Sprycel is the first and only second-generation
tyrosine kinase inhibitor approved for children with Philadelphia
chromosome-positive chronic myeloid leukemia in chronic phase
Approval based on data from the largest
prospective trial in pediatric chronic myeloid leukemia in chronic
phase1
Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S.
Food and Drug Administration (FDA) has expanded the indication for
Sprycel® (dasatinib) tablets to include the treatment of children
with Philadelphia chromosome-positive (Ph+) chronic myeloid
leukemia (CML) in chronic phase (CP).1 This approval for Sprycel in
pediatric patients with Ph+ CML in chronic phase was granted under
priority review, and the indication received orphan drug
designation from the FDA. The safety and efficacy of Sprycel in
pediatric patients was evaluated in two pediatric studies of 97
patients with CP-CML: an open-label, non-randomized, dose-ranging
trial (NCT00306202) and an open-label, non-randomized, single-arm
trial (NCT00777036). Among the 97 patients in the two studies, 51
patients (exclusively from the single-arm trial) had newly
diagnosed CP-CML, and 46 patients (17 from the dose-ranging trial
and 29 from the single-arm trial) were resistant or intolerant to
previous treatment with imatinib.1
Sprycel is associated with the following Warnings and
Precautions: myelosuppression, bleeding-related events, fluid
retention, cardiovascular events, pulmonary arterial hypertension,
QT prolongation, severe dermatologic reactions, tumor lysis
syndrome, embryo-fetal toxicity and effects on growth and
development in pediatric patients.1 Please see detailed Important
Safety Information below.
“While chronic myeloid leukemia is rare in children, accounting
for less than three percent of all pediatric leukemias, it is often
more aggressive in younger patients than in adults and until
recently, there have been few available treatment options,”2,3 said
Vickie Buenger, President, Coalition Against Childhood Cancer. “The
FDA’s decision to approve the expanded use of Sprycel in children
with Philadelphia chromosome-positive chronic myeloid leukemia in
chronic phase may bring new hope to these patients and their
families.”
“Our decision to pursue an expanded indication for Sprycel is
indicative of our commitment to exploring pediatric applications
within our broad development program,” said Johanna Mercier, head,
U.S. Commercial, Bristol-Myers Squibb. “We are pleased this option
is now available for appropriate pediatric chronic phase CML
patients and their physicians.”
As part of its commitment to children and adolescents with
cancer, Bristol-Myers Squibb continues to explore pediatric
applications for investigational oncology agents within its broad
development program. In addition, Bristol-Myers Squibb supports
organizations and initiatives focused on pediatric patients and
their families.
“Options for pediatric patients with chronic myeloid leukemia
are limited, and it is challenging to conduct clinical trials
investigating potential new treatments in this small patient
population,” said Lia Gore, M.D., University of Colorado School of
Medicine and Children’s Hospital Colorado. “Dasatinib is an
important new option to help address the unmet needs of children
with Philadelphia chromosome-positive CML in chronic phase.”
About the Sprycel Studies in Pediatric
Patients
Sprycel was evaluated in two pediatric studies of 97 patients
with CP-CML, including patients who were newly diagnosed and those
who were resistant or intolerant to previous treatment with
imatinib. Ninety-one of the 97 pediatric patients with CP-CML were
treated with Sprycel tablets 60 mg/m2 once daily (maximum dose of
100 mg once daily for patients with high body surface area).
Patients were treated until disease progression or unacceptable
toxicity.
The efficacy endpoints included complete cytogenetic response
(CCyR), major cytogenetic response (MCyR) and major molecular
response (MMR).1 Efficacy results for the two pediatric studies are
summarized in the table below.
