更新于：2024-12-13

Iloperidone

伊潘立酮

更新于：2024-12-13

概要

概要

基本信息

药物类型

小分子化药

别名

1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1- piperidinyl]propoxy]-3-methoxyphenyl]ethanone、4'-(3-(4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino)propoxy)-3'-methoxyacetophenone、Fanaptum

+ [10]

靶点

5-HT2A receptor x D2 receptor

作用机制

5-HT2A receptor拮抗剂(5-羟色胺2A受体拮抗剂)、D2 receptor拮抗剂(多巴胺D2受体拮抗剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Vanda Pharmaceuticals, Inc.

Novartis AG

非在研机构

Novartis Pharmaceuticals Corp.

最高研发阶段批准上市

首次获批日期

美国 (2009-05-06),

精神分裂症

最高研发阶段(中国)-

特殊审评-

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结构

分子式C24H27FN2O4

InChIKeyXMXHEBAFVSFQEX-UHFFFAOYSA-N

CAS号133454-47-4

关联

项与伊潘立酮相关的临床试验

NCT06494397 / Not yet recruiting临床1期

Crossover Bioequivalence Study of 12 mg VHX-896 and Iloperidone Tablets Under Steady-State Conditions

Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I disorder under steady state conditions.

开始日期2024-07-01

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05648591 / Recruiting临床4期

Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

开始日期2023-05-24

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05344365 / Withdrawn临床2期

An Open-label, Sequential Cohorts, Flexible Dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of Iloperidone in Elderly Patients With Parkinson's Disease Psychosis (PDP)

This is an open-label, sequential cohorts, flexible dose study to evaluate the tolerability, safety and pharmacokinetics of iloperidone in elderly patients with Parkinson's disease psychosis (PDP).

开始日期2022-06-01

申办/合作机构

Vanda Pharmaceuticals, Inc.

100 项与伊潘立酮相关的临床结果

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100 项与伊潘立酮相关的转化医学

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100 项与伊潘立酮相关的专利（医药）

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415

项与伊潘立酮相关的文献（医药）

2024-08-01·Pharmacological Reports

The effect of new atypical antipsychotic drugs on the expression of transcription factors regulating cytochrome P450 enzymes in rat liver

Article

作者: Danek, Przemysław J ; Daniel, Władysława A

Abstract:

Background:

Our recent studies showed that prolonged administration of novel atypical antipsychotics affected the expression and activity of cytochrome P450 (CYP), as demonstrated in vitro on human hepatocytes and in vivo on the rat liver. The aim of the present work was to study the effect of repeated treatment with asenapine, iloperidone, and lurasidone on the expression of transcription factors regulating CYP drug-metabolizing enzymes in rat liver.

Methods:

The hepatic mRNA (qRT-PCR) and protein levels (Western blotting) of aryl hydrocarbon receptor (AhR), pregnane X receptor (PXR), constitutive androstane receptor (CAR) and peroxisome proliferator-activated receptor (PPARγ) were measured in male Wistar rats after 2 week-treatment with asenapine, iloperidone or lurasidone.

Results:

The 2-week treatment with asenapine significantly diminished the AhR and PXR expression (mRNA, protein level), and CAR mRNA level in rat liver. Iloperidone lowered the AhR and CAR expression and PXR protein level. Lurasidone did not affect the expression of AhR and CAR, but increased PXR expression. The antipsychotics did not affect PPARγ.

Conclusions:

Prolonged treatment with asenapine, iloperidone, or lurasidone affects the expression of transcription factors regulating the CYP drug-metabolizing enzymes. The changes in the expression of AhR, CAR, and PXR mostly correlate with alterations in the expression and activity of respective CYP enzymes found in our previous studies. Since these transcription factors are also engaged in the expression of phase II drug metabolism and drug transporters, changes in their expression may affect the metabolism of endogenous substrates and pharmacokinetics of concomitantly used drugs.

