PARSIPPANY, N.J. & KANSAS CITY, Kan.--(BUSINESS WIRE)--Dec. 6, 2012--
Pacira
Pharmaceuticals, Inc. (NASDAQ: PCRX) and Aratana
Therapeutics Inc. today announced a global licensing agreement for
the development and commercialization of bupivacaine liposome injectable
suspension for animal health indications. Under the agreement, Aratana
will develop and seek approval for the use of the product in veterinary
surgery to manage postsurgical pain, focusing initially on developing
the product for cats, dogs and other companion animals.
Bupivacaine liposome injectable suspension is approved for human use in
the United States for the management of postsurgical pain and is
currently marketed by Pacira under the name EXPAREL®. EXPAREL
is a non-opioid local anesthetic, which was approved by the U.S. Food
and Drug Administration (FDA) in October 2011 for administration into
the surgical site to produce postsurgical analgesia. EXPAREL utilizes
DepoFoam®, a proprietary delivery technology utilized in
several Pacira products approved for human use. Veterinary development
of the product may address the estimated 33 million surgical procedures
performed each year on companion animals in the U.S.1
Steven St. Peter, M.D., chief executive officer of Aratana Therapeutics,
stated, “Given the rapid and widespread implementation of EXPAREL by
surgeons performing human procedures, we are confident that adoption of
this innovative product by veterinary surgeons will be equally
impressive. The global companion animal health market remains
significantly underserved despite the more than 150 million companion
animals in the U.S.2 – many of whom will undergo surgical
procedures. We believe this product fits nicely into our growing
portfolio of companion animal therapeutics and will be welcomed by
veterinarians committed to providing their patients with the best care
available.”
“The management of postsurgical pain in animal health settings
represents a large and growing market for our EXPAREL product,” said
David Stack, president and chief executive officer of Pacira. “We
continue to see EXPAREL adoption in a wide range of surgical settings,
the generation of positive Phase 4 data and considerable sales growth
during our launch year. We also have recently completed the installation
of our expanded manufacturing suite – these milestones all strongly
position the program for a strategic partnership. Given the Aratana
team’s combined decades of veterinary drug development experience, we
believe Aratana is the ideal partner for maximizing the product’s value
in the companion animal health market.”
Under the agreement, Aratana made a one-time payment to Pacira of $1
million and will pay additional development and commercial milestones
totaling up to $42.5 million. In addition, upon approval of the product
by the FDA, Aratana will pay Pacira a double-digit royalty on net sales
of the product. Should Aratana sublicense the product to a third party,
Aratana and Pacira will share the proceeds by a predetermined formula
(after Aratana has recovered certain direct development costs). Pacira
will be responsible for all product manufacturing, and Pacira and
Aratana will form a joint committee to oversee commercialization and
development activities.
About Pacira
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is an emerging specialty
pharmaceutical company focused on the clinical and commercial
development of 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 commercially launched in the United States in April
2012. EXPAREL and two other products have utilized 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 http://www.pacira.com.
About Aratana Therapeutics
Aratana Therapeutics is a biopharmaceutical company positioned to
deliver high quality new medicines that address significant therapeutic
needs for cats and dogs (companion animals). Aratana licenses and
develops proprietary, patent-protected compounds acquired from human
pharmaceutical and biotechnology companies and then maximizes the value
of the programs for the animal health market. For more information,
please visit www.aratanatherapeutics.com.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about our plans to develop and
commercialize a bupivacaine liposome injectable suspension product for
animal health indications, the size of the market for such a product and
the level and rate of adoption for such a product 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 attainment of all necessary regulatory
approvals for the marketing of any product developed under the Aratana
license agreement; the success of our sales and manufacturing efforts in
support of the commercialization 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" of our most recent Annual Report on Form
10-K for the fiscal year ended December 31, 2011, our most recent
Quarterly Report on Form 10-Q for the quarter ended September 30, 2012,
and in other filings that we periodically make with the SEC. 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.
1 Small Animal and Equine Veterinary Surveys Regarding
Surgical Procedures and Local Anesthetic Use (2008). Brakke Consulting,
Inc., Dallas, TX. Prepared for Pacira Pharmaceuticals, Inc.
2American Veterinary Medical Association (2011). www.avma.org
*EXPAREL is a registered trademark of Pacira Pharmaceuticals, Inc.
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Source: Pacira Pharmaceuticals, Inc.
For Pacira Pharmaceuticals, Inc.
James S. Scibetta,
973-254-3570
or
Media Contact:
Pure Communications, Inc.
Susan
Heins, 864-286-9597
or
For Aratana Therapeutics Inc.
Investors
& Media:
Joshua Drumm, Ph.D. / Andrew Mielach
Tiberend
Strategic Advisors, Inc.
(212) 827-0020
jdrumm@tiberend.com
amielach@tiberend.com