PARSIPPANY, N.J. and SHANGHAI, China, June 19, 2018 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) and Nuance Biotech Co. Ltd (Nuance) today announced that they have entered into an agreement with Nuance, a China based specialty pharmaceutical company, to advance the development and commercialization of EXPAREL® (bupivacaine liposome injectable suspension) in China. EXPAREL is a non-opioid option for achieving long-lasting pain control after surgery via infiltration into the surgical site or administration as an interscalene brachial plexus nerve block.
“We are thrilled to expand the commercial opportunity for EXPAREL to China with a strong locally-based partner,” said Dave Stack, chairman and chief executive officer of Pacira. “Nuance’s highly talented leadership team has deep experience developing and commercializing innovative products in China using tailored sales and marketing strategies. We look forward to working with Nuance to make EXPAREL a success in China in support of our corporate mission to provide a non-opioid option to as many postsurgical patients as possible.”
“EXPAREL is an ideal fit for the Nuance portfolio given our focus on developing and commercializing innovative products for the Chinese market,” stated Mark G. Lotter, chief executive officer and co-founder of Nuance. “With proven expertise in developing and commercializing global brands, especially surgical products, I have every confidence that Nuance will maximize the commercial value of EXPAREL in China through a dedicated sales, marketing and market access effort, as well as an extensive network of key opinion leaders from influential academic centers.”
Under the terms of the agreement, Pacira has granted Nuance the exclusive rights to develop and commercialize EXPAREL in China. The companies will establish a joint steering committee to review all development and commercialization plans for EXPAREL in China. Pacira will receive an upfront payment of $3 million and is eligible to receive future milestone payments of up to $55 million that are triggered by filing for and securing regulatory approval(s) and annual sales exceeding certain levels. Pacira is also entitled to tiered royalties as a percentage of net sales. Nuance intends to file a Clinical Trial Application with the China Food and Drug Administration later this year and begin clinical studies in China as soon as possible thereafter.
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company dedicated to advancing and improving postsurgical outcomes for acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional 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. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation. If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine. EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.
Nuance Biotech is a leading China based specialty pharmaceutical company headquartered in Shanghai. Nuance has been funded by a group of leading venture capital funds that includes Matrix Partners.
The company was established in 2014 and has rapidly built a unique portfolio that includes several leading brands. The portfolio includes a series of products which are currently commercialized, in registration and an impressive portfolio currently in clinical development. Nuance has both a specialty TA focus as well as targeting surgery departments across leading hospitals in China.
Led by a team of seasoned China based executives with a strong track record in China, the company is seeking to further strengthen its China position as well as its presence in the field of surgery. EXPAREL is the latest addition and represents a unique opportunity to strengthen its position in China.