Pacira Pharmaceuticals, Inc., together with its subsidiaries, operates as a specialty pharmaceutical company. The company focuses on the development, commercialization and manufacture of proprietary pharmaceutical products, based on its proprietary DepoFoam extended release drug delivery technology, primarily for use in hospitals and ambulatory surgery centers. EXPAREL The company’s main product, EXPAREL, which consists of bupivacaine encapsulated in DepoFoam, was approved by the United States Food and Drug Administration, or FDA, in 2011 and launched commercially in 2012. DepoFoam is also the basis for the company’s other FDA-approved product, DepoCyt(e), which the company manufactures for its commercial partners. EXPAREL, a liposome injection of bupivacaine, is an amide-type local anesthetic indicated for infiltration into the surgical site to produce postsurgical analgesia. EXPAREL addresses a significant unmet medical need for a long-acting non-opioid postsurgical analgesic, resulting in simplified postsurgical pain management and reduced opioid consumption, to improved patient outcomes and enhanced hospital economics. Other Products DepoCyt(e): DepoCyt(e) is a sustained-release liposomal formulation of the chemotherapeutic agent cytarabine utilizing its DepoFoam technology. DepoCyt(e) is indicated for the intrathecal treatment of lymphomatous meningitis, a life-threatening complication of lymphoma, a cancer of the immune system. Product Candidates In 2015, the company announced two product candidates to its Depo-Foam based pipeline: DepoMeloxicam, or DepoMLX, and DepoTranexamic Acid, or DepoTXA. DepoMeloxicam: The company’s preclinical product candidate, DepoMLX, is a long-acting non-steroidal anti-inflammatory drug (NSAID) designed to treat moderate to severe acute postsurgical pain as part of a non-opioid multimodal regimen. A product designed for single dose local administration such as DepoMLX could provide a longer duration of pain relief at a significantly lower concentration of systemic NSAIDs, which are known to cause dose dependent gastrointestinal side effects. Meloxicam, which is available as an oral formulation, is one of the most potent NSAIDs on the market. DepoTranexamic Acid: Tranexamic Acid, or TXA, is used off-label as a systemic injection or as a topical application, and is used to treat or prevent excessive blood loss during surgery by promoting hemostasis. The formulation of tranexamic acid, however, has a short-lived effect consisting of only a few hours, while the risk of bleeding continues for two to three days after surgery. DepoTXA, a long acting local antifibrinolytic agent combining immediate and extended release TXA, could address the unmet, increasing need for rapid ambulation and discharge in the ambulatory surgery environment for joint surgery (primarily orthopedic surgery, including spine and trauma procedures and cardiothoracic surgery). DepoTXA is in the preclinical phase. Strategy The company’s goal is to be a specialty pharmaceutical company focused on the development, commercialization and manufacture of proprietary pharmaceutical products primarily for use in hospitals and ambulatory surgery centers. The company plans to achieve this by: fully commercializing EXPAREL in the United States for postsurgical analgesia by infiltration; continuing to build and expand a streamlined commercial organization concentrating on major hospitals and ambulatory surgery centers in the United States; demonstrating the economic benefits of EXPAREL, working directly with managed care payers and quality improvement organizations, in the field of postsurgical pain management and influential hospitals in conducting Phase 4 retrospective and prospective trials and drug utilization evaluations; servicing the commercial audiences that are rapidly adopting EXPAREL in local infiltration procedures; obtaining FDA approval for additional indications for EXPAREL including nerve block; leveraging the development success of EXPAREL in the animal health market through a commercial partner Aratana Therapeutics, Inc.; manufacturing all DepoFoam-based products, including EXPAREL, in facilities compliant with current Good Manufacturing Practices, or cGMP, and expanding such manufacturing capacity to meet demand; continuing to expand marketed product portfolio through development of additional DepoFoam-based hospital products; and continuing research and development partnerships to provide DepoFoam-based products to enhance the duration of action and patient compliance for partner products. Customers The company had three customers each comprising 10% or more of its total revenue, as of December 31, 2014: AmerisourceBergen Health Corporation, Cardinal Health, Inc. and McKesson Drug Company, which accounted for 33%, 29% and 24% of its revenues. Patents and Patent Applications As of December 31, 2014, there are approximately 14 families of patents and patent applications relating to various aspects of the DepoFoam delivery technology. Patents have been issued in various countries, with an emphasis on the North American, European and Japanese markets. These patents have a term of 20 years from the date of the nonprovisional filing unless referring to an earlier filed application. Some of its U.S. patents have a term from 17 years from the grant date. The company’s issued patents expire at various dates in the future, as discussed below, with the last currently issued patent expiring in 2018. Regulations Federal Food, Drug and Cosmetic Act: Prescription drug products are subject to extensive pre- and post-market regulation by the FDA, including regulations that govern the testing, manufacturing, distribution, safety, efficacy, approval, labeling, storage, record keeping, reporting, advertising and promotion of such products under the Federal Food, Drug and Cosmetic Act, or FDCA, and its implementing regulations, and by comparable agencies and laws in foreign countries. History Pacira Pharmaceuticals, Inc. was founded in 2006.
pacira pharmaceuticals inc
(PCRX:Consolidated Issue Listed on NASDAQ Global Select )
5 Sylvan Way
Parsippany, NJ 07054
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