07 Aug 5 Companies with Potential to Transform the Rosacea Market
Rosacea affects over 415 million people worldwide, and more than 16 million in the U.S alone, according to research conducted by the University of Copenhagen, Denmark. It is a fairly common skin disorder, but only 18 percent of Americans afflicted with this condition are under medical treatment. This chronic condition often manifests as a flare up or reddening of the skin and progresses to formation of pustules or small blood vessels that are visible. In severe cases the disease can also affect the eye causing irritation, redness and the appearance of watery or bloodshot eyes.
The rise in androgen levels during puberty, growing environmental pollution, stress and unhealthy lifestyles are some of the causative factors of Rosacea and Acne. It causes considerable self–image and confidence issues in people leading them to seek treatment.
The first course of treatment for Rosacea is the prescription of antibiotics such as Topical clindamycin and erythromycin. In spite of being effective these are not preferred as monotherapy options owing to the risk of developing bacterial resistance. Tetracyclines such as minocycline have the lowest resistance rates and are now increasingly being used to come up with novel drugs to treat Rosacea. Conventional therapeutics have limitations such as side effects, misuse for purposes otherwise stated, nausea and birth defects.
The Rosacea treatment market is estimated to be worth over USD 2.6 billion by 2025, according to a report by Grand View Research. There is currently no cure for these disorders, with existing treatment options only aiming at alleviating the symptoms associated with the illness. The industry is moving from small molecule based medications to peptides, combination therapies and biologics.
SOL-GEL Technologies Ltd. (NASDAQ: SLGL)
Market Cap: $181.54M; Current Share Price: 9.58 USD
Data by YCharts
The company uses the Sol-Gel chemical process to mould silica to form microcapsule shells of almost any size and release rate profile using its proprietary technology; it can encapsulate a drug substance by adding it during the sol-gel reaction before creation of rigid silica shell that are shaped like small beads in the range of 1-40µ. Its silica-based delivery system offers regulated release rate, a protective barrier and improved tolerability by using only FDA approved inactive ingredients; it can also create combinations of two or more unstable drug substances as they are enclosed in a protective covering thereby developing novel drug solutions.
Sol-Gel is developing Epsolay (formerly VERED), TWIN and SIRS-T, which are encapsulated forms of tretinoin and benzoyl peroxide for the treatment of Roscea and Acne Vulgaris, which are undergoing phase II and III clinical trials. EPSOLAY is a topical encapsulated benzoyl peroxide cream with a 5% concentration for the treatment of papulopustular rosacea. The company has been able to overcome the limitations posed by benzoyl peroxide, such as causing irritation, by using its silica-based microencapsulation delivery system.
In July 2019, it announced the results from its Phase III clinical trial with 733 adult patients across 54 centres in the U.S. The results have been encouraging with the study achieving significant improvement in clinical endpoints such as a “clear” or “almost clear” in the investigator Global Assessment (IGA) and reduction in inflammatory lesion count, in addition to a favourable safety and tolerability profile.
The company is collaborating with Perrigo and Douglas Pharmaceuticals for developing seven generic topical dermatological products including acyclovir cream, 5% for treatment of herpes labialis which has an FDA approval. Perrigo has also received a tentative approval for a generic ivermectin cream, 1%, for the treatment of rosacea.
The company has built a strong portfolio of Intellectual property rights with TWIN, SIRS-T and Epsoplay (Formerly VERED), enjoying patent coverage until 2032, 2030 and 2032, respectively.
BioPharmX Corp (NYSE American: BPMX)
Market Cap: $3.85M; Current Share Price: 0.3599 USD
Data by YCharts
BPX-04, the company’s lead candidate for the treatment of Rosacea, is a topical antibiotic gel made with solubilised minocycline, using its proprietary HyantX delivery system. An open label feasibility study in 30 subjects, to assess the safety and cutaneous tolerability, has demonstrated no severe side-effects and favourable cutaneous tolerability at 12 weeks, a significant factor for patient adherence. These results led the company to conduct a Phase 2b study with 207 enrolled patients, with a clinical endpoint of measuring absolute mean change in the number of inflammatory lesions. The topline efficacy and safety results of the study are due in July 2019.
HyantX™ delivery system is an anhydrous topical delivery system for hydrophilic molecules, which can stabilise and solubilize hydrophilic molecules in an anhydrous gel environment, and deliver a wide range of active ingredients into the skin. This results in targeted delivery, lower concentration, improved skin penetration, enhanced safety and tolerability, inherent antibacterial properties and hydration of the skin.