2024-02-03·Journal of managed care & specialty pharmacy

A systematic review of the real-world effectiveness and economic and humanistic outcomes of selected oral antipsychotics among patients with schizophrenia in the United States: Updating the evidence and gaps

Review

作者: Ashraf, Md Najeeb ; Zacker, Christopher ; Jeun, Ki Jin ; Adhikari, Keyuri ; Kamal, Khalid M ; Nolfi, David A

BACKGROUND:

Schizophrenia is a chronic, relapsing, and burdensome psychiatric disorder affecting approximately 0.25%-0.6% of the US population. Oral antipsychotic treatment (OAT) remains the cornerstone for managing schizophrenia. However, nonadherence and high treatment failure lead to increased disease burden and medical spending. Cost-effective management of schizophrenia requires understanding the value of current therapies to facilitate better planning of management policies while addressing unmet needs.

OBJECTIVE:

To review existing evidence and gaps regarding real-world effectiveness and economic and humanistic outcomes of OATs, including asenapine, brexpiprazole, cariprazine, iloperidone, lumateperone, lurasidone, olanzapine/samidorphan, paliperidone, and quetiapine.

METHODS:

We conducted a literature search using PubMed, American Psychological Association PsycINFO (EBSCOhost), and the Cumulative Index of Nursing and Allied Health Literature from January 2010 to March 2022 as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. English-language articles describing adults with schizophrenia receiving at least 1 of the selected OATs and reporting real-world effectiveness, direct or indirect costs, humanistic outcomes, behavioral outcomes, adherence/persistence patterns, or product switching were identified.

RESULTS:

We identified 25 studies from a total of 24,190 articles. Real-world effectiveness, cost, and adherence/persistence outcomes were reported for most OATs that were selected. Humanistic outcomes and product switching were reported only for lurasidone. Behavioral outcomes (eg, interpersonal relations and suicide ideation) were not reported for any OAT. The key economic outcomes across studies were incremental cost-effectiveness ratios, cost per quality-adjusted life-years, and health care costs. In studies that compared long-acting injectables (LAIs) with OATs, LAIs had a higher pharmacy and lower medical costs, while total health care cost was similar between LAIs and OATs. Indirect costs associated with presenteeism, absenteeism, or work productivity were not reported for any of the selected OATs. Overall, patients had poor adherence to OATs, ranging between 20% and 61% across studies. Product switching did not impact the all-cause health care costs before and after treatment.

CONCLUSIONS:

Our findings showed considerable gaps exist for evidence on behavioral outcomes, humanistic outcomes, medication switching, and adherence/persistence across OATs. Our findings also suggest an unmet need regarding treatment nonadherence and lack of persistence among patients receiving OATs. We identified a need for research addressing OATs' behavioral and humanistic outcomes and evaluating the impact of product switching in adults with schizophrenia in the United States, which could assist clinicians in promoting patient-centered care and help payers understand the total value of new antipsychotic drugs.

2023-11-22·Journal of biomolecular structure & dynamics

In depth molecular interaction analyses of the complex of a proposed CTXM-inhibitor bound to the bacterial enzyme

