–– Pivotal Programs Initiated for ALKS 3831 for
Schizophrenia and ALKS 8700 for Multiple Sclerosis ––
–– Positive Data Announced From Supportive
Study in FORWARD Pivotal Program for ALKS 5461 in Major Depressive
Disorder ––
–– New Patent Issued for ARISTADA™, Extending
Protection Into 2033 ––
Alkermes plc (NASDAQ: ALKS) today announced new developments and
milestones related to its proprietary product and late-stage
pipeline portfolio of medicines for the treatment of central
nervous system (CNS) diseases. The company has initiated pivotal
clinical development programs for two of its pipeline candidates:
ALKS 3831, a novel, oral atypical antipsychotic drug candidate
designed to be a broad-spectrum treatment for schizophrenia, and
ALKS 8700, a novel, oral monomethyl fumarate (MMF) drug candidate
for the treatment of multiple sclerosis (MS).
Alkermes also announced positive topline results from a
recently-completed human abuse potential study of ALKS 5461, a
once-daily, oral investigational medicine with a novel mechanism of
action for the adjunctive treatment of major depressive disorder.
Additionally, the company announced a newly issued patent expiring
in 2033 that extends patent coverage for ARISTADA™ (aripiprazole
lauroxil) extended-release injectable suspension for the treatment
of schizophrenia.
“As we near the end of 2015, Alkermes is aggressively
executing on our strategy to build a leading biopharmaceutical
company for CNS innovation, characterized by one of the most
exciting late-stage CNS pipelines in the industry,” said Richard
Pops, Chief Executive Officer of Alkermes. “This is a
particularly productive time in the company's history, and looking
ahead to 2016, we expect significant value-creating milestones as
we continue to advance our late-stage pipeline and grow our
commercial products, ARISTADA and VIVITROL.”
“We are pleased with the rapid progress of our late-stage
pipeline, with ALKS 5461 nearing completion of its pivotal phase 3
program, and ALKS 3831 and ALKS 8700 entering registration trials,”
said Elliot Ehrich, M.D., Chief Medical Officer
of Alkermes. “We have successfully hit the key milestones we
set out to achieve in 2015 and look forward to data from the core
efficacy studies of ALKS 5461 in early 2016.”
Highlights of Milestone
Achievements
- ENLIGHTEN pivotal program initiated
for ALKS 3831: The ENLIGHTEN pivotal program for ALKS 3831 is
comprised of two key studies. ENLIGHTEN-1, a multicenter,
randomized, double-blind phase 3 study to evaluate the
antipsychotic efficacy of ALKS 3831 compared to placebo over four
weeks in approximately 390 patients experiencing acute exacerbation
of schizophrenia, is now underway and enrolling patients. The study
will also include an olanzapine comparator arm. ENLIGHTEN-2, a
phase 3 study assessing weight gain with ALKS 3831 compared to
olanzapine in patients with schizophrenia over six months, is
expected to initiate in Q1 2016. The program will also include
supportive studies to evaluate the pharmacokinetic and metabolic
profile of ALKS 3831, as well as long-term safety. Alkermes expects
to use safety and efficacy data from the ENLIGHTEN pivotal program
to serve as the basis for a New Drug Application (NDA) to be
submitted to the U.S. Food and Drug Administration (FDA), pending
study results.
- EVOLVE pivotal program initiated for
ALKS 8700: EVOLVE-1, a two-year, multicenter, open-label study
to assess the safety of ALKS 8700 in approximately 600 patients
with MS, is now underway and enrolling patients. This is the first
study to initiate from the EVOLVE (Endeavoring to Advance Treatment for Patients
Living with Multiple Sclerosis) pivotal program of ALKS 8700
for the treatment of MS. Alkermes plans to include data from
EVOLVE-1, as well as pharmacokinetic bridging data from studies
comparing ALKS 8700 and TECFIDERA®, to support registration of ALKS
8700, based on feedback from the FDA. In addition, Alkermes intends
to initiate EVOLVE-2, a randomized, head-to-head study comparing
the gastrointestinal tolerability of ALKS 8700 and TECFIDERA in up
to 420 patients with MS, in mid-2016. Alkermes plans to submit the
NDA for ALKS 8700 to the FDA in 2018.
