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

Purdue will support SpineThera’s clinical development program to evaluate sustained-release, injectable treatment options for pain in and near the spine

October 22, 2018 03:07 PM Eastern Daylight Time

STAMFORD, Conn. & PLYMOUTH, Minn.--(BUSINESS WIRE)--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.

“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.

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.pdfAccessed October 15, 2018.

Contacts

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

SPINETHERA TO PRESENT AT DISCOVERY SQUARE INNOVATORS & INVESTORS FORUM

On October 10, 2017 the Mayo Clinic Center for Individualized Medicine, Destination Medical Center, and Medical Alley Association are hosting the Discovery Square Innovators + Investors Forum at the Mayo Civic Center.

Jeff Missling, CEO, will describe the value that SpineThera’s sustained-release injectable steroid, SX600, may deliver to patients, physicians, and payers. SpineThera designed SX600 with the goal of providing patients long-term back pain relief from a single epidural steroid injection.  Mr. Missling is scheduled to speak at 3:00 pm.   

About SpineThera:

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.

About the event:

This half-day event features leaders in the healthcare and technology innovation community who are helping grow Minnesota’s healthcare economy.  Following the panel discussions and company presentations, the Investors & Innovators Reception (5:00–7:30 pm) will provide a business casual setting to connect with innovators, investors, industry executives, venture capitalists, philanthropists, key opinion leaders from academia, and key Mayo leadership to explore opportunities for collaboration.

 

SPINETHERA FEATURED AS A MINNESOTA COMPANY WORKING ALTERNATIVES FOR OPIOID PAIN MEDICATION

SpineThera was featured in three news stories published by the Star Tribune about Minnesota companies working on non-opioid technologies to reduce pain. The direct links to the stories can be found below:

Minnesota medical companies work on alternatives for opioid drugs

Minnesota-made anti-pain therapies

State lawmakers gather new ideas for pain treatment from Minnesota Companies

SPINETHERA TO PRESENT AT MEDICAL ALLEY PAIN MANAGEMENT – ALTERNATIVES TO OPIOIDS - ROUNDTABLE

SpineThera will participate in the Medical Alley Association roundtable discussion of alternatives to opioids, which will be held on October 2nd, 2017 at 9 am in the Minnesota Senate Building.  The roundtable discussion will include Minnesota legislative leaders and will showcase pain management technologies developed by Minnesota companies.

Jeff Missling, CEO, will present an overview of SpineThera’s sustained-release injectable steroid, SX600, an investigational drug in development to treat low back pain.  SpineThera designed SX600 with the goal of providing patients long term back pain relief from a single epidural steroid injection.   60% of back pain patients have been reported to receive at least 1 opioid prescription within the first year of their diagnosis. 

About SpineThera:

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.

About the event:

With the opioid crisis enveloping the nation, the Medical Alley Association is working with legislators to highlight alternatives that can be utilized to ensure that a patient can avoid exposure to addictive opioids.   A press conference with participating companies and legislative leaders will take place prior to the roundtable discussion. 

SPINETHERA TO BE FEATURED AT THE GREAT STATE OF PHARMACEUTICALS & BIOTECHNOLOGY 2017 - POWERED BY PHRMA

SpineThera is pleased to announce its participation at The Great State of Pharmaceuticals & Biotechnology 2017 conference to be held on August 1st, 2017 in St. Louis Park, MN.  

Emily Meyering, Director of R&D, will give a company presentation at 1:15 pm as part of the conference Company Showcase series.  The Company Showcase series includes 3 companies from Minnesota’s Medical Alley invited to present their biotechnology to the conference. 

Jeff Missling, CEO, will participate in a panel discussion at 3:50 pm titled “Case Studies of Non-Dilutive Financing in Emerging BioPharma Ventures”.  SpineThera has been awarded $2.34M in non-dilutive funding from 4 government sources. 

More information about the conference can be found at the Great State of Pharmaceuticals & Biotechnology 2017 website.

About SpineThera:

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.

About the event:

The Great State of Pharmaceuticals & Biotechnology 2017 brings Medical Alley’s drug industry together for a day of learning, networking, and fellowship. The conference will feature exceptional industry content and the opportunity to connect with suppliers, consultants and peers to fuel the connectivity of your Medical Alley community. It’s a trade fair, a conference, an exhibition and peer networking event.

