22 Mar A paradigm shift in the ACNE treatment industry?
Acne is one of the most common skin disorders in the U.S affecting over 50 million people annually. An estimated 85% of young adults aged between 12-25 years suffer from it according to the Global Burden of Disease (GDB) study. The rise in androgen levels during puberty, growing environmental pollution, stress and unhealthy lifestyles are some of the causative factors of acne. It causes considerable self –image and confidence issues in people leading them to seek treatment.
The first course of treatment for acne 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 acne. Conventional therapeutics have limitations such as side effects, misuse for purposes otherwise stated, nausea and birth defects.
The ACNE Treatment industry is poised to reach $7.0 billion by 2024 according to a report by Global Market Insights, Inc., growing at a CAGR of 6.9% during the forecast period, owing to growing awareness about treatment options.
The industry is moving from small molecule based medications to peptides, combination therapies and biologics with some companies of these below listed companies leading the innovation bandwagon.
Foamix Pharmaceuticals (NASDAQ: FOMX)
Market Cap: $220.73M; Current Share Price: 4.06 USD
Foamix is a clinical stage biotechnology company that is focused on creating solutions for the unmet needs in dermatology by developing topical therapies. The company’s lead candidate for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris is FMX101 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.
The company manufactures an array of foam based topical application using its proprietary technology which offers improved tolerability, ease of use, high solubility and penetration and targeted drug delivery.
The company’s clinical pipeline consists of FMX101, a potential first-in class Minocycline foam, 4% for the treatment of moderate-to-severe acne. It is currently under phase 3 clinical trials. It is also working on FMX103, Minocycline foam, 1.5% for the treatment of moderate-to-severe Papulopustular Rosacea, which is undergoing phase 2 clinical studies.
Its 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.
As per the company’s year-end financial results, 2018, total revenues for the year ended December 31, 2018 were $3.6 million as compared to $3.7 million for the same period last year, including royalty payments. The company reported $99.4 million in cash and investments as compared to $76.4 million at the end of December 2017.
Novan Therapeutics (NASDAQ: NOVN)
Market Cap: $30.07M; Current Share Price: 1.154 USD
It harnesses the natural antiviral and immunomodulatory mechanisms of action of nitric oxide to develop therapeutics for the treatment of dermatological and oncovirus-mediated diseases. The company intends to leverage its proprietary Nitricil™ technology that can create new chemical entities (NCE’s) along with its topical formulation science to develop product candidates for treatment of specific conditions.
The company’s work is centered on the power of the Nitric Oxide molecule that plays a vital role in biological functions such as wound healing, immune function, blood pressure regulation and neurotransmission by its ability to control inflammation, act as a defense mechanism against invading organisms and even fight cancer cells. It has numerous applications in dermatology as well owing to its anti-inflammatory and anti-microbial properties.
Novan’s NITRICIL™ technology can be used to create new chemical entities (NCE’s) that can store nitric oxide in the gaseous form on large polymers and regulate the size of the molecule, level of storage and timing of release to create targeted delivery.
The company’s pipeline consists of SB204, a once-daily topical monotherapy for the treatment of acne vulgaris, which has completed two successful Phase II clinical trials. In addition, it has candidates for Molluscum and external genital warts (SB206), Onychomycosis/ Tinea Pedis (SB208) and Atopic Dermatitis (SB414).
The company has entered into a licensing agreement with the Japanese Company, Sato Pharmaceuticals, for SB204 meant for the treatment of acne vulgaris. This agreement was recently expanded to include SB206 for the treatment of viral skin infections including warts and molluscum contagiosum.
SOL-GEL Technologies (NASDAQ: SLGL)
Market Cap: $131.89M; Current Share Price: 6.96 USD
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 TWIN, SIRS-T and Epsolay (formerly VERED), which are encapsulated forms of tretinoin and benzoyl peroxide for the treatment of acne vulgaris which are undergoing phase II and III clinical trials. 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.
As per its Q3, 2018 financial results, its cash and cash equivalents stood at $73.5 million. The company raised gross proceeds of $86.3 million through a public offering of 7,187,500 ordinary shares in February 2018.
Paratek Pharmaceuticals (NASDAQ: PRTK)
Market Cap: $209.94M; Current Share Price: 6.48 USD
The company’s lead product candidate for the treatment of acne vulgaris is the FDA approved SEYSARA (sarecycline), a tetracycline-class drug which is marketed by Almirall, LLC in the U.S. It has assigned the marketing and development rights of SYESARA to Allergen PLC, who in turn gave the marketing rights to Almirall LLC. The company received $12 million in milestone payments upon FDA approval and will now receive tiered royalties on sales of SYESARA.
In addition, the company is also developing NUZYRA (omadacycline) for women with uncomplicated UTI and acute pyelonephritis. NUZYRA is the first FDA approved tetracycline class antibacterial for treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults in over 20 years. It is also studying expansion opportunities for use in prostatitis and rickettsial disease.
The company has a research agreement with U.S department of defense to study the use of NUZYRA against pathogenic infectious diseases such as plague, anthrax, etc.
It has collaboration with Zai Lab (Shanghai) Co., Ltd., for development and commercialization of omadacycline in greater China.
As per its 2018 year-end financial results, total cash, cash equivalents and marketable securities stood at $292.8 million.
BioPharmX (NYSE American: BPMX)
Market Cap: $21.71M; Current Share Price: 0.10 USD
The company’s strategy involves developing novel products using active pharmaceutical ingredients (APIs) with demonstrated safety profiles and identifying optimal delivery mechanisms that can help expedite regulatory approvals for treatment of chronic dermatological conditions. It’s proprietary HyantX™ delivery system is an innovative anhydrous topical delivery system for hydrophilic molecules which has demonstrated the ability to delivery actives or a combination of actives with maximum solubility, enhanced skin penetration and antibacterial properties.
The company has developed topical minocycline gel formulation (BPX-01) which is solubilized, stable and capable of targeted skin penetration and delivery for the treatment of both acne and rosacea, by using HyantX™, which offers an enhanced efficacy and safety profile on one hand and higher penetration and lower concentration doses on the other. In addition, it offers enhanced bioavailability and ease of application.
As per its Q3, 2018 financial results the company had cash and cash equivalents of $3.0 million as on 31 October 2018. The company reduced its operating costs by enacting a 33% reduction in workforce and divesting molecular iodine technology business to focus on dermatology.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.