BOULDER, Colo., Aug. 14, 2018 /PRNewswire/ -- Array
BioPharma Inc. (Nasdaq: ARRY) today reported results for its fourth
quarter and full year of fiscal 2018 and provided an update on the
progress of its key commercial products and clinical development
programs.
"We were thrilled to launch BRAFTOVI™ + MEKTOVI® for
patients with BRAF-mutant melanoma in the U.S. after
receiving FDA approval for the combination in June. Since then, we
have seen a very positive reception from melanoma healthcare
providers. With the announcement of a median overall survival of
33.6 months from the Phase 3 COLUMBUS trial at ASCO, and an
attractive tolerability profile, our commercial team is
well-positioned for success," said Ron Squarer, Chief Executive
Officer. "We were also very pleased to announce an observed overall
survival of 62% at one year in patients with BRAF-mutant
metastatic colorectal cancer in updated safety lead-in results from
the Phase 3 BEACON CRC trial. At the time of analysis, the overall
survival data were fully mature through 12.6 months and the median
overall survival had not yet been reached. FDA Breakthrough Therapy
Designation was based on the BEACON CRC safety lead-in data, which
further demonstrates the opportunity for encorafenib and
binimetinib to benefit patients with limited treatment
options."
COMMERCIAL
BRAFTOVI + MEKTOVI Approval and
Launch
On June 27, 2018, the
U.S. Food and Drug Administration (FDA) approved BRAFTOVI capsules
in combination with MEKTOVI tablets for the treatment of patients
with unresectable or metastatic melanoma with a
BRAFV600E or BRAFV600K
mutation, as detected by an FDA-approved test. BRAFTOVI is not
indicated for the treatment of patients with wild-type BRAF
melanoma.
BRAFTOVI + MEKTOVI were available for sale beginning on
July 2, 2018, and patients began
receiving the combination therapy that same week.
In addition, on July 16, 2018,
Array submitted supplementary New Drug Applications to seek
inclusion of overall survival (OS) data from the Phase 3 COLUMBUS
trial in the BRAFTOVI and MEKTOVI labels.
National Comprehensive Cancer Network (NCCN)
Recommendation
On July 13,
2018, the NCCN updated the Clinical Practice Guidelines in
Oncology for Melanoma to include BRAFTOVI in combination with
MEKTOVI as a Category 1 first-line and second-line treatment option
for patients with
BRAFV600E or BRAFV600K-mutant
metastatic or unresectable melanoma. A Category 1 recommendation
indicates that, based upon high-level evidence, there is uniform
NCCN consensus that the intervention is appropriate.
Positive CHMP Opinion for Advanced BRAF-mutant
Melanoma
On July 27, 2018, the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion
recommending approval of BRAFTOVI + MEKTOVI for unresectable or
metastatic BRAFV600-mutant melanoma. This opinion
is based on data from the COLUMBUS trial and the recommendation
will now be reviewed by the European Commission (EC), which has the
authority to approve medicines for the European Union (EU). The
final EC decision, expected by the end of September, will be
applicable to all 28 EU member states, as well as Liechtenstein, Iceland and Norway.
COLUMBUS PHASE 3 TRIAL
Updated COLUMBUS Trial
Results including Overall Survival Announced at ASCO
Array
announced updated results from the COLUMBUS trial in
BRAF-mutant advanced melanoma as part of an oral
presentation at the American Society of Clinical Oncology (ASCO)
annual meeting on June 4, 2018, and
that these results have been selected for the "Best of ASCO"
program.
- The median OS was 33.6 months for patients treated with the
combination of encorafenib and binimetinib compared to 16.9 months
for patients treated with vemurafenib as a monotherapy. The
combination reduced the risk of death compared to treatment with
vemurafenib alone hazard ratio (HR) of 0.61, [95% CI 0.47, 0.79, p
<0.0001].
