Novan(NOVN) MORRISVILLE, N.C., December 21, 2020
Catalent is the leading international provider of innovative delivery technologies, development, and manufacturing options such as biologics, drugs, cell and gene therapies, and consumer health products. Catalent’s innovative formulation development and manufacturing span a range of technology, along with integrated downstream clinical development and commercial supply solutions.
“We are happy to be working with Catalent and to benefit from its experience in drug development and manufacturing, which is of specific interest to us within our COVID-19 program. We look forward to progressing into preclinical IND-enabling studies and taking the next step towards unlocking the potential of the proprietary nitric oxide-based medicines,”
commented Paula Brown Stafford, President and Chief Executive Officer of Novan.
“That is a tremendous opportunity for Catalent and Novan,”
added Jonathan Arnold, President of Oral & Specialty Delivery, Catalent.
“We’re proud to leverage Catalent’s extensive knowledge and expertise in formula and inhalation technology to help address the urgent needs associated with the COVID-19 pandemic.”
Novan pioneered at Vitro evaluations of its NITRICIL™ platform against the publication SARS-CoV-2 coronavirus, targeting the decrease in viral burden in differentiated normal human bronchial epithelial cells. The studies were conducted in the Institute for Antiviral Research at Utah State University, and these results demonstrated that the very first example of an antiviral effect from nitric oxide-based medicine in a 3-D tissue model that has a similar structure to the human airway epithelium. The results in the in vitro evaluation of concentrations as low as 0.75 mg/mL demonstrated that berdazimer sodium decreased 90% of virus after repeat dosing, once daily.
Dependent on the scientific literature and information accessible to-date with berdazimer sodium and Novan’s product candidate SB206, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function essential for viral replication and infection through the generation of reactive intermediates.
“After the first positive at Vitro results we declared earlier, we consider berdazimer sodium has the potential to offer an advantage in preventing the replication of SARS-CoV-2, the virus which causes COVID-19, and we anticipate further exploring its possible. The knowledge and experience in a formulation that Catalent has to offer supplies an integral part as we execute on our development path forward with this important program” commented Dr. Carri Geer, Chief Technology Officer of Novan.
Following the completion of preclinical studies, Novan is targeting filing a potential IND program witH the Food and Drug Administration as well, subject to getting additional financing, targets beginning human clinical trials in the next half of 2021.
Catalent is the leading international provider of innovative delivery technologies, development, and production solutions such as drugs, biologics, gene and cell therapies, and consumer health products.
With over 85 years in the market, Catalent has proven expertise in bringing more client products to market quicker, improving product performance, and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people, including around 2,400 scientists and technicians, at more than 45 centers, and in the financial year, 2020 generated over $3 billion in annual revenue. To learn more, visit www.catalent.com.
Novan, Inc. is a medical development-stage biotechnology company focused on using its proprietary nitric oxide (NO) established technology platform, NITRICIL™ to create macromolecular New Chemical Entities (NCEs) to take care of multiple signs in dermatology, men’s and women’s health, infectious diseases and gastroenterology conditions with significant unmet needs. The Company’s lead product candidate, SB206, a topical antifungal gel for the treatment of molluscum contagiosum, is now being assessed in the B-SIMPLE4 pivotal Phase 3 clinical study. The business believes that SB206, as a topical, at-home, caregiver-applied treatment with a rapid treatment benefit, if approved, would handle significant patient-care demand for the treatment of molluscum.
These statements can be identified by phrases like”belief,” “expect,” “may,” “strategy,” “possible,” “will,” and similar expressions, and are based upon the Company’s current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company’s NITRICIL™ platform technologies, the Company’s pharmaceutical evolution of nitric oxide-releasing product candidates, and the provider’s intention to advance the development of specific product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the organization’s expectations, such as, but not limited to, risks and uncertainties in the organization’s ongoing or future product development activities and preclinical studies, which might not prove effective in demonstrating proof-of idea, or might reveal adverse toxicological findings, and even when effective might not necessarily forecast that subsequent clinical trials will show the required safety and effectiveness of the organization’s product candidates; the organization’s reliance on agreements with third parties to encourage its development efforts and the threat that such parties will not successfully carry out their contractual obligations or meet expected deadlines; risks and uncertainties in the clinical development process, such as, among others, span, expense, ability to register patients, possible for delays or other impacts, whether as a result of the COVID-19 pandemic or other aspects, and that results of earlier research and preclinical or clinical trials might not be predictive of outcomes, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which can be protracted, time-consuming and inherently unpredictable, including the risk that the Company’s product candidates might not be approved or that additional studies may be required for acceptance or other delays may happen and that the company might not obtain funding sufficient to complete the regulatory or development procedure; the organization’s ability to obtain additional financing or input into strategic or other business associations required or useful for the additional development of the organization’s product candidates; the threat that disruptions at the FDA or other agencies may cause such agencies to cancel or postpone meetings or otherwise impact the capacity of such agencies to provide regulatory advice or feedback or timely review and process the Company’s regulatory submissions, all which may have a material adverse effect on the organization’s business; risks related to the manufacture of raw materials, including the organization’s active pharmaceutical ingredient, and drug product components used in clinical trial materials, such as failure to transfer processes and technology to third parties effectively or failure of those third parties to acquire approval of and maintain compliance with the FDA or comparable regulatory authorities; some other operational or other disruptions as a result of the COVID-19 pandemic, such as any delays or disruptions to the registration in and run of their B-SIMPLE4 Stage 3 trial; and additional risks and uncertainties described in the Company’s annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, as amended, and at the organization’s subsequent filings with the SEC, including the organization’s quarterly report on Form 10-Q for the three months ended September 30, 2020. These forward-looking statements speak only as of their date of the press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of these statements, except as may be required by legislation.