Reata Pharmaceuticals Reacquires Rights From AbbVie to Develop and Commercialize Bardoxolone Methyl, Omaveloxolone, and All N...
October 10 2019 - 6:45AM
Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
biopharmaceutical company, today announced the reacquisition of
development, manufacturing and commercialization rights concerning
its proprietary Nrf2 activator product platform originally licensed
to AbbVie, Inc. (AbbVie) for territories outside of the United
States with respect to bardoxolone methyl (bardoxolone) and
worldwide with respect to omaveloxolone and other next-generation
Nrf2 activators. As a result, Reata now possesses exclusive,
worldwide rights to develop, manufacture and commercialize
bardoxolone methyl (bardoxolone), omaveloxolone, and all other
next-generation Nrf2 activators, excluding certain Asian markets
for bardoxolone which are licensed to Kyowa Kirin Co., Ltd.
As consideration for the rights reacquired by
Reata, AbbVie will receive a total of $330 million in cash,
primarily for rights to bardoxolone. Reata will make an upfront
payment of $75 million in 2019, with the remainder payable in
installments in the second quarter of 2020 and in the fourth
quarter of 2021. In addition, AbbVie will receive low single-digit,
tiered royalties from worldwide sales of omaveloxolone and certain
next-generation Nrf2 activators, and no royalties on
bardoxolone.
“AbbVie has been an excellent partner, and our
collaboration was instrumental in the clinical development of
bardoxolone and omaveloxolone,” said Warren Huff, Reata’s Chief
Executive Officer and President. “Regaining these rights will
increase Reata’s strategic flexibility and control regarding the
development and commercialization of our lead drug candidates, and
our next-generation Nrf2 activators. We have been actively
preparing for the commercial launch of bardoxolone and
omaveloxolone in the United States, and we will now expand our
efforts to include these international territories as well.”
Reata has also entered into an amendment to its
loan and security agreement with Oxford Finance LLC and Silicon
Valley Bank. The amended agreement makes $75 million available to
Reata upon positive, topline, registrational data from either the
CARDINAL study of bardoxolone methyl in patients with Alport
syndrome or the MOXIe study of omaveloxolone in patients with
Friedreich’s ataxia. Overall, the term loan facility increased by
$30 million, from $125 million to $155 million.
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 methyl and omaveloxolone, target the important
transcription factor Nrf2 that promotes restoration of
mitochondrial function, reduction of oxidative stress, and
inhibition of pro-inflammatory signaling. Bardoxolone
and omaveloxolone are investigational drugs, and their safety and
efficacy have not been established by any agency.
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,” “model,” 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) 865-2219http://reatapharma.com/
Investor Relations:Vinny
JindalVice President, Strategy(469)
374-8721ir@reatapharma.comhttp://reatapharma.com/contact-us/
Media:Matt Middleman,
M.D.LifeSci Public Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
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