Furthering formulations

MedPharm expands relationship with Novan on formulation science

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DURHAM, N.C.—MedPharm Ltd. and Novan Inc. announced in July that they had expanded their partnership. MedPharm has previously helped to test Novan’s unique formulations using its proprietary in-vitro models to optimize the formulations and de-risk product development.
“MedPharm is delighted to be able to support Novan in advancing and broadening its product pipeline,” said Eugene Ciolfi, MedPharm’s president and CEO. “Our new agreement allows us to react quickly to changes in requirements and makes full use of MedPharm’s comprehensive services for de-risking Novan’s product development.”
MedPharm is a leader in dermatological, nail, eye, airway, mucosal membrane and transdermal formulation science and drug delivery. Novan has previously worked with MedPharm across a number of specific projects, including nonclinical and in-vitro permeation and penetration testing (IVPT) studies, and a variety of targeted formulation projects.
The expanded agreement will broaden the relationship from individual projects to a broader scope of work, activity and initiatives, including development of formulations and selection of product candidates, cost-effective product target screening and the development of in-vitro models focused on Novan’s nitric oxide product technology.
“Novan recognizes MedPharm has in-depth experience in developing new topical products fit for commercialization. The team’s responsiveness, rigorous scientific approach and specialized knowledge makes MedPharm an ideal partner to help Novan achieve its objectives,” added Paula Brown Stafford, Novan’s president and chief operating officer.
In other Novan news, the company recently executed a master contract manufacturing agreement with a full-scale active pharmaceutical ingredient (API) manufacturer. The agreement establishes an operating and business relationship for this manufacturer to become the primary external supplier of Novan’s proprietary berdazimer sodium drug substance.
Also incorporated in the agreement is the process and analytical method transfer necessary to advance the production of Novan’s berdazimer sodium drug substance for future clinical trials and, upon approval of any of the company’s drug product candidates, for commercial purposes on a global basis. Adding an external API provider and business partner alongside the existing Orion Corp. relationship, announced in October 2018, completes an important operating model adjustment for Novan.
“These business advancements highlight our team’s continued focus on leveraging our substantial internal expertise of nitric oxide science with external partners, all of whom are experts in their field,” noted Dr. Carri Geer, senior vice president and chief technology officer of Novan. “Our experiences to date provide us with the foundation upon which to rapidly advance our progress from here across dermatology and other selected clinically meaningful therapeutic applications with the goal of bringing benefit to patients.”
In August, Novan received a federal grant from the U.S. National Institutes of Health (NIH). The company also anticipates receiving an additional federal grant in the very near term. These grants will provide funding on a non-dilutive basis for specific initiatives within product advancement for the treatment of cervical intraepithelial neoplasia.
The NIH grant of approximately $223,000 is a Phase 1 federal grant. Novan intends to use the funds to advance formulation development of an intravaginal gel (WH504). The specific focus is to ensure the nitric oxide delivery from the gel replicates doses of nitric oxide previously demonstrated to be effective against human papilloma virus in Novan’s clinical and in-vitro studies.
Novan hopes to be eligible to receive additional grant dollars for Phase 2 and 3 extensions. The total amount of these awards could be approximately $1.5 million. If awarded, Phase 2 and 3 would focus on the completion of investigational new drug-enabling toxicology and pharmacology studies, and other preclinical activity.
In addition to the NIH grant, Novan is in the final stages of securing a second federal grant. If awarded, this grant would total approximately $1.0 million, and these funds would be earmarked toward the development of an intravaginal suppository (WH602) that demonstrates potent antiviral activity.

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