Key Developments For Alkermes, Inc.
Alkermes, Inc. (ALKS.O) (Nasdaq)
Alkermes, Inc. Initiates Phase 2 Clinical Study Of ALKS 33 For Treatment Of Alcohol Dependence
Alkermes, Inc. announced the initiation of a phase 2 clinical study of ALKS 33, an investigational oral opioid modulator for the potential treatment of alcohol dependence and other central nervous system disorders. The study will assess the safety and efficacy of multiple doses of ALKS 33 in patients with alcohol dependence and is designed to further define the clinical profile of ALKS 33. The phase 2 study is designed to assess the safety and efficacy of ALKS 33 in patients with alcohol dependence. In this multi-center, double-blind, placebo-controlled study, up to 440 patients will be randomized to receive daily oral administrations of one of three doses of ALKS 33 or placebo for a total of 12 weeks of treatment. The phase 2 study has an adaptive study design which enables an interim analysis after 40% of the patients are enrolled and on medication for eight weeks of treatment. The efficacy of ALKS 33 will be evaluated based on the percentage of patients who are abstinent from heavy drinking during the eight-week evaluation phase.
Alkermes, Inc. Announces Positive Results From Phase III Clinical Study Of Naltrexone for Extended-Release Injectable Suspension For Treatment Of Opioid Dependence
Alkermes, Inc. announced the positive preliminary results from a phase III clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase III study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002). Based on the positive results of this phase III study, Alkermes plans to file a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) in the first half of calendar 2010. XR-NTX, marketed by Alkermes as VIVITROL, is an opioid antagonist administered once-monthly by intramuscular injection and is approved in the U.S. for the treatment of alcohol dependence. In addition to meeting the primary efficacy endpoint, the six-month phase 3 study met all secondary efficacy endpoints. Data from the intent-to-treat (ITT) analysis show that the median patient taking XR-NTX had 90% opioid-free urine screens during the evaluation phase of the study and patients treated with XR-NTX demonstrated a significant reduction in opioid craving compared to placebo as measured by a visual analog scale.
Alkermes, Inc. Lowers FY 2010 Guidance
Alkermes, Inc. adjusted its expectation for total revenues for fiscal 2010 to a range of $168 to $183 million, revised from an expectation of $182 to $197 million. The Company adjusted its expectation for operating loss to a range of $45 to $52 million, revised from an expectation of $30 to $40 million. The Company also adjusted its expectation for net loss to a range of $45 to $55 million, revised from an expectation of $30 to $40 million. According to Reuters Estimates, analysts were expecting the Company to report revenue of $185 million, EBIT of $(33) million and net profit of $(36) million for fiscal 2010.
Alkermes, Inc. Announces Initiation Of Phase 1 Clinical Study Of ALKS 37 For Treatment Of Opioid-Induced Constipation
Alkermes, Inc. announced the initiation of a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers. Preclinical studies have shown ALKS 37 targets the gastrointestinal tract following oral administration, with limited systemic exposure. ALKS 37 is a component of ALKS 36, a combination drug candidate for the treatment of pain without the side effects of constipation.
Alkermes, Inc. Announces Positive Results From Two Clinical Trials Of ALKS 33
Alkermes, Inc. announced positive topline data from two clinical trials of ALKS 33, an investigational oral opioid modulator for the treatment of addiction and other central nervous system disorders. Data from the studies, ALK33-003 and ALK33-004, showed that ALKS 33 was generally well tolerated and successfully blocked the effects of an opioid, with a duration of action that supports once daily dosing. Based on these results, Alkermes expects to initiate a phase 2 study of ALKS 33 by the end of calendar 2009. ALK33-003 was a phase 1 randomized, double-blind, placebo-controlled, multi-dose study designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33. In the study, ALKS 33 demonstrated rapid oral absorption and sustained pharmacologically active plasma levels that support once daily dosing. Twenty-four healthy, non-dependent, opioid-experienced subjects were randomized to receive a placebo dose as well as one of two dose levels of ALKS 33, the same doses investigated in ALK33-003. Data showed that the onset of action of ALKS 33 was rapid and observed as early as 15 minutes following oral administration. A full blockade of the opioid agonist was observed and sustained for more than 24 hours following a single administration of ALKS 33. ALKS 33 was generally well tolerated in both studies.