- Positive topline results announced
from human abuse potential study of ALKS 5461: In the study,
all doses of ALKS 5461 tested met the trial’s primary endpoint and
demonstrated a statistically significant and meaningful reduction
in abuse potential compared to buprenorphine (p<0.001). Further,
no difference was observed in overall drug liking for ALKS 5461
compared to placebo. Data from this study is expected to support
the comprehensive data package for ALKS 5461 to be submitted as
part of the NDA to the FDA. The three core efficacy studies for
ALKS 5461 remain on track to read out in 2016, with data from the
first two studies expected in Q1 2016, and data from the third
study anticipated in mid-2016.
- New patent issued for ARISTADA:
The United States Patent and Trademark Office (USPTO) has issued
U.S. Patent No. 9,193,685 covering ARISTADA. The patent covers drug
compositions that confer long-term stability. This patent adds to
the robust, existing patent estate for ARISTADA and is expected to
extend protection to October 2033.
About ALKS 3831
ALKS 3831 is a proprietary, investigational medicine designed as
a broad-spectrum antipsychotic for the treatment of schizophrenia.
ALKS 3831 is composed of samidorphan, a novel, potent mu-opioid
antagonist, in combination with the established antipsychotic drug,
olanzapine.
About ALKS 8700
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate
(MMF) drug candidate in development for the treatment of multiple
sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently
convert to MMF in the body and to offer differentiated features as
compared to the currently marketed dimethyl fumarate,
TECFIDERA®.
About ALKS 5461
ALKS 5461 is a proprietary, oral investigational medicine for
the treatment of major depressive disorder (MDD). ALKS 5461 acts as
a balanced neuromodulator in the brain and represents a new
approach with a novel mechanism of action for treating MDD. In
October 2013, the U.S. Food and Drug Administration (FDA) granted
Fast Track status for ALKS 5461 for the adjunctive treatment of MDD
in patients with an inadequate response to standard antidepressant
therapies.
About ARISTADA™
ARISTADA is an injectable atypical antipsychotic with one-month
and six-week dosing options for the treatment of schizophrenia.
ARISTADA is administered by a healthcare professional. Once in the
body, ARISTADA converts to aripiprazole.
INDICATION and IMPORTANT SAFETY INFORMATION for
ARISTADA™ (aripiprazole lauroxil) extended-release injectable
suspension, for intramuscular use
INDICATION
ARISTADA is indicated for the treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. ARISTADA is
not approved for the treatment of patients with dementia-related
psychosis.
Contraindication: Known hypersensitivity reaction to
aripiprazole. Reactions have ranged from pruritus/urticaria to
anaphylaxis.
Cerebrovascular Adverse Reactions, Including Stroke:
Increased incidence of cerebrovascular adverse reactions (e.g.,
stroke, transient ischemic attack), including fatalities, have been
reported in placebo-controlled trials of elderly patients with
dementia-related psychosis treated with risperidone, aripiprazole,
and olanzapine. ARISTADA is not approved for the treatment of
patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): A potentially fatal
symptom complex sometimes referred to as NMS may occur with
administration of antipsychotic drugs, including ARISTADA. Clinical
manifestations of NMS include hyperpyrexia, muscle rigidity,
altered mental status, and evidence of autonomic instability
(irregular pulse or blood pressure, tachycardia, diaphoresis, and
cardiac dysrhythmia). Additional signs may include elevated
creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute
renal failure. The management of NMS should include:
1) immediate discontinuation of antipsychotic drugs and other
drugs not essential to concurrent therapy; 2) intensive
symptomatic treatment and medical monitoring; and 3) treatment
of any concomitant serious medical problems for which specific
treatments are available.
