US PTO Awards BioPharmX Patent Protection for Novel Tetracycline-Class Topical Drug Compositions

BioPharmX Corporation recently announced the US PTO has granted the first in what the company expects will be a new family of patents protecting its novel topical gel delivery system that allows for greater bioavailability of an active pharmaceutical ingredient (API).

The patent (US Patent No. 9,918,998), titled Pharmaceutical Tetracycline Composition for Dermatological Use, covers a topical composition comprised of minocycline or another tetracycline-class drug and a method for making such compositions. The patent also covers treatments of dermatological inflammation or infection using a minocycline composition. Current formulations protected by the patent include BPX-01 for the treatment of acne and BPX-04 for the treatment of rosacea.

This is the fourth US patent issuance BioPharmX has received. Three earlier-issued US patents protect the company’s encapsulation delivery system, which can isolate the API. The most recent of these patents, US Patent No. 9,901,586, titled Dosage Form Comprising an Active Ingredient and a Plurality of Solid Porous Microcarriers, was granted Feb. 27, 2018.

The US No. 9,918,998 patent protects tetracycline-class products carried by BioPharmX’s innovative delivery system, which for the first time stabilizes and fully solubilizes these drugs to make them effective in a topical formulation. This includes products that use other tetracycline-class drugs as well as combination products that combine antibiotics with other drugs, for example retinoids.

“This patent protection is a significant milestone for BioPharmX,” said President and Co-founder Anja Krammer. “It recognizes that our development of a topical tetracycline-class drug, something that has eluded the pharmaceutical industry since minocycline was first commercially used in the 1970s, is truly unique.
And, like the other patents we hold, it will protect our valuable intellectual property for a substantial length of time. It recognizes the innovative research and development that BioPharmX has successfully completed and ensures that our company and investors will benefit from it as we commercialize our products.”

Oral minocycline has been widely used since the 1970s; however, oral antibiotics tend to flood the body with medicine and are commonly associated with adverse effects that range from nausea to diarrhea. Also, there is growing concern over the rise in antibiotic-resistant bacteria.

In response, the pharmaceutical industry has spent years unsuccessfully trying to develop a stable, soluble topical formulation of minocycline, which produces less resistance than other tetracycline-class antibiotics. BioPharmX is the first company to develop a topical gel formulation of minocycline that reaches targeted areas of the skin, where acne and other conditions develop. By applying minocycline topically, a patient may reduce the systemic uptake of minocycline and focus the drug’s beneficial effects at the skin where they are most needed.
BioPharmX has successfully completed a Phase 2b trial for BPX-01 for acne and is in Phase 3 readiness. The company has reported positive interim results from a feasibility study for BPX-04 for rosacea and is preparing for a Phase 2 trial.
In addition to the four patents it has been awarded on two drug delivery systems, the company has more than a dozen patents pending and in process.

BPX-01 and BPX-04 are hydrophilic (non-oil-based) topical gels with fully solubilized minocycline that have been shown to penetrate the skin to deliver the antibiotic to its target. Following positive results from its previously announced Phase 2b dose-ranging study of BPX-01 in acne, BioPharmX continues with Phase 3 clinical study plans for BPX-01 for the treatment of inflammatory lesions of acne.

BioPharmX Corporation is a Silicon Valley-based specialty pharmaceutical company, which seeks to provide products through proprietary platform technologies for prescription, over-the-counter (OTC), and supplement applications in the health and wellness markets, including dermatology and women’s health. For more information, visit www.BioPharmX.com.