Purdue Pharma Will Obtain Full Worldwide Development and Commercial Rights to AST-005, as well as an Option to Three Additional Collaboration Targets with Associated Intellectual Property
STAMFORD, Conn. & SKOKIE, Ill.–(BUSINESS WIRE)–Purdue Pharma L.P. and Exicure, Inc. today announced a strategic research collaboration, option and license agreement to discover and develop a treatment for psoriasis, and other diseases amenable to a gene regulation approach utilizing Exicure’s Spherical Nucleic Acid (SNA)™ technology. Purdue Pharma, upon exercise of the options, will obtain full worldwide development and commercial rights to AST-005, and rights to three additional collaboration targets with associated intellectual property.
The lead compound, AST-005, is an investigational, topically-applied SNA that targets tumor necrosis factor (TNF), a pro-inflammatory cytokine shown to be a key mediator of psoriasis. In a recently completed Phase 1 trial, fifteen patient volunteers with chronic plaque psoriasis were treated with AST-005 for ten days. The first trial with AST-005, based on Exicure’s proprietary SNA technology, met the safety and tolerability requirements in patients with mild to moderate psoriasis. In addition to the safety data typically collected from the first Phase 1 trial, pharmacodynamic assessments were performed from the treated plaque area.
Psoriasis is an inflammatory disease that results in red, scaly patches on the skin. Current treatments for psoriasis include biologics, orally administered drugs and a variety of non-targeted topical treatments. The unique ability of SNA constructs allows AST-005 to penetrate the skin when applied topically and knock down the TNF gene of interest.
Under the terms of agreement, Exicure received an upfront payment, will receive an equity investment and could potentially receive development, regulatory and commercial milestone compensation, which together with the upfront payment and equity investment, could total up to $790 million, if all programs are fully developed, as well as royalties on potential sales of the products.
“This long-term strategic collaboration agreement represents a significant expansion of Purdue’s pipeline, and provides us with the potential to further our mission of developing novel therapies for patients with chronic conditions,” said Mark Timney, President and Chief Executive Officer, Purdue Pharma L.P. “We look forward to combining Exicure’s SNA technology and deep expertise in this field with Purdue’s resources and expertise in clinical studies, regulatory affairs and commercialization for the benefit of patients.”
“Given the broad potential of SNA technology, we want to forge long-term strategic relationships with best-in-class companies. As we were looking for a global leader with a proven track record in the development and global commercialization of treatments for patients with chronic conditions, we were very impressed with the Purdue Pharma’s clinical and commercial capabilities,” said Dr. David Giljohann, Chief Executive Officer, Exicure.
Chadbourne & Parke LLP served as lead outside counsel for Purdue Pharma. Faber Daeufer & Itrato served as lead outside counsel for Exicure.
Spherical Nucleic Acids (SNA) are nanoscale, spherical arrangements of densely packed and radially oriented nucleic acids. This architecture overcomes one of the most difficult obstacles to nucleic acid based therapeutics: safe and effective delivery into cells and tissues of therapeutic importance without the need for additional physical or chemical methods or components. The SNAs are designed to be extremely potent and highly targeted gene regulation and immune-modulatory agents. SNA™ technology originated in the lab of Professor Chad A. Mirkin at the Northwestern University International Institute for Nanotechnology.
Exicure, Inc. is a clinical stage biotechnology company developing a new class of immunomodulatory and gene silencing drugs against validated targets. The company’s 3-dimensional, spherical nucleic acid (SNA™) architecture unlocks the potential of nucleic acid therapeutics in multiple organs. Exicure’s lead programs address diseases from inflammatory disorders to oncology.
Exicure’s intellectual property portfolio includes 75 pending patent applications and 35 allowed or issued patents. These filings impact numerous jurisdictions worldwide, and they cover a range of inventions, including fundamental nanoparticle manufacturing breakthroughs and numerous application-specific improvements. Exicure is based in Skokie, Ill. For more information, please visit http://www.exicuretx.com.
Purdue Pharma is a privately-held pharmaceutical company and is part of a global network of independent associated companies that is known for pioneering research in chronic pain and opioids with abuse deterrent properties. The company’s leadership and employees are committed to providing healthcare professionals, patients and caregivers quality products and educational resources to support their proper use. Purdue Pharma is engaged in the development, production and distribution of both prescription and over-the-counter medicines and hospital products. With Purdue Pharma’s expertise in drug development, commercialization and life-cycle management, the company is diversifying in high-need areas to expand through strategic acquisitions and creative partnerships. For more information, please visit www.purduepharma.com.