SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 3, 2019--
Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), today announced the hiring of Elizabeth Faust, Ph.D., as Senior Vice President of Medical Affairs. Dr. Faust, who initially joined Tricida as a consultant in September 2019, will lead the strategic development and implementation of Tricida’s medical education, publications and disease awareness activities as the company prepares for the potential launch of veverimer in 2020.
“Elizabeth brings a breadth and depth of strategic and operations experience to Tricida that will enable us to build a highly effective medical affairs function,” said Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President. “Nephrologists understand that metabolic acidosis can lead to accelerated kidney deterioration, muscle wasting and bone loss, but without an FDA-approved therapy, the condition is unfortunately often untreated. Under Elizabeth’s leadership, we will raise the awareness and urgency to manage and treat this serious complication of CKD. We are very excited to have Elizabeth join the Tricida team.”
Dr. Faust has over 20 years of medical affairs experience in the bio-pharmaceutical industry. She has played a key contributing role in nine drug launches across several therapeutic areas. Previously, Dr. Faust served as Vice President of Medical Affairs at Pharmacyclics where she built and led the medical affairs function supporting the execution of four indication launches for Imbruvica over 14 months. Most recently, Dr. Faust served as Vice President of Medical Affairs at Kite Pharma where she built and led the medical affairs function supporting the launch of Yescarta. Dr. Faust has also served in senior roles in medical affairs at Celgene, Gloucester Pharmaceuticals and Amgen.
Dr. Faust holds a B.S. in Microbiology from Auburn University, a M.A. in Biology from the University of California, Riverside and a Ph.D. in Microbiology and Molecular Genetics from UCLA.
“I am thrilled to join Tricida and to advance the medical affairs function and disease state awareness programs that are underway,” said Dr. Faust. “I believe that veverimer has the potential to transform the treatment of patients with metabolic acidosis and CKD. I look forward to working with the Tricida team on the continued development and potential commercialization of this important drug candidate.”
Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with CKD. Metabolic acidosis is a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. It is estimated to pose a health risk to approximately three million patients with CKD in the United States. Tricida is currently conducting its confirmatory postmarketing trial, VALOR-CKD, of veverimer. The Tricida New Drug Application (NDA) for veverimer has been accepted for review by the U.S. Food and Drug Administration (FDA) under the Accelerated Approval Program. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 22, 2020.
For more information about Tricida, please visit www.Tricida.com.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements, including for example, statements about the potential timing for approval or commercial launch of veverimer, the assigned PDUFA goal date of August 22, 2020, the potential availability of the Accelerated Approval Program, the potential development and implementation of medical education and disease awareness efforts, as well as the therapeutic potential of, and potential clinical and commercial development plans for, veverimer. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, that we may not be able to achieve upcoming milestones; the cost, timing and results of clinical trials and other studies; that many drug candidates that have completed Phase 3 trials do not become approved drugs on a timely or cost effective basis, or at all; there can be no assurance that the FDA would approve an NDA under the Accelerated Approval Program, or at all, and even if approval for a drug is obtained, there can be no assurance that it will be adopted in the market or accepted as a benefit to patients and healthcare providers; possible safety and efficacy concerns; and that we completely rely on third-party suppliers to manufacture our clinical drug supply. These and other factors that may affect our future results of operations are identified and described in more detail in our filings with the Securities and Exchange Commission (SEC), including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect Tricida’s current views with respect to future events, and Tricida does not undertake and specifically disclaims any obligation to update any forward-looking statements.
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Source: Tricida, Inc.
Jackie Cossmon, IRC
Vice President of Investor Relations and Communications