SpineThera Receives $2 Million Grant From U.S. Army

SpineThera, Inc., a privately held pharmaceutical company, announced today that the United States Army has awarded the company a grant to support the further development of SX600, a sustained-release, injectable, micro-suspension corticosteroid in development to address the unique requirements of an epidural injection to treat back pain.

Back pain is a significant medical problem for the Armed Forces resulting in evacuations, treatments, and training of replacement personnel. Prevalence among deployed personnel is 21-27%, and it is the most common condition for which medical treatment is sought in the military.

Jeff Missling, Founder and CEO of SpineThera, stated, “We are honored and thankful to receive this $2,019,442 award from the United States Army. Army doctors have shown that treating back pain in forward deployed pain clinics results in return-to-duty rates greater than 90%, but have also reported that 35% of coalition forces who received an epidural steroid injection for back pain returned to these forward deployed pain clinics for another injection. The typical interval between injections was 2-4 weeks. Our goal with SX600 is to offer a long-acting injectable drug that provides pain relief and reduces the need for repeat or frequent epidural steroid injections. Knowing that our drug has potential benefits to deployed military personnel, in addition to non-deployed military personnel and the general patient population, adds further meaning to our work. We aim to offer back pain patients a better treatment option than exists today.”

About the Award:

The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Broad Agency Announcement under Award No. W81XWH-17-1-0014. Opinions, interpretations, conclusions and recommendations are those of the SpineThera and are not necessarily endorsed by the Department of Defense. In conducting research using animals, SpineThera adheres to the laws of the United States and regulations of the Department of Agriculture.

About SpineThera:

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 is an investigational drug.

SpineThera’s Second U.S. Patent to Issue 21 Feb 2017

SpineThera, a privately held, pre-clinical stage pharmaceutical company, announced today that the United States Patent and Trade Mark Office has provided official notice that US Patent 9,572,771 covering sustained-release, injectable drug formulations for the treatment of back pain will issue on 21 Feb 2017.   

“This second patent strengthens the protection of our lead drug, SX600, a sustained-release, injectable, micro-suspension corticosteroid that we have developed to address the unique requirements of an epidural injection to treat back pain,” said Jeff Missling, Founder and CEO of SpineThera. “We are continuing to pursue rapid development of SX600 as we know that 4 million patients receive an epidural steroid injection every year in the United States for back pain despite there being no FDA approved drug for this use.  We aim to replace those off-label epidural steroid injections with SX600 and to improve the duration of pain relief from a single epidural injection.”

SpineThera had previously announced in October 2016 that the United States Patent and Trademark Office had issued a Notice of Allowance for U.S. Patent Application Serial Number 14/561,797. SpineThera has now received an Issue Notification for this application stating that it will issue on 21 Feb 2017 as US Patent 9,572,771.

About SpineThera:

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.

SpineThera Announces Allowance of Patent

SpineThera Inc., a privately held pharmaceutical company, announced today that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/561,797.  Jeff Missling, CEO, commented, “This new patent builds on our previously issued patent and furthers our intellectual property protection of our sustained-release, injectable micro-suspension technology, including our lead drug product candidate.”  SpineThera expects the patent to be issued within the next few months.

 About SpineThera:

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.

SpineThera Featured at BIO - NIH SBIR Innovation Zone

SpineThera, a privately held, pre-clinical stage pharmaceutical company, has been selected to participate in the National Institutes of Health SBIR Innovation Zone at the BIO International convention to be held in San Francisco, June 6-9, 2016.

About BIO: As the world's largest biotechnology conference and exhibition, this annual event attracts 15,000 biotech leaders from 65 countries and covers the wide spectrum of life science innovations and application areas including drug discovery, bio manufacturing, genomics, biofuels, nanotechnology, cell therapy, and more.

About the BIO Innovation Zone: The NIH and NSF have continued their partnership with BIO, where nearly 100 of the most promising SBIR/STTR grantees will showcase and discuss their technologies in the exciting Innovation Zone, a premier partnering opportunity, at the BIO International Convention on June 6-9, 2016, in San Francisco, CA.

Mr. Jeff Missling, CEO of SpineThera said, "We are grateful for the support of NIH who previously funded our Phase 1 SBIR grant and now is providing this opportunity to be featured at BIO 2016. Emily Meyering, our Director of R&D, and I are looking forward to telling SpineThera's story at BIO and welcome invitations for 1:1 meetings with interested parties."