Target $28
Monday, July 15, 2019
Alkermes Expands Application Plan for ALKS 3831 to Include Bipolar I Disorder
Following Pre-NDA Meeting With FDA, Company Plans to Submit New Drug Application for Schizophrenia and Bipolar I Disorder Indications in the Fourth Quarter of 2019
Alkermes plc (Nasdaq: ALKS) today provided an update on its regulatory strategy for ALKS 3831 (olanzapine/samidorphan), the company’s investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. Following a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company plans to expand the NDA for ALKS 3831 to encompass the treatment of bipolar I disorder in addition to the treatment of schizophrenia. The ALKS 3831 NDA, which the company now plans to submit in the fourth quarter of 2019, will include data from the completed ALKS 3831 ENLIGHTEN clinical development program in patients with schizophrenia as well as pharmacokinetic (PK) bridging data comparing ALKS 3831 and ZYPREXA® (olanzapine).
“Bipolar I disorder is a complicated and often misdiagnosed disease, characterized by severe shifts in mood and energy that can impact a person’s ability to complete day-to-day activities. Antipsychotics are a mainstay treatment option for many people living with bipolar I disorder; however, new treatments with differentiated efficacy and tolerability profiles are needed,” said Roger S. McIntyre, M.D., Professor of Psychiatry and Pharmacology at the University of Toronto, Head of the Mood Disorders Psychopharmacology Unit at the University Health Network in Toronto and Director for the Depression and Bipolar Support Alliance (DBSA). “A potential new medication like ALKS 3831 would be a meaningful addition to the bipolar I disorder treatment landscape.”
“As a longstanding leader dedicated to developing new medicines to treat schizophrenia and other serious mental health disorders, we are gratified to now extend that commitment to people living with bipolar I disorder,” said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. “We are pleased to have met with FDA to align on this regulatory review pathway for ALKS 3831 for the treatment of bipolar I disorder, based on pharmacokinetic bridging data and results from our ENLIGHTEN program for schizophrenia. Our NDA preparation is well underway and we anticipate submitting a single NDA for ALKS 3831 later this year for the treatment of schizophrenia and bipolar I disorder.”
The ALKS 3831 NDA will include data to support an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as a monotherapy or adjunct to lithium or valproate and for maintenance treatment of bipolar I disorder; and an indication for the treatment of schizophrenia. The proposed fixed dosage strengths for ALKS 3831 include 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
AbbVie Enhances Early Stage Oncology Pipeline with Acquisition of Mavupharma
AbbVie (NYSE: ABBV) announced today that it has acquired Seattle-based Mavupharma, a privately held biopharmaceutical company focused on novel approaches to target the STING (STimulator of INterferon Genes) pathway for the treatment of cancer.
STING pathway signaling plays an important role in the generation of an immune response directed at tumors, and enhancing STING signaling has shown promise in a variety of tumor models. STING pathway stimulation has the potential to increase the susceptibility of tumors and broaden treatment options for patients.
“AbbVie’s vision in oncology is to advance breakthrough areas of science leading to a strong pipeline of innovative cancer therapies,” said Steve Davidsen, Ph.D., vice president of oncology discovery, AbbVie. “Mavupharma’s platform has the potential to further our immuno-oncology portfolio and assist in the development of transformative medicines for patients.”
Mavupharma’s lead clinical candidate is MAVU-104, a first-in-class, orally active, small molecule inhibitor of ENPP1, an enzyme involved in the regulation of the STING pathway. Inhibiting ENPP1 activity with MAVU-104 allows for highly controlled enhancement of STING signaling in tumors without the need for injections.
“AbbVie has built a leadership position in oncology and their world-class capabilities will enable the accelerated development of our pipeline of STING modulators,” said Michael Gallatin, Ph.D., former president and a co-founder of Mavupharma.
“We made tremendous strides in developing our novel STING modulators and advancing MAVU-104 towards the clinic. We are confident in AbbVie’s ability to continue to advance this exciting science for patients,” added former chief scientific officer and co-founder Gregory Dietsch, Ph.D.
Financial terms of the transaction were not disclosed.
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