BPMX : BioPharmX Corporation Stock Analysis and Research Report

2017-10-09 - by Asif

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BioPharmX Corporation is a specialty pharmaceutical company focused on utilizing its proprietary drug delivery technologies to develop and commercialize novel prescription and over‑the‑counter, or OTC, products that address large markets in dermatology and women’s health. The company's objective is to develop products that treat health or age‑related conditions that: (1) are not presently being addressed or treated or (2) are currently treated with drug therapies or drug delivery approaches that are sub‑optimal. Its strategy is designed to bring new products to market by identifying optimal delivery mechanisms and/or alternative applications for United States Food and Drug Administration, or FDA, approved active pharmaceutical ingredients, or APIs, and biological materials, while, in appropriate circumstances, reducing the time, cost and risk typically associated with new product development by repurposing drugs with demonstrated safety profiles and, when applicable, taking advantage of the regulatory approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FDC Act. Section 505(b)(2) permits an applicant for a new product, such as a new or improved formulation or a new use of an approved product, to rely in part on literature and/or the FDA’s findings of safety and/or effectiveness for a similar previously-approved product. The company believe these approaches may reduce drug development risk and could reduce the time and resources it spend during development. Its current platform technologies include innovative delivery mechanisms for antibiotics, biological materials and molecular iodine (I2).

Since inception, the company has developed its product candidates, including conducting preclinical and clinical trials, and providing general and administrative support for these operations. The company recently presented comprehensive BPX01 Phase 2b clinical data and expect its BPX01 Phase 3 clinical trial to begin later this year. The company began shipping VI2OLET through online stores in December 2014. The company continue to pursue additional channel distribution expansion for VI2OLET by way of partnerships and/or sublicensing opportunities with women’s health and/or consumer companies to provide broader access to consumers. To date, it has generated a de minimis amount of revenue from product sales while it focus on product acceptance and partnering opportunities.

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