ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that
its founder, Harvey J. Berger, M.D., has informed the Board of his
decision to retire as chairman and chief executive officer (CEO)
upon the appointment of his successor or December 31, 2015,
whichever is earlier. The Board has begun a comprehensive search to
identify Dr. Berger’s successor. Dr. Berger has also agreed to
serve as a special advisor to the Board and the new CEO upon his
retirement to facilitate a smooth transition.
Dr. Berger commented on his tenure as ARIAD’s CEO:
- “I am proud to have worked with so many
incredibly talented employees and together to have achieved so much
for cancer patients in need of new treatment options where none
exist,” said Harvey J. Berger, M.D., chairman and chief executive
officer of ARIAD. “With an established path to profitability and a
well-defined set of critical corporate initiatives, ARIAD has a
remarkable future. I had always anticipated retiring around age 65,
which I will reach at the time of our upcoming annual meeting. My
colleagues and I are all driven by our passion for helping cancer
patients, and I hope ARIAD will always be recognized for this
dedication.” Dr. Berger added, “ARIAD has been at the forefront of
precision medicine initiatives in cancer, and I expect that the
Company will continue to lead the way as new targeted therapies
emerge from our drug-discovery platform – built on our
computational and structural technologies.”
Dr. Berger founded ARIAD 23 years ago and has served as its
chairman and chief executive officer since 1991. He has led the
Company’s growth into an integrated global-oncology company serving
patients worldwide. Under his leadership, ARIAD scientists have
discovered five new drug candidates. ARIAD brought Iclusig®
(ponatinib) – a novel BCR-ABL tyrosine kinase inhibitor (TKI) – to
the market for use in the treatment of patients with refractory
chronic myeloid leukemia and Philadelphia chromosome-positive acute
lymphoblastic leukemia, now approved in the US, EU, Switzerland,
Australia, Canada, and Israel. Since its approval, Iclusig has been
launched through ARIAD’s commercial organization in the US and the
16 major markets of the EU and through its distributors in other
regions. Dr. Berger has also overseen the broadened clinical
development of Iclusig and the implementation of a 3-year strategic
plan to achieve sustained profitability for ARIAD.
Brigatinib – a new ALK TKI with Breakthrough Designation from
the FDA – is ARIAD’s next cancer medicine in development. It is
being studied in the ALTA pivotal trial of patients with refractory
ALK+ non-small cell lung cancer (NSCLC), which is on track to
complete patient enrollment in the third quarter of this year,
leading to anticipated NDA filing next year. Recently, ARIAD
announced the discovery of AP32788 – its third internally
discovered novel TKI – for use in the treatment of patients with
NSCLC and a validated class of novel mutated targets; the Company
plans to file an IND for AP32788 later this year.
Some of Dr. Berger’s colleagues, directors and leadership-team
members offered the following comments:
- “For nearly 25 years, Harvey has put
his heart and soul into building a world-class biotechnology
company,” said Wayne Wilson, lead independent director of the ARIAD
Board. “We all appreciate his dedication to cancer patients and his
focus on building sustainable value for our Company. He has
attracted and led outstanding employees – from bench scientists to
physicians to account managers in the field. He has never wavered
in his commitment to being the best in every task that the Company
undertook.” Mr. Wilson added, “The Board will conduct a thorough
search to identify a successor who we expect will guide ARIAD into
its next chapters of innovation and growth, building on the solid
foundation put in place by Harvey and his leadership team.”
- “My lasting memory of my first meeting
with Harvey 25 years ago, when ARIAD was just a twinkle in his eye,
is one that helps explain the direction of ARIAD over this period.
Harvey was passionate about building a company where patients come
first. He saw the promise of modern science to translate to
life-saving medicines. And Harvey has delivered on this vision
through his dedication and leadership,” said Stuart L. Schreiber,
Ph.D., Founding Member of the Broad Institute of Harvard and MIT,
HHMI Investigator, and Morris Loeb Professor of Chemistry and
Chemical Biology, Harvard University.
