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Intra-Cellular's Caplyta Sales Boost Revenues, Dependence a Woe
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Intra-Cellular (ITCI - Free Report) is focused on discovering, developing and commercializing small molecule drugs for treating neuropsychiatric and neurological disorders. The company currently has only one marketed drug in its portfolio, Caplyta (lumateperone 42 mg).
Caplyta – ITCI’s Key Growth Driver
The FDA initially approved Caplyta for the treatment of schizophrenia in adults in December 2019, while the commercial launch began in March 2020. In December 2021, Caplyta’s indication was further expanded to treat bipolar depression in adults. Caplyta is currently the only approved treatment, both as monotherapy and adjunctive therapy with lithium or valproate, for depressive episodes associated with bipolar I or II disorder in adults.
In April 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths have expanded the eligible patient population for Caplyta.
After the launch of its bipolar depression indication, Caplyta sales have increased, with the drug witnessing robust initial prescription growth. Intra-Cellular has also seen an increase in Caplyta prescriptions for the treatment of schizophrenia. Total Caplyta prescriptions grew 85% in 2023 compared with 2022.Net product sales of Caplyta in the first half of 2024 was $306.1 million, representing an increase of 49% compared with the year-ago figure on the back of strong prescription uptake.
Given the strength of the drug’s clinical profile, Intra-Cellular expects higher sales from Caplyta in the upcoming quarters.
ITCI’s Efforts to Further Expand Lumateperone’s Label
Intra-Cellular is simultaneously evaluating lumateperone for several other indications. The most prominent of the additional indications being pursued for the drug is major depressive disorder (MDD). In the first half of 2024, the company reported achieving the primary and key secondary efficacy endpoints in two global phase III studies, 501 and 502, evaluating 42 mg of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD.
The success of both the phase III studies, Study 501 and Study 502, forms the basis for a regulatory filing seeking the label expansion of lumateperone as an adjunctive treatment of MDD. Intra-Cellular anticipates the submission of a supplemental new drug application for lumateperone in the United States to treat the MDD indication in the second half of 2024.
If approved as an adjunctive treatment for MDD, the eligible patient population for Caplyta will be further expanded, which should boost revenues. A third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support the regulatory filing seeking label expansion of the drug for this indication if needed.
Lumateperone is also currently being evaluated for other Central Nervous System (CNS) indications in adult patients. In the fourth-quarter 2023 earnings release, Intra-Cellular announced that it has commenced its lumateperone pediatric program, which includes several ongoing studies evaluating the drug for various CNS indications.
The company is further evaluating a deuterated form of lumateperone, ITI-1248-ODT-SL, formulated as an oral disintegrating tablet for sublingual administration, making it convenient for patients who have difficulty swallowing conventional tablets. Based on encouraging phase I data, Intra-Cellular has initiated phase II programs evaluating ITI-1284-ODT-SL for the treatment of generalized anxiety disorder, psychosis in Alzheimer's disease and agitation in patients with Alzheimer’s disease. Clinical studies are set to begin soon. ITCI’s clinical-stage pipeline also comprises other promising candidates beyond lumateperone, which are currently being developed for other CNS indications as well as cancer.
Potential Limiting Factors
Intra-Cellular’s dependence on a single product for growth has its risks. Any negative news related to Caplyta would adversely impact the company and its growth prospects. Although Caplyta sales are picking up, customer buying patterns and supply chain disruptions can have an unfavorable impact on the drug's sales in future quarters as seen during the COVID-19 pandemic.
Moreover, Intra-Cellular’s early-stage candidates are several years away from commercialization. Any failure of ongoing studies will hinder the stock’s potential significantly.Investors must note that clinical development involves a high amount of risk. Gaining approval for pipeline candidates has become more difficult, given the tough regulatory environment.
There is also considerable rivalry in the market for CNS disorder therapies. One such company operating in this market space is Axsome Therapeutics (AXSM - Free Report) . Axsome’s core CNS product candidates — AXS-05, AXS-07, AXS-09, AXS-12 and AXS-14 — are being developed for multiple CNS indications. In August 2022, AXSM received FDA approval for Auvelity (AXS-05) for the treatment of adults with MDD. A prospective approval for Axsome’s other candidates or label expansion of AXS-05 to treat other CNS indications will create significant competition for ITCI’s Caplyta.
Xenon Pharmaceuticals (XENE - Free Report) is also evaluating its lead product candidate, azetukalner, a differentiated Kv7 potassium channel, to treat MDD and several epilepsy indications. XENE has completed a phase II proof-of-concept study on azetukalner called X-NOVA for patients with MDD.Based on the success of the mid-stage study, Xenon met with the FDA during the first quarter of 2024 and reached alignment regarding the late-stage clinical development program design for azetukalner to treat MDD, which will comprise three phase III clinical studies. Xenon expects to initiate the first phase III study by the end of 2024.
