Foamix Announces the Issuance of Five Additional US Patents

Covers Multiple Technology Platforms and Minocycline Foam


REHOVOT, Israel, April 21, 2014 (GLOBE NEWSWIRE) -- Foamix, a clinical-stage, specialty pharmaceutical company, focused on the development, patenting and commercialization of proprietary topical foams and the first topical minocycline/doxycycline antibiotics to address unmet needs in dermatology, today announced that the United States Patent and Trademark Office ("USPTO") has issued five new patents covering its technologies. Foamix now has a total of 25 issued United States Patents, 61 issued worldwide and 126 patents pending.

These new patents, which were issued between August 2013 and January 2014, cover:

  • The composition of matter of various kinds of pharmaceutical and cosmeceutical foams;
  • Devices for dispensing them; and
  • A novel platform of the topical foam compositions that stabilize unstable drugs such as minocycline and doxycycline, which would otherwise be unstable with other topical carriers.

"Establishing broad and robust patent portfolios in dermatology foams and minocycline/doxycycline is a key part of our strategy," stated Dov Tamarkin, Chief Executive Officer of Foamix, Ltd. "These new patents strengthen our position as the leading company worldwide specializing in developing foam based pharmaceutical products."

"As the intellectual property technology leader in foams, Foamix has licensed various forms of its patented foams to Bayer, Merz, Actavis, Round Table Group and Arkin Dermatology, all of which are in Phase 2 or Phase 3 clinical trials using their own active pharmaceutical ingredients," Dr. Tamarkin said.

The patents, their numbers and links at the USPTO website are as follows:

Patent 8,618,081 – "Compositions, gels, and foams with rheology modulators and uses thereof"

The rheology modulators described in this patent are used to achieve the desired flow dynamics and physical properties of foams, which are important in determining patient acceptability, physical stability, and even biologic availability. This patent covers Foamix's first-in-class stable minocycline and doxycycline foam.  In Phase II clinical studies, products based on this patent have exhibited high efficacy and favorable safety in the treatment of acne and skin infections, and are being investigated for the treatment of rosacea and cancer-related skin conditions.

Patent 8,636,982 "Wax foamable vehicle and pharmaceutical compositions thereof"

Covers unique oil-in-water emulsion foams, capable of stabilizing drug suspensions. One of Foamix's secondary pipeline products, Imiquimod Foam, is covered by this patent. Imiquimod Foam is being investigated for the treatment of actinic keratosis, basal and squamous cell carcinomas and genital warts.

Patent 8,617,100 "Device for delivery of a foamable composition"

Covers a pressurized device for optimal delivery of a foamable composition into a body cavity.  

Patent 8,518,378 "Oleaginous pharmaceutical and cosmetic foam"

Covers stable, oleaginous (oily) foam-forming compositions including at least one active agent for dermal and mucosal delivery. The composition is dispensed as a foam providing a stable product that is pleasant and easy to spread -- properties designed to aid in good patient compliance.

Patent 8,518,376 "Oil-based foamable carriers and formulations"

Covers a waterless foamable pharmaceutical composition, comprising a foamable carrier, a tetracycline antibiotic, and at least one liquefied or compressed gas propellant.

About Foamix

Foamix Ltd. is a clinical-stage, privately held specialty pharmaceutical company focused on the development of patented topical foams for dermatology. The Company's lead product, Minocycline Foam, is the first-ever topical minocycline which can be used for the treatment of acne, skin infections and rosacea.  Minocycline is a well-known broad-spectrum oral antibiotic, which Foamix has uniquely transformed into a topically-applied, patented-form of the drug, thereby increasing efficacy, speed of action and minimizing side effects.  The Company has successfully completed Phase 2 clinical trials in acne and impetigo using its patented foam delivery platform with Minocycline.  Besides these clinical stage drugs, Foamix has many pipeline drugs for dermatology and other indications using its unique topical minocycline or doxycycline and its patented delivery technologies in pre-clinical and pilot study stages.

As the IP technology leader in foams, Foamix has licensed various forms of its patented foam to Bayer, Merz, Actavis, Round Table Group and Arkin Dermatology, all of which are in Phase 2 or Phase 3 clinical trials using their own active pharmaceutical ingredients.

To date, Foamix has 25 issued patents in the United States and 61 granted patents worldwide.

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will," "plan," "could," "may" and similar expressions are intended to identify forward-looking statements.

The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions.

The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.



            

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