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 Robert McKague as Executive Vice President, General Counsel and Chief Compliance Officer. Mr. McKague will join Tricida’s Executive Team and lead the legal and compliance organization as the Company prepares for the potential launch of veverimer in 2020.
"We are excited to have Bob join the Executive Team, where his extensive strategic, regulatory and operational expertise will be invaluable as we grow into a commercial organization," said Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President. "Bob’s specific knowledge and background in regulatory compliance will also help guide our commercial team as we work towards a successful launch of veverimer, if approved."
Prior to joining Tricida, Mr. McKague worked for over ten years at Jazz Pharmaceuticals where he most recently served as Senior Vice President, Associate General Counsel. At Jazz, he was a member of the Executive Committee and managed a team that supported the global operational functions of the business, including support for six product launches, and ensured compliance with applicable laws, regulations and industry codes of practice in numerous countries. Between 2009 and 2011, Mr. McKague held senior legal positions at Actelion Pharmaceuticals and Oracle America. Mr. McKague began his legal career at the Board of Governors of the Federal Reserve System and Morrison & Foerster, LLP. Mr. McKague received his Juris Doctor from the University of California Hastings College of Law and his Bachelor of Arts in International Relations and French from San Francisco State University.
"I am happy to be at Tricida and share their excitement for launching a potential first-in-class FDA-approved treatment for patients with metabolic acidosis and CKD," said Mr. McKague. "I look forward to working with the team on the continued development and potential commercialization of veverimer, providing legal and compliance guidance and supporting the business activities that are underway."
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) through 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, the potential timing for commercial launch of veverimer, the assigned PDUFA goal date of August 22, 2020, and the potential availability of the Accelerated Approval Program. 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 through 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 and manufacturers for many aspects of our business. 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.
Jackie Cossmon, IRC
Vice President of Investor Relations and Communications