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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): June 4, 2016
ARIAD Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-36172
22-3106987
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
26 Landsdowne Street, Cambridge, Massachusetts
02139
(Address of principal executive offices)
(Zip Code)
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))
ITEM 8.01 Other Events.
On June 4, 2016, ARIAD Pharmaceuticals, Inc. (the “Company”) issued the first of three press releases announcing data presented at
the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. This press release detailed updated
clinical data on the Company’s investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma
kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The current results include
more mature efficacy and safety data for brigatinib, including updated response rates and median duration of response in ALK+
NSCLC patients. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 8.01of
this Current Report on Form 8-K.
On June 4, 2014, the Company issued a second press release announcing clinical data from an analysis aimed at characterizing the
activity of brigatinib in patients with ALK+ advanced NSCLC who have progressed on crizotinib. The analysis was based on ALK
mutation status as determined by next-generation sequencing of tumor tissue collected from the ongoing Phase 1/2 and ALTA clinical
trials. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated by reference into this Item 8.01of this Current
Report on Form 8-K.
On June 6, 2014, the Company issued its third and final press release from ASCO announcing updated clinical data on brigatinib from
the pivotal ALTA trial in patients who had experienced disease progression on crizotinib therapy. The data show that, of patients on
the 180 mg regimen (Arm B) with a median follow-up of 8.3 months, 54 percent achieved a confirmed objective response, the trial’s
primary endpoint. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months) in this post-crizotinib
setting. Additionally, a 67 percent confirmed intracranial objective response rate (ORR) was achieved in patients with measurable
brain metastases. These data were presented for the first time on June 6 th at ASCO, reflecting an additional 12 weeks of patient
follow up and new data on central nervous system (CNS) activity compared to the abstract released last month. A copy of the press
release is attached hereto as Exhibit 99.3 and is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
ITEM 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Description
99.1
Press release dated June 4, 2016
99.2
Press release dated June 4, 2016
99.3
Press release dated June 6, 2016
The press releases may contain 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.
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.
ARIAD Pharmaceuticals, Inc.
By:
/s/ Manmeet S. Soni
Manmeet S. Soni
Executive Vice President, Chief Financial Officer
Date: June 7, 2016
Exhibit List
Exhibit
Description
99.1
Press release dated June 4, 2016
99.2
Press release dated June 4, 2016
99.3
Press release dated June 6, 2016
Exhibit 99.1
News Release
ARIAD PRESENTS LONG-TERM PHASE 1/2 TRIAL FOLLOW UP ON
INVESTIGATIONAL DRUG BRIGATINIB WITH MEDIAN TIME ON
TREATMENT OF 17 MONTHS IN ALK+ NSCLC PATIENTS
~ Longest Time on Treatment Now More Than 3.5 Years
for Patients with ALK+ Non-Small Cell Lung Cancer
~ Data from Phase 1/2 Clinical Trial Presented at 2016 ASCO Meeting
Chicago, IL and Cambridge, MA – June 4, 2016 –ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated
clinical data on its investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma kinase-positive
(ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The current results include more mature
efficacy and safety data for brigatinib, including updated response rates and median duration of response in ALK+ NSCLC patients.
The updated Phase 1/2 results are being presented today at the 2016 American Society of Clinical Oncology (ASCO) annual meeting
in Chicago.
Phase 1/2 Study
The data presented at ASCO include safety analyses on all patients in the trial (n=137) and efficacy analyses on all patients with
ALK+ NSCLC (n=79). Of the 79 ALK+ NSCLC patients, all but eight had failed prior crizotinib. The presentation is based on patient
data as of November 2015 with a median time on treatment for ALK+ NSCLC patients of 17.0 months (range, 0.03 – 44.4 months,
ongoing). Patient enrollment in the trial is complete, with the last patient enrolled in July 2014.
“The long-term follow up on this clinical trial of brigatinib shows substantial anti-tumor activity with an objective response rate of
approximately 72 percent in crizotinib-resistant ALK-positive NSCLC patients,” stated D. Ross Camidge, M.D., Ph.D., director of
thoracic oncology at the Colorado University Cancer Center. “The median progression-free survival in this post-crizotinib patient
group exceeds one-year and has not yet been reached in patients not previously treated with crizotinib. Importantly, no new safety
signals have emerged at this later time of follow up.”
Key data from the study include:
Anti-tumor Activity of Brigatinib in ALK+ NSCLC Patients
•
Of the 71 ALK+ NSCLC patients with prior crizotinib therapy, 51 (72%) demonstrated an objective response to
brigatinib. Forty-four responses were confirmed (62%).