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Intra-Cellular's Caplyta Sales Boost Revenues, Dependence a Woe
Intra-Cellular (ITCI - Free Report) is focused on discovering, developing and commercializing small molecule drugs for treating neuropsychiatric and neurological disorders. The company currently has only one marketed drug in its portfolio, Caplyta (lumateperone 42 mg).
Caplyta – ITCI’s Key Growth Driver
The FDA initially approved Caplyta for the treatment of schizophrenia in adults in December 2019, while the commercial launch began in March 2020. In December 2021, Caplyta’s indication was further expanded to treat bipolar depression in adults. Caplyta is currently the only approved treatment, both as monotherapy and adjunctive therapy with lithium or valproate, for depressive episodes associated with bipolar I or II disorder in adults.
In April 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths have expanded the eligible patient population for Caplyta.
After the launch of its bipolar depression indication, Caplyta sales have increased, with the drug witnessing robust initial prescription growth. Intra-Cellular has also seen an increase in Caplyta prescriptions for the treatment of schizophrenia. Total Caplyta prescriptions grew 85% in 2023 compared with 2022.Net product sales of Caplyta in the first half of 2024 was $306.1 million, representing an increase of 49% compared with the year-ago figure on the back of strong prescription uptake.
Given the strength of the drug’s clinical profile, Intra-Cellular expects higher sales from Caplyta in the upcoming quarters.
ITCI’s Efforts to Further Expand Lumateperone’s Label
Intra-Cellular is simultaneously evaluating lumateperone for several other indications. The most prominent of the additional indications being pursued for the drug is major depressive disorder (MDD). In the first half of 2024, the company reported achieving the primary and key secondary efficacy endpoints in two global phase III studies, 501 and 502, evaluating 42 mg of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD.
The success of both the phase III studies, Study 501 and Study 502, forms the basis for a regulatory filing seeking the label expansion of lumateperone as an adjunctive treatment of MDD. Intra-Cellular anticipates the submission of a supplemental new drug application for lumateperone in the United States to treat the MDD indication in the second half of 2024.
If approved as an adjunctive treatment for MDD, the eligible patient population for Caplyta will be further expanded, which should boost revenues. A third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support the regulatory filing seeking label expansion of the drug for this indication if needed.
Lumateperone is also currently being evaluated for other Central Nervous System (CNS) indications in adult patients. In the fourth-quarter 2023 earnings release, Intra-Cellular announced that it has commenced its lumateperone pediatric program, which includes several ongoing studies evaluating the drug for various CNS indications.
The company is further evaluating a deuterated form of lumateperone, ITI-1248-ODT-SL, formulated as an oral disintegrating tablet for sublingual administration, making it convenient for patients who have difficulty swallowing conventional tablets. Based on encouraging phase I data, Intra-Cellular has initiated phase II programs evaluating ITI-1284-ODT-SL for the treatment of generalized anxiety disorder, psychosis in Alzheimer's disease and agitation in patients with Alzheimer’s disease. Clinical studies are set to begin soon. ITCI’s clinical-stage pipeline also comprises other promising candidates beyond lumateperone, which are currently being developed for other CNS indications as well as cancer.
Potential Limiting Factors
Intra-Cellular’s dependence on a single product for growth has its risks. Any negative news related to Caplyta would adversely impact the company and its growth prospects. Although Caplyta sales are picking up, customer buying patterns and supply chain disruptions can have an unfavorable impact on the drug's sales in future quarters as seen during the COVID-19 pandemic.
Moreover, Intra-Cellular’s early-stage candidates are several years away from commercialization. Any failure of ongoing studies will hinder the stock’s potential significantly.Investors must note that clinical development involves a high amount of risk. Gaining approval for pipeline candidates has become more difficult, given the tough regulatory environment.
There is also considerable rivalry in the market for CNS disorder therapies. One such company operating in this market space is Axsome Therapeutics (AXSM - Free Report) . Axsome’s core CNS product candidates — AXS-05, AXS-07, AXS-09, AXS-12 and AXS-14 — are being developed for multiple CNS indications. In August 2022, AXSM received FDA approval for Auvelity (AXS-05) for the treatment of adults with MDD. A prospective approval for Axsome’s other candidates or label expansion of AXS-05 to treat other CNS indications will create significant competition for ITCI’s Caplyta.
Xenon Pharmaceuticals (XENE - Free Report) is also evaluating its lead product candidate, azetukalner, a differentiated Kv7 potassium channel, to treat MDD and several epilepsy indications. XENE has completed a phase II proof-of-concept study on azetukalner called X-NOVA for patients with MDD.Based on the success of the mid-stage study, Xenon met with the FDA during the first quarter of 2024 and reached alignment regarding the late-stage clinical development program design for azetukalner to treat MDD, which will comprise three phase III clinical studies. Xenon expects to initiate the first phase III study by the end of 2024.