- The data showed limited use of post-trial immunotherapy, which
is consistent with other published pivotal trials of BRAF and
MEK-inhibitors in BRAF-mutant advanced melanoma. [1-2]
- As previously reported, the combination of encorafenib and
binimetinib was generally well-tolerated. Grade 3/4 adverse events
(AEs) that occurred in more than 5% of patients receiving the
combination were increased gamma-glutamyltransferase (GGT) (9%),
increased blood creatine phosphokinase (CK) (7%) and hypertension
(6%). The incidence of selected any grade AEs of special interest,
defined based on toxicities commonly associated with commercially
available BRAF+MEK-inhibitor treatments for patients receiving the
combination of encorafenib and binimetinib included: rash (22%),
serous retinopathy (20%), pyrexia (18%) and photosensitivity (5%).
Full safety results of COLUMBUS Part 1 were published in The
Lancet Oncology.
BEACON CRC PHASE 3 TRIAL
Breakthrough Therapy
Designation
On August 7, 2018, Array announced that the FDA
granted Breakthrough Therapy Designation to BRAFTOVI, in
combination with MEKTOVI and cetuximab for the treatment of
patients with BRAFV600E-mutant metastatic
colorectal cancer (mCRC) as detected by an FDA-approved test, after
failure of one to two prior lines of therapy for metastatic
disease. BRAFV600E-mutant mCRC patients have a
mortality risk more than double that of mCRC patients without the
mutation, and currently there are no therapies specifically
approved for this high unmet need population. [3-8] Breakthrough
Therapy Designation is an FDA process designed to expedite the
development and review of drugs that are intended to treat a
serious condition where preliminary clinical evidence indicates
that they may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints.
Regulatory Update
Based on consultation with the FDA
and EMA, Array plans to amend the BEACON CRC protocol to allow for
an interim analysis of trial endpoints. Should a planned analysis
based primarily on confirmed overall response rate (ORR) and
durability of response be supportive, the Company plans to use it
to seek accelerated approval in the U.S. The interim analysis may
also support regulatory submissions in other regions. The Company
anticipates topline results from this analysis in the first half of
2019. This timing allows for the subset of patients required for
the interim analysis of ORR to achieve a response and for the
durability of responses to be appropriately evaluated.
The BEACON CRC trial continues to enroll well. Based on the
updated data presented at the 20th World Congress on
Gastrointestinal Cancer (ESMO World GI), excitement among global
investigators continues to increase. As a result of the recent FDA
approval for BRAFTOVI + MEKTOVI in BRAF-mutant melanoma,
Array has made the decision to conclude U.S.-specific patient
enrollment in the BEACON CRC trial. This action was based on the
recommendation of the trial Steering Committee and Array expects
this will help to avoid introducing unwanted informative censoring
into the trial, as U.S. patients and investigators now have the
potential to access encorafenib and binimetinib via commercial
supply. As the number of active global sites has continued to
increase since the beginning of the year, Array does not believe
this decision will have a material impact on its plan to complete
enrollment of the trial around the end of 2018.
Updated BEACON CRC Safety Lead-In Data including Overall
Survival Results Announced at ESMO World GI
Array
announced updated safety and efficacy results, including OS, from
the safety lead-in of the BEACON CRC trial evaluating the triplet
combination of encorafenib, binimetinib and cetuximab, in 29
patients with BRAFV600E-mutant mCRC during an
oral presentation at ESMO World GI on June 23, 2018.
- At the time of analysis, the OS data were fully mature through
12.6 months and the median OS had not yet been reached. The
observed one-year OS rate for this cohort was 62%.
- The median Progression Free Survival (mPFS) for patients
treated with the triplet was 8 months [95% CI 5.6-9.3] and is
similar between patients receiving one prior line of therapy and
patients receiving two prior lines of therapy.
- The triple combination was generally well-tolerated with no
unexpected toxicities. The most common grade 3 or 4 adverse events
seen in at least 10% of patients were fatigue (13%), anemia (10%),
increased blood CK (10%) and increased aspartate aminotransferase
(10%).
IMMUNO-ONCOLOGY COLLABORATIONS: TRIALS ADVANCING WITH
BRISTOL-MYERS SQUIBB AND MERCK;
TRIAL WITH PFIZER EXPECTED TO START THIRD QUARTER OF 2018
Array is developing binimetinib in combination with PD-1/PD-L1
checkpoint inhibitors and previously announced separate,
strategic collaborations with Bristol-Myers Squibb, Merck and
Pfizer. Each collaboration is pursuing a different rationally
designed clinical approach.