Of the 25 patients treated at the 180 mg dose regimen that included a seven-day lead-in dose of 90 mg, 20
(80%) demonstrated an objective response, of which 19 (76%) were confirmed.
•
Of the eight crizotinib-naive ALK+ NSCLC patients treated with brigatinib, all demonstrated an objective response
(100%), including three complete responses (CR). All responses were confirmed.
•
The “waterfall plot” analysis demonstrated tumor shrinkage in nearly all ALK+ NSCLC patients, with 21 patients
experiencing 100 percent shrinkage of the target lesions.
•
The median duration of response in confirmed responders was 14.5 months in ALK+ NSCLC patients treated with
prior crizotinib therapy and was not yet reached in ALK+ NSCLC patients who were crizotinib-naive.
•
Median progression-free survival (PFS) was 12.9 months in ALK+ NSCLC patients with prior crizotinib therapy and
was not yet reached in ALK+ NSCLC patients who were crizotinib-naive.
•
Overall survival (OS) at one year was 77 percent in patients who received prior crizotinib (projected 2-year OS was
63%) and 100 percent in patients who were crizotinib-naive (projected 2-year OS was 100%).
An evaluation of the efficacy of brigatinib in ALK+ NSCLC patients with intracranial CNS metastases at baseline was also included
in the ASCO presentation. In an independent central review of brain magnetic resonance imaging (MRI) scans, 46 ALK+ NSCLC
patients were evaluable for intracranial response, including 15 who had measurable intracranial
2
CNS metastases at baseline, and 31 patients who had only non-measurable intracranial CNS metastases.

10 of 15 (67%) patients with measurable intracranial CNS metastases had an intracranial objective response, and 13
of 31 (42%) with only non-measurable intracranial CNS metastases had complete disappearance of intracranial
lesions.

Median intracranial PFS for ALK+ NSCLC patients with intracranial CNS metastases at baseline was 15.6 months.
Median duration of intracranial response in confirmed responders was 11.4 months.
Safety and Tolerability – All Patients Enrolled
•
The most common treatment-emergent adverse events (AEs; 30%), regardless of relationship to treatment, in all
patients were nausea (51%), fatigue (42%), diarrhea (41%), headache (34%), and cough (33%).
•
Treatment-emergent AEs, regardless of relationship to treatment, grade 3 or higher, occurring in4% patients were
increased lipase (9%), dyspnea (7%), hypertension (5%), increased amylase (4%), and fatigue (4%)
•
Serious treatment-emergent AEs, regardless of relationship to treatment, occurring in three or more patients were
dyspnea (7%), pneumonia (7%), hypoxia (5%), pulmonary embolism (3%), malignant pericardial effusion (2%), and
pneumonitis (2%).
•
A subset of pulmonary AEs (including dyspnea, hypoxia, pneumonia and/or pneumonitis) was observed to occur
within 7 days of treatment initiation or treatment re-initiation following a prolonged dose interruption. Most events
occurred within 48 hours of dosing and were generally managed with dose interruption or discontinuation.
•

Rates of these AEs were numerically lower with lower starting doses (11/137 [8%], overall)

