Relates to PR: Novan Engages Catalent to Develop Intranasal Formulation of Berdazimer Sodium for COVID-19 Program
December 21, 2020 at 9:00 AM EST
MORRISVILLE, N.C., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced it has entered into a Master Services Agreement (MSA) with Catalent, which will include support of chemistry, manufacturing and control (CMC) activities and development of an intranasal formulation of berdazimer sodium for use in the Company’s coronavirus (COVID-19) program.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. Catalent’s advanced formulation development and manufacturing spans a range of technologies, along with integrated downstream clinical development and commercial supply solutions.
“We are pleased to be working with Catalent, and to benefit from its expertise in drug development and manufacturing, which is of particular interest to us in our COVID-19 program. We look forward to advancing into preclinical IND-enabling studies and taking another step towards unlocking the potential of our proprietary nitric oxide-based medicines,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan.
“This is a tremendous opportunity for Catalent and Novan,” added Jonathan Arnold, President of Oral & Specialty Delivery, Catalent. “We are proud to leverage Catalent’s broad knowledge and expertise in formulation and inhalation technologies to help address the pressing needs associated with the COVID-19 pandemic.”
Novan initiated in vitro assessments of its NITRICIL™ platform against the novel SARS-CoV-2 coronavirus, targeting the reduction of viral burden in differentiated normal human bronchial epithelial cells. The studies were conducted at the Institute for Antiviral Research at Utah State University, and these results demonstrated the first instance of an antiviral effect from a nitric oxide-based medicine in a 3-D tissue model that has similar structure to the human airway epithelium. The results from the in vitro assessment of concentrations as low as 0.75 mg/mL demonstrated that berdazimer sodium reduced 90% of virus after repeat dosing, once daily.
Based on the scientific literature and data available to-date with berdazimer sodium and Novan’s product candidate SB206, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function critical for viral replication and infection through generation of reactive intermediates.
“Following the initial positive in vitro results that we announced earlier, we believe berdazimer sodium has the potential to offer benefit in inhibiting the replication of SARS-CoV-2, the virus that causes COVID-19, and we look forward to further exploring its potential. The knowledge and experience in formulation that Catalent has to offer provides a key component as we execute on our development path forward for 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 application with the U.S. Food and Drug Administration and, subject to obtaining additional funding, targets initiating human clinical trials in the second half of 2021.
About Catalent
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing 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 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.
About Novan
Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging its proprietary nitric oxide (NO) based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications 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 antiviral gel, for the treatment of molluscum contagiosum, is currently being evaluated in the B-SIMPLE4 pivotal Phase 3 clinical study. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would address an important patient-care need for the treatment of molluscum.
