- Urges Shareholders to Vote "FOR" the Ironwood Director Nominees on
the WHITE Proxy Card -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotech company,
today announced that it filed definitive proxy materials with the
Securities and Exchange Commission in connection with Ironwood's Annual
Meeting of Shareholders on May 31, 2018. Ironwood shareholders of record
as of the close of business on April 6, 2018 will be entitled to vote at
the Annual Meeting.
This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180502005777/en/
(Graphic: Business Wire)
The Ironwood Board of Directors strongly recommends that shareholders
vote on the WHITE proxy card "FOR" Ironwood's experienced, diverse and
independent nominees: Lawrence Olanoff, M.D., Ph.D., Amy Schulman and
Douglas Williams, Ph.D.
In conjunction with the filing and mailing of its definitive proxy
statement, Ironwood is mailing a letter to shareholders detailing its
strong commercial business and drug discovery and development
capabilities, its proactive and refreshed Board aligned with shareholder
interests, and why its recently announced intent to separate its sGC
business from its commercial and GI business into two independent,
publicly traded companies provides the best opportunity to unlock
shareholder value. The letter also addresses Sarissa Capital Management
and the reasons why the Ironwood Board believes there is no compelling
reason to add Sarissa's chief investment officer, Alex Denner, to the
Board.
Ironwood's letter to shareholders and other materials regarding the
Board's recommendation for the 2018 Annual Meeting can be found at www.ironwoodannualmeeting.com.
The full text of the letter follows:
May 2, 2018
Dear Fellow Shareholder:
Since Ironwood's founding 20 years ago, we have been motivated by a
simple mission: to generate value for our shareholders by creating and
commercializing innovative drugs that change the lives of patients. To
further this mission, your Board and management team just announced a
transformative plan to enhance shareholder value through its intent to
separate Ironwood into two independent, publicly traded companies
(Ironwood and "R&D Co."):
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Following the separation, Ironwood anticipates being a profitable
company, building on its commercial success to-date to accelerate
growth of its in-market products and advance development programs
targeting treatments for gastrointestinal (GI) diseases, uncontrolled
gout, and abdominal pain.
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R&D Co. will harness the pioneering work in cyclic guanosine
monophosphate (cGMP) pharmacology to advance an innovative soluble
guanylate cyclase (sGC) pipeline expected to focus on the treatment of
serious and orphan diseases, led by Phase II clinical compounds
praliciguat and olinciguat (IW-1701).
Against a backdrop of significant commercial and R&D progress, you have
an important decision to make at our upcoming Annual Meeting of
Shareholders on May 31, 2018. Your Board has three independent directors
up for election, each of whom joined the Board within the last four
years. These directors collectively bring extensive experience in areas
critical to Ironwood's business, including in strategic transactions
(such as business separations), capital allocation and finance, customer
and market insights, and senior leadership in both small,
entrepreneurial companies and in large pharmaceutical organizations. At
the same time, Sarissa Capital Management, a hedge fund that holds less
than 2.5% of Ironwood outstanding shares as of April 18, 2018, has
nominated for Board representation its chief investment officer, Alex
Denner - a nomination that was made after only one meeting with Ironwood
management. In this meeting, Dr. Denner commented that he believes
Ironwood currently has a strong Board, and that both the Board and
management team have done a great job building the company. We agree.
Importantly, Dr. Denner does not add any expertise not already
represented on your Board. Ironwood recommends all shareholders elect
Ironwood's highly qualified nominees - Lawrence Olanoff, M.D., Ph.D.,
Amy Schulman and Douglas Williams, Ph.D. - by voting on the enclosed WHITE
proxy card today.
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To elect the Ironwood Board of Directors' nominees, we
encourage you to vote today by telephone, Internet, or by signing
and dating the enclosed WHITE proxy card and returning it in the
postage-paid envelope provided.
