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Blog Coverage Sonoma Pharmaceuticals Announced FDA Clearance For Loyon Skin Descaler

Upcoming AWS Coverage on Amphastar Pharmaceuticals Post-Earnings Results

LONDON, UK / ACCESSWIRE / March 30, 2017 / Active Wall St. blog coverage looks at the headline from Sonoma Pharmaceuticals, Inc. (NASDAQ: SNOA) as the Company announced on March 29, 2017, it has received a new 510(k) clearance from the US Food and Drug Administration (FDA) for the Company's newest product, Loyon® Skin Descaler for the treatment of skin scaling related to Dermatoses. Register with us now for your free membership and blog access at:
One of Sonoma Pharmaceuticals' competitors within the Drug Manufacturers - Other space, Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH), reported on March 13, 2017, its results for the three months and fiscal year ended December 31, 2016. AWS will be initiating a research report on Amphastar Pharma in the coming days.
Today, AWS is promoting its blog coverage on SNOA; touching on AMPH. Get all of our free blog coverage and more by clicking on the link below:
Sonoma's Loyon Skin Descaler is a unique and patented combination of the dry emollient Cetiol® CC and the medical silicone oil dimethicone. The product can be easily applied and spread into the cracks and crevices of the scale due to its low surface tension. The Company expects to commence US commercialization via Sonoma's dermatology division IntraDerm Pharmaceuticals' direct sales team in summer 2017.
Sonoma in the press release estimated that 25% of the general population has some degree of scaling associated with skin dermatoses.
"Loyon Skin Descaler has demonstrated an impressive level of efficacy in the management of multiple dermatoses including psoriasis capitis and seborrheic dermatitis since first being commercialized in Europe in 2014," said Jeffrey Day, President of IntraDerm Pharmaceuticals, "Nearly a quarter of the US population is afflicted with scaling associated with various skin dermatoses and we believe this product, once launched, will provide this community with a most novel tool for assisting with scale removal in their patient populations."
Payment from Sales of Latin America Business
On March 23, 2017, Sonoma announced receipt of $1.5 million in final payment for the sale of the Company's Latin American-related assets to Invekra S.A.P.I. de C.V. of Mexico for $19.5 million in cash. The sale, which was finalized on October 28, 2016, included an initial upfront payment of $18 million with final payment of the additional $1.5 million predicated upon delivery of certain manufacturing equipment from Sonoma to Invekra.
As part of the sales agreement, Sonoma is maintaining its current manufacturing facility in Guadalajara, Mexico for production of its Microdacyn®-based products for all countries outside of the US and Latin America. Additionally, Sonoma will continue to provide technical assistance to Invekra and work closely with Invekra to protect respective intellectual property ownership.
SebuDerm™ Gel Study in Treatment of Seborrheic Dermatitis
On March 16, 2017, Sonoma announced the results of a clinical study evaluating the impact of SebuDerm™ (topical hypochlorous acid) gel in the treatment of mild to moderate facial and scalp seborrheic dermatitis.
In a 25-patient study, conducted by Zoe Draelos, MD; and president of Dermatology Consulting Services in High Point, North Carolina, two key metrics were utilized in assessing efficacy of SebuDerm: 1) investigator's global assessment (IGA) of efficacy improvement in appearance and symptoms from baseline; and 2) the subject global assessment (SGA) of improvement in itching, burning and stinging. No adverse effects were reported and overall treatment was well tolerated by the subjects.
Author of the study, Zoe Draelos, MD, commented:
"Seborrheic dermatitis is a common condition afflicting men and women of all ages that is challenging for dermatologists to treat. While treatment options exist, recurrence is common and few options exist for disease maintenance. A new addition to the dermatologist's armamentarium will be welcomed."
The IGA of efficacy improvement from baseline was 33% at day 14 and 52% at day 28. The SGA of efficacy improvement from baseline was 62% through day 28.
Sonoma received a new 510(k) clearance from the US Food and Drug Administration (FDA) for the Company's SebuDerm™ Gel as a prescription product, intended to manage and relieve the burning, itching, erythema, scaling, and pain experienced with seborrhea and seborrheic dermatitis in December 2015. The Company stated that US commercialization is underway, and the Company is also in discussions with prospective international distributors and partners to bring this advanced technology to dermatology patients throughout the globe, including Asia, Latin America and Middle East.
According to JAMA Pediatrics, an industry healthcare journal, seborrheic dermatitis is a common complaint brought to pediatricians. Also known as "cradle cap" in infants, "dandruff" in adolescents, seborrheic dermatitis is also found in the face, scalp and chest areas in adults. It is believed this condition is triggered by Malassezia yeasts. Treatment has supported a billion dollar market for over-the-counter treatments.
Stock Performance
On Wednesday, March 29, 2017, following the announcement, the stock closed the trading session at $7.23, rising 2.12% from its previous closing price of $7.08. A total volume of 326.19 thousand shares have exchanged hands, which was higher than the 3-month average volume of 41.97 thousand shares. Sonoma Pharma's stock price soared 41.49% in the last three months, 72.97% in the past six months, and 47.55% in the previous twelve months. The company's shares surged 43.45% since the beginning of the year. At Wednesday's closing price, the stock's net capitalization stands at $30.73 million.
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