- “As CEO of ARIAD, Harvey has been a
committed supporter of The Max Foundation. Through the years, he
has been open to listening to the patient’s perspective as well as
to discussing solutions to help people facing cancer around the
world,” said Pat Garcia-Gonzalez, President and Chief Executive
Officer of The Max Foundation, a global health non-profit
organization that believes that all people living with cancer have
the right to access the best treatment and support. “He has
especially demonstrated an awareness of the needs of people living
with chronic myeloid leukemia and an understanding of the
importance of developing global access strategies for innovative
oncology drugs. I thank him for his service and look forward to
continuing our collaborations with ARIAD.”
- “Harvey founded and built ARIAD with
the clear vision of applying scientific excellence and clinical
scholarship to helping patients in need – a vision that has been
unequivocally fulfilled,” stated Timothy P. Clackson, Ph.D.,
president of R&D and chief scientific officer of ARIAD. “Our
employees and thousands of patients worldwide owe a great debt of
gratitude to his exceptional dedication and perseverance. The ARIAD
leadership team is committed to continuing this work and driving to
further success.”
- “As ARIAD’s founder, Harvey has guided
the Company to a mission intensely focused on helping cancer
patients, by discovering and developing new treatments to allow
them to overcome their diseases. His passion as a physician has
infused its existence. The many patients and families who have been
helped by ARIAD’s medicines can be thankful for his dedication and
insights,” said Frank G. Haluska, M.D., Ph.D., senior vice
president, clinical R&D and chief medical officer of
ARIAD.
- “Harvey enthusiastically embraced the
evolution of ARIAD into a global commercial company,” said Marty J.
Duvall, executive vice president and chief commercial officer of
ARIAD. “His pride, satisfaction and commitment to deliver on the
vision of transforming patient-lives motivates the commercial team
each and every day.”
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
oncology company focused on transforming the lives of cancer
patients with breakthrough medicines. ARIAD is working on new
medicines to advance the treatment of various forms of chronic and
acute leukemia, lung cancer and other difficult-to-treat cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit http://www.ariad.com
or follow ARIAD on Twitter (@ARIADPharm).
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD’s computational and structure-based drug-design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved
TKIs.
Iclusig is approved in the U.S., EU, Australia, Switzerland,
Canada, and Israel.
In the U.S., Iclusig is a kinase inhibitor indicated for
the:
- Treatment of adult patients with
T315I-positive chronic myeloid leukemia (chronic phase, accelerated
phase, or blast phase) or T315I-positive Philadelphia chromosome
positive acute lymphoblastic leukemia (Ph+ ALL).
- Treatment of adult patients with
chronic phase, accelerated phase, or blast phase chronic myeloid
leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor
(TKI) therapy is indicated.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED
WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full prescribing information for complete boxed
warning
• Vascular Occlusion: Arterial and venous thrombosis
and occlusions have occurred in at least 27% of Iclusig treated
patients, including fatal myocardial infarction, stroke, stenosis
of large arterial vessels of the brain, severe peripheral vascular
disease, and the need for urgent revascularization procedures.
Patients with and without cardiovascular risk factors, including
patients less than 50 years old, experienced these events. Monitor
for evidence of thromboembolism and vascular occlusion. Interrupt
or stop Iclusig immediately for vascular occlusion. A benefit risk
consideration should guide a decision to restart Iclusig
therapy.
• Heart Failure, including fatalities, occurred in 8%
of Iclusig-treated patients. Monitor cardiac function. Interrupt or
stop Iclusig for new or worsening heart failure.
• Hepatotoxicity, liver failure and death have
occurred in Iclusig-treated patients. Monitor hepatic function.
Interrupt Iclusig if hepatotoxicity is suspected.