Efficacy of Sprycel in Pediatric
Patients with CP-CML Cumulative Response over Time by
Minimum Follow-Up Period 3 Months 6
Months 12 Months 24 Months
CCyR
(95% CI)
Newly diagnosed 43.1% 66.7% 96.1% 96.1%
(N = 51)a
(29.3, 57.8) (52.1, 79.2) (86.5, 99.5) (86.5, 99.5) Prior imatinib
45.7% 71.7% 78.3% 82.6%
(N = 46)b
(30.9, 61.0) (56.5, 84.0) (63.6, 89.1) (68.6, 92.2)
MCyR
(95% CI) Newly diagnosed 60.8% 90.2% 98.0% 98.0%
(N = 51)a
(46.1, 74.2) (78.6, 96.7) (89.6, 100) (89.6, 100) Prior imatinib
60.9% 82.6% 89.1% 89.1%
(N = 46)b
(45.4, 74.9) (68.6, 92.2) (76.4, 96.4) (76.4, 96.4)
MMR
(95% CI) Newly diagnosed 7.8% 31.4% 56.9% 74.5%
(N = 51)a
(2.2, 18.9) (19.1, 45.9) (42.2, 70.7) (60.4, 85.7) Prior imatinib
15.2% 26.1% 39.1% 52.2%
(N = 46)b
(6.3, 28.9) (14.3, 41.1) (25.1, 54.6)
(36.9, 67.1) a Patients from pediatric study of newly diagnosed
CP-CML receiving oral tablet formulation b Patients from pediatric
studies of imatinib-resistant or -intolerant CP-CML receiving oral
tablet formulation
With a median follow-up of 4.5 years in newly diagnosed
patients, the median durations of CCyR, MCyR and MMR could not be
estimated, as more than half of the responding patients had not
progressed at the time of data cut-off. Range of duration of
response was (2.5+ to 66.5+ months for CCyR), (1.4 to 66.5+ months
for MCyR) and (5.4+ to 72.5+ months for subjects who achieved MMR
by month 24 and 0.03+ to 72.5+ months for subjects who achieved MMR
at any time), where ‘+’ indicates a censored observation.
With a median follow-up of 5.2 years in imatinib-resistant or
-intolerant patients, the median durations of CCyR, MCyR and MMR
could not be estimated, as more than half the responding patients
had not progressed at the time of data cut-off. Range of duration
of response was (2.4 to 86.9+ months for CCyR), (2.4 to 86.9+
months for MCyR) and (2.6+ to 73.6+ months for MMR), where ‘+’
indicates a censored observation.
Drug-related serious adverse events were reported in 14.4% of
Sprycel-treated pediatric patients with Ph+ CML in chronic phase.
Most common adverse reactions (≥15%) included myelosuppression,
headache, nausea, diarrhea, skin rash, pain in extremity and
abdominal pain.
The recommended starting dosage for Sprycel in pediatric
patients with Ph+ CML in chronic phase is based on body weight. The
recommended dose should be administered orally once daily, and the
dose should be recalculated every three months based on changes in
body weight, or more often if necessary.1 Sprycel tablets should
not be crushed, cut or chewed. Tablets should be swallowed whole.
The exposure in patients receiving a crushed tablet is lower than
in those swallowing an intact tablet.
About Sprycel Assist
As part of its commitment to Sprycel patients, Bristol-Myers
Squibb provides Sprycel Assist, which offers a single point of
contact and live support and assistance for Sprycel patients and
their caregivers. Accessible through www.sprycel.com or
1-855-SPRYCEL, Sprycel Assist includes:
- Patient support coordinators
- One-month free trial with Sprycel One
Card for new, eligible Medicare, Medicaid or cash patients*
- $0 monthly co-pay offer with Sprycel
One Card for eligible commercially insured patients (subject to an
annual maximum benefit of $32,000)*
- Educational resources for patients with
Ph+ CML
* Subject to terms and conditions of program, which are
available through 1-855-SPRYCEL or visiting www.sprycel.com
About Chronic Myeloid
Leukemia
Chronic myeloid leukemia is a type of leukemia in which the body
produces an uncontrolled number of abnormal white blood cells.4
Chronic myeloid leukemia occurs when pieces of two different
chromosomes (chromosomes 9 and 22) break off and attach to each
other.5 The newly formed chromosome is called the Philadelphia
chromosome, which contains an abnormal gene called the
BCR-ABL gene. This gene produces the BCR-ABL protein that
signals cells to make too many white blood cells.5 There is no
known cause for the genetic change that results in CML.6
About Sprycel
Sprycel first received U.S. Food and Drug Administration (FDA)
approval in 2006 for the treatment of adults with Philadelphia
chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic
phase (CP) who are resistant or intolerant to prior therapy
including imatinib. At that time, Sprycel also received FDA
approval for adults with Ph+ acute lymphoblastic leukemia (ALL) who
are resistant or intolerant to prior therapy. Sprycel is approved
for these indications in more than 60 countries.