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IRONWOOD HAS BUILT A ROBUST COMMERCIAL BUSINESS AND LEADING DRUG
DISCOVERY AND DEVELOPMENT CAPABILITIES
We are pioneering two important areas: commercializing products in
categories with millions of potential patients and innovating to
discover and develop important new medicines. Ironwood today markets three
commercial medicines, including LINZESS® (linaclotide), a
category leader for the treatment of adults with irritable bowel
syndrome with constipation (IBS-C) and chronic idiopathic constipation
(CIC), and is advancing a deep pipeline of drug candidates
targeting severe and high unmet need diseases. We believe in the
long-term value of our drug candidates and the opportunity for
meaningful future commercialization opportunities, creating value for
both shareholders and patients. We also have made progress on our path
to profitability. We work to allocate capital carefully and
prudently, reinforcing our lean, cost-conscious culture. Our strong
balance sheet has supported continued investment in our commercial
medicines and the advancement of our development stage product
candidates.
We have made significant progress over the past few years, both
commercially and within our pipeline, catalyzing our ability to
separate into two focused, durable businesses poised for long-term
growth.
YOUR BOARD AND MANAGEMENT TEAM ARE TRANSFORMING THE BUSINESS TO
ENHANCE THE VALUE OF YOUR INVESTMENT
In line with our goal of creating shareholder value, your Board and
management team regularly explore strategic opportunities. Following a
comprehensive review, your Board and management team unanimously
determined that a separation of the company's sGC business from its
commercial and GI business, resulting in two independent, publicly
traded companies targeting differentiated areas of focus, presents the
best way to drive operating performance, accelerate growth and unlock
shareholder value.
Our intent to separate marks a transformative milestone for Ironwood and
represents an important step to advance our mission as we look to adapt
more nimbly to rapidly evolving markets.
IRONWOOD HAS A PROACTIVE, REGULARLY REFRESHED BOARD FOCUSED ON
ENHANCING SHAREHOLDER VALUE
Ironwood has a diverse, experienced and regularly refreshed Board that
is actively engaged and taking proactive action designed to unlock the
value inherent in our company. The Ironwood Board regularly reviews its
composition on behalf of its shareholders to ensure that the Board has
the skills and expertise to match the demands of the company's strategy,
including several directors who have specific experience with business
separations. Ironwood has added six new independent directors since 2013
and the average tenure of your independent directors is six years. We
have a comprehensive process for defining the skills and qualities of
potential Board members, which has produced a highly qualified Board
that is aligned with the long-term goals of the company.
Importantly, the interests of your Board are directly aligned with
shareholders, as all Ironwood directors are shareholders in the company,
and each independent director is generally required to hold all shares
of stock acquired as payment for his or her service as a director
throughout his or her term on the Board. The vast majority of
compensation our independent directors receive for service on your Board
is paid in restricted stock.
Your Board's priorities over the next 12 to 18 months are to deliver
shareholder value by:
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Allocating capital to the most promising opportunities,
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Pioneering new growth areas for in-market products,
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Overseeing the advancement of multiple compounds in the clinic, and
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Strong operational execution of the existing business as we drive
toward a smooth and efficient separation.
We are energized by the opportunities ahead and are confident that your
Board comprises the right mix of expertise to achieve these goals.
SARISSA: NO JUSTIFICATION FOR A BOARD SEAT
At Ironwood, we strongly value input from our shareholders that may help
drive growth and enhance shareholder value. We actively engage with our
shareholders on an ongoing basis, and contacted Sarissa to initiate a
dialogue shortly after we were made aware of its investment in Ironwood
on February 14, 2018. On March 27, 2018, members of Ironwood's
management team had an initial introductory meeting with Dr. Denner. Two
days after this initial introductory meeting, Sarissa notified the
company of its intention to nominate Dr. Denner to the Ironwood Board.
Following receipt of the notice of nomination, your Board followed its
standard protocol for reviewing director candidates and maintained an
open dialogue with Dr. Denner.
After additional meetings between Dr. Denner and members of Ironwood's
management team and Board (including the company's governance and
nominating committee), Dr. Denner has not made clear what skills or
experience he would bring to the Ironwood Board that it does not already
possess.
