UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): January
13, 2015
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
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001-36172
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22-3106987
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(I.R.S.
Employer
Identification
No.)
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26 Landsdowne Street, Cambridge, Massachusetts
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02139
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including
area code: (617) 494-0400
Not
Applicable
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2.
below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Forward-Looking Statements
This Form 8-K and the exhibits attached hereto and incorporated by
reference herein contain forward-looking statements of ARIAD
Pharmaceuticals, Inc. that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in
this Form 8-K and the exhibits attached hereto, are forward-looking
statements. The words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,”
“will,” “would,” “could,” “should,” “continue,” “contemplate,” or the
negative of these terms or other similar expressions are intended to
identify forward-looking statements, although not all forward-looking
statements contain these identifying words. These forward-looking
statements include, among others, statements about our selected
estimated and unaudited financial results for year-end 2014; our key
strategic objectives for 2015; the timing and results of our preclinical
and clinical trials; and our plans to achieve sustained
profitability. These “forward-looking statements” are based on
management’s good-faith 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 statements. These factors, risks and uncertainties
include, but are not limited to, our ability to meet anticipated
clinical trial commencement and completion dates for our products and
product candidates and to move new development candidates into clinical
trials; our ability to secure a partnership for brigatinib
(AP26113); difficulties or delays in filing for approvals and 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; the
ability of our regional commercialization and distribution partners to
perform as required; 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 enrollment, conduct, timing and results of pre-clinical
and clinical studies of our product candidates; the adequacy of our
capital resources and the availability of additional funding; and other
factors detailed in our public filings with the U.S. Securities and
Exchange Commission. The information contained in this Form 8-K and the
exhibits attached hereto are believed to be current as of the date of
original issue. After the date of these documents, we do not intend to
update any of the forward-looking statements to conform these statements
to actual results or to changes in management’s expectations, except as
required by law.
ITEM 2.02 Results of
Operations and Financial Condition.
On January 13, 2015, ARIAD Pharmaceuticals, Inc. (“ARIAD” or the
“Company”) issued a press release in which it announced selected
preliminary financial results for the fiscal year ended December 31,
2014. A copy of the press release is attached hereto as Exhibit 99.1.
The information under the heading “2014 Key Financial Results” in the
press release is incorporated by reference into this Item 2.02 of this
Current Report on Form 8-K.
The Company has not completed its financial close process for the year.
During the course of that process, the Company may identify items that
would require it to make adjustments, which may be material, to the
selected preliminary financial information presented in the press
release. As a result, the preliminary financial estimates included in
the press release constitute forward-looking information and are subject
to risks and uncertainties, including possible adjustments to
preliminary operating and other financial results.
ITEM 7.01 Regulation
FD Disclosure.
In the press release dated January 13, 2015, the Company also announced
key strategic objectives for 2015, details of which will be presented at
the 33rd Annual J.P. Morgan Healthcare Conference on January 14, 2015 in
San Francisco (the “J.P. Morgan Conference”). These objectives are
focused on expanded commercial, research and development, and new
business development initiatives that together are expected to lead
ARIAD to sustained profitability beginning in 2018 without the need for
additional equity capital to fund operations.
These objectives include:
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Expanding the global commercial opportunity for Iclusig through a
Japan/Asia partnership with Otsuka Pharmaceutical Co., Ltd., and
additional regional distributorships,
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Leveraging its existing commercial infrastructure and investment,
particularly in Europe,
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Securing a broad co-development and co-commercialization partnership
for brigatinib (AP26113) that will accelerate the study of brigatinib
in earlier lines of treatment,
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Investing in three randomized clinical trials to evaluate Iclusig in
earlier lines of treatment and potentially to expand its addressable
market,
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Advancing its new development candidate, AP32788, into the clinic, and
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Achieving sustained profitability in 2018 by reaching global product
revenue of more than $400 million.
In the press release dated January 13, 2015, the Company also provided
an update on its Iclusig, brigatinib (AP26113) and newly announced
AP32788 programs, as well as information on its plan for profitability
and its presentation at the J.P. Morgan Conference.
A copy of the press release is attached as Exhibit 99.1 to this Current
Report on Form 8-K, and the information contained therein, other than
the information under the captions “2014 Key Financial Results” and
“About Iclusig (ponatinib) tablets, ” is incorporated by reference into
this Item 7.01 of this Current Report on Form 8-K.