In October 2010, Sprycel received accelerated FDA approval for
the treatment of adults with newly diagnosed Ph+ CML in chronic
phase. This indication is approved in more than 50 countries.
SPRYCEL® (dasatinib) INDICATIONS &
IMPORTANT SAFETY INFORMATION
INDICATIONS
SPRYCEL® (dasatinib) is indicated for the treatment of adults
with:
- Newly diagnosed Philadelphia
chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic
phase
- Chronic, accelerated, or myeloid or
lymphoid blast phase Ph+ CML with resistance or intolerance to
prior therapy including imatinib
- Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to
prior therapy
SPRYCEL is indicated for the treatment of pediatric patients
with:
- Ph+ CML in chronic phase.
IMPORTANT SAFETY INFORMATION
Myelosuppression:
Treatment with SPRYCEL is associated with severe (NCI CTCAE
Grade 3/4) thrombocytopenia, neutropenia, and anemia, which occur
earlier and more frequently in patients with advanced phase CML or
Ph+ ALL than in patients with chronic phase CML. Myelosuppression
was reported in patients with normal baseline laboratory values as
well as in patients with pre-existing laboratory abnormalities.
- In patients with chronic phase CML,
perform complete blood counts (CBCs) every 2 weeks for 12 weeks,
then every 3 months thereafter, or as clinically indicated
- In patients with advanced phase CML or
Ph+ ALL, perform CBCs weekly for the first 2 months and then
monthly thereafter, or as clinically indicated
- Myelosuppression is generally
reversible and usually managed by withholding SPRYCEL temporarily
and/or dose reduction
- In clinical studies, myelosuppression
may have also been managed by discontinuation of study therapy
- Hematopoietic growth factor has been
used in patients with resistant myelosuppression
Bleeding-Related Events:
SPRYCEL can cause serious and fatal bleeding. In all CML or Ph+
ALL clinical studies, Grade ≥3 central nervous system (CNS)
hemorrhages, including fatalities, occurred in <1% of patients
receiving SPRYCEL. The incidence of Grade 3/4 hemorrhage, occurred
in 5.8% of adult patients and generally required treatment
interruptions and transfusions. The incidence of Grade 5 hemorrhage
occurred in 0.4% of adult patients. The most frequent site of
hemorrhage was gastrointestinal.
- Most bleeding events in clinical
studies were associated with severe thrombocytopenia
- In addition to causing thrombocytopenia
in human subjects, dasatinib caused platelet dysfunction in
vitro
- Concomitant medications that inhibit
platelet function or anticoagulants may increase the risk of
hemorrhage
Fluid Retention:
SPRYCEL may cause fluid retention. After 5 years of follow-up in
the adult randomized newly diagnosed chronic phase CML study
(n=258), grade 3/4 fluid retention was reported in 5% of patients,
including 3% of patients with grade 3/4 pleural effusion. In adult
patients with newly diagnosed or imatinib resistant or intolerant
chronic phase CML, grade 3/4 fluid retention occurred in 6% of
patients treated with SPRYCEL at the recommended dose (n=548). In
adult patients with advanced phase CML or Ph+ ALL treated with
SPRYCEL at the recommended dose (n=304), grade 3/4 fluid retention
was reported in 8% of patients, including grade 3/4 pleural
effusion reported in 7% of patients. In pediatric patients with
chronic phase CML cases of Grade 1 or 2 fluid retention were
reported in 10.3% of patients.
