Extends Veverimer Patent Protection into 2038
SOUTH SAN FRANCISCO, Calif., March 03, 2021 (GLOBE NEWSWIRE) -- Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its investigational drug candidate, veverimer, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), today announced today that U.S. patent number 10,934,380, entitled “CROSSLINKED POLY(ALLYLAMINE) POLYMER COMPOSITIONS” has issued from the United States Patent and Trademark Office. The newly issued patent covers additional composition of matter claims for veverimer to 2038 and extends the Tricida patent portfolio, which is solely owned by the company, to a total of 210 patents in 49 different countries, including two previously issued U.S. composition of matter patents and four issued U.S. method of treatment patents which provide protection to 2034. In addition, Tricida holds three issued European Patent Office patents providing patent protection until 2034 and two additional issued patents providing protection until 2035 in Europe, as well as patent protection expected to provide protection for veverimer until at least 2034 in Australia, China, Hong Kong, Israel, Japan, Mexico and certain other markets. Tricida solely owns other patent applications relating to veverimer that are currently pending in Australia, Brazil, Canada, China, Europe, Hong Kong, India, Israel, Japan, Mexico, Republic of Korea, Russia, and the United States.
“This new composition of matter patent will enable us to fully capitalize on veverimer’s U.S. potential into 2038,” said Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President. “While our focus today is on the continued successful execution of the VALOR-CKD trial, we are not losing sight of the commercial opportunity for veverimer. This patent adds four years of additional patent protection to our timeline to obtain the full value of veverimer.”
Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its investigational drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with CKD. Tricida is currently conducting a renal outcomes clinical trial, VALOR-CKD, to determine if veverimer slows CKD progression in patients with metabolic acidosis associated with CKD. There are no FDA-approved treatments for chronic metabolic acidosis, 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.
For more information about Tricida, please visit www.Tricida.com.
Cautionary Note on Forward-Looking Statements
This press release includes 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. Forward-looking statements relate to expectations concerning matters that are not historical facts. Words such as “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” and similar words and expressions are intended to identify forward-looking statements. Any statements contained herein which do not describe historical facts, including the Company’s plans and expectations with regard to the potential issuance of additional patents to the Company in the U.S. and other countries and the anticipated period of protection provided by such patents, if issued, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, whether the FDA will accept the Company’s resubmission of an NDA for veverimer; the timing of the FDA’s approval of veverimer, if at all; the potential availability of the Accelerated Approval Program and the approvability of veverimer under that program; the Company’s plans and expectations with regard to its interactions with the FDA; the Company’s plans and expectations for VALOR-CKD and future clinical and product development milestones; the Company’s financial projections and cost estimates; the enforceability of our patent estate and our ability to defend against infringement of our patents; and risks associated with the Company’s business prospects, financial results and business operations. These and other factors that may affect the Company’s future business prospects, results and operations are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report filed on Form 10-K and the subsequently filed Quarterly Report(s) on Form 10-Q. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by applicable law, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results, later events or circumstances or to reflect the occurrence of unanticipated events.
Jackie Cossmon, IRC
Senior Vice President of
Investor Relations and Communications
Source: Tricida, Inc.