Akebia Therapeutics, Inc. (Nasdaq:AKBA) and Keryx
Biopharmaceuticals, Inc. today announced the successful completion
of their previously announced merger.
"We are very pleased to announce the completion of our merger
with Keryx to create a fully integrated renal company that has the
potential to set new standards of care for patients with kidney
disease," said John P. Butler, President and Chief Executive
Officer of Akebia. "With established renal development,
manufacturing and commercial capabilities, strong cash position, a
flexible balance sheet and experienced management team, our company
is uniquely positioned to capitalize on the significant market
opportunity by maximizing the growth of Auryxia® (ferric citrate)
and build launch momentum for our Phase 3 product candidate,
vadadustat, subject to approval by the U.S. Food and Drug
Administration (FDA). On behalf of everyone at Akebia, we welcome
Keryx and its talented team, and look forward to working together
to achieve a seamless transition and to build value for all of our
stakeholders."
As previously announced, Keryx shareholders are entitled to
receive 0.37433 common shares of Akebia for each common share of
Keryx they own.
The combined company will be Akebia Therapeutics, Inc., which
will continue to trade on The Nasdaq Global Market under the ticker
symbol AKBA. Keryx is no longer listed for trading on The Nasdaq
Capital Market.
About Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl
hydroxylase inhibitor (HIF-PHI) currently in global Phase 3
development for the treatment of anemia due to chronic kidney
disease. Vadadustat’s proposed mechanism of action is designed to
mimic the physiologic effect of altitude on oxygen availability. At
higher altitudes, the body responds to lower oxygen availability
with increased production of HIF, which coordinates the
interdependent processes of iron mobilization and erythropoietin
production to increase red blood cell production and, ultimately,
improve oxygen delivery. Vadadustat is an investigational therapy
and is not approved by the FDA or any regulatory
authority.
About Auryxia (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by the FDA
on September 5, 2014, for the control of serum phosphorus
levels in adult patients with chronic kidney disease on dialysis
and approved by the FDA on November 6, 2017, for the
treatment of iron deficiency anemia in adult patients with chronic
kidney disease not on dialysis. Auryxia tablets were designed to
contain 210 mg of ferric iron, equivalent to 1 gram of ferric
citrate, and offers convenient mealtime dosing. For more
information about Auryxia and the U.S. full prescribing
information, please visit www.auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric
citrate)
Contraindication: Patients with iron overload
syndrome, e.g., hemochromatosis, should not take AURYXIA® (ferric
citrate).
Iron Overload: Iron absorption from AURYXIA may lead
to increased iron in storage sites. Iron parameters should be
monitored prior to and while on AURYXIA. Patients receiving
concomitant intravenous (IV) iron may require a reduction in dose
or discontinuation of IV iron therapy.
Risk of Overdosage in Children Due to Accidental
Ingestion: Accidental overdose of iron containing products
is a leading cause of fatal poisoning in children under 6 years of
age. Keep AURYXIA away from children. Call a poison control center
or your physician in case of an accidental overdose in a child.
Adverse Events: The most common adverse events
occurring in at least 5% of patients treated with AURYXIA were,
diarrhea, constipation, nausea, vomiting, cough, abdominal pain,
and high levels of potassium in the blood.
AURYXIA contains iron and may cause dark stools, which is
considered normal with oral medications containing iron.
Please click here to see full prescribing information
for Auryxia.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated
biopharmaceutical company focused on the development and
commercialization of therapeutics for patients with chronic kidney
disease. The company was founded in 2007 and is headquartered in
Cambridge, Massachusetts. For more information, please visit our
website at www.akebia.com, which does not form a part of this
release.
Forward Looking Statements
This document contains forward-looking statements within the
meaning of the federal securities law. Such statements are based
upon current plans, estimates and expectations that are subject to
various risks and uncertainties. The inclusion of forward-looking
statements should not be regarded as a representation that such
plans, estimates and expectations will be achieved. Words such as
“anticipate,” “create,” “expect,” “project,” “intend,” “believe,”
“may,” “will,” “should,” “plan,” “could,” “target,” “contemplate,”
“estimate,” “position,” “predict,” “potential,” “opportunity,”
“working to,” “look forward” and words and terms of similar
substance used in connection with any discussion of future plans,
actions or events identify forward-looking statements. All
statements, other than historical facts, including the potential to
set a new standard of care, market and growth opportunity and
potential, and the potential to realize benefits following the
merger, are forward looking statements. Important factors that
could cause actual results to differ materially from Akebia’s
plans, estimates or expectations could include, but are not limited
to: the outcome of any legal proceedings related to the
merger; Akebia may be adversely affected by various economic,
business, and/or competitive factors, including the receipt by
Keryx of a notice letters on October 31, 2018, and November 6,
2018, regarding abbreviated new drug applications submitted to the
FDA requesting approval to market, sell and use a generic version
of the Auryxia; risks that the anticipated benefits of the merger
or other commercial opportunities may otherwise not be fully
realized or may take longer to realize than expected; the impact of
legislative, regulatory, competitive and technological changes,
including the recent changes to reimbursement coverage for Auryxia
that could have a material adverse effect on Auryxia sales and
profitability; expectations for future clinical trials, the timing
and potential outcomes of clinical trials and interactions with
regulatory authorities. Additional factors that may affect the
future results of Akebia are set forth in Akebia’s and Keryx’s
respective filings with the U.S. Securities and Exchange Commission
(the “SEC”), including each of Akebia’s and Keryx’s most recently
filed Annual Report on Form 10-K, subsequent Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K,
the definitive joint proxy statement/prospectus filed by Akebia and
Keryx on October 30, 2018, and other filings with the SEC, which
are available on the SEC’s website at www.sec.gov. See in
particular “Risk Factors” in the definitive joint proxy
statement/prospectus, Item 1A of Akebia’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2018,
under the heading “Risk Factors” and Item 1A of Keryx’s Quarterly
Report on Form 10-Q for the quarter ended
September 30, 2018, under the heading “Risk Factors.” The
risks and uncertainties described above and in the definitive joint
proxy statement/prospectus, Akebia’s most recent Quarterly Report
on Form 10-Q and Keryx’s most recent Quarterly Report on
Form 10-Q are not exclusive and further information
concerning Akebia and its business, including factors that
potentially could materially affect its business, financial
condition or operating results, may emerge from time to time.
Readers are urged to consider these factors carefully in evaluating
these forward-looking statements, and not to place undue reliance
on any forward-looking statements. Readers should also carefully
review the risk factors described in other documents that Akebia
files from time to time with the SEC. The forward-looking
statements in these materials speak only as of the date of these
materials. Except as required by law, Akebia assumes no obligation
to update or revise these forward-looking statements for any
reason, even if new information becomes available in the
future.
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Akebia TherapeuticsArgot PartnersMelissa Forst / Maghan
Meyers(212) 600-1902
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