- Patients who develop symptoms of
pleural effusion or other fluid retention, such as new or worsened
dyspnea on exertion or at rest, pleuritic chest pain, or dry cough
should be evaluated promptly with a chest x-ray or additional
diagnostic imaging as appropriate
- Fluid retention events were typically
managed by supportive care measures that may include diuretics or
short courses of steroids
- Severe pleural effusion may require
thoracentesis and oxygen therapy
- Consider dose reduction or treatment
interruption
Cardiovascular Events:
SPRYCEL can cause cardiac dysfunction. After 5 years of
follow-up in the randomized newly diagnosed chronic phase CML trial
in adults (n=258), the following cardiac adverse reactions
occurred:
- Cardiac ischemic events (3.9% dasatinib
vs 1.6% imatinib), cardiac related fluid retention (8.5% dasatinib
vs 3.9% imatinib), and conduction system abnormalities, most
commonly arrhythmia and palpitations (7.0% dasatinib vs 5.0%
imatinib). Two cases (0.8%) of peripheral arterial occlusive
disease occurred with imatinib and 2 (0.8%) transient ischemic
attacks occurred with dasatinib
Monitor patients for signs or symptoms consistent with cardiac
dysfunction and treat appropriately.
Pulmonary Arterial Hypertension (PAH):
SPRYCEL may increase the risk of developing PAH in adult and
pediatric patients, which may occur any time after initiation,
including after more than 1 year of treatment. Manifestations
include dyspnea, fatigue, hypoxia, and fluid retention. PAH may be
reversible on discontinuation of SPRYCEL.
- Evaluate patients for signs and
symptoms of underlying cardiopulmonary disease prior to initiating
SPRYCEL and during treatment. If PAH is confirmed, SPRYCEL should
be permanently discontinued
QT Prolongation:
SPRYCEL may increase the risk of prolongation of QTc in patients
including those with hypokalemia or hypomagnesemia, patients with
congenital long QT syndrome, patients taking antiarrhythmic
medicines or other medicinal products that lead to QT prolongation,
and cumulative high-dose anthracycline therapy
- Correct hypokalemia or hypomagnesemia
prior to and during SPRYCEL administration
Severe Dermatologic Reactions:
Cases of severe mucocutaneous dermatologic reactions, including
Stevens-Johnson syndrome and erythema multiforme, have been
reported in patients treated with SPRYCEL.
- Discontinue permanently in patients who
experience a severe mucocutaneous reaction during treatment if no
other etiology can be identified
Tumor Lysis Syndrome (TLS):
TLS has been reported in patients with resistance to prior
imatinib therapy, primarily in advanced phase disease.
- Due to potential for TLS, maintain
adequate hydration, correct uric acid levels prior to initiating
therapy with SPRYCEL, and monitor electrolyte levels
- Patients with advanced stage disease
and/or high tumor burden may be at increased risk and should be
monitored more frequently
Embryo-Fetal Toxicity:
Based on limited human data, SPRYCEL can cause fetal harm when
administered to a pregnant woman. Hydrops fetalis, fetal leukopenia
and fetal thrombocytopenia have been reported with maternal
exposure to SPRYCEL. Transplacental transfer of dasatinib has been
measured in fetal plasma and amniotic fluid at concentrations
comparable to those in maternal plasma.
- Advise females of reproductive
potential to avoid pregnancy, which may include the use of
effective contraception, during treatment with SPRYCEL and for 30
days after the final dose
Effects on Growth and Development in Pediatric Patients
In pediatric trials of SPRYCEL in chronic phase CML after at
least 2 years of treatment, adverse reactions associated with bone
growth and development were reported in 5 (5.2%) patients, one of
which was severe in intensity (Growth Retardation Grade 3). These 5
cases included cases of epiphyses delayed fusion, osteopenia,
growth retardation, and gynecomastia. Of these 5 cases, 1 case of
osteopenia and 1 case of gynecomastia resolved during
treatment.
Lactation:
No data are available regarding the presence of dasatinib in
human milk, the effects of the drug on the breastfed child or the
effects of the drug on milk production. However, dasatinib is
present in the milk of lactating rats.