In addition, a copy of the Company’s presentation at the J.P. Morgan
Conference is attached as Exhibit 99.2 to this Current Report on Form
8-K, and the information contained therein is incorporated by reference
into this Item 7.01 of this Current Report on Form 8-K.
ITEM 9.01 Financial Statements and Exhibits
(d) The following exhibits are furnished with this report:
Exhibit Number
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Description
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99.1
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Press Release dated January 13, 2015.
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99.2
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ARIAD Pharmaceuticals, Inc. Presentation for the 33rd
Annual J.P. Morgan Healthcare Conference dated January 14, 2015.
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The press release contains hypertext links to information on our
websites. The information on our websites is not incorporated by
reference into this Current Report on Form 8-K and does not constitute a
part of this Form 8-K.
The press release and investor presentation are being furnished pursuant
to Items 2.02 and/or 7.01 of this Current Report on Form 8-K and shall
not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise
subject to the liabilities of that Section, nor shall they be deemed
incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, except as shall be expressly set
forth by specific reference in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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ARIAD Pharmaceuticals, Inc.
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By:
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/s/ Edward M. Fitzgerald
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Edward M. Fitzgerald
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Executive Vice President, Chief Financial Officer
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Date:
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January 13, 2015
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4
Exhibit 99.1
ARIAD
Announces Key Strategic Objectives for 2015 Expected to Lead Company to
Profitability in Three Years
Iclusig
Commercial Opportunity Expected to Expand -- Three New Clinical Trials
to Begin in 2015, including a Global, Randomized Trial of Iclusig vs.
Nilotinib in Second-Line CML
CAMBRIDGE, Mass.--(BUSINESS WIRE)--January 13, 2015--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced its key strategic
objectives for 2015, details of which will be presented at the 33rd
Annual J.P. Morgan Healthcare Conference on January 14, 2015 in San
Francisco, California. These objectives are focused on expanded
commercial, research and development, and new business development
initiatives that together are expected to lead ARIAD to sustained
profitability beginning in 2018 without the need for additional equity
capital to fund its operations.
“We made excellent progress over the past year to successfully re-launch
Iclusig® (ponatinib) in the U.S., to expand Iclusig’s
commercialization in Europe, and to better understand ponatinib’s
benefit/risk profile using lower doses,” said Harvey J. Berger, M.D.,
chairman and chief executive officer of ARIAD. “Additionally, we secured
an experienced Japanese partner for Iclusig, an important step in
expanding its global commercial opportunity. We also advanced our
pipeline, moving brigatinib -- our investigational ALK inhibitor -- into
a pivotal trial and nominating our next internally discovered oncology
drug candidate -- AP32788 -- into development. As we begin 2015, we are
focusing our investment on value-driving clinical initiatives and
positioning the Company for solid growth with the key objective of
achieving sustained profitability in three years.”
ARIAD management will provide detail on its corporate strategy for the
next several years. This new focus includes:
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Expanding the global commercial opportunity for Iclusig through a
Japan/Asia partnership with Otsuka Pharmaceutical Co., Ltd., and
additional regional distributorships,
-
Leveraging its existing commercial infrastructure and investment,
particularly in Europe,
-
Securing a broad co-development and co-commercialization partnership
for brigatinib (AP26113) that will accelerate the study of brigatinib
in earlier lines of treatment,
-
Investing in three randomized clinical trials to evaluate Iclusig in
earlier lines of treatment and potentially to expand its addressable
market,
-
Advancing its new development candidate, AP32788, into the clinic, and
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Achieving sustained profitability in 2018 by reaching global product
revenue of more than $400 million.
Evaluating Iclusig in Earlier Lines of Chronic Myeloid Leukemia (CML)
Three key Iclusig clinical trials will begin in 2015 including a
randomized, Phase 3 trial in patients with chronic-phase CML (CP-CML)
who have experienced failure after imatinib therapy. This second-line,
global trial will evaluate two doses of Iclusig vs. the standard
dose of nilotinib. The primary endpoint of the trial will be major
molecular response (MMR) by 12 months. The trial is expected to open to
patient enrollment in the second half of 2015 and will be integral to
potentially expanding Iclusig into earlier lines of treatment. We expect
that approximately 500 patients will be enrolled in this trial.
