Pacira Pharmaceuticals, Inc.’s (PCRX - Analyst Report) shares gained 10.7% after the U.S. Food and Drug Administration (FDA) approved of an additional manufacturing suite (Suite C) for Exparel. We note that Pacira had submitted a Prior Approval Supplement (PAS) with the FDA for this site in Dec 2013. Suite C is located at the company’s Science Center Campus in San Diego.
Pacira’s lead product Exparel is approved by the FDA for administration into the surgical site to produce post-surgical analgesia. The drug was launched in Apr 2012. Net Exparel revenues were $76.2 million in 2013.
Pacira is putting in efforts to expand Exparel’s label. Pacira expects to submit a supplemental New Drug Application (sNDA) for femoral nerve-block in total knee arthroplasty in the second quarter of 2014. Last month, Pacira released new data from two studies evaluating the use of Exparel to manage post surgical pain following total joint arthroplasty (TJA), which includes hip and knee replacement surgeries.
At the end of 2013, 2,106 customers ordered Exparel since its launch, with roughly 250 customers each ordering more than $100,000. Pacira reported an average of 29 new customers per week in the fourth quarter of 2013.
The Suite C approval will lead to the expansion of Exparel’s manufacturing capacity to meet the growing demand for the drug.
Pacira carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the pharma sector may consider companies like Impax Laboratories Inc. (IPXL - Analyst Report) , Actavis plc and Lannett Co., Inc. (LCI - Snapshot Report) . Actavis and Impax Labs carry a Zacks Rank #2 (Buy) while Lannett carries a Zacks Rank #1 (Strong Buy).