- Because of the potential for serious
adverse reactions in nursing children from SPRYCEL, breastfeeding
is not recommended during treatment with SPRYCEL and for 2 weeks
after the final dose
Drug Interactions:
Effect of Other Drugs on Dasatinib
- Strong CYP3A4 inhibitors: The
coadministration with strong CYP3A inhibitors may increase
dasatinib concentrations. Increased dasatinib concentrations may
increase the risk of toxicity. Avoid concomitant use of strong
CYP3A4 inhibitors. If concomitant administration of a strong CYP3A4
inhibitor cannot be avoided, consider a SPRYCEL dose reduction
- Grapefruit juice may increase
plasma concentrations of SPRYCEL and should be avoided
- Strong CYP3A4 inducers: The
coadministration of SPRYCEL with strong CYP3A inducers may decrease
dasatinib concentrations. Decreased dasatinib concentrations may
reduce efficacy. Consider alternative drugs with less enzyme
induction potential. If concomitant administration of a strong
CYP3A4 inducer cannot be avoided, consider a SPRYCEL dose increase
- St. John’s wort may decrease
plasma concentrations of SPRYCEL and should be avoided
- Gastric Acid Reducing Agents:
The coadministration of SPRYCEL with a gastric acid reducing agent
may decrease the concentrations of dasatinib. Decreased dasatinib
concentrations may reduce efficacy.Do not administer H2 antagonists
or proton pump inhibitors with SPRYCEL. Consider the use of
antacids in place of H2 antagonists or proton pump inhibitors.
Administer the antacid at least 2 hours prior to or 2 hours after
the dose of SPRYCEL. Avoid simultaneous administration of SPRYCEL
with antacids.
Adverse Reactions:
The safety data reflects exposure to SPRYCEL at all doses tested
in clinical studies (n=2809) including 324 adult patients with
newly diagnosed chronic phase CML, 2388 adult patients with
imatinib resistant or intolerant chronic or advanced phase CML or
Ph+ ALL, and 97 pediatric patients with chronic phase CML.
The median duration of therapy in a total of 2712
SPRYCEL-treated adult patients was 19.2 months (range 0–93.2
months). Median duration of therapy in:
- 1618 adult patients with chronic phase
CML was 29 months (range 0–92.9 months)
- Median duration for 324 adult patients
in the newly diagnosed chronic phase CML trial was approximately 60
months
1094 adult patients with advanced phase CML
or Ph+ ALL was 6.2 months (range 0–93.2 months)
In two non-randomized trials in 97 pediatric patients with
chronic phase CML (51 patients newly diagnosed and 46 patients
resistant or intolerant to previous treatment with imatinib), the
median duration of therapy was 51.1 months (range 1.9 to 99.6
months).
In the newly diagnosed adult chronic phase CML trial, after a
minimum of 60 months of follow-up, the cumulative discontinuation
rate for 258 patients was 39%.
In the overall population of 2712 adult SPRYCEL-treated
patients, 88% of patients experienced adverse reactions at some
time and 19% experienced adverse reactions leading to treatment
discontinuation.
Among the 1618 adult SPRYCEL-treated patients with chronic phase
CML, drug-related adverse reactions leading to discontinuation were
reported in 329 (20.3%) patients.
- In the adult newly diagnosed chronic
phase CML trial, drug was discontinued for adverse reactions in 16%
of SPRYCEL-treated patients with a minimum of 60 months of
follow-up
Among the 1094 SPRYCEL-treated patients with advanced phase CML
or Ph+ ALL, drug-related adverse reactions leading to
discontinuation were reported in 191 (17.5%) patients.
Among the 97 pediatric subjects, drug-related adverse reactions
leading to discontinuation were reported in 1 patient (1%).
Patients ≥65 years are more likely to experience the commonly
reported adverse reactions of fatigue, pleural effusion, diarrhea,
dyspnea, cough, lower gastrointestinal hemorrhage, and appetite
disturbance, and more likely to experience the less frequently
reported adverse reactions of abdominal distention, dizziness,
pericardial effusion, congestive heart failure, hypertension,
pulmonary edema and weight decrease, and should be monitored
closely.