We will begin patient enrollment in a dose-ranging, third-line trial of
Iclusig in patients with CP-CML, who have become resistant to at least
two prior tyrosine kinase inhibitors (TKIs). This global, randomized
trial will evaluate three starting doses of Iclusig in patients with
refractory CP-CML. The trial is expected to inform the optimal use of
Iclusig in these patients and will begin by mid-2015. We expect that
approximately 450 patients will be enrolled in this trial.
An early-switch trial of Iclusig in second-line CP-CML patients will
also begin in the United Kingdom. This investigator-sponsored trial
(SPIRIT3) will be coordinated by the Newcastle University, U.K., on
behalf of the U.K. National Cancer Research Institute (NCRI) CML Working
Group. It will enroll newly diagnosed patients with CP-CML, who will be
randomized to either imatinib or nilotinib. Patients failing to reach an
early molecular response at three months will then be switched to
Iclusig in the second line. We expect the trial to inform the use of
Iclusig as part of the emerging paradigm in CML for early switching of
TKIs in patients with suboptimal responses. We anticipate that the trial
will begin in the first half of 2015 and will enroll approximately 1,000
patients. Clinical data presentations from the trial are anticipated at
various times over several years.
Securing a Broad Partnership for Brigatinib
In a major strategic shift for ARIAD, we expect to secure a broad
partnership in 2015 to co-develop and co-commercialize brigatinib. In
doing so, we will continue to leverage our existing infrastructure and
capabilities, allowing us to accelerate the start of a randomized,
first-line trial of brigatinib vs. crizotinib. A partnership will
also provide for the exploration of new combination therapies in lung
cancer that include brigatinib potentially with other approved and
unapproved medicines.
Brigatinib received Breakthrough Therapy designation by the U.S. Food
and Drug Administration in 2014 which may accelerate its regulatory
approval timeline. Brigatinib is currently being evaluated in the
global, Phase 2 pivotal ALTA trial that is anticipated to form the basis
for its initial approval. We expect to achieve full patient enrollment
in the ALTA trial in the third quarter 2015 and to file for approval of
brigatinib in mid-2016.
Expanding its Pipeline
At the end of 2014, we nominated our next internally discovered
development candidate, AP32788. This orally active TKI has a unique
profile against a validated class of mutated targets in non-small cell
lung cancer and certain other solid tumors and addresses an unmet
medical need. We expect to file an investigational new drug (IND)
application for AP32788 this year and to begin a Phase 1/2
proof-of-concept trial in 2016. This will be our third IND filing of an
internally discovered oncology development candidate in the past eight
years.
This complements our earlier discovery of ridaforolimus, which is being
developed by Medinol Ltd. for use in drug-eluting stents (BioNIR) and is
in global pivotal trials, and rimiducid (AP1903), which is being
developed by Bellicum Pharmaceuticals, Inc. for use in novel cellular
immunotherapies and is in Phase 2 clinical trials.
Path to Profitability
We expect to achieve profitability in 2018 through revenue growth and
strategic partnerships over the next three years. This includes Iclusig
revenue growth in the U.S. and in Europe, as well as Iclusig revenue
from Japan and new geographies. We also anticipate increased cash flow
from brigatinib revenue and partnership payments during this time
period. We expect approval of Iclusig in Canada and Israel in 2015 and
in Japan in 2016.
Strategic investments to support the long-term growth of the Company
include its commercial presence in the U.S. and the 16 major European
Union countries, the development of Iclusig in earlier lines of therapy,
and the development of brigatinib and AP32788. Importantly, with a broad
co-development and co-commercialization partnership for brigatinib, we
do not anticipate a need for additional equity capital to fund
operations. Based on this plan, we expect to achieve sustained
profitability based on more than $400 million in anticipated product
revenue in 2018.
2014 Key Financial Results
In conjunction with the corporate strategy update, ARIAD will also
highlight key financial results for full-year 2014. Estimated and
unaudited financial results for full-year 2014 include:
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Net sales of Iclusig were approximately $55 million for the year ended
December 31, 2014.
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License revenue was approximately $45 million for the year ended
December 31, 2014.
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Research and development expenses were approximately $120 million for
the full-year 2014
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Selling, general and administrative expenses were approximately $140
million for the full-year 2014.
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As of December 31, 2014, cash and cash equivalents totaled
approximately $350 million.
Presentation Reminder
As previously announced, our chairman and chief executive officer, Dr.
