Foamix’s Nano-Emulsion Foam Fights Acne

The U.S. market for branded prescription drugs for acne was estimated to be approximately $2.6 billion for the 12 months ended March 31, 2014, of which $1.6 billion was attributed to topical drugs such as Epiduo and Aczone and $1 billion was attributed to oral drugs. Orally administered Solodyn is the brand name for an antibiotic called minocycline which is the current standard of care for moderate-to-severe acne. One company, Foamix, has developed a nano-emulsion foam that can be used to administer minocycline topically with greater effectiveness and fewer side effects.

About Foamix

Founded in 2003, Israeli company Foamix is looking to address the dermatology industry with a unique nano-emulsion drug delivery technology that is suitable for any drug and that can penetrate the skin safely with improved solubility and enhanced bioavailability. The Company recently filed for an IPO to raise around $60 million. Foamix has taken in just over $14 million in revenues from licensee agreements since inception, and has a deficit of just over $6 million. The Company has 54 granted patents worldwide, including 19 issued patents in the United States. Additionally, the company has more than 135 pending patent applications worldwide, of which over 70 applications are filed in the U.S.

Fighting Acne with FMX101

Foamix’s lead drug candidate is FMX101, a topically administered formulation of minocycline that is delivered using their nano-emulsion foam technology. Solodyn’s orally administered minocycline states that it can achieve only a 44% reduction of inflammatory lesions in 12 weeks and that it does not demonstrate any effect on non-inflammatory lesions. This comes with common side effects that include headaches, fatigue, dizziness, and severe itchiness. FMX101, on the other hand, reduces inflammatory acne lesions by 71% in only six weeks and non-inflammatory lesions by 73% in 12 weeks with no side effects observed.
Foamix_Results
Foamix expects to begin Phase III clinical trials of FMX101 in mid-2015, funding for which will be provided by proceeds from their IPO. In addition to their acne treatment product candidate, Foamix also has a pipeline of other products that are in varying stages of development:
Foamix_Pipeline
In addition to Foamix’s product candidates, they have entered into development and license agreements with companies such as Bayer, Merz, and Actavis, to combine their foam technology with various drugs selected by the licensee. The prospective products under these various agreements are currently in pre-clinical Phase II, Phase III and pre-approval stages.
Foamix has a unique technology platform, and their lead acne drug candidate has a total potential market of $2.6 billion that can be targeted. In addition to their other product candidates being developed in house, they can potentially receive royalties and payments from any of their licensees that successfully commercializes a product using their platform. It remains to be seen if they will be able to successfully raise the $60 million they are looking for from their IPO which will be critical in bringing their lead product candidate to commercialization. Foamix plans to list on NASDAQ under the symbol “FOMX.”

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