It is fairly common for patients to experience pain after undergoing surgery. Opioids, non-steroidal anti-inflammatory drugs, gabapentin-type drugs, glucocorticoids and local anesthetics are some of the various classes of drugs that are recommended for postoperative pain management. The local anesthetics provide only short-lasting pain relief and there exists a huge unmet need for non-opioid choices too.
Working on the development of a long-acting non-opioid post-surgical analgesic is an emerging specialty pharmaceutical company Pacira Pharmaceuticals Inc. (PCRX), which went public in February 2011.
For readers who are new to the Parsippany, New Jersey-based Pacira, here's the upcoming event to watch out for...
Pacira has a target date with the FDA set for October 28th to get the regulatory agency's decision on lead investigational product candidate Exparel for post-surgical pain management. Exparel consists of analgesic bupivacaine encapsulated in DepoFoam, Pacira's proprietary, extended release drug delivery technology.
Bupivacaine has an established safety profile with more than 20 years of use in the United States and DepoFoam is the basis for two FDA-approved commercial products of Pacira.
According to clinical trials, Exparel has proven to provide analgesia for up to 72 hours post-surgery, compared with bupivacaine's analgesic timeline of 7 hours or less.
Pacira filed a New Drug Application for Exparel for post-surgical pain management in September 2010. The NDA for Exparel is a 505(b)(2) application. The 505(b)(2) regulatory pathway allows a company to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug (the "reference drug").
The NDA for Exparel, which was taken up for review by the FDA, was originally assigned a decision date of July 28, 2011 but was then postponed by three months - with the decision delayed until October 28.
Pacira believes that Exparel, if approved, may help to reduce the dependence on opioid use in the post operative setting and result in improved patient satisfaction and outcomes.
It is estimated that about 45 million surgical procedures are performed in the U.S. annually. Bupivacaine, the most commonly used local anesthetic for surgery, is used in 7.2 million cases and therefore, there exists an opportunity of 37.8 million cases for Exparel, according to Pacira.
According to brokerage firm Wedbush Securities, Exparel can fetch gross peak sales of $576 million worldwide and $362 million in the U.S.
Seeking support for the anticipated launch of Exparel, if approved, Pacira has inked an agreement with Quintiles Commercial US, Inc. and Integrated Commercialization Services Inc. Under the terms of the agreements that were signed yesterday (Sep.6), Quintiles will provide a U.S. sales force of 70 people exclusively dedicated to Exparel and will support sales efforts through December 31, 2012, or beyond while Integrated Commercialization Services will serve as the exclusive third party logistics provider to Pacira to support the U.S. commercialization of Exparel for the next three years. Both agreements may be terminated by Pacira at will in accordance with the terms of the agreements.
The company has two marketed products, DepoCyt(e), to treat lymphomatous meningitis and DepoDur for relief of post-operative pain, following major orthopaedic, abdominal or pelvic surgery. The two products are based on DepoFoam, a unique technology that enables the release of an encapsulated drug over a desired period of time, from 1 to 30 days.
Earlier this year, Pacira signed a development and license agreement with Danish company Novo Nordisk A/S, under which Novo was granted non-exclusive rights to develop a proprietary drug using DepoFoam drug delivery technology.
A quick look at Pacira's balance sheet...
The company has incurred significant operating losses since inception in 2007. Revenue is derived from the two marketed products as supply revenue and royalties, and from collaborations with third parties.
Pacira's total revenue in the second quarter of 2011 rose 19% to $3.64 million compared to the year-ago quarter. Net loss in the three months ended June 30, 2011 was $8.8 million or $0.51 per share (based on 17.2 million weighted average shares outstanding), compared with $6.8 million, or $11.86 per share, in the year-ago same period (based on 0.6 million weighted average shares outstanding). At the end of June 2011, Pacira had cash totaling $47.2 million, up from $26.1 million on December 31, 2010.
Pacira went public at $4 per share , well below the original range of $14 to $16. The company's shares have a 52-week price range of $6.16 to $15.34. The stock closed Tuesday's trading at $7.74, up 5.59%, compared with the previous day.
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