, while we may elect to update these forward-looking statements
at some point in the future, we specifically disclaim any obligation to
do so. These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of this
press release.

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