UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 24, 2017
PACIRA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-35060 |
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51-0619477 |
(State or other jurisdiction |
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(Commission |
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(IRS Employer |
of incorporation) |
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File Number) |
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Identification No.) |
5 Sylvan Way, Suite 300, Parsippany, New Jersey 07054
(Address of principal executive offices) (Zip Code)
(973) 254-3560
Registrants telephone number, including area code
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01. Entry into a Material Definitive Agreement.
On January 24, 2017, Pacira Pharmaceuticals, Inc. (Pacira) and DuPuy Synthes Sales, Inc. (DuPuy) entered into a five-year arrangement for the promotion and sale of Paciras lead product, EXPAREL®, pursuant to the terms of a Co-Promotion Agreement between the parties (the Agreement).
Pursuant to the Agreement, Pacira appointed DuPuy as the exclusive third-party distributor during the term of the Agreement to promote and sell EXPAREL for operating room use for orthopedic and spine surgeries (including knee, hip, shoulder, sports and trauma surgeries) in the United States. DuPuy is entitled to annual royalty payments on its sales of EXPAREL under the Agreement, subject to conditions, limitations and adjustments. The initial term of the Agreement commences on January 24, 2017 and ends on December 31, 2021, with the option to extend the Agreement in additional 12 month increments upon mutual agreement of the parties, subject to certain conditions.
Pacira and DuPuy have mutual termination rights under the Agreement, subject to certain terms, conditions and advance notice requirements; provided that Pacira or DuPuy generally may not terminate the Agreement, without cause, within three years of the effective date of the Agreement. Pacira also has additional unilateral termination rights under certain circumstances. The Agreement contains customary representations, warranties, covenants and confidentiality provisions, and also contains mutual indemnification obligations. DuPuy is also subject to certain obligations and restrictions, including required compliance with certain laws and regulations and Paciras policies, in connection with fulfilling their obligations under the Agreement.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by the terms of the Agreement. A copy of the Agreement will be filed by Pacira as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2017.
A copy of Paciras press release announcing the Agreement is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
99.1 |
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Press Release dated January 25, 2017. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Pacira Pharmaceuticals, Inc. | |
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Date: January 25, 2017 |
By: |
/s/ Kristen Williams |
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Kristen Williams |
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Chief Administrative Officer, General Counsel |
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and Secretary |
Exhibit 99.1
NEWS RELEASE |
FOR IMMEDIATE RELEASE
Pacira Pharmaceuticals Announces Collaboration with DePuy Synthes to Support Promotion, Education and Training of EXPAREL® in Orthopedics
Collaboration will focus on opportunities in joint reconstruction, spine, sports medicine, and trauma specialties
Conference call today at 8:30 a.m. ET
PARSIPPANY, N.J., January 25, 2017 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the initiation of an agreement with DePuy Synthes Sales Inc. to market and promote the use of EXPAREL® (bupivacaine liposome injectable suspension) for orthopedic procedures in the United States market.
With the opioid epidemic raging across the United States, and the evidence that the operating room serves as a gateway to opioid abuse, we believe our collaboration with DePuy Synthes will accelerate and enhance our education and training efforts with orthopedic customers, said Dave Stack, chairman and chief executive officer of Pacira. By benefiting from the scale, existing relationships and commercial capabilities of DePuy Synthes, we aim to broaden and strengthen the adoption and use of EXPARELespecially important given the number of key EXPAREL data sets in orthopedic procedures that we expect this year.
DePuy Synthes field representatives, specializing in joint reconstruction, spine, sports medicine and trauma, will collaborate with, and supplement, the Pacira field teams by expanding the reach and frequency of EXPAREL education in the hospital surgical suite and ambulatory surgery center settings. In addition to supporting DePuy Synthes, Pacira will focus on soft tissue surgeons in key specialties and anesthesiologists, and continue to act as the overall EXPAREL account manager.
Mr. Stack continued: The ability to provide patients with long-acting postsurgical pain control with an opioid minimization strategy is critical to the rehabilitation process following orthopedic procedures, especially when taking into account the expected April 1, 2017 initiation of CMS bundled payments for hip and knee replacements. This collaboration between our commercial organizations will allow us to expand and tailor our marketing and educational activities for EXPAREL by patient group, enabling us to maximize the availability of EXPAREL to as many patients as appropriate.
Conference Call and Webcast
The Pacira management team will host a conference call to discuss the contents of this press release today, Wednesday, January 25, 2017, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) 10 minutes prior to the start of the call and providing the Conference ID 59892663.
A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 59892663. The replay of the call will be available for two weeks from the date of the live call.
The live, listen-only webcast of the conference call can also be accessed by visiting the Investors & Media section of the companys website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.
About Pacira
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is a 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 companys flagship product, EXPAREL® (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and 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 currently indicated for single-dose infiltration 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. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Forward Looking Statements
Any statements in this press release about our future expectations, plans, outlook and prospects, and other statements containing the words believes, anticipates, plans, estimates, expects, intends, may 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 commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL and our other products; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications; the outcome of the U.S. Department of Justice inquiry; our plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical trials in support of an existing or potential DepoFoam-based product; our plans to continue to manufacture and
provide support services for our commercial partners who have licensed DepoCyt(e); our commercialization and marketing capabilities; our and Patheon UK Limiteds ability to successfully and timely construct dedicated EXPAREL manufacturing suites; 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, 2015 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. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such 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.
Company Contact:
Pacira Pharmaceuticals, Inc.
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com
Media Contact:
Coyne Public Relations
Alyssa Schneider, (973) 588-2270
aschneider@coynepr.com
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