Bristol-Myers Squibb
- The clinical trial continues to advance and is designed to
investigate the safety, tolerability and efficacy of binimetinib in
combination with nivolumab (anti-PD-1 therapy), with and without
ipilimumab (CTLA-4 antibody), in patients with advanced metastatic
microsatellite stable (MSS) CRC and the presence of a RAS
mutation who have received one or two prior regimens.
- The trial is jointly supported by Array and Bristol-Myers
Squibb and sponsored by Array.
Merck
- The clinical trial continues to advance and is designed to
investigate the safety, tolerability and efficacy of binimetinib in
combination with pembrolizumab (anti-PD-1 therapy), with and
without FOLFOX or FOLFIRI (chemotherapy), in first or second-line
patients with CRC whose tumors are not microsatellite
instability-high (MSI-H).
- The trial is sponsored and funded by Merck, with Array
providing binimetinib supply.
Pfizer
- The clinical trial is designed to investigate the safety,
tolerability and efficacy of several novel anti-cancer
combinations, including binimetinib, avelumab (anti-PD-L1 therapy)
and talazoparib (PARP inhibitor) across various tumor types and is
expected to begin during the third quarter of 2018.
- Initially, the focus will be in non-small cell lung cancer and
pancreatic cancer, with additional indications being explored at a
later stage.
- The trial will be sponsored and funded by Pfizer, with Array
providing binimetinib supply.
CORPORATE UPDATE
On August 10, 2018, Array announced
that Carrie S. Cox joined the
Company's Board of Directors as Chairman, effective immediately.
Ms. Cox served as Executive Vice President and President of both
Schering-Plough and Pharmacia's Global Pharmaceutical Businesses
and has been named to FORTUNE Magazine's list of the "50 Most
Powerful Women in Business" six times. As an experienced corporate
director with a wealth of commercial expertise and a distinguished
career in the biopharmaceutical industry, Ms. Cox's leadership will
help drive the success of the Company's recent launch of BRAFTOVI +
MEKTOVI and advance Array's innovative treatments for patients in
critical need. Kyle Lefkoff, General
Partner of Boulder Ventures Ltd., and former Array Chairman, will
continue to serve as a director.
FINANCIAL HIGHLIGHTS
Fourth Quarter of Fiscal 2018 Compared to Third Quarter of
Fiscal 2018 (Sequential Quarters Comparison)
- Revenue for the fourth quarter of fiscal 2018 was
$35.4 million, compared to
$66.4 million for the prior quarter.
The decrease was primarily due to a one-time upfront license fee
from ASLAN Pharmaceuticals received during the prior quarter as
well as lower Novartis reimburseable activities.
- Cost of partnered programs for the fourth quarter of
fiscal 2018 was $16.2 million,
compared to $17.7 million for the
prior quarter. The decrease was primarily due to timing of clinical
trial expense.
- Research and development expense for proprietary
programs was $48.1 million,
compared to $53.6 million in the
prior quarter. The decrease was driven by activity on the Novartis
transitioned trials.
- Selling, General and Administrative for the fourth
quarter of fiscal 2018 was $19.3
million, compared to $15.6
million for the prior quarter, primarily driven by increased
commercial expenses.
- Loss from operations for the quarter was $48.1 million, compared to a loss from operations
of $20.6 million in the previous
quarter. The increase in net loss was primarily due to lower
partner revenue during the current quarter.
- Net loss for the fourth quarter was $52.4 million, or ($0.25) per share, compared to $22.9 million, or ($0.11) per share, in the prior quarter.
- Cash, cash equivalents and marketable securities as of
June 30, 2018 were $413 million.
Fourth Quarter of Fiscal 2018 Compared to Fourth Quarter
of Fiscal 2017 (Prior Year Comparison)
- Revenue for the fourth quarter of fiscal 2018 increased
by $1.7 million compared to the same
quarter of fiscal 2017. The increase was primarily due to increased
reimbursement of BEACON CRC trial expenses as well as new and
expanded collaborations and milestones earned.
- Cost of partnered programs increased $6.1 million compared to the fourth quarter of
fiscal 2017. The increase was primarily due to higher costs
incurred for the BEACON CRC trial, and more resources engaged on
collaborations.
