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Last updated on April 17, 2014 at 15:32 EDT

Superior Results in Foamix’s Minocycline Foam Clinical Study: 71% Reduction in Inflammatory Lesions in 6 Weeks

June 11, 2013

REHOVOT, Israel, June 11, 2013 /PRNewswire/ –

Foamix, a clinical stage specialty pharma company, has announced today the successful
completion of its Minocycline foam Phase II clinical trial. The drug was shown to be
highly effective in this double blind, dose ranging, placebo controlled study of 150
moderate to severe acne patients. Once daily treatment of Minocycline Foam 4% exhibited an
average 71% reduction in inflammatory lesions after 6 weeks with a respective reduction of
55% in non-inflammatory lesions. These extremely positive Minocycline Foam results follow
on from those of the Impetigo Study announced in March last year.

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/61915-foamix-minocycline-acne-foam-clinical-results

Patients were randomized into three equal groups of 50 patients, who received placebo,
or one of two Minocycline Foams – 1% or 4%. Study procedures, criteria and endpoints were
based on the current FDA guidance for acne studies.

At the end of the treatment (“EOT”) period (12 weeks) of the acne study, the reduction
in inflammatory lesions was at 72%, close to its 6 week level, with the reduction in
non-inflammatory lesions reaching 73%. The effects were dose-dependent, as demonstrated by
the lower effects of the 1% foam and the placebo (Table 1). Table 1 further shows the
statistical significance of these results.

Likewise, the Investigator’s Global Assessment (“IGA”) scores significantly improved
during the trial. At the EOT, 53% of the patients had an IGA score of either “Clear” or
“Almost clear”, while only 20% of the placebo-treated patients had the same scores.

Table 1. Average % reduction in total, inflammatory and non-inflammatory lesion counts
after 6 weeks and 12 weeks, and IGA Score Success

                                        Treatment group              P-value
                                                        Placebo
                                Minocycline Minocycline
                                  Foam 4%     Foam 1%     (P)   4% vs. P 1% vs. P
        Lesion count % reduction (6 weeks)
        Inflammatory                71%         59%       50%    0.0007   0.1681
        Non-inflammatory            55%         51%       49%    0.3686   0.7966
        Total                       62%         54%       49%    0.0189   0.4303
        Lesion count % reduction (EOT, 12 weeks)
        Inflammatory                72%         67%       51%    0.0001   0.0072
        Non-inflammatory            73%         65%       57%    0.0197   0.1587
        Total                       72%         64%       54%    0.0023   0.0631
        IGA Score "Success" (12
        weeks)*                     53%         37%       20%    0.0010   0.0640

* IGA Score “Success” defined as the IGA score reducing to either “Almost clear” or
“Clear” at EOT, 12 weeks.

The study showed a very encouraging safety profile, with very few patients exhibiting
mild and transient skin dryness, peeling and/or erythema, who were evenly distributed
among the treatment groups. No drug-related systemic adverse events were noted.

Patient satisfaction is of utmost importance. This is especially true for a topical
drug, as ease of application will encourage continued use. In the Minocycline-4% group,
61% of patients stated that the efficacy was very high or high, and 27% rated the efficacy
as moderate (median efficacy rating in this group was “high,” and was “moderate” in the
placebo group)”. Furthermore, 86% of the patients rated the drug as “very-highly” or
“highly” better than other drugs they had formerly used.

As for ease of use of the drug, 98% of all the patients said they were generally
satisfied from the ease of use. Patients noted that there was an oily feeling after use;
however, 71% rated the overall after-use feeling as very-highly, highly, or moderately
satisfactory. In comparison with former topical acne drugs, most of the patients (60%)
rated Minocycline Foam as more convenient than other drugs they know.

In literature comparison, published results of Solodyn(R) (oral minocycline) and
recently-approved topical drugs reveal that the results observed for Minocycline Foam are
superior, as shown in Table 2.

