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Pacira Focused on Exparel Development Amid Competition

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We issued an updated research report on Pacira Pharmaceuticals, Inc. (PCRX - Free Report) on July 13.

Pacira’s top line mainly comprises contribution from its marketed product, -Exparel. Exparel is a liposome injection of bupivacaine, which is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. The company projects Exparel sales to be in the range of $300 million to $310 million in 2018.

The company’s efforts to expand Exparel's label to boost sales in oral surgery and chronic pain are encouraging. In April 2018, the FDA approved Pacira’s sNDA seeking expansion of the Exparel label to include administration via nerve block for prolonged regional analgesia. With this approval, Exparel is the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.

The company is also conducting a phase IV study of Exparel in spinal fusion surgery. The company is also launching a series of phase IV studies in soft tissue procedures. These studies will assess Exparel as part of its multimodal protocol for C-section, colon cancer and breast reconstruction surgery. The company is currently enrolling patients and data is expected later in 2018.

Pacira is looking to expand Exparel's label in the animal health market as well. In 2012, the company signed a licensing agreement with Aratana for the development and commercialization of Exparel for animal health indications. Expansion into the animal health market will diversify Exparel's franchise and boost its commercial potential.

In 2012, the company signed a licensing agreement with Aratana for the development and commercialization of Exparel for animal health indications. In January 2017, Pacira signed an agreement with DePuy Synthes Sales Inc. -- a subsidiary of Johnson & Johnson (JNJ - Free Report) -- to market and promote the use of Exparel for orthopedic procedures in the United States' market.

The company has one promising early-stage asset that is based on its DepoFoam technology. DepoMeloxicam I a nonsteroidal antiinflammatory agent is being studied for postsurgical analgesia. The company has submitted an investigational new drug application and subsequently plans to initiate a phase I study of DepoMLX in 2018.

In June 2018, Pacira and Nuance Biotech Co. Ltd. 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.

Under the terms of the agreement, Pacira granted Nuance the exclusive rights to develop and commercialize Exparel in China. Nuance intends to file a Clinical Trial Application with the China Food and Drug Administration later in 2018 and begin clinical studies in China as soon as possible thereafter.

Year to date, shares of Pacira have decreased 20.3% against the industry’s gain of 3.1%.  

However, Exparel competes with well-established products for postsurgical pain management. Opioid analgesics such as morphine, Duragesic (fentanyl), Demerol (meperidine) and Dilaudid (hydromorphone) pose significant competitive threat.

 

Zacks Rank & Stocks to Consider

Pacira has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Eisai Co. and  Amgen Inc. (AMGN - Free Report) . While Eisai carries a Zacks Rank #1 (Strong Buy), Amgen carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Eisai’s earnings estimates have moved up from $1.93 to $1.94 for 2018 and from $1.38 to $1.39 for 2019 over the past 60 days. The stock has rallied 69.7% so far this year.

Amgen’s earnings per share estimates have increased from $13.63 to $13.67 for 2018 and from $14.09 to $14.19 for 2018 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 3.54%. The stock has rallied 128.8% so far this year.

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