Novan Announces Berdazimer Gel (10.3%) as Potential First-in-Class Prescription Treatment for Molluscum Contagiosum Following Successful Phase 3 Trial

Recently, U.S. pharmaceutical company Novan published the Phase 3 study results of its Berdazimer gel (10.3%) for the treatment of molluscum contagiosum in the peer-reviewed journal JAMA Dermatology. The data demonstrated that the drug has favorable efficacy and tolerability. If approved,Berdazimer Gel (10.3%) will be the first FDA-approved prescription product for the treatment of this viral skin infection.

Based on its exclusive nitric oxide (NO) technology platform, NITRICIL^TM, NOVAN focuses on the research, development, and commercialization of innovative therapeutic products for dermatological conditions, with indications including plaque psoriasis, rosacea, and acne. The company completed its initial public offering in 2016 and acquired EPI Health, a dermatology-specialized company, in 2022.

Berdazimer gel (10.3%) is a topically applied nitric oxide (NO)-releasing agent for the treatment of molluscum contagiosum (SB206). In Phase III clinical trials, NOVAN enrolled 891 patients aged 6 months or older, each presenting with 3 to 70 raised molluscum lesions. After 12 weeks of treatment, 32.4% of patients in the berdazimer group achieved complete lesion clearance, compared with 19.7% in the control group. The incidence of adverse events was low, with the most common being mild pain and erythema at the application site.

Molluscum contagiosum is a common contagious viral skin infection caused by the molluscum contagiosum virus, which spreads through direct skin-to-skin contact or by sharing contaminated items. In the United States,The virus affects approximately 6 million people annually., the prevalence among children aged 0–16 years is 5.1%–11.5%. Infected individuals typically present with 10 to 30 lesions concentrated on the face, trunk, extremities, and axillae; in severe cases, there may be approximately 100 lesions.

Despite its high contagiousness, there remains a significant unmet patient need in the treatment of molluscum contagiosum. Current treatment options for molluscum contagiosum are limited to physical therapies, cantharidin, or off-label prescription and over-the-counter products. In the United States,More than 70% of molluscum contagiosum patients remain untreated,Molluscum contagiosum may take a long time to resolve, with lesions persisting for 13 months to 5 years.

Clinical studies have demonstrated that,Berdazimer Gel (10.3%) may become the first and only product forMolluscum Contagiosum Treatmentprescription drugs.“Patients and caregivers achieved complete clearance of lesions through the topical application of a nitric oxide (NO)-releasing gel, marking a significant breakthrough in the treatment of molluscum contagiosum,” said Adelaide Herbert, MD, Director of Pediatric Dermatology at McGovern Medical School and Children’s Memorial Hermann Hospital.

Berdazimer gel (10.3%) is one of the products within NOVAN’s proprietary NITRICIL™ technology platform. Leveraging the natural antimicrobial and immunomodulatory effects of nitric oxide (NO), NITRICIL™ stores gaseous NO on large polymers and scientifically modulates the timing and duration of NO release to simulate an immune response at specific sites.This technology enables control over the storage levels, release kinetics, and molecular size for targeted delivery of nitric oxide (NO)., thereby selecting stable, pharmaceutically acceptable NO for specific indications.

NOVAN believes that NO can develop new therapies to address medical needs across multiple therapeutic areas:

• Nitric Oxide-Based Topical Therapy as an Alternative to Traditional Antibiotics, Steroids, and Biologics

• NO can inhibit viral replication by forming reactive intermediates that alter viral proteins or host cell functions required for persistent infection.

• NO can inhibit HPV viral replication and may be used as an adjunctive therapy to supplement prophylactic vaccines.

  
  

R&D Pipeline

Image source: NOVAN official website

Paula Brown Stafford, President and Chief Executive Officer and Chairman of the Board of Novan, has over 30 years of experience in the biopharmaceutical services and consulting sector.She served as an independent director of Bio-Imaging Technologies, a publicly listed company, and participated in the founding of Quintiles (now IQVIA, following its merger with IMS Health), a global leader in pharmaceutical services, where she also served as President of Quintiles Clinical Development.。

Since leaving Quintiles, Paula has focused on board service and leadership development. She has served as Chair of the Board of the UNC Chapel Hill Foundation for Public Health and as a member of CDISC (Clinical Data Interchange Standards Consortium).

In recognition of her outstanding contributions to healthcare and drug development, Paula was honored with the “Women in Business” award by the Triangle Business Journal in 2011; in 2012, she was namedTop Ten Outstanding Women in the United Statesone of the recipients; in 2016, he was awarded the Distinguished Alumni Award by his alma mater, the University of North Carolina at Chapel Hill.

Paula Brown Stafford

Image source: NOVAN official website

In 2018, Novan expanded its nitric oxide (NO)-based dermatology business partnership with the Japanese pharmaceutical company Sato. Under the terms of the agreement, Novan granted Sato exclusive rights to develop and commercialize a molluscum contagiosum treatment and other related formulations in Japan.Japan is the world's second-largest dermatology market., skin conditions such as acne, molluscum contagiosum, and warts are highly prevalent. Therefore, this collaboration provides Novan with an opportunity to penetrate the global market.

March 2022，Novan Announces Acquisition of EPI Health to Create a Fully Integrated Specialty Dermatology CompanyEPI Health is one of the leading companies in the field of dermatology in the United States, with a strong pipeline of candidate drugs and a mature sales force and commercial team.Possesses deep market relationships within the dermatology community.

On November 9, 2022, Novan announced that Wynzora cream (calcipotriene and betamethasone dipropionate), indicated for the treatment of plaque psoriasis, has been included in the national preferred formulary of Express Scripts, a pharmacy benefit manager (PBM). Leveraging EPI Health’s proprietary PAD™ technology, Wynzora maintains the stability of calcipotriene and betamethasone dipropionate in an easy-to-use aqueous formulation. In Phase 3 trials conducted at multiple sites across the United States and the European Union, the drug demonstrated favorable clinical efficacy, safety, and high convenience.

Additionally, EPI Health offers a portfolio of topical products for the treatment of dermatological conditions, targeting indications such as cold sores, eczema, nail damage, persistent facial erythema associated with rosacea in adults, and papules and non-nodular inflammatory lesions of moderate to severe acne.

On September 26, 2016, Novan announced the completion of its initial public offering (IPO). The IPO offered 4.715 million shares of common stock at a price of $11.00 per share, generating total proceeds of approximately $51.9 million. Subsequently, Novan conducted several follow-on public offerings, with the most recent one concluding in June 2021, totalingRaised $40 million.To date, Novan has raised more than $200 million in total funding., its net proceeds, together with existing cash, are primarily used to fund R&D program activities.

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As of September 30, 2022, Novan’s total revenue for the third quarter of 2022 was $5.1 million, with net product revenue of $4.6 million. Among this, sales of RHOFADE (oxymetazoline hydrochloride) increased by 37% compared to the same period in 2021;WYNZORA increased by 216% compared to the same period in 2021; MINOLIRA (minocycline hydrochloride) increased by 59% compared to the same period in 2021.

John Donofrio, Executive Vice President, Chief Operating Officer, and President of EPI Health at Novan, commented, “Our focus in the fourth quarter is to continue executing our plan: raising awareness among prescribers and leadership, and enhancing product messaging.” Novan currently aims to submit a New Drug Application for Berdazimer gel (10.3%) for the treatment of molluscum contagiosum by the end of 2022, while finalizing its licensing agreement with Sato Pharmaceutical for the sale of Rhofade in Japan, thereby continuing to drive year-over-year growth in its product portfolio.