U.S. Patent and Trademark Office Awards BioPharmX Patent Protection for Novel Tetracycline-class Topical Drug Compositions
Patent protects a new category of innovative drug delivery systems
New patent is the second granted to BioPharmX in 3 weeks
Mar 20, 2018
MENLO PARK, Calif., March 20, 2018 /PRNewswire/ -- BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced the U.S. Patent and Trademark Office 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 (U.S. Patent No. 9,918,998), entitled "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 U.S. patent issuance BioPharmX has received. Three earlier-issued U.S. patents protect the company's encapsulation delivery system, which can isolate the API. The most recent of these patents, U.S. Patent No. 9,901,586, entitled "Dosage Form Comprising an Active Ingredient and a Plurality of Solid Porous Microcarriers," was granted Feb. 27.
The US 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," she said. "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.
About BPX-01 and BPX-04
BPX-011 and BPX-041 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.
About BioPharmX Corporation
BioPharmX Corporation (NYSE American: BPMX) 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. To learn more about BioPharmX, visit www.BioPharmX.com.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. This press release contains forward-looking statements about the company's expectations, plans, intentions, and strategies, including, but not limited to, statements regarding strategic partnering alternatives, the safety and medical effects of BPX-01 and BPX-04, the effect BPX-01 and BPX-04 may have on the treatment of acne and rosacea, the commencement and results of future trials of BPX-01 and BPX-04 and the size of such trials, continued and consistent results in future tests of BPX-01 and BPX-04, absence of side effects of future use of BPX-01 and BPX-04 and ability to advance BPX-01 and BPX-04 through a successful NDA submission and commercialization. These forward-looking statements may be identified by words such as "plan," "expect," "anticipate," "believe" or similar expressions that are intended to identify such forward-looking statements.
These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The risks and uncertainties include those described in the company's filings with the Securities and Exchange Commission, including our annual report on Form 10-K for the period ended Jan. 31, 2017 and our quarterly report on Form 10-Q for the period ended July 31, 2017. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements included in this news release are made only as of the date hereof, and the company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
1 Caution: BPX-01 and BPX-04 are new drugs limited by U.S. law to investigational use.
SOURCE BioPharmX Corporation
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