Tardive Dyskinesia (TD): The risk of developing TD (a
syndrome of abnormal, involuntary movements) and the potential for
it to become irreversible are believed to increase as the duration
of treatment and the total cumulative dose of antipsychotic
increase. The syndrome can develop, although much less commonly,
after relatively brief treatment periods at low doses. Prescribing
should be consistent with the need to minimize TD. Discontinue
ARISTADA if clinically appropriate. There is no known treatment for
established TD, although the syndrome may remit, partially or
completely, if antipsychotic treatment is withdrawn.
Metabolic Changes: Atypical antipsychotic drugs have been
associated with metabolic changes that include:
- Hyperglycemia/Diabetes Mellitus:
Hyperglycemia, in some cases extreme and associated with
ketoacidosis, coma, or death, has been reported in patients treated
with atypical antipsychotics. There have been reports of
hyperglycemia in patients treated with oral aripiprazole. Patients
with diabetes should be regularly monitored for worsening of
glucose control; those with risk factors for diabetes should
undergo baseline and periodic fasting blood glucose testing. Any
patient treated with atypical antipsychotics should be monitored
for symptoms of hyperglycemia, including polydipsia, polyuria,
polyphagia, and weakness. Patients who develop symptoms of
hyperglycemia should also undergo fasting blood glucose testing. In
some cases, hyperglycemia has resolved when the atypical
antipsychotic was discontinued; however, some patients require
continuation of antidiabetic treatment despite discontinuation of
the suspect drug.
- Dyslipidemia: Undesirable
alterations in lipids have been observed in patients treated with
atypical antipsychotics.
- Weight Gain: Weight gain has
been observed with atypical antipsychotic use. Clinical monitoring
of weight is recommended.
Orthostatic Hypotension: Aripiprazole may cause
orthostatic hypotension which can be associated with dizziness,
lightheadedness and tachycardia. Monitor heart rate and blood
pressure, and warn patients with known cardiovascular or
cerebrovascular disease and risk of dehydration and syncope.
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia,
neutropenia, and agranulocytosis have been reported. Patients with
a history of clinically significant low white blood cell count
(WBC)/absolute neutrophil count (ANC) and history of drug-induced
leukopenia/neutropenia should have frequent complete blood count
(CBC) during the first few months of receiving ARISTADA. Consider
discontinuation of ARISTADA at the first sign of a clinically
significant decline in WBC count in the absence of other causative
factors. Monitor patients with clinically significant neutropenia
for fever or other symptoms or signs of infection and treat
promptly if such symptoms or signs occur. Discontinue ARISTADA in
patients with severe neutropenia (absolute neutrophil count
<1000/mm3) and follow their WBC until recovery.
Seizures: ARISTADA should be used with caution in
patients with a history of seizures or with conditions that lower
the seizure threshold.
Potential for Cognitive and Motor Impairment: ARISTADA
may impair judgment, thinking, or motor skills. Patients should be
cautioned about operating hazardous machinery, including
automobiles, until they are certain ARISTADA does not affect them
adversely.
Body Temperature Regulation: Disruption of the body’s
ability to reduce core body temperature has been attributed to
antipsychotic agents. Advise patients regarding appropriate care in
avoiding overheating and dehydration. Appropriate care is advised
for patients who may exercise strenuously, may be exposed to
extreme heat, receive concomitant medication with anticholinergic
activity, or are subject to dehydration.
Dysphagia: Esophageal dysmotility and aspiration have
been associated with antipsychotic drug use; use caution in
patients at risk for aspiration pneumonia.
Concomitant Medication: Decreasing the ARISTADA dosage is
recommended in patients taking strong CYP3A4 inhibitors and/or
strong CYP2D6 inhibitors for longer than 2 weeks. Increasing the
ARISTADA dosage is recommended in patients taking CYP3A4 inducers
for longer than 2 weeks. No ARISTADA dosage changes are recommended
for patients taking CYP450 modulators for less than 2 weeks.
Most Commonly Observed Adverse Reaction: The most common
adverse reaction (≥5% incidence and at least twice the rate of
placebo in patients treated with ARISTADA) was akathisia.
