NEWARK, CA -- (Marketwired) -- 08/06/15 -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, today announced that the US Patent and Trademark Office (USPTO) has issued two new patents for arhalofenate, CymaBay's lead product candidate for the treatment of gout. These patents are expected to provide additional protection for arhalofenate through at least 2032 before accounting for any potential patent term extension.
"Building and enhancing strong intellectual property around arhalofenate is an important strategic priority for CymaBay," said Harold Van Wart, Chief Executive Officer of CymaBay Therapeutics. "These patents specifically support our positioning of arhalofenate to be used in combination with febuxostat to address the two key unmet needs of gout patients today -- the need for additional uric acid lowering and the need for better flare control. By accomplishing both of these goals, arhalofenate could define a new class of gout therapies that we refer to as Urate Lowering Anti-Flare Therapy (ULAFT). We believe that these patents further enhance the value of arhalofenate as a differentiated potential therapy for a significant number of patients that are inadequately treated by current therapies today."
Patent #9,023,856 -- "Methods For Treating Hyperuricemia in Patients With Gout Using Halofenate or Halofenic Acid and a Second Urate-Lowering Agent" covers the use of arhalofenate for treating hyperuricemia when used in combination with febuxostat.
Patent #9,060,987 -- "Methods for Treating Gout Flares" covers the use of arhalofenate for treating gout flares including the prevention of flares while lowering serum uric acid.
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, including serious rare and orphan disorders. Arhalofenate, the company's lead product candidate, has shown two therapeutic actions in a single drug in multiple Phase 2 gout studies. In gout patients, arhalofenate is intended to prevent painful flares in joints while at the same time promoting excretion of uric acid by the kidney, thereby addressing both the signs and symptoms of gout and the hyperuricemia that is the root cause of the disease. CymaBay's second product candidate, MBX-8025 is a potent, selective, orally active PPARδ agonist. A Phase 2 study of MBX-8025 in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile. CymaBay has initiated a pilot study of MBX-8025 in patients with homozygous familial hypercholesterolemia.
For additional information about CymaBay visit www.cymabay.com.
Forward Looking Statements
The statements in this press release, including those statements regarding the protection or enforceability of any intellectual property rights related to arhalofenate, the potential of arhalofenate to treat gout, the therapeutic and commercial potential of arhalofenate and the anticipated timing and therapeutic and commercial potential of other product candidates of CymaBay Therapeutics, Inc. are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of arhalofenate and other product candidates of CymaBay could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; the inability to obtain or maintain patent or other intellectual property rights related to CymaBay's product candidates in the United States or worldwide; the ability of CymaBay to attract funding partners or collaborators with development, regulatory and commercialization expertise; the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide; and the market potential for CymaBay's product candidates. Additional risks relating to CymaBay are contained in CymaBay's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on May 11, 2015. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.
CymaBay Therapeutics, Inc.
LifeSci Advisors, LLC
Source: CymaBay Therapeutics