Article

作者: Shakil, Shazi ; Greig, Nigel H. ; Rizvi, Syed M. Danish

A 'Thumb Rule for Antibiotic Design' against bacteria can be given as, 'The minimum pace of drug design ought to match the swiftness with which bacteria display cutting-edge resistance mechanisms; thereby outwitting the antibiotics and, in turn, the researchers'. Occurrence of drug resistance attributable to CXTM-variants in bacterial pathogens is widespread. In line with our above proposed thumb rule, the present article employed concatenation of virtual screening, docking and simulation to identify a potent in silico validated anti-CTXM-14 ligand. Specifically, this research used the 'MCULE' drug discovery platform to screen a total of 5 million candidate inhibitors to evaluate their binding efficacy with an antibiotic resistance enzyme, CTXM-14 found in bacterial pathogens. A new median approach between 'structure' and 'ligand'-based protocols was employed. Pharmacokinetic profiling was achieved by 'SWISS ADME'. Safety profile for humans was appraised by 'Toxicity Checker'. The complex consisting of the 'Top ligand' (obtained from the screen) harbored within the active pocket of the bacterial CTXM-14 was subjected to 60 ns molecular dynamics simulation with the aid of licensed YASARA STRUCTURE v.21.8.27. Complex tasks were performed by YANACONDA. Fine resolution figures (notably, plots generated from trajectory analyses) were constructed. Simulation snaps were acquired at every 250 picoseconds of the run. The ligand having the IUPAC name as 1-Amino-3-(4-hydroxyphenyl)pyrido[1,2-a]benzimidazole-2,4-dicarbonitrile demonstrated the overall best binding with CTXM-14. Fifteen amino acid residues were found to line the interacting pocket. Remarkably, all of these interacting residues were found to be present among the interacting residues displayed by the reference complex as well, i.e. CTXM-14:Vaborbactam complex (PDB ID 6V7H). A total of 240 simulation snaps were retrieved. The RMSD plot revealed that a plateau was achieved at 32 ns, after which the backbone RMSD fluctuations remained confined within 1.4-2 Å. Video recording of molecular actions was also achieved. In conclusion, this study provides a fresh lead molecule, 1-Amino-3-(4-hydroxyphenyl)pyrido[1,2-a]benzimidazole-2,4-dicarbonitrile against bacterial CTXM-14 protein. The study utilized a new median approach between 'structure' and 'ligand'-based drug design. The lead molecule passed ADMET conditions and an array of medicinal chemistry filters, and is further supported by a stable molecular dynamics. An acceptable skin permeation supports its probable use in antibiotic creams. Moreover, the study provides a clear 'Thumb Rule for Antibiotic Design' against bacteria, which although often assumed, can be clearly stated for the first time. Synthesis of the screening-proposed molecule followed by in-vitro and in-vivo validation is highly recommended.Communicated by Ramaswamy H. Sarma.

