Reata Announces Receipt of $30 Million Milestone Payment From Kyowa Hakko Kirin
August 30 2018 - 6:40PM
Reata Pharmaceuticals, Inc. (Nasdaq:RETA), a clinical-stage
biopharmaceutical company, today announced that it has received a
$30 million milestone payment from its licensee, Kyowa Hakko Kirin
Co., Ltd. (Kyowa Hakko Kirin), following the initiation of AYAME, a
Phase 3 clinical trial to assess the efficacy and safety of
bardoxolone methyl (bardoxolone) for the treatment of diabetic
kidney disease in Japan.
In December 2009, Reata granted Kyowa Hakko
Kirin the exclusive license to develop and commercialize
bardoxolone in renal disease and certain other indications in
Japan, China, Taiwan, South Korea, and Southeast Asia. Last year,
Kyowa Hakko Kirin reported positive results from the Phase 2
TSUBAKI trial of bardoxolone in patients with type 2 diabetes and
chronic kidney disease. The pivotal AYAME trial began in May of
this year and will enroll an estimated 700 diabetic kidney disease
patients, with an estimated study completion date of March 2022.
Kyowa Hakko Kirin is also collaborating with Reata in Japan on the
ongoing Phase 3 CARDINAL trial of bardoxolone for the treatment of
Alport syndrome, a severe, hereditary form of chronic kidney
disease.
About Bardoxolone
Bardoxolone is an experimental, oral, once-daily
activator of Nrf2, a transcription factor that induces molecular
pathways that promote the resolution of inflammation by restoring
mitochondrial function, reducing oxidative stress, and inhibiting
pro-inflammatory signaling. The FDA has granted Orphan Drug
designation to bardoxolone for the treatment of Alport syndrome and
pulmonary arterial hypertension. The European Commission has
granted Orphan Drug designation in Europe to bardoxolone for the
treatment of Alport syndrome. In addition to CARDINAL and AYAME,
bardoxolone is currently being studied in CATALYST, a Phase 3 study
for the treatment of connective tissue disease associated pulmonary
arterial hypertension, and PHOENIX, a Phase 2 study for the
treatment of autosomal dominant polycystic kidney disease, IgA
nephropathy, focal segmental glomerulosclerosis, and CKD associated
with type 1 diabetes.
About Reata Pharmaceuticals,
Inc.
Reata is a clinical-stage biopharmaceutical
company that develops novel therapeutics for patients with serious
or life-threatening diseases by targeting molecular pathways
involved in the regulation of cellular metabolism and inflammation.
Reata’s two most advanced clinical candidates, bardoxolone and
omaveloxolone, target the important transcription factor Nrf2 that
promotes the resolution of inflammation by restoring mitochondrial
function, reducing oxidative stress, and inhibiting
pro-inflammatory signaling.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding the success, cost and timing of
our product development activities and clinical trials, our plans
to research, develop and commercialize our product candidates, and
our ability to obtain and retain regulatory approval of our product
candidates. You can identify forward-looking statements because
they contain words such as “believes,” “will,” “may,” “aims,”
“plans,” and “expects.” Forward-looking statements are based on
Reata’s current expectations and assumptions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks, and changes in circumstances that
may differ materially from those contemplated by the
forward-looking statements, which are neither statements of
historical fact nor guarantees or assurances of future performance.
Important factors that could cause actual results to differ
materially from those in the forward-looking statements include,
but are not limited to, (i) the timing, costs, conduct, and outcome
of our clinical trials and future preclinical studies and clinical
trials, including the timing of the initiation and availability of
data from such trials; (ii) the timing and likelihood of regulatory
filings and approvals for our product candidates; (iii) the
potential market size and the size of the patient populations for
our product candidates, if approved for commercial use, and the
market opportunities for our product candidates; and (iv) other
factors set forth in Reata’s filings with the U.S. Securities and
Exchange Commission, including its Annual Report on Form 10-K,
under the caption “Risk Factors.” The forward-looking statements
speak only as of the date made and, other than as required by law,
we undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
Contact:Reata Pharmaceuticals,
Inc.(972)
865-2219info@reatapharma.comhttp://news.reatapharma.com
Investor Relations:Vinny
JindalVice President, Strategy(469) 374-8721ir@reatapharma.com
Media:Matt Middleman,
M.D.LifeSci Public Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
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