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): October 1, 2013
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 100, 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.
Effective October 1, 2013, Pacira Pharmaceuticals, Inc. (Pacira) and Crosslink BioScience, LLC (Crosslink) commenced a five-year arrangement for the promotion and sale of Paciras lead product, EXPAREL®, pursuant to the terms of a Master Distributor Agreement (as amended, the Agreement). Pacira and Crosslink entered into the Agreement on March 11, 2013, which provided for an initial small-scale pilot period commencing on April 1, 2013 and ending on September 30, 2013 (the Pilot Period), during which Crosslink was appointed as the exclusive distributor of EXPAREL for certain specified accounts. The Agreement permitted either party to terminate the Agreement within 15 days prior to the expiration of the Pilot Period, and unless such termination was effected, the Agreement would automatically renew for a term of five years, commencing on October 1, 2013 and ending on September 30, 2018 (the Term). Neither party provided notice of termination, and upon the commencement of the Term, certain performance metrics and payment terms became effective, and Crosslinks distribution territory expanded.
Under the Agreement, Pacira appointed Crosslink as the exclusive third-party distributor during the Term to promote and sell EXPAREL for orthopedic and spine surgeries in the United States, with the exception of certain geographical areas and accounts (the Territory). The prices and purchasing terms related to sales of EXPAREL are determined by Pacira, and all orders are subject to acceptance or rejection by Pacira. Crosslink is entitled to receive commissions on its sales of EXPAREL in the Territory, subject to certain conditions and adjustments. Crosslink may receive additional performance-based payments if it achieves certain sales goals, and Pacira may terminate the Agreement if Crosslink fails to meet certain minimum performance metrics.
Crosslink and any sub-distributors engaged by Crosslink pursuant to the terms of the Agreement are subject to certain obligations and restrictions, including required compliance with certain laws and regulations, confidentiality obligations and Paciras policies. The Agreement contains customary representations and warranties and mutual indemnification obligations. In addition, Crosslink and its sub-distributors are prohibited from promoting, selling or distributing any competitive products during the Term.
Pacira and Crosslink have mutual termination rights under the Agreement, and Pacira has additional unilateral termination rights under certain circumstances. The Agreement also permits Pacira to terminate the Agreement without cause effective September 30, 2016, subject to certain terms and conditions set forth in 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 Annual Report on Form 10-K for the year ending December 31, 2013.
A copy of the Companys press release announcing the Pacira and Crosslink arrangement 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 October 1, 2013 |
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: October 1, 2013 |
By: |
/s/ James Scibetta |
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James Scibetta |
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Chief Financial Officer |
Exhibit 99.1
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NEWS RELEASE |
FOR IMMEDIATE RELEASE
Pacira Pharmaceuticals, Inc. Announces Partnership to Support Uptake of EXPAREL® Among the Orthopedic Marketplace
Five-year arrangement with CrossLink Bioscience, LLC follows initial pilot program
PARSIPPANY, N.J., October 1, 2013 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the initiation of a five-year promotion arrangement with CrossLink Bioscience, LLC, an orthopedic device distributor based in Atlanta. Under the agreement, CrossLink will act as a local agent as well as a lead partner in current collaboration with additional distributors in select markets across the United States to promote and sell EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain management following orthopedic procedures.
Distributors representing several orthopedic manufacturers with exclusive territory designations participated in a pilot program, which began in April 2013. The formal Pacira and CrossLink partnership represents an extension of that initial program, aimed at addressing the growing interest in EXPAREL among orthopedic customers.
The ability to provide patients with up to 72 hours of non-opioid postsurgical pain control without the need for catheters or external deviceswhich can limit mobility and delay the ambulation that we know is critical to the rehabilitation process following orthopedic proceduresmakes EXPAREL an important option for patient care, said Dave Stack, president, chief executive officer and chairman of Pacira. This collaborative effort allows Pacira to partner with several hundred orthopedic distributor representatives who cover select geographies in the United States.
Under the terms of the agreement, CrossLink is compensated on a variable cost basis, based on performance in designated hospitals and geography, reported monthly to Pacira. The parties may elect, by mutual agreement, to add additional orthopedic distributors and/or geographies to the five-year agreement. In addition, Pacira and Crosslink have mutual termination rights under the agreement, with Pacira having unilateral termination rights under certain circumstances. The agreement also permits Pacira to terminate without cause effective September 30, 2016, subject to certain terms and conditions.
To further support this interest in EXPAREL among orthopedic surgeons, Pacira Professional Services and Surgical Account Specialists will also expand their education, promotion and selling to surgeons managing pain in orthopedic procedures.
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 companys 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 www.pacira.com.
About CrossLink
CrossLink Bioscience, LLC is a subsidiary of CrossLink Life Sciences, LLC, one of the largest orthopedic and spine device distributorships in the United States. Over the past 35 years CrossLink has built a world class specialty sales organization, formed lasting partnerships with the worlds foremost medical device innovators, and provided superior service to world renowned healthcare providers with a foundational goal of improving patient outcomes. Additional information about CrossLink is available at www.crosslinklifesciences.com.
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is 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 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 http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.
Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about our plans and expectations regarding EXPAREL, 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 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 plans to expand the indications of EXPAREL to include nerve block, including the timing and success of an sNDA; our plans to continue to manufacture and provide support services for our commercial partners who have licensed DepoCyt(e); 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, 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.
Contacts:
Company Contact:
Pacira Pharmaceuticals, Inc.
Jessica Cho, (973) 254-3574
Media Contact:
Pure Communications, Inc.
Susan Heins, (864) 286-9597
sjheins@purecommunicationsinc.com
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