项与伊潘立酮相关的新闻（医药）

2024-11-06

·PRNewswire

Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results

Revenues for Q3 2024 were $47.7 million, an increase of 23% compared to Q3 2023 Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash ranges Fanapt® launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023 Fanapt® long acting injectable program expected to be initiated in Q4 2024 Milsaperidone NDA for schizophrenia and bipolar I disorder expected to be submitted in early 2025; initiation of major depressive disorder program expected in Q4 2024 PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024 PONVORY® IND applications for psoriasis and ulcerative colitis expected to be submitted in Q4 2024 Tradipitant NDA for motion sickness expected to be submitted in Q4 2024 WASHINGTON, Nov. 6, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2024. "We are very pleased with the lead indicators of the initial market response to our commercial launch of Fanapt in bipolar I disorder, a testament to the strong clinical evidence and the strength of our commercial strategy, and we look forward to continuous growth in the coming quarters. In parallel, we have launched Ponvory for multiple sclerosis and we are looking forward to increased prescriber and patient awareness in the near future. We expect Fanapt, milsaperidone and Fanapt LAI to form a diverse and expanding psychiatry franchise for years to come," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "On the research and development front, we are focused on completing in the coming months our New Drug Applications for tradipitant in motion sickness and for milsaperidone in schizophrenia and bipolar I disorder. IND filings are expected to be completed for Ponvory in ulcerative colitis and psoriasis later this quarter. We are committed to growing our revenue from our existing products and continuing to diversify our sources of revenue through indication expansion and new product development." Financial Highlights Third Quarter of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $47.7 million in the third quarter of 2024, a 23% increase compared to $38.8 million in the third quarter of 2023. Fanapt® net product sales were $23.9 million in the third quarter of 2024, a 12% increase compared to $21.3 million in the third quarter of 2023. HETLIOZ® net product sales were $17.9 million in the third quarter of 2024, a 2% increase compared to $17.5 million in the third quarter of 2023. PONVORY® net product sales were $5.9 million in the third quarter of 2024, a decrease of 32% compared to $8.6 million in the second quarter of 2024. The acquisition of PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, was completed on December 7, 2023. Net loss was $5.3 million in the third quarter of 2024 compared to net income of $0.1 million in the third quarter of 2023. Cash, cash equivalents and marketable securities (Cash) was $376.3 million as of September 30, 2024, representing a decrease to Cash of $11.4 million compared to June 30, 2024. The Cash balance of $376.3 million as of September 30, 2024 does not include a payment from Janssen for $8.1 million primarily related to second quarter 2024 PONVORY® revenue receivables, which was received in the fourth quarter of 2024. First Nine Months of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $145.6 million in the first nine months of 2024, a 1% decrease compared to $147.4 million in the first nine months of 2023. Fanapt® net product sales were $67.6 million in the first nine months of 2024, a 1% decrease compared to $68.3 million in the first nine months of 2023. HETLIOZ® net product sales were $56.6 million in the first nine months of 2024, a 28% decrease compared to $79.1 million in the first nine months of 2023. The decrease relative to the first nine months of 2023 was the result of continued generic competition in the U.S. PONVORY® net product sales were $21.3 million in the first nine months of 2024. The acquisition of PONVORY® from Janssen was completed on December 7, 2023. Net loss was $14.0 million in the first nine months of 2024, compared to net income of $4.9 million in the first nine months of 2023. Cash was $376.3 million as of September 30, 2024, representing a decrease to Cash of $12.0 million compared to December 31, 2023. The Cash balance of $376.3 million as of September 30, 2024 does not include a payment from Janssen for $8.1 million primarily related to second quarter 2024 PONVORY® revenue receivables, which was received in the fourth quarter of 2024. Key Operational Highlights Psychiatry Portfolio Fanapt® (iloperidone): Vanda initiated the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults in the third quarter of 2024, which included the expansion of its existing sales force and the introduction of prescriber awareness and comprehensive marketing programs. Several lead indicators suggest a strong initial market response including new patient starts as reflected by new to brand prescriptions (NBRx),1 increasing by over 90% in the third quarter of 2024 as compared to the third quarter of 2023. Milsaperidone: Vanda expects to submit a New Drug Application (NDA) for milsaperidone (also known as VHX-896 and P-88), the active metabolite of Fanapt®, for the treatments of schizophrenia and acute bipolar I disorder to the U.S. Food and Drug Administration (FDA) in early 2025. Vanda expects to initiate a Phase III program for milsaperidone for major depressive disorder (MDD) by the end of 2024. Iloperidone long acting injectable (LAI): Vanda expects to initiate a Phase III program for the LAI formulation of Fanapt® in the fourth quarter of 2024. HETLIOZ® (tasimelteon) Vanda has initiated a HETLIOZ LQ® program in pediatric insomnia. Although the prevalence of insomnia in children is difficult to determine, it is estimated that 20-40% of children experience significant sleep problems.2,3 There are currently no approved treatments for pediatric insomnia. Vanda continues to pursue FDA approval for HETLIOZ® for the treatments of jet lag disorder and insomnia. Vanda is challenging the FDA's rejection of Vanda's supplemental New Drug Application (sNDA) for the treatment of jet lag disorder in the U.S. Court of Appeals for the D.C. Circuit. