Relypsa Provides Corporate Update

Relypsa Provides Corporate Update

REDWOOD CITY, Calif., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Relypsa, Inc.
(Nasdaq:RLYP), a clinical-stage biopharmaceutical company, today provided a
corporate update including new data on the modification of
renin-angiotensin-aldosterone system inhibiting (RAASi) therapies from Part B
of its two-part Phase 3 trial evaluating patiromer as a treatment for
hyperkalemia; a new agreement with Lanxess to ensure the commercial
manufacture and supply of the active ingredient of patiromer; and an update
with respect to its senior management team. In addition, Relypsa confirmed
that it is on track to submit a new drug application (NDA) for patiromer to
the U.S. Food and Drug Administration (FDA) in the third quarter of this year,
and expects to complete an approximately 20-patient Phase 1 onset-of-action
study in the first half of this year.

New RAASi data from Pivotal Phase 3 Study

Relypsa commented today on results from the pre-defined exploratory endpoints
from its two-part pivotal Phase 3 clinical trial evaluating patiromer for the
treatment of hyperkalemia, which was conducted under an agreed upon special
protocol assessment (SPA) with the FDA. The exploratory endpoints consisted of
(1) the proportion of subjects requiring any dose modification of RAASi
therapies (i.e. down titration or discontinuation) because of hyperkalemia at
any time during the Part B 8-week period and (2) the proportion of subjects
receiving any dose of a RAASi medication at the end of Part B. After achieving
normalized serum potassium levels with patiromer treatment in Part A, subjects
entered the Part B withdrawal phase and were randomized to either continue
treatment with patiromer or receive placebo. If recurrent hyperkalemia
developed during Part B, RAASi therapy dose reduction occurred in the placebo
group and patiromer up titration occurred in the patiromer group. In either
group, if these interventions did not normalize serum potassium,
discontinuation of RAASi medication was required in order to control rising
potassium levels.

The pivotal Phase 3 clinical trial data show that as a result of recurrent
hyperkalemia, significantly more placebo patients required dose modification
of their RAASi therapies (62%) than patiromer patients (6%), p < 0.001; with
more patiromer patients (94%) still on RAASi medication at the end of the
trial than placebo patients (48%), p < 0.001.

According to Dr. Lance Berman, Chief Medical Officer at Relypsa, "Both Heart
Failure and Chronic Kidney Disease guidelines developed by expert clinicians,
as well as the drug labels, advise dose reduction or discontinuation of the
RAASi if a patient develops hyperkalemia. The additional findings from our
pivotal Phase 3 trial suggest that by maintaining control of serum potassium
with patiromer, more patients can remain on their guideline-recommended RAASi
medication. This potential benefit could address the unmet need faced by
nephrologists and cardiologists because for the first time, with patiromer, we
may have a novel, well tolerated potassium-lowering therapy that can be used
daily, over the long term, to treat chronic hyperkalemia and reduce the need
to modify or stop RAASi therapies. "

Manufacturing and Supply Agreement

Relypsa also announced that it has entered into a multi-year manufacturing and
supply agreement with Lanxess Corporation, a contract manufacturer of clinical
material for the company's clinical trials and a subsidiary of the
German-based specialty chemical group Lanxess. The agreement governs the
manufacturing and supply for commercial sale of the active pharmaceutical
ingredient (API) for patiromer as well as the support of Relypsa in preparing
and filing its NDA. The operation will be executed by Lanxess' affiliate
Saltigo, a leading supplier in the field of custom synthesis and contract
manufacturing. Relypsa has already issued certain purchase orders for raw
materials and API under a prior Memorandum of Understanding that will now be
governed by the manufacturing and supply agreement, and going forward, Relypsa
has agreed to purchase certain quantities of API.

Management Changes

Relypsa's Chief Executive Officer, John Orwin, announced that Mary Corbett has
joined the company as Senior Vice President for Human Resources in December
2013. Corbett brings to Relypsa over 30 years of experience in human resources
in a wide range of industries, including life sciences, technology, financial
services and consumer goods. Previously, Corbett was Vice President for Human
Resources at Verinata Health, a company acquired by Illumina, Inc., and prior
to that, Corbett served as Vice President, Human Resources of Pacific
Biosciences of California, Inc. During her tenure at Pacific Biosciences, the
company grew from 150 to over 500 employees, launched its first product and
completed an initial public offering. Corbett also previously headed the HR
function for Synarc, Broadlane, myCFO, and MarketMile and had a consulting
practice based in Paris for six years. She holds a BA from Fordham University
and an MA from Columbia University.

At the same time, Orwin noted that Jerry Buysse, Senior Vice President and
Chief Scientific Officer, has recently transitioned from a full-time position
to a consultant for the Company. Dr. Buysse is one of several Relypsa
founders, having led the team that discovered patiromer and advanced it from
the laboratory to human clinical trials.

"Dr. Buysse will continue to provide expertise and guidance as we complete the
preparation of our NDA submission and engage in conversations with the FDA
about patiromer's potential approval and launch. Since the inception of
Relypsa, his contributions have been significant, and we look forward to our
new consulting relationship under which he intends to continue to work closely
with us to see our common vision through to reality, while he also pursues new
career opportunities," noted Orwin.

About Relypsa, Inc.

Relypsa, Inc. is a clinical-stage biopharmaceutical company focused on the
development and commercialization of non-absorbed polymeric drugs to treat
disorders in the areas of renal, cardiovascular and metabolic diseases. The
Company's two-part pivotal Phase 3 trial of its lead product candidate,
patiromer, for the treatment of hyperkalemia, a life-threatening condition
defined as abnormally elevated levels of potassium in the blood, has been
completed and the primary and secondary endpoints were met. Relypsa has global
royalty-free commercialization rights to patiromer, which has intellectual
property protection in the U.S. until at least 2030. More information is
available at www.relypsa.com.

Forward Looking Statements

To the extent that statements contained in this press release are not
descriptions of historical facts regarding Relypsa, they are forward-looking
statements reflecting the current beliefs and expectations of management made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, including its expectations regarding (i) the timing of the
submission of its NDA for patiromer, (ii) the timing of completion of its
Phase 1 onset-of-action study, (iii) the potential of patiromer to reduce the
need to modify or stop RAASi therapies and (iv) Dr. Buysse's contributions to
the company as a consultant. Such forward-looking statements involve
substantial risks and uncertainties that could cause our clinical development
programs, future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent in the
clinical drug development process, including the regulatory approval process,
the timing of our regulatory filings, our substantial dependence on patiromer
and other matters that could affect the availability or commercial potential
of our drug candidate. Relypsa undertakes no obligation to update or revise
any forward-looking statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those expressed
in these forward-looking statements, as well as risks relating to the business
of the Company in general, see Relypsa's prospectus filed with the Securities
and Exchange Commission on November 15, 2013, and its future periodic reports
to be filed with the Securities and Exchange Commission.

CONTACT: Relypsa, Inc.
         Shari Annes, IR and Corporate Communications
         IR@relypsa.com, 650-888-0902

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