–– Company on Track to Initiate Registration Program for Novel Twice-Daily Oral Candidate by End of 2015 and File New Drug Application in 2018 ––
DUBLIN, Ireland I October 29, 2015 I Alkermes plc (NASDAQ: ALKS) today provided an update on its regulatory strategy and positive clinical trial results for ALKS 8700, a novel, oral monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA®.
Regulatory update: Based on a meeting with the U.S. Food and Drug Administration (FDA), Alkermes plans to file a 505(b)(2) New Drug Application (NDA) using pharmacokinetic bridging data from studies comparing ALKS 8700 and TECFIDERA, as well as a two-year phase 3 safety study of ALKS 8700 in approximately 600 patients with MS. Importantly, this means that Alkermes will not be required to conduct a separate phase 3 efficacy study in patients with MS. In addition, Alkermes intends to initiate a randomized, head-to-head study comparing the gastrointestinal (GI) tolerability of ALKS 8700 and TECFIDERA in approximately 420 patients with MS in mid-2016. Alkermes expects to complete these studies and file the NDA in 2018.
Clinical update: Alkermes recently completed a randomized, double-blind phase 1 comparative pharmacokinetic study evaluating plasma MMF levels achieved by administration of single doses of ALKS 8700 and TECFIDERA. Initial data from this study showed that ALKS 8700 met the pharmacokinetic criteria for bioequivalence to TECFIDERA. The most common adverse events (AEs) in the study were flushing, dizziness and constipation for ALKS 8700, and flushing, nausea and diarrhea for TECFIDERA. Based on these results, Alkermes has selected the ALKS 8700 dose to be used in the registration program. Alkermes will need to conduct additional preclinical studies and pharmacokinetic studies to further support pharmacokinetic comparability to TECFIDERA.
“With these positive pharmacokinetic bridging results and agreement with the FDA on our regulatory strategy in hand, our path to approval for ALKS 8700 has been clarified. A key component of the program is the comparison of GI tolerability, as we see this as an opportunity to potentially provide new benefits to MS patients,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We remain on track to advance ALKS 8700 twice-daily into phase 3 development with the initiation of the two-year safety study later this year, and we plan to file the NDA in 2018.”
Recent Phase 1 Study Design and Results
This phase 1, randomized, double-blind clinical study evaluated the safety, tolerability and single-dose pharmacokinetics (PK) of ALKS 8700 compared to active control in 35 healthy volunteers. In this two-treatment, two-period crossover design, subjects received a single dose of either ALKS 8700 or TECFIDERA, followed by the other agent in the subsequent treatment period, thereby enabling a crossover comparison of PK and tolerability within the same subjects. Initial data from this study showed that ALKS 8700 met the pharmacokinetic criteria for bioequivalence to TECFIDERA.
The most common AEs in the study were flushing, dizziness and constipation for ALKS 8700, and flushing, nausea and diarrhea for TECFIDERA. No serious AEs or discontinuations due to AEs were observed in the study. Alkermes will present safety and PK data from the phase 1 study at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal.
About ALKS 8700
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF) molecule 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 Multiple Sclerosis
Multiple sclerosis (MS) is an unpredictable, often disabling disease of the central nervous system (CNS), which interrupts the flow of information within the brain, and between the brain and body.1 MS symptoms can vary over time and from person to person. Symptoms may include extreme fatigue, impaired vision, problems with balance and walking, numbness or pain and other sensory changes, bladder and bowel symptoms, tremors, problems with memory and concentration and mood changes, among others.1 Approximately 400,000 individuals in the U.S. and 2.5 million people worldwide have MS, and most are diagnosed between the ages of 15 and 50.2
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.
SOURCE: Alkermes
Post Views: 192
–– Company on Track to Initiate Registration Program for Novel Twice-Daily Oral Candidate by End of 2015 and File New Drug Application in 2018 ––
DUBLIN, Ireland I October 29, 2015 I Alkermes plc (NASDAQ: ALKS) today provided an update on its regulatory strategy and positive clinical trial results for ALKS 8700, a novel, oral monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA®.
Regulatory update: Based on a meeting with the U.S. Food and Drug Administration (FDA), Alkermes plans to file a 505(b)(2) New Drug Application (NDA) using pharmacokinetic bridging data from studies comparing ALKS 8700 and TECFIDERA, as well as a two-year phase 3 safety study of ALKS 8700 in approximately 600 patients with MS. Importantly, this means that Alkermes will not be required to conduct a separate phase 3 efficacy study in patients with MS. In addition, Alkermes intends to initiate a randomized, head-to-head study comparing the gastrointestinal (GI) tolerability of ALKS 8700 and TECFIDERA in approximately 420 patients with MS in mid-2016. Alkermes expects to complete these studies and file the NDA in 2018.
Clinical update: Alkermes recently completed a randomized, double-blind phase 1 comparative pharmacokinetic study evaluating plasma MMF levels achieved by administration of single doses of ALKS 8700 and TECFIDERA. Initial data from this study showed that ALKS 8700 met the pharmacokinetic criteria for bioequivalence to TECFIDERA. The most common adverse events (AEs) in the study were flushing, dizziness and constipation for ALKS 8700, and flushing, nausea and diarrhea for TECFIDERA. Based on these results, Alkermes has selected the ALKS 8700 dose to be used in the registration program. Alkermes will need to conduct additional preclinical studies and pharmacokinetic studies to further support pharmacokinetic comparability to TECFIDERA.
“With these positive pharmacokinetic bridging results and agreement with the FDA on our regulatory strategy in hand, our path to approval for ALKS 8700 has been clarified. A key component of the program is the comparison of GI tolerability, as we see this as an opportunity to potentially provide new benefits to MS patients,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We remain on track to advance ALKS 8700 twice-daily into phase 3 development with the initiation of the two-year safety study later this year, and we plan to file the NDA in 2018.”
Recent Phase 1 Study Design and Results
This phase 1, randomized, double-blind clinical study evaluated the safety, tolerability and single-dose pharmacokinetics (PK) of ALKS 8700 compared to active control in 35 healthy volunteers. In this two-treatment, two-period crossover design, subjects received a single dose of either ALKS 8700 or TECFIDERA, followed by the other agent in the subsequent treatment period, thereby enabling a crossover comparison of PK and tolerability within the same subjects. Initial data from this study showed that ALKS 8700 met the pharmacokinetic criteria for bioequivalence to TECFIDERA.
The most common AEs in the study were flushing, dizziness and constipation for ALKS 8700, and flushing, nausea and diarrhea for TECFIDERA. No serious AEs or discontinuations due to AEs were observed in the study. Alkermes will present safety and PK data from the phase 1 study at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal.
About ALKS 8700
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF) molecule 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 Multiple Sclerosis
Multiple sclerosis (MS) is an unpredictable, often disabling disease of the central nervous system (CNS), which interrupts the flow of information within the brain, and between the brain and body.1 MS symptoms can vary over time and from person to person. Symptoms may include extreme fatigue, impaired vision, problems with balance and walking, numbness or pain and other sensory changes, bladder and bowel symptoms, tremors, problems with memory and concentration and mood changes, among others.1 Approximately 400,000 individuals in the U.S. and 2.5 million people worldwide have MS, and most are diagnosed between the ages of 15 and 50.2
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.
SOURCE: Alkermes
Post Views: 192