Injection-Site Reactions: Injection-site reactions were
reported by 4%, 5%, and 2% of patients treated with 441 mg
ARISTADA, 882 mg ARISTADA, and placebo, respectively. Most of these
were injection-site pain and associated with the first injection
and decreased with each subsequent injection. Other injection-site
reactions (induration, swelling, and redness) occurred at less than
1%.
Dystonia: Symptoms of dystonia, prolonged abnormal
contractions of muscle groups, may occur in susceptible individuals
during the first days of treatment and at low doses.
Pregnancy/Nursing: May cause extrapyramidal and/or
withdrawal symptoms in neonates with third trimester exposure.
Advise patients to notify their healthcare provider of a known or
suspected pregnancy. Inform patients that there is a pregnancy
exposure registry that monitors pregnancy outcomes in women exposed
to ARISTADA during pregnancy. Aripiprazole is present in human
breast milk. The benefits of breastfeeding should be considered
along with the mother’s clinical need for ARISTADA and any
potential adverse effects on the infant from ARISTADA or from the
underlying maternal condition.
Please see FULL PRESCRIBING INFORMATION, including
Boxed Warning for ARISTADA.
About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical
company developing innovative medicines for the treatment of
central nervous system (CNS) diseases. The company has a
diversified commercial product portfolio and a substantial clinical
pipeline of product candidates for chronic diseases that include
schizophrenia, depression, addiction and multiple sclerosis.
Headquartered in Dublin, Ireland, Alkermes plc has an R&D
center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and a manufacturing facility in
Wilmington, Ohio. For more information, please visit Alkermes’
website at www.alkermes.com.
Note Regarding Forward-Looking
Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning: the nature, timing and
likelihood of success of clinical development activities for, and
the therapeutic value of, ALKS 3831, ALKS 8700 and ALKS 5461; the
number of patients to be enrolled in the phase 3 studies for ALKS
3831 and ALKS 8700; the adequacy of the ENLIGHTEN and EVOLVE
pivotal programs for ALKS 3831 and ALKS 8700, respectively, to
serve as the basis for NDAs for each such product; the timing of
regulatory submissions to the FDA; and whether U.S. Patent No.
9,193,685 covering ARISTADA will adequately protect the
pharmaceutical composition against competition until October 2033.
You are cautioned that forward-looking statements are inherently
uncertain. Although the company believes that such statements are
based on reasonable assumptions within the bounds of its knowledge
of its business and operations, the forward-looking statements are
neither promises nor guarantees and they are necessarily subject to
a high degree of uncertainty and risk. Actual performance and
results may differ materially from those expressed or implied in
the forward-looking statements due to various risks and
uncertainties. These risks and uncertainties include, among others:
whether preclinical and early clinical results for our clinical
candidates will be predictive of future clinical study results;
whether ongoing or future clinical trials for our clinical
candidates will be initiated or completed on time or at all;
changes in the cost, scope and duration of the ALKS 3831 and ALKS
8700 clinical trials; whether our clinical candidates could be
shown ineffective or unsafe during clinical studies and whether, in
such instances, Alkermes may not be permitted by regulatory
authorities to undertake new or additional clinical studies of our
clinical candidates; whether regulatory submissions for our
clinical candidates will be submitted on time or at all; whether
adverse decisions by regulatory authorities in respect of our
clinical candidates will occur; whether the validity of U.S. Patent
No. 9,193,685 will be challenged by one or more third parties and
upheld; and those risks described in the Alkermes plc Quarterly
Report on Form 10-Q for the period ended Sept. 30, 2015 and Annual
Report on Form 10-K for the fiscal year ended Dec. 31, 2014, and in
other subsequent filings made by the company with the U.S.
Securities and Exchange Commission (SEC), which are available on
the SEC’s website at www.sec.gov. The information contained in this
press release is provided by the company as of the date hereof,
and, except as required by law, the company disclaims any intention
or responsibility for updating or revising any forward-looking
information contained in this press release.
TECFIDERA® is a registered trademark of Biogen MA Inc.
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AlkermesFor Investors:Eva Stroynowski, +1 781-609-6823orFor
Media:Jennifer Snyder, +1 781-609-6166
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