Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection

  Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of
  OMONTYS® (peginesatide) Injection

Business Wire

PALO ALTO, Calif. & OSAKA, Japan -- February 23, 2013

Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited
(Takeda) today have decided to voluntarily recall all lots of OMONTYS^®
(peginesatide) Injection to the user level as a result of new postmarketing
reports regarding serious hypersensitivity reactions, including anaphylaxis,
which can be life-threatening or fatal. The companies have been working
actively with the U.S. Food and Drug Administration (FDA) which has indicated
its agreement with this decision. The companies have also issued a letter to
health care professionals indicating that no new or existing patients should
receive OMONTYS.

To date, fatal reactions have been reported in approximately 0.02% of patients
following the first dose of intravenous administration. The reported serious
hypersensitivity reactions have occurred within 30 minutes after such
administration of OMONTYS. There have been no reports of such reactions
following subsequent dosing, or in patients who have completed their dialysis
session. Since launch, more than 25,000 patients have received OMONTYS in the
postmarketing setting. The rate of overall hypersensitivity reactions reported
is approximately 0.2% with approximately a third of these being serious in
nature including anaphylaxis requiring prompt medical intervention and in some
cases hospitalization. The companies are actively investigating these cases.
In the meantime, dialysis organizations are instructed to discontinue use.
Customers will be provided instructions on how to return the product to the
manufacturer for a refund. For customers with questions, please call
1-855-466-6689 [9:00 a.m. to 5:00 p.m. Eastern Standard Time, Monday through

OMONTYS (peginesatide) Injection is indicated for the treatment of anemia due
to chronic kidney disease in adult patients on dialysis and is packaged in 10
mg and 20 mg Multi-dose vials:

10mg Multi-dose Vials - NDC 64764-610-10

20mg Multi-dose vials - NDC 64764-620-20

All lots of OMONTYS are affected by this recall:

10 mg Multi-dose vials        20 mg Multi-dose vials
Lots C18685, C18881, C19258   Lots C18686, C18696

The product can be identified by its product labeling featuring the name
OMONTYS. OMONTYS was distributed Nationwide, including Puerto Rico and Guam,
to dialysis centers via specialty distributors.

Adverse reactions or quality problems experienced with the use of this product
may be reported to the FDA's MedWatch Adverse Event Reporting program either
online, by regular mail or by fax.

  *Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: Mail to address on the pre-addressed
  *Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug

Affymax Teleconference and Webcast

Affymax will host a teleconference and webcast at 5:30 a.m. Pacific Time; 8:30
a.m. Eastern Time on Monday, February 25 to further discuss this news
announcement. Interested parties can listen to the live teleconference by
dialing (866) 393-1565 from the U.S. or +1(973) 409-9608 for international
callers. Individuals may access the live audio webcast by visiting and going to the Investors section. A replay of the webcast
will be available on the company’s website for 30 days following the live


Chronic Kidney Disease:
• In controlled trials, patients experienced greater risks for death, serious
adverse cardiovascular reactions, and stroke when administered
erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of
greater than 11 g/dL.
• No trial has identified a hemoglobin target level, ESA dose, or dosing
strategy that does not increase these risks.
• Use the lowest OMONTYS dose sufficient to reduce the need for RBC


OMONTYS is contraindicated in patients with uncontrolled hypertension and in
patients who have had serious allergic reactions, which may include
anaphylaxis, to OMONTYS.

Warnings and Precautions

Increased mortality, myocardial infarction, stroke, and thromboembolism:

  *Using ESAs to target a hemoglobin level of greater than 11 g/dL increases
    the risk of serious adverse cardiovascular reactions and has not been
    shown to provide additional benefit. Use caution in patients with
    coexistent cardiovascular disease and stroke. Patients with CKD and an
    insufficient hemoglobin response to ESA therapy may be at even greater
    risk for cardiovascular reactions and mortality. A rate of hemoglobin rise
    of >1 g/dL over 2 weeks may contribute to these risks.
  *In controlled clinical trials of ESAs in patients with cancer, increased
    risk for death and serious adverse cardiovascular reactions including
    myocardial infarction and stroke was observed.
  *There is increased mortality and/or increased risk of tumor progression or
    recurrence in patients with cancer receiving ESAs.
  *In controlled clinical trials of ESAs, ESAs increased the risk of death in
    patients undergoing coronary artery bypass graft surgery (CABG) and deep
    venous thrombosis (DVT) in patients undergoing orthopedic procedures.
  *In 2 trials of OMONTYS, patients with CKD not on dialysis experienced
    increased specific cardiovascular events.

Hypertension (see Contraindications): Appropriately control hypertension prior
to initiation of and during treatment with OMONTYS. Reduce or withhold OMONTYS
if blood pressure becomes difficult to control.

