Businessweek

Pacira Pharmaceuticals, Inc., a specialty pharmaceutical company, engages in the development, manufacture, and commercialization of proprietary pharmaceutical products, based on its DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. Products EXPAREL: The company's primary product candidate is EXPAREL, a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL provides continuous and extended postsurgical analgesia for up to 72 hours and reduces the consumption of supplemental opioid medications. This would simplify postsurgical pain management, minimize breakthrough episodes of pain and result in improved patient outcomes. 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. In October 2011, the United States Food and Drug Administration (FDA) approved the company’s New Drug Application (NDA) for EXPAREL. The target customers for EXPAREL include healthcare practitioners who influence pain management decisions, including surgeons, anesthesiologists, pharmacists, and nurses. 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. DepoDur: DepoDur is an extended-release injectable formulation of morphine utilizing its DepoFoam technology. DepoDur is indicated for epidural administration for the treatment of pain following major surgery. DepoDur is designed to provide effective pain relief of up to 48 hours. DepoDur is approved by the FDA. Product Candidates DepoNSAID: The company’s preclinical product candidates, extended release formulations of NSAIDs (non-steroidal anti-inflammatory drugs), are designed to provide the benefits of injectable NSAIDs with a prolonged duration of action to improve patient care and ease of use in the acute pain environment. DepoMethotrexate: The company’s preclinical product candidate, an extended release formulation of methotrexate, is designed to improve the market utility of methotrexate, the most commonly used disease modifying anti-rheumatic drug. Commercial Partners and Agreements Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau): The company has a supply and distribution agreement with Sigma-Tau to sell DepoCyt in the United States and Canada. Under the supply and distribution agreement, the company supplies unlabeled DepoCyt vials to Sigma-Tau for finished packaging. Mundipharma International Holdings Limited (Mundipharma): The company has an agreement granting Mundipharma, marketing and distribution rights to DepoCyte in the European Union and certain other European countries. Flynn Pharma Limited (Flynn): The company has a marketing agreement with Flynn granting them distribution rights to DepoDur in the European Union, certain other European countries, South Africa, and the Middle East. Novo Nordisk A/S (Novo): In 2011, the company entered into an agreement with Novo pursuant to which it granted non-exclusive rights to Novo under certain of its patents and know-how to develop, manufacture, and commercialize formulations of a Novo proprietary drug using its DepoFoam drug delivery technology. Patents As of December 31, 2011, there were approximately 15 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. Regulation The Drug Enforcement Administration (DEA) Regulation: The company’s marketed product, DepoDur, is regulated as a ‘controlled substance’ as defined in the Controlled Substances Act of 1970 (CSA), which establishes registration, security, recordkeeping, reporting, storage, distribution and other requirements administered by the DEA. The DEA is concerned with the control of handlers of controlled substances, and with the equipment and raw materials used in their manufacture and packaging, to prevent loss and diversion into illicit channels of commerce. History Pacira Pharmaceuticals, Inc. was founded in 2006. The company was incorporated in Delaware under the name Blue Acquisition Corp. in 2006 and changed its name to Pacira, Inc. in 2007. Further, it changed its name to Pacira Pharmaceuticals, Inc. in 2010.