Harvey J. Berger, will provide an overview of the Company at the 33rd
Annual J.P. Morgan Healthcare Conference on January 14, 2015 in San
Francisco, California, at 3:00 p.m. PT (6:00 p.m. ET), highlighting the
Company’s strategic operating plan.
The ARIAD presentation will be webcast live and can be accessed by
visiting the investor relations section of the Company's website at http://www.ariad.com/investor.
A replay will be available on the ARIAD website approximately 24 hours
after the presentation and will be archived for four weeks.
About Iclusig® (ponatinib) tablets
Iclusig is approved in the U.S., EU, Australia and Switzerland.
In the U.S., Iclusig is a kinase inhibitor indicated for the:
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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).
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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
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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.
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Heart Failure, including fatalities, occurred in 8% of
Iclusig-treated patients. Monitor cardiac function. Interrupt or stop
Iclusig for new or worsening heart failure.
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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.
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).
This press release contains “forward-looking statements” which are based
on management's good-faith 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 statements. These factors, risks and
uncertainties include, but are not limited to, our ability to meet
anticipated clinical trial commencement 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 AP26113;
difficulties or delays in filing for approvals and 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; the ability of our regional
commercialization and distribution partners to perform as required;
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
enrollment, conduct, timing and results of pre-clinical and clinical
studies of our product candidates, the adequacy of our capital resources
and the availability of additional funding, and other factors detailed
in the Company's public filings with the U.S. Securities and Exchange
Commission. The information contained in this press release is believed
to be current as of the date of original issue. After the date of this
document, the Company does not intend to update any of the
forward-looking statements to conform these statements to actual results
or to changes in the Company's expectations, except as required by law.
Iclusig® is a registered trademark of ARIAD
Pharmaceuticals, Inc.
CONTACT:
ARIAD Pharmaceuticals, Inc.
For Investors
Kendra
Adams, (617) 503-7028
Kendra.adams@ariad.com
or
For
Media
Liza Heapes, (617) 620-4888
Liza.heapes@ariad.com
Exhibit 99.2
Path to Value and
Profitability Elsa So Non-small cell lung cancer ARIAD clinical trial
patient Harvey J. Berger M.D. Chairman and Chief Executive Officer ARIAD
Pharmaceuticals, Inc.
01.14.2015 J.P.
Morgan Healthcare Conference Some of the statements in this presentation
constitute “forward looking statements” under the Private Securities
Litigation Reform Act of 1995. Such statements are subject to factors,
risks and uncertainties (such as those detailed in the Company’s
periodic filings with the SEC) that may cause actual results to differ
materially from those expressed or implied by such forward looking
statements.
01.14.2015 J.P.
Morgan Healthcare Conference ARIAD 2014: key areas of progress
Re-launched Iclusig in the U.S. with ~800 patients treated Successfully
completed EMA review - Iclusig indication statement unchanged Improved
understanding of benefit/risk profile of ponatinib Achieved positive P&R
outcomes in key European countries Concluded consultations with FDA and
EMA on Iclusig dose-ranging trial Secured experienced Japanese partner
for Iclusig Advanced brigatinib (AP26113) into pivotal trial and
designated as Breakthrough Therapy Nominated new development candidate
(AP32788)
01.14.2015 J.P.
Morgan Healthcare Conference 4 ARIAD 2015: our strategic focus Expand
the Iclusig global commercial opportunity Leverage existing commercial
infrastructure and investment Secure a broad partnership for brigatinib
Invest in randomized trials to advance Iclusig and brigatinib into
earlier lines of treatment, expand addressable market Achieve sustained
profitability in 2018 by reaching global product revenue of >$400M
01.14.2015 J.P.
Morgan Healthcare Conference 5 Iclusig: seeking to expand the global
opportunity in resistant Ph+ leukemias Early-switch 2nd line 2nd line
3rd line No other options T315I
01.14.2015 J.P.
Morgan Healthcare Conference Iclusig: seeking to expand the global
opportunity in resistant Ph+ leukemias Chronic Phase Accelerated Phase
Blast Phase Ph+ ALL
01.14.2015 J.P.
Morgan Healthcare Conference Iclusig: leverage existing infrastructure
and investment U.S. and Europe Further expand into chronic-phase disease
and earlier lines of therapy Advance to market leader in 3rd line
chronic-phase CML Continue launching throughout EU28 countries* Japan
Otsuka partnership in Japan and select Asian countries Commercial launch
expected in 2016 Rest of World Additional regional distribution
agreements in 2015 *Includes Central and Eastern Europe distributorship
with CSC Pharmaceuticals, a subsidiary of Angelini Pharma.