- Research and development expense for proprietary
programs increased $9.0 million,
compared to the fourth quarter of fiscal 2017. The increase was
driven by research and clinical activity on our proprietary
programs.
- Selling, General and Administrative increased
$8.3 million compared to fourth
quarter of fiscal 2017, primarily driven by increased commercial
expenses.
- Net loss for the fourth quarter of fiscal 2018 was
$52.4 million, or ($0.25) per share, compared to $29.6 million, or ($0.17) per share, for the same quarter in fiscal
2017. The increase in net loss was primarily due to increased
research and development expense and costs to establish our
commercial infrastructure in preparation for the BRAFTOVI + MEKTOVI
launch.
Full Year of Fiscal 2018 Compared to Full Year of Fiscal
2017 (Prior Year Comparison)
- Revenue was $173.8 million
for the fiscal year ended June 30, 2018, compared to $150.9 million in fiscal 2017. This increase was
primarily driven by higher license and milestone revenue earned in
2018 from Asahi Kasei Pharmaceutical, ASLAN Pharmaceuticals, Loxo
Oncology, Mirati and Ono Pharmaceutical Co., Ltd.
- Net loss for the fiscal year ended June 30, 2018, was
$147.3 million, or ($0.74) per share, compared to a net loss of
$116.8 million, or ($0.72) per share, in fiscal 2017. The increase
in net loss was primarily due to increased research and development
expense to advance our proprietary programs and costs to establish
our commercial infrastructure in preparation of the BRAFTOVI +
MEKTOVI launch.
- Net cash used in operating activities for the fiscal
year ended June 30, 2018, was $119.8
million, compared to $39.4
million in fiscal 2017. The increase in cash used in 2018
was driven by increased research and development expense and costs
to establish our commercial infrastructure in preparation for the
BRAFTOVI + MEKTOVI launch.
CONFERENCE CALL INFORMATION
Array will hold a
conference call on Tuesday, August 14, 2018, at 9:00 a.m. Eastern
Time to discuss these results and provide an update on the progress
of its key commercial products and clinical development programs.
Ron Squarer, Chief Executive Officer, will lead the call.
Date:
Tuesday, August 14, 2018
Time:
9:00 a.m. Eastern Time
Toll-Free: (844)
464-3927
Toll:
(765) 507-2598
Pass Code: 1766079
Webcast, including Replay and Conference Call Slides:
https://edge.media-server.com/m6/p/qe7apmnp
About BRAF-mutant Metastatic
Melanoma
Melanoma develops when unrepaired DNA damage to
skin cells triggers mutations that may lead them to multiply and
form malignant tumors. Metastatic melanoma is the most serious and
life-threatening type of skin cancer and is associated with low
survival rates. [10,11] There are a variety of gene mutations that
can lead to metastatic melanoma. The most common genetic mutation
in metastatic melanoma is BRAF. There are about 200,000 new
cases of melanoma diagnosed worldwide each year, approximately half
of which have BRAF mutations, a key target in the
treatment of metastatic melanoma. [10,12-14]
About BRAFTOVI + MEKTOVI
BRAFTOVI is an oral small
molecule BRAF kinase inhibitor and MEKTOVI is an oral small
molecule MEK inhibitor which target key enzymes in the MAPK
signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of
proteins in this pathway has been shown to occur in many cancers
including melanoma, colorectal cancer, non-small cell lung cancer,
thyroid and others. In the U.S., BRAFTOVI + MEKTOVI are approved
for the treatment of unresectable or metastatic melanoma with a
BRAFV600E or BRAFV600K
mutation, as detected by an FDA-approved test. BRAFTOVI is not
indicated for treatment of patients with wild-type BRAF
melanoma.
Array has exclusive rights to BRAFTOVI and MEKTOVI in the U.S.
and Canada. Array has granted Ono
Pharmaceutical exclusive rights to commercialize both products in
Japan and South Korea, Medison exclusive rights to
commercialize both products in Israel and Pierre
Fabre exclusive rights to commercialize both products in all
other countries, including Europe,
Asia and Latin America.
