– Novan is a totally built-in pharmaceutical firm with confirmed capabilities throughout drug improvement by means of to commercialization –
– EPI Well being adopts Novan company branding, creating unified identification prematurely of potential industrial launch of berdazimer gel, 10.3% (SB206) –
DURHAM, N.C., March 08, 2023 (GLOBE NEWSWIRE) — Novan, Inc. (“the Firm” or “Novan”) (Nasdaq: NOVN), at present introduced that its industrial subsidiary, EPI Well being, will now unify below one model identify, Novan.
“For the reason that closing of our acquisition of EPI Well being in March of 2022, we’ve got made important progress integrating our organizations into one cohesive enterprise. As of at present, we’re happy to maneuver ahead as one united model, Novan, with the unified aim of constructing a premier medical dermatology firm. We imagine our built-in enterprise will streamline our pre-commercial actions for berdazimer gel, 10.3%,” commented Paula Brown Stafford, President and Chief Government Officer of Novan.
In early 2022, Novan accomplished the acquisition of EPI Well being, equipping the Firm with the industrial infrastructure essential to deliver to market, if authorized, our lead product candidate, berdazimer gel, 10.3% (SB206). This infrastructure features a extremely skilled gross sales and advertising crew, provide chain capabilities, market entry data, medical affairs specialists, and a community of associated companions. The mixed group is a totally built-in pharmaceutical firm with capabilities throughout drug improvement and commercialization with a confirmed product portfolio throughout a number of illness states inside dermatology.
Novan, Inc. is a medical dermatology firm primarily targeted on researching, creating, and commercializing modern therapeutic merchandise for pores and skin illnesses. Our aim is to ship secure and efficacious therapies to sufferers, together with creating product candidates the place there are unmet medical wants. Novan has a sturdy industrial infrastructure throughout gross sales, advertising, and communications, in addition to absolutely devoted market entry and pharmacy relation groups, selling merchandise for plaque psoriasis, rosacea and zits. The U.S. Meals and Drug Administration (“FDA”) has accepted Novan’s new drug utility (“NDA”) submission for overview for berdazimer gel, 10.3% (SB206) as a topical prescription gel for the remedy of molluscum contagiosum. The Firm additionally has a pipeline of potential product candidates utilizing its proprietary nitric oxide-based expertise platform, NITRICIL™, to generate new therapies for a number of indications.
Any statements contained on this press launch that don’t describe historic details might represent forward-looking statements as that time period is outlined within the Personal Securities Litigation Reform Act of 1995. These statements could also be recognized by phrases reminiscent of “imagine,” “count on,” “goal,” “anticipate,” “might,” “plan,” “potential,” “will,” “look ahead to” and comparable expressions, and are based mostly on the Firm’s present beliefs and expectations. These forward-looking statements embody, however are usually not restricted to, statements associated to the potential FDA approval of the Firm’s NDA for berdazimer gel, 10.3% (SB206) for molluscum contagiosum, the therapeutic worth and advantages of the Firm’s Nitricil™ platform expertise and its product candidates, together with berdazimer gel, 10.3% (SB206), the capabilities of the Firm’s industrial infrastructure, and the potential market alternative for the Firm’s product candidates. Ahead-looking statements are topic to a variety of dangers and uncertainties that might trigger precise outcomes to vary materially from the Firm’s expectations, together with, however not restricted to, dangers associated to the acquisition of EPI Well being; dangers associated to the regulatory approval course of, which is prolonged, time-consuming and inherently unpredictable, together with the danger that the FDA won’t agree with the Firm’s strategy to our NDA submission, that the Firm’s product candidates will not be authorized or that extra research could also be required for approval or different delays might happen, that the Firm might not have enough portions of drug substance and/or drug product to help regulatory submissions and that the Firm might not receive funding enough to increase its money runway or to finish the regulatory or improvement course of; the Firm’s restricted expertise as an organization in acquiring regulatory approvals for and launching merchandise developed internally and its means to recruit and retain certified personnel and key expertise; modifications within the dimension and nature of the marketplace for the Firm’s product candidates and promoted merchandise, together with potential competitors, affected person and payer perceptions and reimbursement determinations; the Firm’s means to develop revenues from promoted merchandise and the dangers that previous efficiency will not be indicative of future efficiency; dangers and uncertainties within the Firm’s ongoing or future product improvement actions and preclinical research, which can not show profitable in demonstrating proof-of idea, or might present adversarial toxicological findings, and even when profitable might not essentially predict that subsequent medical trials will present the requisite security and efficacy of the Firm’s product candidates, or that any of the Firm’s product candidates, if authorized, will proceed to display requisite security and efficacy following their industrial launch; any operational or different disruptions because of the COVID-19 pandemic; dangers associated to the manufacture of uncooked supplies and completed drug product, reminiscent of provide chain disruptions or delays, failure to switch expertise and processes to 3rd events successfully or failure of these third events (or the Firm in reference to the Firm’s facility) to acquire approval of and keep compliance with the FDA or comparable regulatory authorities; the Firm’s reliance on preparations with third events to help its operations and its improvement, manufacturing and commercialization efforts and the danger that such events won’t efficiently perform their contractual duties or meet anticipated deadlines; the Firm’s means to acquire extra funding or enter into strategic or different enterprise relationships essential or helpful for the additional improvement or commercialization of the Firm’s product candidates and the operation of its enterprise on phrases which can be acceptable to the Firm or in any respect or if such relationships or transactions are unsuccessful or the Firm is unable to comprehend the potential financial advantages of such relationships or transactions; and different dangers and uncertainties described within the Firm’s annual report filed with the Securities and Change Fee on Kind 10-Ok for the twelve months ended December 31, 2021, and within the Firm’s subsequent filings with the Securities and Change Fee. Such forward-looking statements communicate solely as of the date of this press launch, and the Firm disclaims any intent or obligation to replace these forward-looking statements to replicate occasions or circumstances after the date of such statements, besides as could also be required by legislation.
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