Catalent and Cingulate Therapeutics Sign Exclusive Agreement for Development of New ADHD Treatments

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Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it had reached an exclusive development and licensing agreement with privately held biopharmaceutical company, Cingulate Therapeutics (CTx), to support the development of a series of new prescription pharmaceutical products for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) using Catalent’s OSDrC® OptiDose™ drug delivery platform.

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it had reached an exclusive development and licensing agreement with privately held biopharmaceutical company, Cingulate Therapeutics (CTx), to support the development of a series of new prescription pharmaceutical products for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) using Catalent’s OSDrC® OptiDose™ drug delivery platform.

The products, CTX-1301 and CTX-1302, are currently in pre-clinical development and are designed to overcome several long-standing unmet needs of patients diagnosed with ADHD. The company’s lead product, CTX-1301, is expected to complete initial Phase I/Phase II human trials in early 2015. Cingulate Therapeutics primary focus is to develop and commercialize the CTx products in the United States subsequent to FDA review and approval, followed by the EU and other strategically important markets.

Catalent’s OSDrC OptiDose is an innovative, flexible core tableting technology that enables the formulation and manufacturing of single or multi-cored tablets with differentiated controlled release functionality and a range of unique dose forms, including fixed dose combination tablets.

“OptiDose enables the design of dividable, multi-layer, single or multi-core tablets with a variety of core numbers, shapes, sizes, and placement, providing new alternatives in controlled release designs for drug formulators, developers, and marketers in a high quality, one step manufacturing process,” commented Barry Littlejohns, President of Advanced Delivery Technologies for Catalent. “We are excited to be working with Cingulate Therapeutics to bring these important treatments to market as quickly and efficiently as possible.”

“Cingulate Therapeutics is proud to partner with Catalent in developing these innovative therapies, designed to overcome longstanding unmet needs in ADHD,” added Shane Schaffer, Chairman and CEO of Cingulate Therapeutics. “After extensive evaluation of several drug delivery technologies, OptiDose was clearly identified as the leading platform technology to support our development strategy. The precision engineered, cutting-edge technology and strong patent protection inherent to OptiDose, coupled with Catalent’s unparalleled expertise in drug formulation, provides Cingulate Therapeutics great confidence in its overall ability to deliver safe, effective and innovative treatment options to clinicians and patients alike.”

About Cingulate Therapeutics

Cingulate Therapeutics (CTx) is a privately held biopharmaceutical company focused on the development of new products for the treatment of Central Nervous System and Neurobiological Disorders. Currently, CTx is developing two products for the treatment of ADHD. CTx’s cornerstone principles focus on overcoming unmet medical needs, innovation and at its core, the patient. The leadership team brings extensive expertise in ADHD, clinical trials, patient care, pharmaceutical development and new product commercialization. Cingulate Therapeutics is headquartered in Morristown, NJ with operations in Kansas City, KS and Houston, TX. For more information, visit http://www.CingulateTherapeutics.com

About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents. Catalent is headquartered in Somerset, N.J. For more information visit http://www.catalent.com

More products. Better treatments. Reliably supplied.™

OSDrC® is a registered trademark of Sanwa Kagaku Kenkyusho Co., Ltd
OPTIDOSE™ is a trademark of Catalent Pharma Solutions

About ADHD

Attention-Deficit/Hyperactivity Disorder is a neurobehavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level. ADHD is one of the most common childhood psychiatric disorders. Although many people tend to think of ADHD as a childhood problem, 60% to 85% of children with ADHD may continue to meet the criteria for the disorder during teenage and adult years. An estimated 11% (6.4 million) of US school-aged children have been diagnosed with ADHD in their lifetime. The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5®) or International Classification of Diseases, 10th revision (ICD-10). Only a trained health care professional can evaluate and diagnose ADHD. Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies that may include behavioral modification, and/or medication. Ongoing assessment and treatment may be necessary.

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