DPH001 – Pipeline project

Disruptive Pharma is leveraging its in-house expertise in Formulite^™ to develop a proprietary pipeline based on established APIs with a significant improvement opportunity of the approved product.

Disruptive Pharma’s lead product candidate, DPH001 will be improved sorafenib based Formulite^™ amorphous reformulation of NEXAVAR^®

NEXAVAR^® is a protein kinase inhibitor, approved for the treatment of certain types of liver, kidney, and thyroid cancer in adults. Disruptive Pharma will leverage the amorphous stabilization properties of a Formulite-sorafenib formulation to demonstrate bioequivalence at reduced API dosing, expected to yield an improved tolerability profile.

Disruptive Pharma is seeking partnerships for its pipeline projects.

Intellectual Property

Disruptive Pharma holds exclusive worldwide rights for the manufacture and use of Formulite^™ in pharmaceutical applications. Drug loading and formulation patent applications including MMC are on file. Reformulated APIs can be protected through formulation patents, supporting the use of Formulite^™ in lifecycle management considerations.

Disruptive Pharma makes its Formulite^™ available to development partners for two principal use cases; formulation of drugs in development (NCEs) and reformulation of established APIs. We work with our partners to get the most out of their innovations and turn new product ideas into novel and commercially viable therapeutic drug products

Lifecycle management

For many drugs side effects may limit the usage despite a highly efficacious mechanism of action, often driven by low bioavailability and consequently high API dosing. Disruptive Pharma’s MMC technology is ideally suited to address the root cause of the side effects and improve patient tolerability of these drugs. With an established regulatory pathway and exclusivity protection through a formulation patent, Formulite^™ is ideally suited as a lifecycle management initiative. Formulite^™ offers an attractive combination of excellent amorphous API stability, improved bioavailability, scalable manufacturing and stronger patent protection for the product.

Formulite^™ is expected to be regulated as an excipient and a reformulation with Formulite^™ is expected to follow the appropriate guidelines.

Pipeline expansion

Disruptive Pharma will establish its own proprietary pipeline by developing selected drug products by combining its Formulite^™ technology platform with known APIs to produce supergeneric/505(b)(2) products with improved characteristics over the approved product. We will utilize our superior Formulite^™ technology to develop products with an improved side effect profile and reduced variability, for the benefit of patients. A large number of APIs have already been evaluated with Formulite^™ and sorafenib was selected as the first one to be developed and commercialized (the DPH001 project).