Citius Pharmaceuticals Expands Leadership Team With Appointment Of Kelly Creighton, PhD As Executive Vice President Of Chemistry, Manufacturing And Controls

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CRANFORD, New Jersey, November 5, 2021 / PRNewswire / – Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), an advanced-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products and stem cell therapies, announced today the appointment of a pharmaceutical industry veteran Kelly creighton, PhD as Executive Vice President of Chemistry, Manufacturing and Controls (CMC). Mr. Creighton will be responsible for the global strategic regulatory development and manufacturing plans for Citius’ five pipeline programs.

“With two Phase 3 trials nearing completion, we continue to prepare the organization for commercial success. Kelly is a pharmaceutical industry veteran whose accomplishments include more than 50 Investigational New Drug Submissions (INDs) and 20 approved market applications spanning multiple therapeutic areas including oncology, infectious disease and cell therapy. Kelly has been a longtime advisor to Team Citius on all aspects of the regulatory path for Mino-Lok® and we anticipate a smooth transition to this newly created internal role. He brings an ideal blend of strategic thinking, leadership skills, and in-depth global regulatory and product development expertise, which he will apply across our clinical program as we continue to develop the Citius pipeline. “, said Myron Holubiak, CEO of Citius.

Kelly creighton, PhD joins Citius from Clinipace Worldwide, a leading global contract research organization, where he served as Vice President of Regulatory and Strategic Development. As a senior regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies including gene and cell therapies, and combination products, he has provided comprehensive assessments of regulatory strategy, development plans and regulatory briefs for programs in a wide range of therapeutic areas. As head of CMC’s global regulatory activities for investigational products, he led teams throughout North America, Europe and the Asia Pacific region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has led the implementation of several CMC development plans including: selection of contract manufacturing organizations, product manufacturing, analytical development, product characterization, specification setting, systems container closure and stability requirements. In addition, his substantial product development experience extends to biologics / biosimilars, small molecule, gene and cell therapies, cancer immunotherapies, live oncolytic biotherapies and microbiome therapies. Twenty products for which he has prepared regulatory marketing submissions (NDA, ANDA and BLA) have been approved in the US and the EU. In addition, he has performed internal and external quality assurance audits for drug products, drug substances, and tissue and cell therapy products.

Kelly graduated from New Mexico State University and his master’s and doctorate from University of Nebraska.

About Citius Pharmaceuticals, Inc.
Citius is an advanced stage biopharmaceutical company dedicated to the development and commercialization of leading critical care products, with a focus on oncology, anti-infectives in complementary cancer care, prescription products unique and stem cell therapies. The Company has two late stage product candidates, Mino-Lok®, an antibiotic locking solution for the treatment of patients with catheter-related blood infections (CRBSI), which is currently enrolling patients in a pivotal phase 3 superiority trial, and I / ONTAK (E7777), a new IL immunotherapy -2R for a first indication in cutaneous T cell lymphoma (CTCL), which has completed recruitment in its pivotal phase 3 trial. Mino-Lok® has obtained Fast Track designation from the United States Food and Drug Administration (FDA). I / ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and Peripheral T-Cell Lymphoma (PTCL). Through its subsidiary NoveCite, Inc., Citius is developing a proprietary new mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSC) for acute respiratory conditions, with a short-term focus on distress syndrome acute respiratory (ARDS) associated with COVID. -19. For more information, please visit www.citiuspharma.com.

Safe harbor
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on our expectations and beliefs regarding future events affecting Citius . You can identify these statements by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “plan”, “should” and “could” and others. words and terms with similar meanings or the use of future dates. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could adversely affect our business, results of operations, financial condition and the price of our shares. Factors that could cause actual results to differ materially from those currently expected are: our ability to attract, integrate and retain key personnel; risks related to the results of research and development activities, including those of existing and new pipeline assets; uncertainties relating to preclinical and clinical trials; our need for substantial additional funds; the initial stage of products under development; our dependence on third party suppliers; our ability to initiate and successfully complete clinical trials and the results of such trials for our product candidates; the estimated markets for our product candidates and their acceptance by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our ability to market our products if they are FDA approved; market and other conditions; risks related to our growth strategy; patent and intellectual property issues; our ability to attract, integrate and retain key personnel; our ability to secure, execute and maintain funding and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and businesses successfully and in a timely manner; our ability to source a cGMP commercial scale supply; government regulations; competetion; as well as other risks described in our documents filed with the SEC. These risks have been and could still be impacted by the Covid-19. Therefore, these forward-looking statements are not guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. The risks relating to our business are described in detail in our filings with the Securities and Exchange Commission (“SEC”) which are available on the SEC’s website at www.sec.gov, including in our report. annual on Form 10-K for the fiscal year ended. September 30, 2020, filed with the SEC on December 16, 2020 and updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or commitment to publicly release any update or revision to any forward-looking statement contained herein to reflect any change in our expectations or any changes. in the events, conditions or circumstances on which such a statement is based, except as required by law.

Investor Relations for Citius Pharmaceuticals:
Ilanit Allen
Vice-President, Investor Relations and Corporate Communications
T: 908-967-6677 x113
E: [email protected]

SOURCE Citius Pharmaceuticals, Inc.

Related links

http://www.citiuspharma.com


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