BioPharmX submits request for pre-IND meeting to FDA for topical antibiotic acne compound

Dec 2 2014

BioPharmX Corporation (OTCQB: BPMX), a biotechnology company focused on the development of novel drug delivery products to address unmet needs in large, well-defined and underserved markets, today announced that it has submitted a request for a pre-IND (Investigational New Drug) meeting to the U.S. Food and Drug Administration (FDA) for the company's topical antibiotic acne compound currently under development. The company plans to follow up by submitting a briefing package on a later date in support of a pre-IND meeting to review the company's proposed strategy and plan for conducting safety and toxicology studies and human clinical trials required for approval of its acne product.

"This marks a major step in BioPharmX's plan to introduce products that target large, multi-billion-dollar markets," said Jim Pekarsky, chief executive officer and co-founder of BioPharmX. "Leading oral antibiotic acne products have potential side effects, and, as we move forward, we are hopeful that the initial pre-clinical results we've seen thus far for our topical antibiotic acne solution will eventually lead to an approved alternative," said Pekarsky. "Longer term, we believe this potential product could be just one leg of a multi-faceted growth strategy BioPharmX has planned that is focused on the women's health, dermatology, and otolaryngology health care segments."

BioPharmX announced on November 10, 2014 that the company had secured up to $12 million in a Series A private placement (Series A). The total amount includes $2 million in funding subject to the company achieving certain milestones. The proceeds are being used to advance the company's pipeline of products in the fields of women's health and dermatology and to fund the near-term launch and commercialization of the company's women's health product.

SOURCE BioPharmX Corporation