BRAFTOVI + MEKTOVI are not approved outside of the U.S. The
European Medicines Agency (EMA), as well as the Swiss Medicines
Agency (Swissmedic) and the Australian Therapeutic Goods
Administration (TGA), are currently reviewing the Marketing
Authorization Applications submitted by Pierre Fabre, and Japan's Pharmaceuticals and Medical Devices
Agency has accepted the Manufacturing and Marketing Approval
applications submitted by Ono Pharmaceutical Co, Ltd.
Indications and Usage
BRAFTOVI™ (encorafenib) and
MEKTOVI® (binimetinib) are kinase
inhibitors indicated for use in combination for the treatment
of patients with unresectable or metastatic melanoma with
a BRAFV600E or BRAFV600K mutation,
as detected by an FDA-approved test.
Limitations of Use: BRAFTOVI is not indicated for the treatment
of patients with wild-type BRAF melanoma.
BRAFTOVI + MEKTOVI Important Safety
Information
The information below applies to the safety
of the combination of BRAFTOVI and MEKTOVI unless otherwise
noted.
Warnings and Precautions New Primary
Malignancies: New primary malignancies, cutaneous and
non-cutaneous malignancies can occur. In the COLUMBUS trial,
cutaneous squamous cell carcinoma, including keratoacanthoma,
occurred in 2.6% and basal cell carcinoma occurred in 1.6% of
patients. Perform dermatologic evaluations prior to initiating
treatment, every 2 months during treatment, and for up to 6 months
following discontinuation of treatment. Discontinue BRAFTOVI
for RAS mutation-positive non-cutaneous
malignancies.
Tumor Promotion in BRAF Wild-Type
Tumors: Confirm evidence
of BRAFV600E or BRAFV600Kmutation
prior to initiating BRAFTOVI.
Cardiomyopathy: In the COLUMBUS trial,
cardiomyopathy occurred in 7% and Grade 3 left ventricular
dysfunction occurred in 1.6% of patients. Cardiomyopathy resolved
in 87% of patients. Assess left ventricular ejection fraction by
echocardiogram or MUGA scan prior to initiating treatment, 1 month
after initiating treatment, and then every 2 to 3 months during
treatment. The safety has not been established in patients with a
baseline ejection fraction that is either below 50% or below the
institutional lower limit of normal.
Venous Thromboembolism (VTE): In the COLUMBUS trial,
VTE occurred in 6% of patients, including 3.1% of patients who
developed pulmonary embolism.
Hemorrhage: In the COLUMBUS trial, hemorrhage
occurred in 19% of patients and ≥Grade 3 hemorrhage occurred in
3.2% of patients. Fatal intracranial hemorrhage in the setting of
new or progressive brain metastases occurred in 1.6% of
patients.
Ocular Toxicities: In the COLUMBUS trial, serous
retinopathy occurred in 20% of patients; 8% were retinal detachment
and 6% were macular edema. Symptomatic serous retinopathy occurred
in 8% of patients with no cases of blindness. In patients
with BRAF mutation-positive melanoma across
multiple clinical trials, 0.1% of patients experienced retinal vein
occlusion (RVO). Permanently discontinue MEKTOVI in patients with
documented RVO. In COLUMBUS, uveitis, including iritis and
iridocyclitis, was reported in 4% of patients. Assess for visual
symptoms at each visit. Perform ophthalmic evaluation at regular
intervals and for any visual disturbances.
Interstitial Lung Disease (ILD): ILD, including
pneumonitis, occurred in 0.3% of patients
with BRAFmutation-positive melanoma across multiple
clinical trials. Assess new or progressive unexplained pulmonary
symptoms or findings for possible ILD.
Hepatotoxicity: In the COLUMBUS trial, the incidence
of Grade 3 or 4 increases in liver function laboratory tests was 6%
for alanine aminotransferase (ALT) and 2.6% for aspartate
aminotransferase (AST). Monitor liver laboratory tests before and
during treatment and as clinically indicated.
Rhabdomyolysis: In the COLUMBUS trial, elevation of
laboratory values of serum creatine phosphokinase (CPK) occurred in
58% of patients. Rhabdomyolysis was reported in 0.1% of patients
with BRAF mutation-positive melanoma across
multiple clinical trials. Monitor CPK periodically and as
clinically indicated.