- In adult newly diagnosed chronic phase
CML patients:
- Drug-related serious adverse reactions
(SARs) were reported for 16.7% of patients. Serious adverse
reactions reported in ≥5% of patients included pleural effusion
(5%)
- Grade 3/4 laboratory abnormalities
included neutropenia (29%), thrombocytopenia (22%), anemia (13%),
hypophosphatemia (7%), hypocalcemia (4%), elevated bilirubin (1%),
and elevated creatinine (1%)
- In adult patients resistant or
intolerant to prior imatinib therapy:
- Drug-related SARs were reported for
26.1% of SPRYCEL-treated patients treated at the recommended dose
of 100 mg once daily in the randomized dose-optimization trial of
patients with chronic phase CML resistant or intolerant to prior
imatinib therapy. Serious adverse reactions reported in ≥5% of
patients included pleural effusion (10%)
- Grade 3/4 hematologic laboratory
abnormalities in chronic phase CML patients resistant or intolerant
to prior imatinib therapy who received SPRYCEL 100 mg once daily
with a minimum follow up of 60 months included neutropenia (36%),
thrombocytopenia (24%), and anemia (13%). Other grade 3/4
laboratory abnormalities included: hypophosphatemia (10%), and
hypokalemia (2%)
- Among chronic phase CML patients with
resistance or intolerance to prior imatinib therapy, cumulative
grade 3/4 cytopenias were similar at 2 and 5 years including:
neutropenia (36% vs 36%), thrombocytopenia (23% vs 24%), and anemia
(13% vs 13%)
- Grade 3/4 elevations of transaminases
or bilirubin and Grade 3/4 hypocalcemia, hypokalemia, and
hypophosphatemia were reported in patients with all phases of CML
- Elevations in transaminases or
bilirubin were usually managed with dose reduction or
interruption
- Patients developing Grade 3/4
hypocalcemia during the course of SPRYCEL therapy often had
recovery with oral calcium supplementation
- In pediatric subjects with Ph+ CML in
chronic phase
- Drug-related SARs were reported for
14.4% of pediatric patients
- In the pediatric studies, the rates of
laboratory abnormalities were consistent with the known profile for
laboratory parameters in adults
- Most common adverse reactions (≥15%) in
patients included myelosuppression, fluid retention events,
diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue,
nausea, and musculoskeletal pain
Please see full Prescribing Information here.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
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Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb’s business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb’s Annual Report on Form 10-K for the year ended December 31,
2016 in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
References
1. Sprycel Prescribing Information. Sprycel U.S. Product
Information. Last updated: November, 2017. Princeton, NJ:
Bristol-Myers Squibb Company.
2. National Comprehensive Cancer Network. NCCN Clinical Practice
Guidelines in Oncology. Chronic Myeloid Leukemia. 2017.
1.2018:MS-24.
3. Hijiya N, Schultz K, Metzler M, et al. “Pediatric chronic
myeloid leukemia is a unique disease that requires a different
approach.” Blood. 2016. 127(4): 392-399.
4. American Cancer Society. “What Is Chronic Myeloid Leukemia?”
https://www.cancer.org/cancer/chronic-myeloid-leukemia/about/what-is-cml.html.
Accessed September 18, 2017.
5. National Cancer Institute. “Chronic Myelogenous Leukemia
Treatment (PDQ®)–Patient Version.”
https://www.cancer.gov/types/leukemia/patient/cml-treatment-pdq.
Accessed September 18, 2017.
6. American Cancer Society. “Do We Know What Causes Chronic
Myeloid Leukemia?”
https://www.cancer.org/cancer/chronic-myeloid-leukemia/causes-risks-prevention/what-causes.html.
Accessed September 18, 2017.
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Bristol-Myers Squibb CompanyMedia Inquiries:Laurel
Sacks, 609-302-5456917-861-0746
(cell)laurel.sacks@bms.comorInvestors:Tim Power,
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