01.14.2015 J.P.
Morgan Healthcare Conference ARIAD and Otsuka: a strategic Iclusig
partnership in Japan and Asia Existing hematology sales force with CML
TKI experience Exclusive commercialization by Otsuka in ten Asian
countries Building major hematology/oncology business in Territory $77.5
million upfront, future milestones and substantial portion of net
product sales to ARIAD Joint development in Territory with Otsuka
funding additional agreed-upon clinical studies ARIAD rights to
co-promotion in Japan and China beginning in third year of
commercialization* Approval and launch of Iclusig in Japan expected in
2016 *ARIAD to bear its own cost for the co-promotion and receive a
higher share of incremental sales above a baseline forecast
01.14.2015 J.P.
Morgan Healthcare Conference 2018: product revenues reach >$400M
Revenue projections do not assume an Iclusig 2nd line indication in the
U.S. or an expanded 2nd line indication in Europe during this timeframe.
Global product revenue – with no change to U.S./EU Iclusig label $0 $100
$200 $300 $400 $500 $600 2015E 2016E 2017E 2018E >$400M Sales in
millions Brigatinib Iclusig
01.14.2015 J.P.
Morgan Healthcare Conference Iclusig: potential 2nd line indication more
than doubles the Iclusig opportunity Potential annual CML patients
eligible for Iclusig in 2018/2019 ~3,300 U.S. Source: Kantar Health and
internal data; ROW= Rest of world Europe ~4,000 Japan ~800 ROW ~1,000
01.14.2015 J.P.
Morgan Healthcare Conference Brigatinib – ALK+ NSCLC AP32788 – NSCLC
Lung Cancer: two distinct opportunities - Potential best-in-class orally
active TKI - Highly competitive profile expected to garner significant
market share - Global market approaches $2B by 2020 - Orally active TKI
- Unique profile against a validated class of mutated targets -
Addresses unmet medical need
01.14.2015 J.P.
Morgan Healthcare Conference Brigatinib: maximizing the full value
Secure a broad partnership to co-develop and co-commercialize brigatinib
in 2015 - Leverage existing infrastructure and capabilities - Accelerate
randomized, 1st line trial against crizotinib - Explore new combination
therapies - Mitigate risk ALTA trial forms basis for initial approval;
filing expected mid-2016 Breakthrough therapy designation may accelerate
approval timeline
01.14.2015 J.P.
Morgan Healthcare Conference ALK + NSCLC market: a significant
opportunity 2015 annual incidence ~9,000 U.S. Europe ~5,500
Japan ~3,500 ROW ~4,700 Sources: SEER Cancer Statistics Review
1975-2010; UpToDate; 2012 SEER Data (Cancer Statistics Review,
1975-2008); Cancer.gov; incidence reflects mid-point of range; ROW =
Rest of world
01.14.2015 J.P.
Morgan Healthcare Conference ALK+ NSCLC market: approaching $2B in 5
years Sources: * Xalkori consensus from Thomson Cortellis (7 analysts)
** Zykadia consensus from Thomson Cortellis (4 analysts) *** Alecensa
consensus from Thomson Cortellis (3 analysts) Global ALK Inhibitor
Consensus Revenue Forecasts $0 $400 $800 $1,200 $1,600 $2,000 2015E
2019E ~$700M ~$1.7B Product revenue in millions Alecensa Consensus***
Zykadia Consensus** Xalkori Consensus*
01.14.2015 J.P.
Morgan Healthcare Conference Research & Development Key Investments J.P.
