Purdue Pharma L.P. Enters into Exclusive Option Agreement to Acquire SpineThera, Inc. and Its Non-Opioid Product in Development for Epidural Steroid Injection for the Treatment of Low Back Pain

STAMFORD, Conn. & PLYMOUTH, Minn.--(BUSINESS WIRE)--Oct 22, 2018--Purdue Pharma L.P. and SpineThera, Inc. today announced that the companies have entered into an agreement that provides Purdue the exclusive option to acquire SpineThera, Inc. and gain worldwide rights to its products and technology platforms, including lead asset SX600, a novel dexamethasone containing microsphere that is in development for epidural administration for low back pain. This technology has potential for development of non-opioid treatments for acute and chronic pain.

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“We are pleased to partner with SpineThera to support further development of its novel steroid product for epidural injection for patients who suffer from low back pain,” said Craig Landau, MD, President and CEO, Purdue Pharma. “We are committed to alleviating pain through new and innovative non-opioid medicines. SX600 represents an exciting opportunity to meet this important medical need and advance our mission.”

Epidural steroid injections are a commonly performed procedure in the United States for low back pain, with approximately nine million performed annually in the U.S. 1 The companies believe there is a substantial clinical need for an FDA-approved epidural steroid that demonstrates a long duration of pain relief with a favorable safety profile. The active ingredient in SX600 is dexamethasone acetate, which has been reformulated into an injectable micro-suspension containing microspheres that are much smaller than the particles in a standard corticosteroid suspension and smaller than a red blood cell. The active drug is encapsulated within these tiny biodegradable microspheres, which provides sustained release delivery of dexamethasone.

“We look forward to developing this important future product with the financial support of Purdue,” said Jeff Missling, CEO of SpineThera. “Their expertise in pain management is critical as we embark on this meaningful collaboration.”

Safety and tolerability of SX600 will be evaluated during the clinical development program, which will be initiated by SpineThera in 2019.

The agreement is subject to final shareholder approval and customary closing conditions. Terms of the deal have not been disclosed.

Lake Street Capital Markets, LLC acted as financial advisor and Fox Rothschild LLP served as legal counsel to SpineThera, Inc. on this transaction. Arnold & Porter served as legal counsel to Purdue Pharma L.P.

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About Purdue Pharma L.P.

Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. For more information, please visit www.purduepharma.com .

About SpineThera, Inc.

SpineThera designs and develops sustained-release, injectable drugs to meet the unique safety requirements for administration in and near the spine. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs. SX600, our lead product candidate, is an investigational drug.

Reference:

1 American Academy of Pain Medicine. Critically evaluating the evidence for epidural injections for failed back surgery syndrome: should pain physicians be bracing for impact? Available at https://academic.oup.com/painmedicine/article-pdf/19/7/1299/25128470/pny101.pdf . Accessed October 15, 2018.

View source version on businesswire.com:https://www.businesswire.com/news/home/20181022005844/en/

CONTACT: Media:

Robert Josephson

Purdue Pharma L.P.

+1-203-588-7114

Robert.Josephson@pharma.com

or

Jeff Missling

SpineThera, Inc.

+1-612-444-1154

jmissling@spinethera.com

KEYWORD: UNITED STATES NORTH AMERICA CONNECTICUT MINNESOTA

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS PHARMACEUTICAL FDA

SOURCE: Purdue Pharma L.P.

Copyright Business Wire 2018.

PUB: 10/22/2018 03:07 PM/DISC: 10/22/2018 03:07 PM

http://www.businesswire.com/news/home/20181022005844/en