Vascular Occlusion: Arterial and venous thrombosis and
occlusions, including fatal myocardial infarction, stroke, stenosis
of large arterial vessels of the brain, severe peripheral vascular
disease, and the need for urgent revascularization procedures have
occurred in at least 27% of Iclusig-treated patients from the phase
1 and phase 2 trials. Iclusig can also cause recurrent or
multi-site vascular occlusion. Overall, 20% of Iclusig-treated
patients experienced an arterial occlusion and thrombosis event of
any grade. Fatal and life-threatening vascular occlusion has
occurred within 2 weeks of starting Iclusig treatment and in
patients treated with average daily dose intensities as low as 15
mg per day. The median time to onset of the first vascular
occlusion event was 5 months. Patients with and without
cardiovascular risk factors have experienced vascular occlusion
although these events were more frequent with increasing age and in
patients with prior history of ischemia, hypertension, diabetes, or
hyperlipidemia. Interrupt or stop Iclusig immediately in patients
who develop vascular occlusion events.
Heart Failure: Fatal and serious heart failure or left
ventricular dysfunction occurred in 5% of Iclusig-treated patients
(22/449). Eight percent of patients (35/449) experienced any grade
of heart failure or left ventricular dysfunction. Monitor patients
for signs or symptoms consistent with heart failure and treat as
clinically indicated, including interruption of Iclusig. Consider
discontinuation of Iclusig in patients who develop serious heart
failure.
Hepatotoxicity: Iclusig can cause hepatotoxicity,
including liver failure and death. Fulminant hepatic failure
leading to death occurred in an Iclusig-treated patient within one
week of starting Iclusig. Two additional fatal cases of acute liver
failure also occurred. The fatal cases occurred in patients with
blast phase CML (BP-CML) or Philadelphia chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Severe hepatotoxicity occurred in
all disease cohorts. Iclusig treatment may result in elevation in
ALT, AST, or both. Monitor liver function tests at baseline, then
at least monthly or as clinically indicated. Interrupt, reduce or
discontinue Iclusig as clinically indicated.
Hypertension: Treatment-emergent hypertension (defined as
systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg on at least one
occasion) occurred in 67% of patients (300/449). Eight patients
treated with Iclusig (2%) experienced treatment-emergent
symptomatic hypertension as a serious adverse reaction, including
one patient (<1%) with hypertensive crisis. Patients may require
urgent clinical intervention for hypertension associated with
confusion, headache, chest pain, or shortness of breath. In 131
patients with Stage 1 hypertension at baseline, 61% (80/131)
developed Stage 2 hypertension. Monitor and manage blood pressure
elevations during Iclusig use and treat hypertension to normalize
blood pressure. Interrupt, dose reduce, or stop Iclusig if
hypertension is not medically controlled.
Pancreatitis: Clinical pancreatitis occurred in 6%
(28/449) of patients (5% Grade 3) treated with Iclusig.
Pancreatitis resulted in discontinuation or treatment interruption
in 6% of patients (25/449). The incidence of treatment-emergent
lipase elevation was 41%. Check serum lipase every 2 weeks for the
first 2 months and then monthly thereafter or as clinically
indicated. Consider additional serum lipase monitoring in patients
with a history of pancreatitis or alcohol abuse. Dose interruption
or reduction may be required. In cases where lipase elevations are
accompanied by abdominal symptoms, interrupt treatment with Iclusig
and evaluate patients for pancreatitis. Do not consider restarting
Iclusig until patients have complete resolution of symptoms and
lipase levels are less than 1.5 x ULN.
Neuropathy: Peripheral and cranial neuropathy have
occurred in Iclusig-treated patients. Overall, 13% (59/449) of
Iclusig-treated patients experienced a peripheral neuropathy event
of any grade (2%, grade 3/4). In clinical trials, the most common
peripheral neuropathies reported were peripheral neuropathy (4%,
18/449), paresthesia (4%, 17/449), hypoesthesia (2%, 11/449), and
hyperesthesia (1%, 5/449). Cranial neuropathy developed in 1%
(6/449) of Iclusig-treated patients (<1% grade 3/4). Of the
patients who developed neuropathy, 31% (20/65) developed neuropathy
during the first month of treatment. Monitor patients for symptoms
of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia,
discomfort, a burning sensation, neuropathic pain or weakness.
Consider interrupting Iclusig and evaluate if neuropathy is
suspected.
