PRODUCT PORTFOLIO

Building a Pipeline of High-Performance Amorphous Formulations enabled by Formulite

Product Candidates

Disruptive Pharma is leveraging its proprietary Formuliteplatform to build a differentiated pipeline of value-added product candidates based on established active pharmaceutical ingredients (APIs).

Pipeline Strategy
By transforming marketed drugs into high-performance, amorphous formulations, we aim to unlock untapped clinical and commercial potential. The current pipeline includes both preclinical and clinical-stage assets, with an initial focus in oncology, and expansion into additional therapeutic areas underway. Our lead candidate, DPH008, is a next-generation version of a marketed drug for prostate cancer, designed using the Formuliteplatform to improve performance and patient outcomes. Prostate cancer represents a strategically attractive area, combining strong clinical need and large market potential.

Extensive Platform Validation
We have established feasibility on over 100 APIs, with more than 20 compounds evaluated in pharmacokinetic (PK) studies, confirming the broad applicability and performance of Formulite
Partnering Opportunities
Disruptive Pharma is actively seeking strategic partnerships for co-development, out-licensing, or joint commercialization of our product candidates.

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 Formulitetechnology platform with known APIs to produce supergeneric/505(b)(2) products with improved characteristics over the approved product. We will utilize our superior Formulitetechnology 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 Sorafenib (the DPH001 project) was selected as the project to obtain clinical validation.