Table 2. Literature comparison between the efficacy of Minocycline Foam and the
published efficacies of Solodyn(R), Epiduo(R), Acanya(R) and Ziana(R) and the most
recently approved acne drug Fabior(TM)*

                                                                           Ziana(R)
                                                 Epiduo(R)                (Retinoic    Fabior
                                     Solodyn(R)              Acanya(R)       acid       (TM)
                          Foamix                 (Adapalene                           (Tazaro
                        Minocycline    (Oral                (Clindamycin      +         -tene
                         Foam (4%)  Minocycline)   + BPO)      + BPO)    Clindamycin)   Foam)
        Inflammatory
        lesion count %
        reduction**          72%         44%         47%         55%          54%          57%
        Non-inflammatory
        lesion count %
        reduction**          73%      No effect*     49%         43%          43%          55%
        IGA Score
        "Success"            53%         17%          -          29%          31%          29%

* Source: Prescription Instruction leaflets of Solodyn(R), Epiduo(R), Acanya(R),
Ziana(R) and Fabior(TM) (average of Phase III clinical studies, as presented in the
“clinical studies” section).

** All studies included 12 weeks of treatment.

Foamix’s current Phase II study has shown its Minocycline Foam to be a safe and
effective topical treatment and an alternative to oral antibiotics, with superior efficacy
and no significant side effects. Moreover, Minocycline Foam may further capture material
portions of the market for topical antibiotics, retinoids and combination products.

About Acne

Acne vulgaris is a common human skin disease, characterized by areas of skin with
seborrhea, comedones (blackheads and whiteheads), papules, pustules, nodules (large
papules) and possibly scarring. The disease occurs most commonly during adolescence, and
often continues into adulthood. In adolescence, acne is usually caused by an increase in
testosterone, which accrues during puberty, regardless of sex.

Acne is a very common condition, affecting over 80% of individuals at some point in
their lives (British Medical Journal. 2006; 333; 949 – 953). Globally acne affects
approximately 650 million people or about 9.4% of the population, as of 2010 (Lancet 2012;
380: 2163-96). In the United States acne affects 40 to 50 million people (J. Am. Acad.
Dermatol. 39 (2 Pt 3): S34-7).

According to GBI Research report “The Future of Dermatology Therapeutics, Analysis and
Market Forecasts to 2016″ (2010; pp. 71-83) the global acne market was worth $2.8 billion
in 2009; and it is estimated to reach revenues of $3 billion by 2016.

Moderate to severe acne vulgaris is estimated to affect approximately three to four
million people in the U.S. Moderate to severe acne is often treated with orally
administered antibiotics, primarily oral minocycline and doxycycline, which both have
multiple adverse effects. According to one of the leading data providers, Thomson Reuters,
oral minocycline and doxycycline account for over $1.2 billion sales and about 5 million
prescriptions annually. In more severe cases, isotretinoin (an oral retinoid drug)
treatment may be prescribed, although it is only available through a restricted
distribution program due to some of its serious potential side effects.

About Foamix

Foamix is a clinical stage specialty pharmaceutical company. The company’s lead
product, Minocycline Foam, is the first-ever topical minocycline which can be used for the
treatment of acne, rosacea and skin infections.

Minocycline, a well know broad-spectrum antibiotics, is given today solely in an oral
manner, mainly for the treatment of Acne. Foamix believes that topical Minocycline foam
will take over a major portion of the current oral anti-acne and anti-rosacea drug market,
as it offers high efficacy with a favorable safety profile; and thus, to capture a large
and growing market of over 1 billion dollars a year in the US.

To date, Foamix has 16 issued patents in the United States. Additionally, the Company
has more than 135 pending patent applications worldwide, of which over 65 applications are
filed in the U.S.

As a technology leader, Foamix collaborates with multinational and local
pharmaceutical companies, in the development of patent-protected, unique topical products
using its versatile patent protected foam platforms.

Acknowledgement: The development of Minocycline foam was supported by the BIRD
Foundation: http://www.birdf.com

More information about Foamix can be found at http://www.foamix.co.il

        Contact:
        Dov Tamarkin, CEO
        Foamix Ltd.
        dov@foamix.co.il

        Dorit Hayon, Business Development Manager
        Foamix Ltd.
        dorit@foamix.co.il


    Video: 

http://www.multivu.com/mnr/61915-foamix-minocycline-acne-foam-clinical-results

SOURCE Foamix


Source: PR Newswire