Your Board believes that there is no compelling reason to add Dr. Denner
to the Board given his minimal interactions with the company and without
a clear justification. Your Board has a rigorous process in place to
determine the Board make-up and has an excellent group of individuals
with the appropriate skills. We work hard to maintain an active dialogue
with our shareholders and remain open to engaging with Dr. Denner as a
shareholder. However, we strongly believe that Dr. Denner has not made a
compelling case for his joining the Board given the skills, experience
and diversity of your existing directors and your Board's proactive
action designed to unlock value for Ironwood shareholders. As such, we
do not endorse adding Dr. Denner to the Board and we urge you to discard
any gold proxy card you may receive from Sarissa.
PROTECT THE VALUE OF YOUR INVESTMENT IN IRONWOOD:
VOTE
THE WHITE PROXY CARD TODAY
Whether or not you plan to attend the Annual Meeting, you have an
opportunity to protect your investment in Ironwood by voting the WHITE
proxy card "FOR ALL" of our nominees. YOUR VOTE IS EXTREMELY
IMPORTANT!
We urge you to vote today by telephone, Internet, or by signing and
dating the enclosed WHITE proxy card
and returning it in the postage-paid envelope provided.
Please disregard any gold proxy card you get from Sarissa.
If you have any questions about how to vote your shares, or need
additional assistance, please contact our proxy solicitors, MacKenzie
Partners, Inc. toll-free at (800) 322-2885 or at (212) 929-5500 or via
email to proxy@mackenziepartners.com.
We are excited about the opportunities ahead for Ironwood, and thank you
for your continued support.
Sincerely,
The Ironwood Board of Directors
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology
company focused on creating medicines that make a difference for
patients, building value for our fellow shareholders, and empowering our
passionate team. We are commercializing two innovative primary care
products: linaclotide, the U.S. branded prescription market leader for
adults with irritable bowel syndrome with constipation (IBS-C) or
chronic idiopathic constipation (CIC), and lesinurad, which is approved
to be taken with a xanthine oxidase inhibitor (XOI), or as a fixed-dose
combination with allopurinol, for the treatment of hyperuricemia
associated with gout. We are also advancing a pipeline of innovative
product candidates in areas of significant unmet need, including
uncontrolled gastroesophageal reflux disease, diabetic nephropathy,
heart failure with preserved ejection fraction, achalasia and sickle
cell disease. Ironwood was founded in 1998 and is headquartered
in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com
or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand for the treatment of adult patients
with irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC), based on IQVIA data. Since its FDA
approval in August of 2012 and subsequent launch in December 2012,
greater than 2 million unique patients have filled approximately 10
million prescriptions for LINZESS, according to IQVIA.
LINZESS is a once-daily capsule that helps relieve the abdominal pain
and constipation associated with IBS-C, as well as the constipation,
infrequent stools, hard stools, straining, and incomplete evacuation
associated with CIC. The recommended dose is 290 mcg for IBS-C patients
and 145 mcg for CIC patients, with a 72 mcg dose approved for use in CIC
depending on individual patient presentation or tolerability. LINZESS
should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6 years of
age. The safety and effectiveness of LINZESS in pediatric patients less
than 18 years of age have not been established. In neonatal mice,
linaclotide increased fluid secretion as a consequence of GC-C agonism
resulting in mortality within the first 24 hours due to dehydration. Due
to increased intestinal expression of GC-C, patients less than 6 years
of age may be more likely than patients 6 years of age and older to
develop severe diarrhea and its potentially serious consequences. In
adults with IBS-C or CIC treated with LINZESS, the most commonly
reported adverse event was diarrhea.
LINZESS is not a laxative; it is the first medicine approved by the FDA
in a class called guanylate cyclase-C (GC-C) agonists. LINZESS contains
a peptide called linaclotide that activates the GC-C receptor in the
intestine. Activation of GC-C is thought to result in increased
intestinal fluid secretion and accelerated transit and a decrease in the
activity of pain-sensing nerves in the intestine. The clinical relevance
of the effect on pain fibers, which is based on nonclinical studies, has
not been established.
In the United States, Ironwood and Allergan plc co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or CIC.
In Europe, Allergan markets linaclotide under the brand name CONSTELLA®
for the treatment of adults with moderate to severe IBS-C. In Japan,
Ironwood's partner Astellas markets linaclotide under the brand name
LINZESS for the treatment of adults with IBS-C. Ironwood also has
partnered with AstraZeneca for development and commercialization of
linaclotide in China, and with Allergan for development and
commercialization of linaclotide in all other territories worldwide.