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the insomnia sNDA. Vanda's litigation asserting HETLIOZ® Patent No. 11,285,129 against generic manufacturers is currently pending in the U.S. District Court for the District of Delaware. A jury trial has been scheduled for the first quarter of 2026. European Medicines Agency action on Vanda's Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome is expected in the first quarter of 2025. PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024, which included the deployment of a specialty sales force. Vanda expects Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis to be completed in the fourth quarter of 2024. Tradipitant Gastroparesis NDA: In September 2024, the FDA declined to approve Vanda's NDA for tradipitant for the treatment of symptoms of gastroparesis. Vanda plans to continue to pursue the marketing authorization for tradipitant and support the expanded access program that is currently serving several dozen patients with gastroparesis. Motion Sickness NDA: Vanda expects to submit an NDA for tradipitant for the treatment of motion sickness to the FDA in the fourth quarter of 2024. The NDA for the treatment of motion sickness is expected to include the positive results of three placebo controlled clinical studies where tradipitant was effective in preventing vomiting associated with motion. Vanda plans to initiate a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog (semaglutide) in the fourth quarter of 2024. Early-Stage Programs Vanda plans to proceed with studies of VSJ-110, a CFTR activator, for the treatment of dry eye disorder. An ongoing proof of concept study indicates an effect in improving the signs (fluorescein corneal staining) of dry eye disease. VPO-227, a CFTR inhibitor for the treatment of cholera, has received approval to proceed in a Phase I study in Bangladesh, a country where the treatment of cholera remains a significant and unmet need. Vanda plans to initiate this study by the end of 2024. The Phase I clinical study for VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, expects to enroll the patient by the end of 2024. The Phase I clinical study for VTR-297 for the treatment of onychomycosis, a fungal infection of the nail, was initiated in April 2024. The study is fully enrolled, and results are expected by the end of 2024. VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. GAAP Financial Results Net loss was $5.3 million in the third quarter of 2024 compared to net income of $0.1 million in the third quarter of 2023. Diluted net loss per share was $0.09 in the third quarter of 2024 compared to diluted net income per share of $0.00 in the third quarter of 2023. Net loss was $14.0 million in the first nine months of 2024 compared to net income of $4.9 million in the first nine months of 2023. Diluted net loss per share was $0.24 in the first nine months of 2024 compared to diluted net income per share of $0.09 in the first nine months of 2023. 2024 Financial Guidance Vanda is updating its 2024 financial guidance and expects to achieve the following financial objectives in 2024: Conference Call Vanda has scheduled a conference call for today, Wednesday, November 6, 2024, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2024 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 2555000. A replay of the call will be available on Wednesday, November 6, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, November 13, 2024 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 2555000. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Calhoun SL, Fernandez-Mendoza J, Vgontzas AN, Liao D, Bixler EO. Prevalence of insomnia symptoms in a general population sample of young children and preadolescents: gender effects. Sleep Med. 2014 Jan;15(1):91-5. doi: 10.1016/j.sleep.2013.08.787. Epub 2013 Oct 16. PMID: 24333223; PMCID: PMC3912735. Fricke-Oerkermann L, Plück J, Schredl M, Heinz K, Mitschke A, Wiater A, Lehmkuhl G. Prevalence and course of sleep problems in childhood. Sleep. 2007 Oct;30(10):1371-7. doi: 10.1093/sleep/30.10.1371. PMID: 17969471; PMCID: PMC2266270. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2024 Financial Guidance" above, and statements regarding Vanda's plans to strengthen and grow its business and diversify its sources of revenue; Vanda's plans for pursuit of FDA approval of milsaperidone for the treatments of schizophrenia and acute bipolar I disorder, tradipitant for the treatments of motion sickness and gastroparesis, and HETLIOZ® for the treatments of jet lag disorder and insomnia; European Medicines Agency action on the Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome; Vanda's clinical development plans for milsaperidone for the treatment of MDD, the LAI formulation of Fanapt®, PONVORY® for the treatments of psoriasis and ulcerative colitis, tradipitant for the prevention of vomiting induced by a GLP-1 analog, VSJ-110 for the treatment of dry eye, VPO-227 for the treatment of cholera, VCA-894A for the treatment of CMT2S, VTR-297 for the treatment of onychomycosis and VQW-765 for the treatment of acute performance anxiety in social situations; the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I in adults; the prevalence of pediatric sleep disorders; the regulatory status of Vanda's Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for SMS in Europe and its NDA for tradipitant for the treatment of symptoms of gastroparesis in the U.S.; and Vanda's plans to continue to support the tradipitant expanded access program for gastroparesis patients are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to correct the deficiencies identified by the FDA in the CRL with respect to the NDA for tradipitant for the treatment of symptoms of gastroparesis; Vanda's ability to complete and submit to the FDA the NDAs for tradipitant for the treatment of motion sickness and milsaperidone for the treatments of schizophrenia and acute bipolar I disorder within the specified timeframes; the FDA's assessment of the sufficiency of the data packages to be included in the NDAs for tradipitant and milsaperidone; Vanda's ability to correct the deficiencies identified by the FDA in the Complete Response Letter (CRL) with respect to the sNDA for HETLIOZ® for the treatment of insomnia; the outcome in the U.S. Court of Appeals of Vanda's challenge to the FDA's rejection of its sNDA for HETLIOZ® for the treatment of jet lag disorder; the accuracy of the lead indicators regarding the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults; Vanda's ability to initiate the Phase III programs for milsaperidone for MDD and the LAI formulation of Fanapt® by the end of 2024; the accuracy of the estimates regarding the prevalence of pediatric sleep disorders; Vanda's ability to file the INDs for PONVORY® for the treatments of psoriasis and ulcerative colitis by the end of 2024; Vanda's ability to initiate the Phase I study for VPO-227 for the treatment of cholera by the end of 2024; Vanda's ability to enroll the patient for the Phase I study for VCA-894A for the treatment of CMT2S by the end of 2024; and Vanda's ability to complete the Phase I study of VTR-297 for the treatment of onychomycosis by the end of 2024. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. 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临床1期上市批准财报申请上市并购