6/44 (14%) in patients started at 180 mg qd

1/50 (2%) in patients started at 90 mg qd

Among 32 patients treated with 90 mg qd for 7 days followed by 180 mg qd, no such events were reported after dose
escalation
Administration of brigatinib at 180 mg with a 7-day lead-in at 90 mg appears to not be associated with an increased
risk of additional early pulmonary AEs, when compared with continuous administration of brigatinib at 90 mg.
3
About Brigatinib
Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development
for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is
resistant to crizotinib. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for
its initial regulatory review. ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy of brigatinib in comparison to
crizotinib. More information on brigatinib clinical trials, including the expanded access program (EAP) can be found here .
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is an orphan 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 orphan 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 ).
Forward-Looking Statements
This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts,
including, but not limited to, statements regarding: updated clinical data for brigatinib and the therapeutic potential of brigatinib are
forward-looking statements which 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
statements. These factors, risks and uncertainties include, among others: early-stage clinical data may not be replicated in later-stage
clinical studies; the costs associated with our research, development, manufacturing and other activities; the adequacy of our capital
resources and the availability of additional funding; our ongoing and additional clinical trials of brigatinib may not be successful or
initiated, enrolled or conducted in a timely manner; regulatory developments and safety issues; competitive risks; manufacturing
issues and those additional factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our
most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward4
looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these
statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance
on the forward-looking statements contained in this press release. All forward-looking statements in this press release are qualified in
their entirety by this cautionary statement.
CONTACTS:
For Investors
Manmeet S. Soni
[email protected]
(617) 503-7298
For Media
Liza Heapes
[email protected]
(617) 621-2315
###
5
Exhibit 99.2
News Release
ARIAD PRESENTS DATA FROM MUTATIONAL PROFILING IN
CRIZOTINIB-RESISTANT PATIENTS TREATED WITH INVESTIGATIONAL
MEDICINE BRIGATINIB SHOWING SIMILAR RESPONSE RATES IN
PATIENTS WITH AND WITHOUT SECONDARY ALK MUTATIONS
~ Brigatinib Achieves Confirmed Response in Patient with G1202R Mutation that Emerges
Following Treatment with Current Approved Therapies
Chicago, IL and Cambridge, MA – June 4, 2016 –ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced clinical data
from an analysis aimed at characterizing the activity of its investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with
anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The
analysis was based on ALK mutation status as determined by next-generation sequencing (NGS) of tumor tissue collected from the
ongoing Phase 1/2 and ALTA clinical trials.
Data from this analysis showed that brigatinib yields confirmed responses in patients with multiple different secondary ALK
mutations, including one G1202R case. There are no currently approved ALK treatments that have demonstrated activity against the
G1202R mutation.
These data are being presented today at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Study Methods
Requirements for the Phase 1/2 and ALTA trials of brigatinib included that tumor tissue be collected at patient screening after failure
on crizotinib therapy and prior to brigatinib treatment. An optional post-baseline tumor biopsy also was requested following disease
progression on brigatinib. Tumor samples were analyzed using a NGS (next-generation sequencing) platform that examined the entire
coding sequence of 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer. This analysis focuses on
the relationship between brigatinib clinical activity and ALK mutation status at baseline and after disease progression on brigatinib
therapy.
A total of 32 baseline tumor samples from the clinical trials of brigatinib were evaluable using NGS, and a total of six post-baseline
samples following disease progression on brigatinib were evaluable by NGS.
Study Results
•
Of the 32 patients with baseline NGS data, 22 (69%) achieved a confirmed objective response on brigatinib.
•
Of the 9 patients with secondary ALK mutations at baseline, 7 (78%) achieved a confirmed objective response on
brigatinib.
•
Of the 23 patients without secondary ALK mutations at baseline, 15 (65%) achieved a confirmed objective response
rate (ORR) on brigatinib.
•
Of the 6 patients with evaluable tissue samples collected after progression on brigatinib therapy, 5 (83%) were
determined to have detectable secondary mutations in the ALK kinase domain. Three out of five of these patients had
complex mutation patterns, following responses lasting 5.4, 7.4 and 28.5 months. Two out of five had single
secondary ALK kinase domain mutations detected, following responses lasting 10.9 and 11 months.
•
Of the one patient with a secondary G1202R mutation, the patient achieved a confirmed response on brigatinib and
the response is on-going.
“It is encouraging that responses to brigatinib were observed in patients with crizotinib resistant ALK+ lung cancer with and without
the presence of ALK resistance mutations. This is consistent with preclinical studies showing brigatinib to be a potent pan-inhibitor of
all known ALK secondary resistance mutants,” stated Scott N. Gettinger, M.D., associate professor of medicine at Yale Cancer