About ZURAMPIC (lesinurad) 200mg tablets
ZURAMPIC® (lesinurad) works in combination with xanthine oxidase
inhibitors (XOIs) to treat hyperuricemia associated with uncontrolled
gout. ZURAMPIC is not recommended for the treatment of asymptomatic
hyperuricemia and should not be used as monotherapy. XOIs reduce the
production of uric acid; ZURAMPIC increases the excretion of uric acid.
Together, the combination of ZURAMPIC and an XOI provides a dual
mechanism of action that both decreases production and increases
excretion of uric acid, thereby lowering serum uric acid (sUA) levels in
patients who have not achieved target serum uric acid levels with XOI
treatment alone. ZURAMPIC selectively inhibits the function of
transporter proteins uric acid transporter 1 (URAT1) and organic anion
transporter 4 (OAT4), involved in uric acid reabsorption in the kidney.
The safety and efficacy of ZURAMPIC was established in three Phase III
clinical trials that evaluated a once-daily dose of ZURAMPIC in
combination with the XOI allopurinol or febuxostat compared to XOI
alone. The boxed warning for ZURAMPIC states that acute renal failure
has occurred with ZURAMPIC and was more common when ZURAMPIC was given
alone and reinforces that ZURAMPIC should be used in combination with an
XOI.
About DUZALLO (lesinurad and allopurinol)
DUZALLO® (lesinurad and allopurinol) is a once-daily oral therapy that
contains lesinurad 200 mg plus allopurinol 300 mg; it is also available
in a lesinurad 200 mg plus allopurinol 200 mg dosage. DUZALLO is
approved by the FDA as a once-daily oral treatment for hyperuricemia
associated with gout in patients who have not achieved target serum uric
acid (sUA) levels with a medically appropriate daily dose of allopurinol
alone. DUZALLO is not recommended for the treatment of asymptomatic
hyperuricemia. Allopurinol is an XOI whose action differs from that of
uricosuric agents such as lesinurad. Allopurinol reduces the production
of uric acid (UA); lesinurad increases renal excretion of UA by
selectively inhibiting the action of URAT1, the UA transporter
responsible for the majority of renal UA reabsorption. The
dual-mechanism combination of DUZALLO can address both inefficient
excretion and overproduction of UA, thereby lowering sUA levels. DUZALLO
should be taken in the morning with food and water, and patients should
be advised to stay well hydrated when taking DUZALLO (about 2 liters of
liquid a day).
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both
irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC).
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IMPORTANT SAFETY INFORMATION
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WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
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LINZESS is contraindicated in patients less than 6 years of
age. In nonclinical studies in neonatal mice, administration of a
single, clinically relevant adult oral dose of linaclotide caused
deaths due to dehydration. Use of LINZESS should be avoided in
patients 6 years to less than 18 years of age. The safety and
effectiveness of LINZESS have not been established in patients
less than 18 years of age.
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Contraindications
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LINZESS is contraindicated in patients less than 6 years of age due to
the risk of serious dehydration.
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LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
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LINZESS is contraindicated in patients less than 6 years of age. The
safety and effectiveness of LINZESS in patients less than 18 years of
age have not been established. In neonatal mice, linaclotide increased
fluid secretion as a consequence of GC-C agonism resulting in
mortality within the first 24 hours due to dehydration. Due to
increased intestinal expression of GC-C, patients less than 6 years of
age may be more likely than patients 6 years of age and older to
develop severe diarrhea and its potentially serious consequences.
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Use of LINZESS should be avoided in pediatric patients 6 years to less
than 18 years of age. Although there were no deaths in older juvenile
mice, given the deaths in young juvenile mice and the lack of clinical
safety and efficacy data in pediatric patients, use of LINZESS should
be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
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Diarrhea was the most common adverse reaction in LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. The incidence of diarrhea was similar in the IBS-C and CIC
populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg
LINZESS-treated patients, and in < 1% of 72 mcg LINZESS-treated CIC
patients. If severe diarrhea occurs, dosing should be suspended and
the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
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In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain
(7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral
gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
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In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo),
abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory
tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal
distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19%
vs 7% placebo) and abdominal distension (2% vs < 1%).