Ocular Toxicity: Serious ocular toxicities leading to
blindness or blurred vision have occurred in Iclusig-treated
patients. Retinal toxicities including macular edema, retinal vein
occlusion, and retinal hemorrhage occurred in 3% of Iclusig-treated
patients. Conjunctival or corneal irritation, dry eye, or eye pain
occurred in 13% of patients. Visual blurring occurred in 6% of the
patients. Other ocular toxicities include cataracts, glaucoma,
iritis, iridocyclitis, and ulcerative keratitis. Conduct
comprehensive eye exams at baseline and periodically during
treatment.
Hemorrhage: Serious bleeding events, including
fatalities, occurred in 5% (22/449) of patients treated with
Iclusig. Hemorrhagic events occurred in 24% of patients. The
incidence of serious bleeding events was higher in patients with
accelerated phase CML (AP-CML), BP-CML, and Ph+ ALL. Most
hemorrhagic events, but not all occurred in patients with grade 4
thrombocytopenia. Interrupt Iclusig for serious or severe
hemorrhage and evaluate.
Fluid Retention: Serious fluid retention events occurred
in 3% (13/449) of patients treated with Iclusig. One instance of
brain edema was fatal. In total, fluid retention occurred in 23% of
the patients. The most common fluid retention events were
peripheral edema (16%), pleural effusion (7%), and pericardial
effusion (3%). Monitor patients for fluid retention and manage
patients as clinically indicated. Interrupt, reduce, or discontinue
Iclusig as clinically indicated.
Cardiac Arrhythmias: Symptomatic bradyarrhythmias that
led to a requirement for pacemaker implantation occurred in 1%
(3/449) of Iclusig-treated patients. Advise patients to report
signs and symptoms suggestive of slow heart rate (fainting,
dizziness, or chest pain). Supraventricular tachyarrhythmias
occurred in 5% (25/449) of Iclusig-treated patients. Atrial
fibrillation was the most common supraventricular tachyarrhythmia
and occurred in 20 patients. For 13 patients, the event led to
hospitalization. Advise patients to report signs and symptoms of
rapid heart rate (palpitations, dizziness). Interrupt Iclusig and
evaluate.
Myelosuppression: Severe (grade 3 or 4) myelosuppression
occurred in 48% (215/449) of patients treated with Iclusig. The
incidence of these events was greater in patients with AP-CML,
BP-CML and Ph+ ALL than in patients with CP-CML. Obtain complete
blood counts every 2 weeks for the first 3 months and then monthly
or as clinically indicated, and adjust the dose as recommended.
Tumor Lysis Syndrome: Two patients (<1%) with advanced
disease (AP-CML, BP-CML, or Ph+ ALL) treated with Iclusig developed
serious tumor lysis syndrome. Hyperuricemia occurred in 7% (30/449)
of patients overall; the majority had CP-CML (19 patients). Due to
the potential for tumor lysis syndrome in patients with advanced
disease, ensure adequate hydration and treat high uric acid levels
prior to initiating therapy with Iclusig.
Compromised Wound Healing and Gastrointestinal
Perforation: Since Iclusig may compromise wound healing,
interrupt Iclusig for at least 1 week prior to major surgery.
Serious gastrointestinal perforation (fistula) occurred in one
patient 38 days post-cholecystectomy.
Embryo-Fetal Toxicity: Iclusig can cause fetal harm. If
Iclusig is used during pregnancy, or if the patient becomes
pregnant while taking Iclusig, the patient should be apprised of
the potential hazard to the fetus. Advise women to avoid pregnancy
while taking Iclusig.
Most common non-hematologic adverse reactions: (≥20%) were
hypertension, rash, abdominal pain, fatigue, headache, dry skin,
constipation, arthralgia, nausea, and pyrexia. Hematologic adverse
reactions included thrombocytopenia, anemia, neutropenia,
lymphopenia, and leukopenia.
Please see the full U.S. Prescribing Information for Iclusig,
including the Boxed Warning, for additional important safety
information.
