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– Catalent has a proven track record of accelerating molecules from early development through commercial manufacturing –
– Company targets initiating preclinical Investigational New Drug (IND) enabling studies in Q1 2021 –
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.
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.
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.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on 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 technology, the Company’s pharmaceutical development of nitric oxide-releasing product candidates and the Company’s intention to advance development of certain product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company’s expectations, including, but not limited to, risks and uncertainties in the Company’s ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of the Company’s product candidates; the Company’s reliance on arrangements with third parties to support its development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, potential for delays or other impacts, whether as a result of the COVID-19 pandemic or other factors, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the Company’s product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company’s ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of the Company’s product candidates; the risk that disruptions at the FDA or other agencies could cause such agencies to cancel or postpone meetings or otherwise impact the ability of such agencies to provide regulatory guidance or feedback or timely review and process the Company’s regulatory submissions, all of which could have a material adverse effect on the Company’s business; risks related to the manufacture of raw materials, including the Company’s active pharmaceutical ingredient, and drug product components utilized in clinical trial materials, including failure to transfer technology and processes to third parties effectively or failure of those third parties to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the enrollment in and conduct of the B-SIMPLE4 Phase 3 trial; and other 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 in the Company’s subsequent filings with the SEC, including the Company’s quarterly report on Form 10-Q for the three months ended September 30, 2020. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
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