Please see full Prescribing Information including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi
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ZURAMPIC Important Safety Information and Limitations of Use
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WARNING: RISK OF ACUTE RENAL FAILURE MORE COMMON WHEN USED
WITHOUT A XANTHINE OXIDASE INHIBITOR (XOI)
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Acute renal failure has occurred with ZURAMPIC and was more
common when ZURAMPIC was given alone
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ZURAMPIC should be used in combination with an XOI
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Contraindications:
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Severe renal impairment (eCLcr less than 30 mL/min), end-stage renal
disease, kidney transplant recipients, or patients on dialysis
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Tumor lysis syndrome or Lesch-Nyhan syndrome
Warnings and Precautions:
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Renal events: Adverse reactions related to renal function have
occurred after initiating ZURAMPIC. A higher incidence was observed at
the 400-mg dose, with the highest incidence occurring with monotherapy
use. Monitor renal function at initiation and during therapy with
ZURAMPIC, particularly in patients with eCLcr below 60 mL/min or with
serum creatinine elevations 1.5 to 2 times the pre-treatment value,
and evaluate for signs and symptoms of acute uric acid nephropathy.
Interrupt treatment with ZURAMPIC if serum creatinine is elevated to
greater than 2 times the pre-treatment value or if there are symptoms
that may indicate acute uric acid nephropathy. ZURAMPIC should not be
restarted without another explanation for the serum creatinine
abnormalities. ZURAMPIC should not be initiated in patients with an
eCLcr less than 45 mL/min.
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Cardiovascular events: In clinical trials, major adverse
cardiovascular events (defined as cardiovascular deaths, non-fatal
myocardial infarctions, or non-fatal strokes) were observed with
ZURAMPIC. A causal relationship has not been established.
Adverse Reactions:
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Most common adverse reactions with ZURAMPIC (in combination with an
XOI and more frequently than on an XOI alone) were headache,
influenza, blood creatinine increased, and gastroesophageal reflux
disease
Indication and Limitations of Use for ZURAMPIC
ZURAMPIC is a URAT1 inhibitor indicated in combination with an XOI for
the treatment of hyperuricemia associated with gout in patients who have
not achieved target serum uric acid levels with an XOI alone.
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ZURAMPIC is not recommended for the treatment of asymptomatic
hyperuricemia
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ZURAMPIC should not be used as monotherapy
Please see full Prescribing Information, including Boxed Warning,
at: http://irwdpi.com/zurampic/ZURAMPIC_PI_and_Medguide_2017.pdf#page=1
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DUZALLO Important Safety Information
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WARNING: RISK OF ACUTE RENAL FAILURE
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Acute renal failure has occurred with lesinurad, one of the
components of DUZALLO
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Contraindications:
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Severe renal impairment (estimated creatinine clearance [eCLcr] < 30
mL/min), end-stage renal disease, kidney transplant recipients, or
patients on dialysis
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Tumor lysis syndrome or Lesch-Nyhan syndrome
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Known hypersensitivity to allopurinol, including previous occurrence
of skin rash
Warnings and Precautions:
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Renal events: Adverse reactions related to renal function,
including acute renal failure, can occur after initiating DUZALLO.