QTc Prolongation: In the COLUMBUS trial, an increase
in QTcF to >500 ms was measured in 0.5% (1/192) of patients.
Monitor patients who already have or who are at significant risk of
developing QTc prolongation. Correct hypokalemia and hypomagnesemia
prior to and during BRAFTOVI administration. Withhold, reduce dose,
or permanently discontinue for QTc >500 ms.
Embryo-Fetal Toxicity: BRAFTOVI or MEKTOVI can cause
fetal harm when administered to pregnant women. Nonhormonal
contraceptives should be used during treatment and for at least 30
days after the final dose for patients taking BRAFTOVI +
MEKTOVI.
Adverse Reactions
The most common adverse reactions
(≥20%, all Grades, in the COLUMBUS trial) were: fatigue, nausea,
diarrhea, vomiting, abdominal pain, arthralgia, myopathy,
hyperkeratosis, rash, headache, constipation, visual impairment,
serous retinopathy.
In the COLUMBUS trial, the most common laboratory abnormalities
(≥20%, all Grades) included: increased creatinine, increased CPK,
increased gamma glutamyl transferase, anemia, increased ALT,
hyperglycemia, increased AST, and increased alkaline
phosphatase.
Drug interactions
Avoid concomitant use of strong or moderate CYP3A4 inhibitors or
inducers and sensitive CYP3A4 substrates with BRAFTOVI.
Modify BRAFTOVI dose if concomitant use of strong or moderate
CYP3A4 inhibitors cannot be avoided.
Please see full Prescribing Information for
BRAFTOVI and full Prescribing Information for
MEKTOVI for additional information. You may report
side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Array at 1-844-Rx-Array
(1-844-792-7729).
About COLUMBUS
The COLUMBUS trial (NCT01909453) is a
two-part, international, randomized, open label Phase 3 trial
evaluating the efficacy and safety of BRAFTOVI (encorafenib) in
combination with MEKTOVI (binimetinib) compared to vemurafenib and
encorafenib monotherapy in 921 patients with locally advanced,
unresectable or metastatic melanoma with BRAFV600
mutation. All secondary efficacy analyses, including overall
survival, are descriptive in nature. Over 200 sites across
North America, Europe, South
America, Africa,
Asia and Australia participated in the trial.
About Colorectal Cancer
Worldwide, colorectal cancer
is the third most common type of cancer in men and the second most
common in women, with approximately 1.4 million new diagnoses in
2012. Globally in 2012, approximately 694,000 deaths were
attributed to colorectal cancer. [15] In the U.S. alone, an
estimated 140,250 patients will be diagnosed with cancer of the
colon or rectum in 2018, and approximately 50,000 are estimated to
die of their disease. [16] In the U.S., BRAF mutations are
estimated to occur in 10% to 15% of patients with colorectal cancer
and represent a poor prognosis for these patients. [7,8,17,18] The
risk of mortality in CRC patients with the
BRAFV600E mutation is more than two times higher
than for those with wild-type BRAF. [19] Several irinotecan
and cetuximab-containing regimens, similar to the BEACON CRC
control arm, have established clinical activity benchmarks in
BRAFV600E-mutant mCRC patients, whose disease has
progressed after one or two prior lines of therapy. These
benchmarks include ORR of 4% to 8% ,mPFS of 1.8 to 2.5 months and
median OS of 4 to 6 months. [3-9]
About BEACON CRC
BEACON CRC is a randomized,
open-label, global trial evaluating the efficacy and safety of
BRAFTOVI, MEKTOVI and cetuximab in patients with
BRAFV600E-mutant mCRC whose disease has
progressed after one or two prior regimens. BEACON CRC is the first
and only Phase 3 trial designed to test a BRAF/MEK combo targeted
therapy in BRAFV600E-mutant mCRC. Thirty patients
were treated in the safety lead-in and received the triplet
combination (BRAFTOVI 300 mg daily, MEKTOVI 45 mg twice daily and
cetuximab per label). Of the 30 patients, 29 had a
BRAFV600E mutation. MSI-H, resulting from
defective DNA mismatch repair, was detected in only 1 patient. As
previously announced, the triplet combination demonstrated good
tolerability, supporting initiation of the randomized portion of
the trial.