Forward-Looking Statements
This communication contains “forward-looking statements”
including, but not limited to, statements regarding future events
and ARIAD’s business, strategy and results. These statements are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995 and are identified by use
of words such as “may,” “anticipate,” “estimate,” “expect,”
“project,” “intend,” “plan,” “believe” and other words and terms of
similar meaning. Such statements are based on management’s
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events,
timing and performance to differ materially from those expressed or
implied by such forward looking statements. These risks and
uncertainties include, but are not limited to, our ability to meet
anticipated clinical trial commencement, enrollment and completion
dates for our products and product candidates and to move new
development candidates into the clinic; our ability to secure a
partnership for brigatinib (AP26113); difficulties or delays in
obtaining regulatory and pricing and reimbursement approvals to
market our products; our ability to successfully commercialize and
generate profits from sales of Iclusig; competition from
alternative therapies; our reliance on the performance of
third-party manufacturers and specialty pharmacies for the
distribution of Iclusig; the occurrence of adverse safety events
with our products and product candidates; preclinical data and
early-stage clinical data that may not be replicated in later-stage
clinical studies; the costs associated with our research,
development, manufacturing and other activities; the conduct and
results of preclinical and clinical studies of our product
candidates; the adequacy of our capital resources and the
availability of additional funding; patent protection and
third-party intellectual property claims; litigation, including our
pending securities class action and derivative lawsuits; our
operations in foreign countries; risks related to key employees,
markets, economic conditions, health care reform, prices and
reimbursement rates; and other risk factors detailed in ARIAD’s
public filings with the U.S. Securities and Exchange Commission.
The information contained in this communication is believed to be
current as of the date of original issue. After the date of this
communication, ARIAD does not intend to update any of the
forward-looking statements to conform these statements to actual
results or to changes in ARIAD’s expectations, except as required
by law.
Important Additional Information
ARIAD, its directors and certain of its executive officers may
be deemed to be participants in the solicitation of proxies from
ARIAD stockholders in connection with the matters to be considered
at ARIAD’s 2015 annual meeting of stockholders. ARIAD intends to
file a proxy statement and accompanying proxy card with the U.S.
Securities and Exchange Commission (the “SEC”) in connection with
any such solicitation of proxies from ARIAD stockholders. ARIAD
STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ ANY SUCH PROXY
STATEMENT AND ACCOMPANYING PROXY CARD AND OTHER DOCUMENTS FILED
WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.
Information regarding ARIAD’s directors and executive officers is
available in ARIAD’s proxy statement, dated May 9, 2014, for its
2014 annual meeting of stockholders. To the extent holdings of
ARIAD’s securities by directors or executive officers have changed
since the amounts set forth in the 2014 proxy statement, such
changes have been or will be reflected on Initial Statements of
Beneficial Ownership on Form 3 or Statements of Change in Ownership
on Form 4 filed with the SEC. More detailed information regarding
the identity of participants, and their direct or indirect
interests, by security holdings or otherwise, will be set forth in
the proxy statement and other materials to be filed with the SEC in
connection with ARIAD’s 2015 annual meeting of stockholders.
Additional information can also be found in ARIAD’s Annual Report
on Form 10-K for the year ended December 31, 2014, filed with the
SEC on March 2, 2015, and in ARIAD’s Quarterly Reports on Form
10-Q. ARIAD’s stockholders will be able to obtain, free of charge,
any proxy statement, any amendments or supplements to the proxy
statement and any other documents filed by ARIAD with the SEC at
the SEC’s website at http://www.sec.gov. In addition, copies will
be available free of charge at ARIAD’s website at
http://www.ariad.com or by contacting ARIAD’s Investor Relations by
mail at ARIAD Pharmaceuticals, Inc., 26 Landsdowne Street,
Cambridge, MA 02139 or by phone at 617-503-7028.
ARIAD Pharmaceuticals, Inc.For Investors:Kendra
Adams, 617-503-7028Kendra.adams@ariad.comorMaria
Cantor, 617-621-2208Maria.cantor@ariad.comFor
Media:Sard Verbinnen & Co.George Sard/Andrew Cole/Chris
Kittredge212-687-8080
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