Additionally, its pipeline consists of BPX-01, a proprietary topical minocycline gel formulation indicated for the treatment of Acne Vulgaris. It is planning to expand its pipeline by using its patented HyantX™ delivery system to address unmet needs and develop innovative dermatalogical products. The company is pursuing new opportunities based on currently approved active pharmaceutical ingredients (API).
Biofrontera AG ( NASDAQ: BFRA)
Market Cap: $315.11M; Current Share Price: 14.48 USD
Data by YCharts
The Company’s product BELIXOS indicated for the treatment of Rosacea is made up of biocolloids, a plant-based microscopic drop of botanical oils referred to as micelles, the outer layer of which is built of phospholipids derived from soy lecithin. These phospholipids are identical to substances found in the human body. These help transport the active plant ingredients in belixos® products directly into the epidermis, by enhancing permeability and absorption by the skin.
In March 2019, Biofrontera acquired Cutanea, a biopharmaceutical company focussed on dermatology products. Biofrontera took over Cutanea’s supply chain management, customer service and market access support for all of Cutanea U.S product portfolio. Cutanea ‘s portfolio consists of two FDA-approved prescription drugs – Xepi indicated for the treatment of impetigo (a common bacterial skin infection) and Aktipak®, a generic drug for the treatment of mild to moderate acne.
Cutanea has an extensive pipeline of drugs to treat a variety of dermatological indications, including CLS001 for the treatment of Rosacea, which is currently undergoing Phase III clinical trials. It has filed for an NDA with the FDA for CLS008, aimed at the treatment of Psoriasis. Other areas of interest include Verruca Vulgaris, Acne, Atopic Dermatitis, Gential HPV to name a few.
Maruho, the owner of Cutanea, will be eligible to receive the actual start-up costs requested by Biofrontera by Jaunary 2023, as part of a deferred purchase price agreement between the companies. Maruho will bear the restructuring cost in the first three months and the cost of all of Cutanea’s potential liabilities, in addition to USD $7.3 million as start-up costs to cover any incremental costs from business activities resulting from the purchase of Cutanea as per a company statement. Furthermore profits from the sale of Cutanea products will be equally shared between Maruho and Biofrontera until 2030.
Dermata Therapeutics ( Private)
Dermata develops novel botanical products for treatment of skin diseases. The company’s technology harnesses the complex compounds of nature, to develop an array of products that preserve the natural qualities of the skin, while treating it for any disorders. DMT400, its product candidate for the treatment of conditions such as rosacea, hyperhidrosis, psoriasis, acne, is combination of its novel DMT310 sponge product (Spongilla lacustris powder ) which can increase the permeability of the skin, making way for improved dermal delivery of macromolecules.
The biggest advantage of its DMT310 is that it eliminates the need for injections and promotes patient adherence. Its microscopic spicules, which are needle–like structures, can easily pass through the stratus corneum and create microchannels in the skin, making way for easier penetration of topical macromolecules. This can also reduce the systemic exposure caused by the use of injections, thereby enabling the use of biologics in a wider patient population. It offers numerous medicinal and cosmetic applications. The sponge product was licensed by the company from Villani in December 2017 , in exchange for milestone and royalty payments.
Demata’s pipeline also consists of DMT410, a combination regimen with Botox indicated for the treatment of primary axillary hyperhidrosis. The company recently announced positive results from a phase I clinical trial of DMT410 for the treatment of Botulinum Toxin.
Foamix Pharmaceuticals (NASDAQ: FOMX)
Market Cap: $130.16M; Current Share Price: 2.39 USD
Data by YCharts
FMX103, the company’s lead candidate for the treatment of papulopustular rosacea, is Minocycline foam (1.5%), which on approval will be the first FDA-approved topical minocycline treatment for this condition. The company has already released the Top-line results for first two Phase 3 pivotal studies and is in the process of filing an IND with the FDA. The company manufactures an array of foam based topical applications using its proprietary technology which offers improved tolerability, ease of use, high solubility and penetration and targeted drug delivery.
Additionally, the company’s candidate for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris is FMX101; it is potential first-in-class Minocycline foam (4%), which has received a New Drug Application status from the FDA with a Prescription Drug User Fee Act (PDUFA) action date of October 20th, 2019.
Foamix’s proprietary foam technology uses a hydrophobic composition and offers multiple advantages such as safe and stable delivery of the inherently unstable APIs, absence of primary irritants, ease of use to name a few.
According to its first quarter 2019 financial results, the company had cash and cash equivalents of $82.9 million as of March 31, 2019, as against cash and cash equivalents of $99.4 million as on December 31, 2018.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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