Supports Clinical Advancement of Remedisc™ for Degenerative Disc Disease

NEW YORK, April 20, 2021 /PRNewswire/ — Spine BioPharma, LLC, a company committed to developing non-opiate, non-surgical therapies for the treatment of pain and disability from chronic low back pain caused by degenerative disc disease, today announced a $3 million investment by Pacira Biosciences in the form of a convertible note. The investment will support the further development of Remedisc, a first-in-class therapeutic for the treatment of degenerative disc disease. Pacira will make an additional $7 million investment predicated upon achieving certain prespecified milestones.

Pacira’s investment follows on the closing of Spine BioPharma’s recent Series A financing round, led by Viscogliosi Bros. with participation by Vulcan Capital and others. Marc Viscogliosi, CEO of Spine BioPharma, stated, “We are delighted to welcome two investment partners that bring significant biopharma expertise, relationships, and scale to our ambitious mission of changing the lives of millions of patients suffering from chronic low back pain. Remedisc represents a unique, best-in-class, first-in-class therapeutic that can provide a non-opiate, non-surgical treatment option to these patients.”

Remedisc is a 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1), which is often highly expressed in the degenerated discs of patients with lower back pain. Abnormal TGFβ1 signaling is associated with the degradation of extracellular matrix components that maintain the structural integrity of healthy spinal discs. TGFβ1 is also reported to stimulate the expression of nerve growth factor leading to an increase in sensory neurons and discogenic pain. Intradiscal injection of Remedisc in patients with degenerative disc disease was developed as a first-in-class regenerative approach to treating chronic back pain and disability, preventing progression of disc degeneration through TGFβ1 modulation.

Spine BioPharma expects to file an Investigational New Drug Application with the U.S. Food and Drug Administration seeking approval of a Phase 2/3 multicenter, randomized controlled study of Remedisc later this year.

Troutman Pepper is acting as legal advisor to Spine BioPharma in connection with the transaction.

About Degenerative Disc Disease
266 million individuals around the world have Degenerative Disc Disease, or DDD, and its associated Chronic Low Back Pain each year. DDD of the lumbar, or lower, spine is a significant cause of disability in the world and a tremendous expense to the healthcare system. It is associated with a variety of clinical symptoms, including, weakness, low back pain and disability of varying levels of severity. There is currently no treatment for the underlying cause of DDD and current approaches are aimed at managing pain through a variety of approaches that include physical therapy, chiropractic care, over the counter medications like non-steroidal anti-inflammatory drugs (NSAIDS) or prescription opioids.  or patients with moderate to severe pain that persists chronically, treatment plans include epidural steroid injections, nerve blocks, radiofrequency ablation or surgical intervention. Clinical outcomes vary and often do not provide predictable benefit.  Given the substantial costs, pain, and disability associated with DDD, and the current lack of an approved disease-modifying agent, a therapy that could relieve pain and increase function with the potential to mediate the progression of DDD or achieve a regenerative effect could revolutionize the standard of care.

About Spine BioPharma
Spine BioPharma specializes in non-surgical therapies that will reduce pain, restore function and slow or stop pathological spinal disease progression without the use of  opioids. Spine BioPharma’s lead candidate, Remedisc™, is a first-in-class, therapeutic for the treatment of degenerative disc disease, offering clinical benefits of pain relief, restoration of function and potential prevention of disease progression. To learn more about Spine BioPharma, visit www.spinebiopharma.com.

About Pacira Biosciences
Pacira BioSciences, Inc. (NASDAQ: PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients’ journeys along the neural pain pathway. The company’s long-acting local analgesic, 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. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

SOURCE: Spine Biopharma, LLC, PR Newswire, 20th April 2021