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Adial Pharmaceuticals Announces Appointment of Monika Rogozinska as Senior Vice President of Drug and Business Development
CHARLOTTESVILLE, Va., Aug. 15, 2018 — Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol use disorder, today announced the appointment of Monika Z. Rogozinska as Senior Vice President of Drug and Business Development.
Prior to joining Adial, Ms. Rogozinska served as Vice President and Head of Portfolio, Program & Project Management at ECRC in Boston, where she managed a portfolio of complex projects as the clinical contact and spokesperson for potential licensing, acquisition, collaborations, co-development agreements and strategic alliances. Previously, Ms. Rogozinska served as Senior Director and Global Program Leader at EMD Serono, an affiliate of Merck KGaA, where she led the clinical development, regulatory submissions and lifecycle management of various drugs under clinical development including Bavencio® (avelumab). Within this role, she developed, in a joint collaboration with Pfizer, the global development strategies and operational plans leading to a total of 30 clinical programs and nine pivotal studies in 3.5 years. Under her leadership, the Bavencio® (avelumab) program reached its first phase 3 start within 25 months of testing the first patient, commenced 6 Phase 3 trials in one year and led to successful BLA filing and FDA approval. Ms. Rogozinska has also held senior clinical and operational roles with Pfizer, Covidien and Quintiles. While at EDM Serono, she received the Merck KGaA CEO 2015 Award. Ms. Rogozinska completed the General Management Program at Harvard Business School and holds a Master of Science in Pharmacy degree from Nicolaus Copernicus University.
“I am pleased to join Adial Pharmaceuticals at this exciting time, as the company prepares to commence its first Phase 3 clinical trial. Importantly, alcohol use disorder is a dramatically underserved market with limited options for patients, and yet the combined market in the U.S. and Europe alone is estimated at approximately 90 million people. Given the favorable safety profile, low cost manufacturing, strong patent protection, and promising Phase 2 data for ADO4, I am encouraged by the expected benefit it will bring to patients and the resulting market potential for this first targeted product. I look forward to helping the Company advance through its clinical and regulatory process and towards commercialization,” stated Monika Rogozinska.
“We are pleased to welcome Monika to our senior leadership team,” commented William Stilley, CEO of Adial Pharmaceuticals. “She brings extensive program management, clinical development and regulatory experience, which should be invaluable as we advance the Phase 3 clinical program of AD04 for the treatment of alcohol use disorder. Importantly, she brings a strong track record overseeing large multi-national projects, ensuring they are completed on time, with quality and within budget. Moreover, she has been heavily involved in conducting due diligence on new assets, led R&D strategy and operations for early and late stage assets, managed R&D portfolios, and helped form strategic alliances and partnerships, all of which we expect will play a role as we seek to become a leading player in the war on addiction.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted therapeutic agent for the treatment of alcohol use disorder (“AUD”). A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). The Company plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity.
Forward Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements are based upon current beliefs, expectations and assumptions and include statements regarding the expected benefit AD04 will bring to patients and the resulting market potential for this first targeted product, Ms. Rogozinska’s extensive program management, clinical development and regulatory experience being invaluable as we advance to our Phase 3 clinical trial of AD04 for the treatment of alcohol use disorder, and Ms. Rogozinska’s involvement in conducting due diligence on new assets, leading R&D strategy and operations for early and late stage assets, managing R&D portfolios, and helping form strategic alliances and partnerships, playing a role as we seek to become a leading player in the war on addiction. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the contribution of Ms. Rogozinska to advancing our Phase 3 clinical trial of AD04 and our plan to become a leading player in the war on addiction, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our registration statement on Form S-1 that we have filed with the SEC and the final prospectus. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Crescendo Communications, LLC