It was a busy week for the biotech sector, with lots of regulatory and pipeline updates amid fears of a global recession sparked by the ongoing global trade war. Most bigwigs came out with important updates. Among these, Pacira Biosciences, Inc. PCRX was up on a positive patent settlement agreement, while Edgewise Therapeutics EWTX stock plunged on study data.
Shares of Pacira Biosciences gained after the company announced settlement agreement with Fresenius, Jiangsu Hengrui Pharmaceuticals and eVenus Pharmaceuticals Laboratories, related to patents for pain management drug Exparel (bupivacaine liposome injectable suspension).
Following the settlement, which resolves the patent litigation brought by Pacira BioSciences against the companies, Consent Judgments will be filed in multiple courts, preventing Fresenius, like the others, from marketing generic bupivacaine liposome injectable suspension before the relevant patents expire, except as outlined in the agreement.
As part of the settlement, Pacira Biosciences granted Fresenius a license to its patents, allowing limited-volume sales of generic bupivacaine liposome injectable suspension in the United States starting early 2030. This license permits market entry of generic versions before the final patent for Exparel expires on July 2, 2044.
Fresenius will initially distribute a high-single-digit percentage of the total U.S. market supply and gradually increase each year, reaching the low thirties by 2033. It will continue to rise modestly over the following two years before peaking in the high thirties during the agreement’s final three years. Additionally, Pacira has granted Fresenius a license to manufacture and sell an unlimited quantity of generic bupivacaine liposome injectable suspension in the United States, beginning no earlier than 2039.
Exparel is PCRX’s lead drug, and patent settlement regarding the same bodes well for the company.
Pacira BioSciences currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Shares of Sarepta Therapeutics SRPT declined after the EMA placed a clinical hold on all studies evaluating Elevidys, its one-shot gene therapy for Duchenne muscular dystrophy (DMD).
This hold has been placed in response to a patient’s death post-treatment with Elevidys, which was reported in March. Though the death was due to acute liver failure, Sarepta believes that the patient’s recent cytomegalovirus infection might have contributed to the outcome. Investigation is still ongoing.