The randomized portion of the BEACON CRC trial is designed to
assess the efficacy of BRAFTOVI in combination with cetuximab with
or without MEKTOVI compared to cetuximab and irinotecan-based
therapy. Approximately 615 patients are expected to be randomized
1:1:1 to receive triplet combination, doublet combination (BRAFTOVI
and cetuximab) or the control arm (irinotecan-based therapy and
cetuximab). The primary endpoint of the trial is overall survival
of the triplet combination compared to the control arm. Secondary
endpoints address efficacy of the doublet combination compared to
the control arm, and the triplet combination compared to the
doublet therapy. Other secondary endpoints include PFS, ORR,
duration of response, safety and tolerability. Health related
quality of life data will also be assessed. The trial is being
conducted at over 200 investigational sites in North America, South
America, Europe and the
Asia Pacific region. The BEACON
CRC trial is being conducted with support from Ono Pharmaceutical
Co., Pierre Fabre and Merck KGaA,
Darmstadt, Germany (support is for
sites outside of North
America).
About Array BioPharma
Array BioPharma Inc. is a
fully-integrated, biopharmaceutical company focused on the
discovery, development and commercialization of transformative and
well-tolerated targeted small molecule drugs to treat patients
afflicted with cancer and other high-burden diseases. Array markets
in the United States
BRAFTOVITM (encorafenib) capsules in combination with
MEKTOVI® (binimetinib) tablets for the treatment of
patients with unresectable or metastatic melanoma with a
BRAFV600E or BRAFV600K
mutation. Array's lead clinical programs, encorafenib and
binimetinib, are being investigated in over 30 clinical trials
across a number of solid tumor indications, including a Phase 3
trial in BRAF-mutant colorectal cancer. Array's pipeline
includes several additional programs being advanced by Array or
current license-holders, including selumetinib (partnered with
AstraZeneca), larotrectinib (partnered with Loxo Oncology),
ipatasertib (partnered with Genentech), tucatinib (partnered with
Seattle Genetics) and ARRY-797 (being developed by Yarra
Therapeutics, a wholly-owned subsidiary of Array), all of which are
currently in registration trials. Ganovo® (danoprevir,
partnered with Roche) was recently approved in China for the treatment of viral hepatitis C.
For more information on Array, please visit www.arraybiopharma.com
or follow @arraybiopharma on Twitter and LinkedIn.
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[10] Melanoma Skin Cancer. American Cancer Society. Available
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[16] Cancer Facts & Figures 2018. American Cancer
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[19] Safaee, et al. PLoS One. 2012.
BRAFTOVI™ (encorafenib) Prescribing Information. Array BioPharma
Inc., June 2018
MEKTOVI® (binimetinib) Prescribing Information. Array
BioPharma Inc., June 2018
Forward-Looking Statement
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including, among others,
statements about the future development plans of encorafenib and
binimetinib; expectations that events will occur that will create
greater value for Array; and the potential for the results of
current and future clinical trials to support regulatory approval
or the marketing success of encorafenib and binimetinib. Because
these statements reflect our current expectations concerning future
events and involve significant risks and uncertainties, our actual
results could differ materially from those anticipated in these
forward-looking statements as a result of many factors. These
factors include, but are not limited to, the potential that the
FDA, EMA or other regulatory agencies determine results from
clinical trials are not sufficient to support registration or
marketing approval of encorafenib and binimetinib; our ability to
effectively and timely conduct clinical trials in light of
increasing costs and difficulties in locating appropriate trial
sites and in enrolling patients who meet the criteria for certain
clinical trials; risks associated with our dependence on
third-party service providers to successfully conduct clinical
trials and to manufacture drug substance and product within and
outside the U.S.; our ability to grow and successfully develop
commercialization capabilities; our ability to achieve and maintain
profitability and maintain sufficient cash resources; and our
ability to attract and retain experienced scientists and
management. Additional information concerning these and other risk
factors can be found in our most recent annual report filed on Form
10-K, in our quarterly reports filed on Form 10-Q, and in other
reports filed by Array with the Securities and Exchange Commission.
We are providing this information as of August 14, 2018. We undertake no duty to update
any forward-looking statements to reflect the occurrence of events
or circumstances after the date of such statements or of
anticipated or unanticipated events that alter any assumptions
underlying such statements.