Renal function should be evaluated prior to initiation of DUZALLO and
periodically thereafter, as clinically indicated. More frequent renal
function monitoring is recommended in patients with eCLcr < 60 mL/min
or with serum creatinine elevations 1.5 to 2 times the value when
lesinurad treatment was initiated. DUZALLO should not be initiated in
patients with an eCLcr < 45 mL/min. Interrupt treatment with DUZALLO
if serum creatinine is elevated to > 2 times the pretreatment value or
if there are symptoms that may indicate acute uric acid nephropathy,
including flank pain, nausea, or vomiting. DUZALLO should not be
restarted without another explanation for the serum creatinine
abnormalities
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Skin rash and hypersensitivity: Skin rash is a frequently
reported adverse event in patients taking allopurinol. In some
instances, a skin rash may be followed by more severe hypersensitivity
reactions associated with exfoliation, fever, lymphadenopathy,
arthralgia, and/or eosinophilia including Stevens-Johnson syndrome and
toxic epidermal necrolysis. Associated vasculitis and tissue response
may be manifested in various ways including hepatitis, renal
impairment, seizures, and on rare occasions, death. Hypersensitivity
reactions to allopurinol may be increased in patients with decreased
renal function who are receiving thiazide diuretics and DUZALLO
concurrently. DUZALLO should be discontinued immediately at the first
appearance of skin rash or other signs that may indicate an allergic
reaction, and additional medical care should be provided as needed
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Hepatotoxicity: A few cases of reversible clinical
hepatotoxicity have been reported in patients taking allopurinol and,
in some patients, asymptomatic rises in serum alkaline phosphatase or
serum transaminase have been observed. If anorexia, weight loss, or
pruritus develops in patients taking DUZALLO, evaluation of liver
function should be performed. In patients with preexisting liver
disease, periodic liver function tests are recommended
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Cardiovascular events: In clinical trials, major adverse
cardiovascular events (defined as cardiovascular deaths, nonfatal
myocardial infarctions, and nonfatal strokes) were observed with
DUZALLO. A causal relationship has not been established
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Bone marrow depression: Bone marrow depression has been
reported in patients receiving allopurinol, most of whom received
concomitant drugs with the potential for causing this reaction. This
has occurred as early as 6 weeks to as long as 6 years after the
initiation of allopurinol therapy. Rarely, a patient may develop
varying degrees of bone marrow depression, affecting one or more cell
lines, while receiving allopurinol alone. Patients taking allopurinol
and mercaptopurine or azathioprine require a reduction in dose to
approximately one-third to one-fourth of the usual dose of
mercaptopurine or azathioprine
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Increase in prothrombin time: It has been reported that
allopurinol prolongs the half-life of dicumarol, a coumarin
anticoagulant. The prothrombin time should be reassessed periodically
in patients receiving coumarin anticoagulants (dicumarol, warfarin)
concomitantly with DUZALLO
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Drowsiness: Occasional occurrence of drowsiness was reported in
patients taking allopurinol. Patients should be alerted to the need
for caution when engaging in activities where alertness is mandatory
Adverse Reactions:
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The most common adverse reactions in controlled studies (occurring in
2% or more of patients on lesinurad in combination with allopurinol
and at least 1% greater than observed in patients on allopurinol
alone) were headache, influenza, blood creatinine increased, and
gastroesophageal reflux disease
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The most common adverse reactions identified during post-approval use
of allopurinol are skin rash, nausea, and diarrhea
Indication and Limitations of Use:
DUZALLO, a combination of lesinurad, a URAT1 inhibitor, and allopurinol,
a xanthine oxidase inhibitor, is indicated for the treatment of
hyperuricemia associated with gout in patients who have not achieved
target serum uric acid levels with a medically appropriate daily dose of
allopurinol alone.
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DUZALLO is not recommended for the treatment of asymptomatic
hyperuricemia
Please see full Prescribing Information, including Boxed, at https://www.irwdpi.com/duzallo/DuzalloPIandMedguide2017.pdf#page=1
LINZESS® and CONSTELLA® are registered trademarks of Ironwood
Pharmaceuticals, Inc., and ZURAMPIC® and DUZALLO®are
registered trademarks of AstraZeneca AB. Any other trademarks referred
to in this press release are the property of their respective owners.
All rights reserved.