Center.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is an orphan 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 orphan 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 ).
2
Forward-Looking Statements
This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts,
including, but not limited to, statements regarding: updated clinical data for brigatinib and the therapeutic potential of brigatinib are
forward-looking statements which 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
statements. These factors, risks and uncertainties include, among others: early-stage clinical data may not be replicated in later-stage
clinical studies; the costs associated with our research, development, manufacturing and other activities; the adequacy of our capital
resources and the availability of additional funding; our ongoing and additional clinical trials of brigatinib may not be successful or
initiated, enrolled or conducted in a timely manner; regulatory developments and safety issues; competitive risks; manufacturing
issues and those additional factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our
most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of
these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press release. All forward-looking statements in this press release are
qualified in their entirety by this cautionary statement.
CONTACTS:
For Investors
Manmeet S. Soni
[email protected]
(617) 503-7298
For Media
Liza Heapes
[email protected]
(617) 621-2315
###
3
Exhibit 99.3
News Release
FOR IMMEDIATE RELEASE
ARIAD’S INVESTIGATIONAL MEDICINE BRIGATINIB DEMONSTRATES 54
PERCENT CONFIRMED OBJECTIVE RESPONSE RATE AND 12.9-MONTH
MEDIAN PROGRESSION-FREE SURVIVAL IN ALTA STUDY
~ 67 Percent Confirmed Intracranial Objective Response Rate
in Patients with Measurable Brain Metastases
~ Data from Pivotal Study in Refractory ALK Positive
Non-Small Cell Lung Cancer Patients
~ Investor and Analyst Webcast to be Held at the 2016 ASCO Meeting Today at 7 a.m. CT
Cambridge, MA, June 6, 2016 –ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data on
brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in patients who had
experienced disease progression on crizotinib therapy. The data show that, of patients on the 180 mg regimen (Arm B) with a median
follow-up of 8.3 months, 54 percent achieved a confirmed objective response, the trial’s primary endpoint. In this arm, the median
progression free survival (PFS) exceeded one year (12.9 months) in this post-crizotinib setting. Additionally, a 67 percent confirmed
intracranial objective response rate (ORR) was achieved in patients with measurable brain metastases. These data will be presented
today, for the first time, at the Annual Meeting of the American Society of Clinical Oncology (ASCO), reflecting an additional 12
weeks of patient follow up and new data on central nervous system (CNS) activity compared to the abstract released last month.
“Most patients with ALK-positive non-small cell lung cancer who are treated with crizotinib eventually experience disease
progression, often due to acquired ALK resistance mutations or metastases in the central nervous system,” said presenting author
Dong-Wan Kim, M.D., Ph.D., head of the Cancer Clinical Trials Center at the Seoul National University Hospital in South Korea.
“For these patients, we are very excited by the brigatinib ALTA trial data, which showed compelling efficacy and safety data,
including complete responses and activity in the CNS.”
The ALTA trial
The primary endpoint of the ALTA (ALK in Lung Cancer Trial of AP26113) trial is investigator-assessed confirmed objective
response rate (ORR) as measured by the
2
Response Evaluation Criteria in Solid Tumors (RECIST). Key secondary endpoints include progression free survival (PFS),
confirmed ORR assessed by an independent review committee (IRC), CNS response (IRC-assessed intracranial ORR and PFS),
overall survival, safety and tolerability. Brigatinib was granted the U.S. Food and Drug Administration (FDA) Orphan Drug
designation for ALK+ non-small cell lung cancer (NSCLC) and the FDA Breakthrough Therapy designation for the treatment of
patients with ALK+ non-small cell lung cancer (NSCLC) that is resistant to crizotinib.
The trial enrolled 222 patients with ALK+ NSCLC who had been treated with and experienced disease progression on crizotinib.
Patients were randomized one-to-one to receive either 90 mg of brigatinib once per day (QD) (Arm A), or 180 mg QD with a seven
day lead-in at 90 mg QD (Arm B).
In addition, patients were stratified by the presence of brain metastases at baseline and best response to prior crizotinib.
Key Data from the ALTA Trial
Brigatinib Efficacy and Safety in ALK+ NSCLC Patients:
Data as of February 29, 2016
•
A total of 222 patients with ALK+ NSCLC treated with prior crizotinib therapy were randomized in the study (110
patients in Arm B at the 180 mg dose level with 7-day lead-in at 90 mg and 112 patients in Arm A at the 90 mg dose
level). The last patient enrolled in the study in September 2015.
•
The median follow-up was 8.3 months in Arm B (range 0.1–20.2) and 7.8 months in Arm A (range 0.1–16.7).
•
Investigator-assessed confirmed ORR in Arm B was 54 percent, including four complete responses. Confirmed ORR
in Arm A was 45 percent, including one complete response.
•
Responses in Arm B included a confirmed partial response in a patient with the ALK kinase domain G1202R
mutation at baseline, which is associated with resistance to all approved tyrosine kinase inhibitors (TKIs).
•
Median PFS was 12.9 months and 9.2 months in Arm B and Arm A, respectively. Probability of overall survival (OS)
at 1-year was 80 percent and 71 percent in Arm B and Arm A, respectively.
•
An evaluation of the efficacy of brigatinib in ALK+ NSCLC patients with intracranial CNS metastases at baseline
was also included in the ASCO presentation.
3