BRAFTOVI™ is a trademark of Array BioPharma Inc.
MEKTOVI® is a registered trademark of Array BioPharma
Inc. in the United States and
various other countries.
Array BioPharma
Inc.
|
Consolidated
Statements of Operations
|
(Unaudited)
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
|
|
|
|
|
June
30,
|
|
June
30,
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
Reimbursement
revenue
|
|
|
$
15,620
|
|
$
21,843
|
|
$
80,958
|
|
$
107,197
|
|
Collaboration
revenue
|
|
|
9,644
|
|
5,962
|
|
36,273
|
|
23,811
|
|
License and milestone
revenue
|
|
|
10,173
|
|
5,973
|
|
56,537
|
|
19,844
|
|
|
Total
revenue
|
|
|
35,437
|
|
33,778
|
|
173,768
|
|
150,852
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
Cost of partnered
programs
|
|
|
16,187
|
|
10,092
|
|
59,374
|
|
35,395
|
|
Research and
development for proprietary programs
|
|
|
48,127
|
|
39,098
|
|
185,821
|
|
178,199
|
|
Selling, general and
administrative
|
|
|
19,272
|
|
10,926
|
|
58,500
|
|
39,336
|
|
|
Total operating
expenses
|
|
|
83,586
|
|
60,116
|
|
303,695
|
|
252,930
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(48,149)
|
|
(26,338)
|
|
(129,927)
|
|
(102,078)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
|
Loss on
extinguishment and conversion of Notes
|
|
|
—
|
|
—
|
|
(6,457)
|
|
—
|
|
Impairment loss
related to cost method investment
|
|
|
—
|
|
—
|
|
—
|
|
(1,500)
|
|
Realized gain on
investments and other
|
|
|
—
|
|
112
|
|
69
|
|
897
|
|
Change in fair value
of notes payable
|
|
|
(2,187)
|
|
(500)
|
|
(2,387)
|
|
(2,600)
|
|
Interest
income
|
|
|
1,395
|
|
286
|
|
4,470
|
|
796
|
|
Interest
expense
|
|
|
(2,407)
|
|
(3,152)
|
|
(10,814)
|
|
(12,333)
|
|
|
Total other expense,
net
|
|
|
(3,199)
|
|
(3,254)
|
|
(15,119)
|
|
(14,740)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
tax expense
|
|
|
(51,348)
|
|
(29,592)
|
|
(145,046)
|
|
(116,818)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
|
1,100
|
|
—
|
|
2,300
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
$
(52,448)
|
|
$
(29,592)
|
|
$
(147,346)
|
|
$
(116,818)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
- basic
|
|
|
$
(0.25)
|
|
$
(0.17)
|
|
$
(0.74)
|
|
$
(0.72)
|
Net loss per share
- diluted
|
|
|
$
(0.25)
|
|
$
(0.17)
|
|
$
(0.74)
|
|
$
(0.72)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
|
210,705
|
|
170,779
|
|
198,490
|
|
163,207
|
Weighted average
shares outstanding - diluted
|
|
|
210,705
|
|
170,779
|
|
198,490
|
|
163,207
|
Summary
Consolidated Balance Sheet Data
|
(Unadudited)
|
(in
thousands)
|
|
|
|
|
|
|
June 30,
2018
|
|
June 30,
2017
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
|
$
413,406
|
|
$
235,055
|
Working
capital
|
|
|
$
355,612
|
|
$
200,626
|
Total
assets
|
|
|
$
460,364
|
|
$
279,145
|
Long-term debt, net
and note payable at fair value
|
|
|
$
111,775
|
|
$
133,905
|
Total stockholders'
equity
|
|
|
$
219,743
|
|
$
11,727
|
CONTACT:
Array BioPharma
Andrea N. Flynn, Ph.D.
Senior Director, Investor Relations & Corporate
Communications
(303) 381-6600
ir@arraybiopharma.com
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multimedia:http://www.prnewswire.com/news-releases/array-biopharma-reports-financial-results-for-the-fourth-quarter-and-full-year-of-fiscal-2018-300696556.html
SOURCE Array BioPharma Inc.