2024-10-18

·生物制药小编

万达制药三拒收购

近日，Vanda Pharmaceuticals再次拒绝了Cycle Pharmaceuticals收购要约。相比第一次，Cycle的报价不变，仍然是每股8美元，总计合计4.88亿美元。 2024年6月，Cycle首次对Vanda 提出了收购邀约，当时公司股价还上涨了24%。在Cycle这两次报价中，发生的一件重大事件就是Vanda的胃轻瘫药物tradipitant的新药上市申请遭到FDA拒绝批准。 tradipitant被拒后，Vanda并没有因此觉得自己掉价了，仍然坚持认为Cycle第二次提出的报价严重低估了公司的价值，不符合公司及其股东的最佳利益。Vanda甚至还将Cycle的收购邀约描述为“投机主义”，试图以折让的价格收购公司股票。在被Vanda拒绝的邀邀约收购的名单上，并非只有Cycle一家。在此之前（2024年5月），Vanda董事会还拒绝了CDMO公司Future Pak提出的每股7.25—7.75美元的收购邀约。董事会认为，Future Pak的收购会给公司带来巨大的风险和不确定性，不符合股东的最佳利益。为了避免公司被恶意收购，Vanda还因此启动了一项“毒丸计划”。多次硬刚FDA 如果要描述Vanda的一个突出特点的话，那就是“刚”。一般的药企在新药上市申请遭到监管拒绝后，都是老老实实补充相关数据，以达到FDA的监管要求，但大多数情况下，这家公司在遇到与FDA意见分歧的时候都选择了硬刚。早在2018年，FDA部分暂停了tradipitant的两项临床研究后，Vanda就将FDA告上法庭。因为FDA要求Vanda提供动物的临床前毒理数据，而Vanda认为动物研究并非必要的（之后提交新药上市申请的时候，Vanda还是坚持己见，选择了基于微生理系统的非动物临床前毒理学数据，不难理解，FDA最终向公司发出了一封CRL）。同年，FDA拒绝批准Hetlioz治疗时差障碍的新适应症后，Vanda再度选择与FDA当庭对峙。这次，tradipitant治疗胃轻瘫的上市申请被拒后，Vanda也同样对FDA的批准决定进行了指责。相关阅读：药物被拒，反而指责FDA违宪营收下滑挑战不论是Future Pak，还是Cycle，对Vanda都是提出的溢价收购——目前Vanda的股价为4.8美元/股。对于Vanda而言，需要应对的是营收出现显著下滑的情况，2023年公司营收较2022年（约2.544亿美元）下降了约24%，为1.926亿美元。公司收入主要来自两款上市产品Hetlioz和Fanapt。 Hetlioz是一款褪黑素受体激动剂，2014年获得FDA批准用以治疗非24小时睡醒周期障碍，此后又被批准用于治疗史密斯-马吉利综合征。作为公司的一大营收支柱，Hetlioz贡献了超一半的收入。然而Hetlioz在2023年销售业绩出现显著下滑，同比2022年（1.597亿美元）下降了37%，至1.002亿美元。2024年上半年销售额同样较2023年上半年下降了37%，至3880万美元。除了销售下滑之外，Hetlioz今年也是流年不利，3月的时候，用于失眠适应症的新药补充上市申请遭到了FDA的拒绝，在4月，Hetlioz还输掉了与仿制药厂家的诉讼，未来Hetlioz想要扭转销售下跌势头将更具挑战。 Fanapt算是有个好消息，今年在4月成功获批了I型双相情感障碍的新适应症批准。Fanapt在2009年首次获得FDA批准，用于急性成人精神分裂症。今年上半年，Fanapt已经成为公司销售额第一的的产品，不过相比2023年（4700万美元），销售额还是下滑了7%，为4370万美元。事实上，Vanda应该也是对这种情况有所预料，在去年底，Vanda花了1亿美元从强生那收购了一款自免新药Ponvory的美国以及加拿大权益。2024年上半年，Ponvory贡献了1540万美元的销售收入。参考出处 https://www.fiercepharma.com/pharma/vanda-swats-down-another-buyout-bid-cycle https://www.biospace.com/business/vanda-rejects-another-acquisition-offer-from-cycle-affirms-confidence-in-business药品上市被拒，Vanda再次破防