01.14.2015 Morgan
Healthcare Conference Iclusig – doseranging trial in 3rd line CML
Iclusig – randomized trial vs. nilotinib in 2nd line CML Iclusig –
early-switch trial in 2nd line CML (SPIRIT3) Brigatinib – ALTA trial in
refractory ALK+ NSCLC Brigatinib – randomized trial vs. crizotinib in
1st line ALK+ NSCLC AP32788 – Clinical proof-of-concept Hematology Lung
Cancer Our R&D strategy: focused on six investments
01.14.2015 J.P.
Morgan Healthcare Conference Iclusig: dose-ranging 3rd line CML trial
Trial to open by mid-2015 Adult CP-CML patients resistant to ≥ 2 TKIs,
N=450 Primary endpoint: MCyR by 12 months Minimum follow-up of 2 years
1:1:1 Randomization Dose reduction to 15 mg upon achievement of MCyR
Ponatinib 15 mg Ponatinib 30 mg Ponatinib 45 mg
01.14.2015 J.P.
Morgan Healthcare Conference Iclusig: randomized phase 3 trial in 2nd
line CML Global trial evaluating two doses of ponatinib vs. nilotinib;
N=~500 Key Features CML patients resistant to imatinib Population
Primary endpoint of MMR by 12 months Efficacy Focus on arterial
thrombotic events Safety Trial to open 2H 2015
01.14.2015 J.P.
Morgan Healthcare Conference Iclusig: early-switch trial in 2nd line
CML (SPIRIT3) EMR = early molecular response (MR 10) Trial to open 1H
2015 Patients failing to reach EMR at 3 months switch to ponatinib
Reduce dose in patients in MMR for ≥ 2 years; stop treatment if MMR
maintained 1:1 Randomization Newly diagnosed CP-CML patients in the UK;
N = 1,000 Primary endpoint: MMR at 3 years Imatinib 400 mg Nilotinib 300
mg BID Imatinib 400 mg Ponatinib 30 mg Ponatinib 30 mg Nilotinib 300 mg
BID
01.14.2015 J.P.
Morgan Healthcare Conference Brigatinib: pivotal ALTA trial in
refractory LK+ NSCLC Primary endpoint = ORR Non-comparative trial Full
patient enrollment expected in Q3 2015 Brigatinib 90 mg All Patients
Global Trial N= 220 patients Includes patients with brain metastases
Randomized 1:1 1 Week Continue on 90 mg 110 patients Increase to 180 mg
110 patients
01.14.2015 J.P.
Morgan Healthcare Conference 2015 2016 2017 Iclusig • Start of 3 CML
trials • Data presented from ISTs • Early data from dose-ranging trial
Data presented from ISTs Approval in Japan Full patient enrollment in
2nd line trial Additional data from dose-ranging trial brigatinib Full
patient enrollment in ALTA trial Early data from ALTA trial U.S. filing
and approval in refractory ALK+ NSCLC 1st line trial enrolling U.S.
launch EU filing in refractory ALK+ NSCLC AP32788 IND filing Start of
Phase 1/2 trial Pre-clinical data presented Phase 1/2 Proof of Concept
data Key R&D milestones: next 3 years
01.14.2015 J.P.
Morgan Healthcare Conference Marcele Wilson Chronic myeloid leukemia
ARIAD clinical trial patient Achieving Profitability in 2018
01.14.2015 J.P.
Morgan 01.14.2015 Healthcare Conference Revenue – product and license
$100 Selling, general and administrative expenses $140 Research and
development expenses $120 Cash and cash equivalents as of 12/31/14 $350
2014 Key financial results *All amounts presented are unaudited
estimates; revenue includes product revenue from sales of Iclusig and
license revenue including revenue related to the revised license
agreement with Bellicum Estimated FY 2014 financials* (dollars in
millions)
01.14.2015 J.P.
Morgan Healthcare Conference Path to sustained profitability 2015 2016
2017 2018 Revenue growth and partnerships drive increased cash flow
Iclusig revenue growth in U.S. and Europe from current label Iclusig
revenue from Japan and new geographies Brigatinib revenue and
partnership payments Sustained profitability achieved on >$400M revenues
in 2018 Strategic investment to support long-term growth Commercial
presence in U.S. and Europe Iclusig development in earlier lines of
therapy Brigatinib and AP32788 development No requirement for additional
equity capital Broad co-development and co-commercialization partnership
for brigatinib
01.14.2015 J.P.
Morgan Healthcare Conference ARIAD 2015: key catalysts Accelerate
Iclusig sales in U.S. and Europe Initiate key Iclusig trials
Dose-ranging trial Randomized 2nd line trial vs. nilotinib Early- switch
2nd line trial (SPIRIT3) Secure broad partnership for brigatinib Present
early data from brigatinib pivotal ALTA trial File for approval of
Iclusig in Japan with Otsuka File IND for new development candidate
AP32788
ARIAD®
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