Serious allergic reactions (see Contraindications): Serious allergic
reactions, including anaphylactic reactions, hypotension, bronchospasm,
angioedema and generalized pruritus, may occur in patients treated with
OMONTYS. Immediately and permanently discontinue OMONTYS and administer
appropriate therapy if a serious allergic reaction occurs.

Lack or loss of response to OMONTYS: Initiate a search for causative factors.
If typical causes of lack or loss of hemoglobin response are excluded,
evaluate for antibodies to peginesatide.

Dialysis management: Patients receiving OMONTYS may require adjustments to
dialysis prescriptions and/or increased anticoagulation with heparin to
prevent clotting of the extracorporeal circuit during hemodialysis.

Laboratory monitoring: Evaluate transferrin saturation and serum ferritin
prior to and during OMONTYS treatment. Administer supplemental iron therapy
when serum ferritin is less than 100mcg/L or when serum transferrin saturation
is less than 20%. Monitor hemoglobin every 2 weeks until stable and the need
for RBC transfusions is minimized. Then, monitor monthly.

Adverse reactions

Most common adverse reactions in clinical studies in patients with CKD on
dialysis treated with OMONTYS were dyspnea, diarrhea, nausea, cough, and
arteriovenous fistula site complication.

Please click here for Full Prescribing Information, including Boxed WARNINGS,
also available at

OMONTYS Indication and Limitations of Use

OMONTYS® (peginesatide) Injection is indicated for the treatment of anemia due
to chronic kidney disease (CKD) in adult patients on dialysis.

OMONTYS is not indicated and is not recommended for use in patients with CKD
not on dialysis, in patients receiving treatment for cancer and whose anemia
is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in
patients who require immediate correction of anemia. OMONTYS has not been
shown to improve symptoms, physical functioning, or health-related quality of

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company based in Palo Alto, California.
Affymax's mission is to discover, develop and deliver innovative therapies
that improve the lives of patients with kidney disease and other serious and
often life-threatening illnesses. For additional information on Affymax,
please visit

Affymax Forward-Looking Statement

This release contains forward-looking statements, including statements
regarding the potential attributes and safety profile of OMONTYS, the
continuation and success of Affymax's collaboration with Takeda and the
commercialization of OMONTYS. Affymax's actual results may differ materially
from those indicated in these forward-looking statements due to risks and
uncertainties, including risks relating to the recall and adverse events,
ability to re-introduce OMONTYS to the market and future acceptance by
dialysis organizations, patients and the medical community, and other factors
affecting the commercial potential of OMONTYS, the continued safety and
efficacy of OMONTYS, the industry and competitive environment, regulatory
requirements or actions by the FDA or other regulatory authorities, including
withdrawal, further changes to the label, post-marketing studies, trials and
Risk Evaluation and Mitigation Strategy, the potential for disruptions to
supply, potential litigation, financing requirements and our ability to access
capital and other matters that are described in Affymax's Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission. Investors are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release. Affymax undertakes no
obligation to update any forward-looking statement in this press release.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its
main focus on pharmaceuticals. As the largest pharmaceutical company in Japan
and one of the global leaders of the industry, Takeda is committed to strive
towards better health for patients worldwide through leading innovation in
medicine. Additional information about Takeda is available through its
corporate website,

Takeda Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking
statements include statements regarding Takeda's plans, outlook, strategies,
results for the future, and other statements that are not descriptions of
historical facts. Forward-looking statements may be identified by the use of
forward-looking words such as "may," "believe," "will," "expect," "project,"
"estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro
forma," "potential," "target," "forecast," "guidance," "outlook" or "intend"
or other similar words or expressions of the negative thereof. Forward-looking
statements are based on estimates and assumptions made by management that are
believed to be reasonable, though they are inherently uncertain and difficult
to predict. Investors are cautioned not to unduly rely on such forward-looking

Forward-looking statements involve risks and uncertainties that could cause
actual results or experience to differ materially from that expressed or
implied by the forward-looking statements. Some of these risks and
uncertainties include, but are not limited to, (1) the economic circumstances
surrounding Takeda's business, including general economic conditions in Japan,
the United States and worldwide; (2) competitive pressures and developments;
(3) applicable laws and regulations; (4) the success or failure of product
development programs; (5) actions of regulatory authorities and the timing
thereof; (6) changes in exchange rates; (7) claims or concerns regarding the
safety or efficacy of marketed products or product candidates in development;
and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as
of the date of this press release, and Takeda undertakes no obligation to
revise or update any forward-looking statements to reflect new information,
future events or circumstances after the date of the forward-looking
statement. If Takeda does update or correct one or more of these statements,
investors and others should not conclude that Takeda will make additional
updates or corrections.

Photos/Multimedia Gallery Available:



Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Takeda Pharmaceuticals U.S.A., Inc
Jocelyn M. Gerst, 224-554-5542
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
Press spacebar to pause and continue. Press esc to stop.