并购

2024-10-15

·echemi

Vanda Pharmaceutical’s Stock Soars 11.37%! Rejects $800 Million Acquisition Offer from UK Company

In Monday's deal, Vanda Pharmaceutical Inc categorically rejected a second takeover proposal from Britain's Cycle Pharmaceuticals that valued the company at $8 per share. Vanda Pharmaceutical is sticking to its position despite a significant drop in its stock price following the US Food and Drug Administration's (FDA) refusal to approve its drug for a stomach ailment. In a formal statement, Vanda Pharmaceutical pointed out that Cycle Pharma's proposed acquisition terms are economically identical to the previous proposal that was evaluated and rejected by Vanda Pharmaceutical. This means that Cycle Pharma's latest offer did not convince Vanda Pharmaceutical's board. Cycle Pharma's $8 per share offer represents an 80% premium to Vanda Pharmaceutical's most recent closing price, valuing the company at $488 million. However, Vanda Pharmaceutical's Board of Directors believes that this valuation significantly undervalues the true value of the Company and is not in the best interests of the Company and its shareholders. Earlier, the FDA refused to approve Vanda Pharmaceutical's stomach disease drug, and the news sent shares of Vanda Pharmaceutical down 4.5%. In June, Vanda Pharmaceutical had already rejected Cycle Pharma's initial offer, as well as a revised offer from contract manufacturer Future Pak. To reduce the risk of a hostile takeover, Vanda Pharmaceutical adopted a shareholder rights plan, commonly known as a "poison pill," in April. Vanda Pharmaceutical has three approved products: Hetlioz for sleep disorders, Fanapt for bipolar I disorder and Ponvory for multiple sclerosis. After carefully reviewing Cycle Pharma's second proposal, Vanda Pharmaceutical's Board of Directors unanimously concluded that the proposal did not adequately reflect the value of Vanda Pharmaceutical and decided not to pursue the proposal. In a statement, Cycle Pharma said it remains willing to work with Vanda Pharmaceutical's board of directors and management team to reach an agreement that provides a compelling premium and some cash value to all of Vanda Pharmaceutical's shareholders. After Vanda Pharmaceutical rejected the takeover proposal, its shares rose 11.37 percent to $4.95 per share in trading on Monday. This increase in the share price reflects the market's positive reaction to Vanda Pharmaceutical's rejection of the acquisition proposal, as well as confidence in the company's future prospects.