Forward-Looking Statements
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including statements about the benefits of a potential
separation, including with respect to Ironwood's and R&D Co.'s
competitive position, attractiveness to investors and enhanced
operational, commercial and scientific effectiveness; the timing,
leadership, structure, including the division of assets among Ironwood
and R&D Co., and impact of a separation; the strategy, including the
intended development and commercialization plans for each of Ironwood
and R&D Co., and potential corporate development opportunities; the tax
free nature of the separation; the market size, commercial potential,
prevalence, and the growth in, and potential demand for, linaclotide,
lesinurad and other product candidates (and the drivers, timing and
impact thereof), for each of Ironwood and R&D Co., as applicable; the
potential indications for, and benefits of, linaclotide, lesinurad and
other product candidates, for each of Ironwood and R&D Co., as
applicable; the strength of the intellectual property protection for
linaclotide, lesinurad and other product candidates; growth in LINZESS
prescriptions; the number of potential patients; the anticipated timing
of preclinical, clinical and regulatory developments and the design,
timing and results of clinical and preclinical studies; expected periods
of patent exclusivity, durability and life of the respective patent
portfolios for linaclotide, lesinurad and other product candidates;
Ironwood's and R&D Co.'s financial performance and results, and guidance
and expectations related thereto (including the drivers and timing
thereof); and expectations related to revenue growth for in-market
products, commercial margin, cash flow and profitability growth and
LINZESS U.S. net sales. Each forward-looking statement is subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied in such statement. Applicable
risks and uncertainties include those related to the possibility that we
may not complete the separation on the terms or timeline currently
contemplated if at all, achieve the expected benefits of a separation,
and that a separation could harm our business, results of operations and
financial condition; the risk that the transaction might not be
tax-free; the risk that we may be unable to make, on a timely or
cost-effective basis, the changes necessary to operate as independent
companies; R&D Co.'s lack of independent operating history and the risk
that its accounting and other management systems may not be prepared to
meet the financial reporting and other requirements of operating as an
independent public company; the risk that a separation may adversely
impact our ability to attract or retain key personnel; the effectiveness
of development and commercialization efforts by us and our partners;
preclinical and clinical development, manufacturing and formulation
development; the risk that findings from our completed nonclinical and
clinical studies may not be replicated in later studies; efficacy,
safety and tolerability of linaclotide, lesinurad and our product
candidates; decisions by regulatory and judicial authorities; the risk
that we are unable to successfully commercialize lesinurad or realize
the anticipated benefits of the lesinurad transaction; the risk that we
may never get sufficient patent protection for linaclotide, lesinurad
and our product candidates or that we are not able to successfully
protect such patents; the outcomes in legal proceedings to protect or
enforce the patents relating to our products and product candidates,
including ANDA litigation; developments in the intellectual property
landscape; challenges from and rights of competitors or potential
competitors; the risk that our planned investments do not have the
anticipated effect on our company revenues, linaclotide, lesinurad or
our product candidates; the risk that we are unable to manage our
operating expenses or cash use for operations, or are unable to
commercialize our products, within the guided ranges or otherwise as
expected; and the risks listed under the heading "Risk Factors" and
elsewhere in Ironwood's Annual Report on Form 10-K for the year ended
December 31, 2017, and in our subsequent SEC filings. These
forward-looking statements (except as otherwise noted) speak only as of
the date of this letter, and Ironwood undertakes no obligation to update
these forward-looking statements.
Additional Information
On May 2, 2018, Ironwood filed a definitive proxy statement and WHITE
proxy card with the U.S. Securities and Exchange Commission (the "SEC")
in connection with the company's 2018 Annual Meeting of Shareholders.
SHAREHOLDERS ARE STRONGLY ENCOURAGED TO READ SUCH DEFINITIVE PROXY
STATEMENT AND ACCOMPANYING WHITE PROXY CARD AS THEY CONTAIN IMPORTANT
INFORMATION. Shareholders are able to obtain the proxy statement, any
amendments or supplements to the proxy statement and other documents
filed by the company with the SEC for no charge at the SEC's website at www.sec.gov.
Copies are also be available at no charge at the company's website at www.ironwoodpharma.com.
If you have any questions regarding this information or the proxy
materials, please contact MacKenzie Partners, Inc., our proxy solicitor
assisting us in connection with the annual meeting, toll-free at
(800) 322-2885 or at (212) 929-5500 or via email to proxy@mackenziepartners.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180502005777/en/
Investors:
Ironwood Pharmaceuticals, Inc.
Meredith
Kaya, 617-374-5082
Vice President, Investor Relations and Corporate
Communications
mkaya@ironwoodpharma.com
or
Media:
Joele
Frank, Wilkinson Brimmer Katcher
Andi Rose / Mahmoud Siddig,
212-355-4449
Source: Ironwood Pharmaceuticals, Inc.
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