In an independent central review of brain magnetic resonance imaging (MRI) scans, 18 patients in Arm B and 25
patients in Arm A were identified as having measurable CNS metastases at baseline.

Among patients with measurable CNS metastases at baseline, the IRC-assessed confirmed intracranial ORR was 67
percent (12/18) in Arm B and 36 percent (9/25) in Arm A; among the subset of patients with measurable, active
brain metastases, confirmed intracranial ORR was 73 percent (11/15) in Arm B and 36 percent (7/19) in Arm A.
Measurable, active brain metastases are defined as having had no prior radiotherapy or progression following
radiotherapy.

Median intracranial PFS for patients with intracranial CNS metastases at baseline was not yet reached in Arm B and
was 15.6 months in Arm A.
•
The most common treatment-emergent adverse events (TEAEs; 25% of all patients, [Arm B/A]), regardless of
relationship to treatment, were nausea (40%/33%), diarrhea (38%/19%), cough (34%/18%), and headache
(27%/28%).
•
TEAEs, grade 3, occurring in 5 percent of all patients (Arm B/A), were increased blood creatine phosphokinase
(9%/3%) and hypertension (6%/6%).
•
A subset of pulmonary adverse events with early onset (median: Day 2; range: Day 1-9) occurred in 6 percent of all
patients ( grade 3 in 3% of patients); no such events with early onset occurred after dose escalation to 180 mg QD
in Arm B.
•
Discontinuations and dose reductions due to AEs (Arm B/A) were 8 percent/3 percent and 20 percent/7 percent,
respectively. Discontinuations due to progressive disease (Arm B/A) were 17 percent and 30 percent.
“The ALTA trial data support our planned NDA submission with a recommendation for dosing with 180 mg once daily following a
seven-day lead-in at 90 mg. We are on track for submission in the third quarter,” stated Timothy P. Clackson, Ph.D., president of
research and development and chief scientific officer at ARIAD. “We believe brigatinib’s antitumor activity both on disease in the
lungs and in the central nervous system, safety profile, and once-daily dosing regimen taken with or without food, provide the
potential for brigatinib to be an important new therapeutic option for the crizotinib-resistant patient population.”
Investor and Analyst Briefing and Webcast
A breakfast meeting featuring D. Ross Camidge, M.D., Ph.D., director of thoracic oncology at the Colorado University Cancer Center,
to review the updated brigatinib clinical data from the ALTA trial will be webcast live along with slides and can be
4
accessed by visiting the investor relations section of ARIAD’s website at http://investor.ariad.com.
Date:
Monday, June 6, 2016
Time:
7:00 a.m. to 8:00 a.m. (CT)
Location: Hyatt McCormick Place
A replay of the investor event will be available on the ARIAD website approximately three hours after the presentation and will be
archived on the site for four weeks. To ensure a timely connection to the live webcast, participants should log onto the webcast at least
15 minutes prior to the scheduled start time.
About Brigatinib
Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development
for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is
resistant to crizotinib. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for
its initial regulatory review. ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy of brigatinib in comparison to
crizotinib. More information on brigatinib clinical trials, including the expanded access program (EAP) can be found here .
Brigatinib Oral Presentation
The oral presentation, “Brigatinib (BRG) in patients (pts) with crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer
(NSCLC): first report of efficacy and safety from a pivotal randomized phase (ph) 2 trial (ALTA),” (Abstract #9007) will be presented
today, Monday, June 6 in the Arie Crown Theater at 11:57 a.m. CT.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is an orphan 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 orphan 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 ).
5
Forward-Looking Statements
This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any
statements contained herein which do not describe historical facts, including, but not limited to the statements made by Drs. Kim and
Clackson, are forward-looking statements that 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 statements. These factors, risks and uncertainties include, but are not limited to, our ongoing strategic review, our
ability to successfully commercialize and generate profits from sales of Iclusig and our product candidates, if approved; competition
from alternative therapies; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and
regulatory filing dates for our products and product candidates and to move new development candidates into the clinic; our ability to
execute on our key corporate initiatives; regulatory developments and safety issues, including difficulties or delays in obtaining
regulatory and pricing and reimbursement approvals to market our products; our reliance on the performance of third-party
manufacturers and specialty pharmacies for the supply and distribution of our products and product candidates; the occurrence of
adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing,
commercialization and other activities; the conduct, timing and results of preclinical and clinical studies of our products and product
candidates, including that preclinical data and early-stage clinical data may not be replicated in later-stage clinical studies; the
adequacy of our capital resources and the availability of additional funding; the ability to satisfy our contractual obligations, including
under our leases, convertible debt and royalty financing agreements; patent protection and third-party intellectual property claims;
litigation; 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 our public filings with the U.S. Securities and Exchange Commission,
including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted,
these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any
of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press release.
CONTACTS:
For Investors
Manmeet S. Soni
[email protected]
(617) 503-7298
For Media
Liza Heapes
[email protected]
(617) 621-2315
###