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Alkermes, Inc.

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Richard F. Pops, Chairman, President and commented on the FORWARD program for ALKS 5461. He stated, "Last month, we announced data from the first study in the pivotal program called Forward-1. These data were very positive and clearly replicated results from our previous phase-II study. Seeing these consistent effects, study-to-study gives us a sense of confidence and robustness of the effective ALKS-5461 in this patient population and its ability to potentially to improve the standard of care. We are continuing to enroll the three core efficacy study with the Forward program in 2015. We are on track to report data in 2016."
Source: Q4 2014 earnings conference call, 2/24/15.

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Alkermes Announces Initiation of FORWARD-3 and FORWARD-4 Efficacy Studies in Pivotal Program for ALKS 5461 for Treatment of Major Depressive Disorder
DUBLIN, Ireland--(BUSINESS WIRE)--Jun. 10, 2014-- Alkermes plc (NASDAQ: ALKS) today announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). These studies will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Approximately two-thirds of patients who are diagnosed with MDD do not adequately respond to initial antidepressant therapy.1

“FORWARD-3 and FORWARD-4 incorporate features from our previous successful studies of ALKS 5461, including state-of-the-art design elements to reduce the impact of placebo response in depression trials,” stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “With these study initiations, four of the 12 studies from the FORWARD program are now underway since the launch of the pivotal program in March.”

FORWARD-3 and FORWARD-4 are both phase 3, multinational, randomized, double-blind, placebo-controlled studies designed to evaluate the efficacy and safety of ALKS 5461 as adjunctive treatment in patients with MDD. The two studies combined are expected to randomize approximately 1,000 patients and incorporate sophisticated design features to ensure rigorous patient selection, monitoring and evaluation. Data from these two core efficacy studies are expected in 2016. FORWARD-5, the third core efficacy trial, is expected to initiate in mid 2014.

Further information about the initiated FORWARD studies can be found at www.clinicaltrials.gov.
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Source: press release, 6/10/14. http://investor.alkermes.com/phoenix.zhtml?c=92211&p=irol-newsArticle&ID...

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FORWARD-4 - A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
Estimated Enrollment: 350
Study Start Date: May 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02158533?term=ALKS+5461&rank=2

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
ALKS-5461PsychiatryDepression MajorOpioid receptor modulatormu, kappa, delta and ORL1 receptors

Mechanism of action: ALKS-5461 is the combination of ALKS 33 and buprenorphine and is designed to be a non-addictive opioid modulator. ALKS-33 is an investigational oral opioid modulator in development for the treatment of reward disorders and other central nervous system (CNS) disorders. ALKS 33 acts as an opioid modulators as either an agonist or antagonist at multiple receptor sites (mu, kappa, delta and ORL1). Buprenorphine is a semi-synthetic opioid that is used to treat opioid addiction.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-06-01 - 2016-07-31

Results:

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Alkermes Announces Topline Results of FORWARD-3 and FORWARD-4, Two Phase 3 Studies of ALKS 5461 in Major Depressive Disorder
-- Neither Study Met Primary Endpoint; Additional Analyses of FORWARD-4 Provide Supportive Evidence of Efficacy --

-- Third Efficacy Study, FORWARD-5, Will Recruit Additional Patients; Data May Provide Regulatory Path Forward for ALKS 5461 --

DUBLIN--(BUSINESS WIRE)--Jan. 21, 2016-- Alkermes plc (NASDAQ: ALKS) today announced preliminary topline results from FORWARD-3 and FORWARD-4, the first two of three phase 3 efficacy studies to read out from the comprehensive FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. Neither of the two studies met the prespecified primary efficacy endpoint, which compared ALKS 5461 to placebo on the change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS).

FORWARD-4 tested two dose levels of ALKS 5461 (2mg/2mg and 0.5mg/0.5mg) compared to placebo. 385 patients entered the study. There was a clear trend toward efficacy with the 2mg/2mg dose of ALKS 5461 on the primary endpoint, and post hoc analyses achieved statistical significance for the entire 2mg/2mg dose group on the MADRS endpoint. Based on these analyses, Alkermes believes that FORWARD-4 provides supportive evidence of the efficacy of ALKS 5461 in the treatment of major depressive disorder.

FORWARD-3 tested ALKS 5461 (2mg/2mg) compared to placebo. 429 patients entered the study. Placebo response was greater than that observed in FORWARD-4 and no treatment effect of ALKS 5461 was observed. Negative trials due to significant placebo effect are not uncommon in the study of major depressive disorder.

FORWARD-5, the third pivotal efficacy study in the FORWARD program, is ongoing, testing two dose levels of ALKS 5461 (2mg/2mg and 1mg/1mg). FORWARD-5 shares common design and analysis features with FORWARD-4. Based on information gained from FORWARD-3 and FORWARD-4, patient enrollment in FORWARD-5 will be increased and the statistical analysis plan will be updated. Alkermes will provide an update later this quarter on the projected timing of completion of FORWARD-5.

In the case of a clear positive outcome for FORWARD-5, Alkermes believes that the evidence provided by it and the previously completed successful, randomized, placebo-controlled phase 2 study, together with supportive evidence from FORWARD-4, collectively could provide substantial evidence of efficacy for ALKS 5461 for the adjunctive treatment of MDD. In that case, Alkermes would request a meeting with the U.S. Food and Drug Administration’s (FDA) Division of Psychiatric Products to discuss the regulatory path for this Fast Track designated medicine.

“We are gaining important insights as we proceed with the FORWARD program for ALKS 5461. The third pivotal efficacy study, FORWARD-5, is ongoing and we plan to adapt it to incorporate findings from FORWARD-3 and FORWARD-4,” stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Clinical trials of new medicines for the treatment of major depressive disorder are complicated by significant placebo response. We designed the FORWARD pivotal program to include three efficacy studies as we recognize that this is a challenging disease state where multiple clinical studies and expansive analyses are generally necessary to confirm the efficacy of a new medicine.”

“We are steadfast in our commitment to developing new medicines for serious CNS conditions where there is a clear and compelling need for new treatment options for patients and their families,” said Richard Pops, Chief Executive Officer of Alkermes. “Major depressive disorder is one of these conditions. We are building a large body of evidence supporting our belief in the clinical utility and the novel mechanism of action of ALKS 5461. We await the results of FORWARD-5 and will determine our next steps along the regulatory path with those results in hand.”

In FORWARD-3, the most commonly reported adverse events were nausea, headache and fatigue, and in FORWARD-4 they were nausea, headache and dizziness. The safety and tolerability profile of ALKS 5461 was consistent with that reported for the phase 2 and FORWARD-1 studies.
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Source: press release, 1/21/16. http://investor.alkermes.com/phoenix.zhtml?c=92211&p=irol-newsArticle&ID...

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