上市批准并购

100 项与伊潘立酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02666	伊潘立酮	N05AX14	DB04946

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
躁郁症1型	美国	Vanda Pharmaceuticals, Inc.	2024-04-02
躁狂	美国	Vanda Pharmaceuticals, Inc.	2024-04-02
精神分裂症	美国	Vanda Pharmaceuticals, Inc.	2009-05-06

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性精神分裂症	临床3期	美国	Vanda Pharmaceuticals, Inc.	2005-11-18
急性精神分裂症	临床3期	印度	Vanda Pharmaceuticals, Inc.	2005-11-18
原发性肥大性骨关节病	临床2期	美国	Vanda Pharmaceuticals, Inc.	2022-06-01
帕金森病	临床2期	美国	Vanda Pharmaceuticals, Inc.	2022-06-01
情绪易怒	临床2期	美国	Novartis Pharmaceuticals Corp.	2013-07-01
入睡和睡眠障碍	临床2期	美国	Novartis Pharmaceuticals Corp.	2013-07-01
创伤后应激障碍	临床2期	美国	Novartis Pharmaceuticals Corp.	2013-07-01
肝病	临床1期	美国	Novartis Pharmaceuticals Corp.	2010-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04819776 (CTgov)	临床3期	躁狂 \| 躁郁症1型	417	Iloperidone (Iloperidone)	簾廠製顧艱襯顧獵簾構(壓繭鏇窪艱觸鏇糧夢簾) = 獵繭鑰簾窪窪鏇夢築夢糧膚醖觸觸壓鑰遞鹽鑰 (鹹糧壓鏇窪鹹糧構糧願, 積築築壓鹽獵遞艱觸衊 ~ 獵觸鬱醖襯衊鑰製鹹鬱) 更多	-	2024-04-16
				Iloperidone Placebo (Placebo)	簾廠製顧艱襯顧獵簾構(壓繭鏇窪艱觸鏇糧夢簾) = 壓膚艱糧艱夢齋觸積餘糧膚醖觸觸壓鑰遞鹽鑰 (鹹糧壓鏇窪鹹糧構糧願, 鹹壓窪網鑰鹹壓選憲繭 ~ 築觸選膚夢鹽壓蓋壓鬱) 更多
NCT01291511 (REPRIEVE, CTgov)	临床3期	精神分裂症	635	Iloperidone (Iloperidone)	壓夢壓築膚築範壓願鑰(觸製夢鑰淵積夢淵艱衊) = 壓壓窪遞餘遞網製壓淵艱糧獵獵醖膚觸選廠顧 (獵窪願壓廠顧築膚鹹積, 築醖簾鏇膚願憲鹹築製 ~ 廠觸願襯膚鑰遞網鑰簾) 更多	-	2023-07-17
				Placebo (Placebo)	壓夢壓築膚築範壓願鑰(觸製夢鑰淵積夢淵艱衊) = 鏇鹹蓋築鏇築淵廠繭膚艱糧獵獵醖膚觸選廠顧 (獵窪願壓廠顧築膚鹹積, 廠鏇壓網選淵襯簾觸築 ~ 積襯鏇齋夢壓齋衊鏇廠) 更多
NCT01917318 (CTgov)	临床2期	入睡和睡眠障碍 \| 创伤后应激障碍 \| 情绪易怒	1	Placebo+Iloperidone (Iloperidone / Placebo)	醖蓋選網膚鏇觸觸襯鑰(糧構築獵觸鹹範鏇鹹餘) = 衊糧醖鬱鏇顧廠憲繭鏇齋壓獵觸夢觸蓋鹹淵繭 (膚構構艱糧鏇顧鬱壓製, 憲製鏇憲憲壓淵鹽鬱願 ~ 鬱範廠簾鏇獵廠壓網獵) 更多	-	2020-01-31
				Placebo+Iloperidone (Placebo / Iloperidone)	鏇夢襯顧構衊壓鏇鏇構(願鏇廠衊顧觸壓壓願鹽) = 廠齋遞積顧積淵築獵築範窪鑰簾鬱鹹網鬱夢鬱 (顧鹹選齋鏇憲構夢製鑰, 衊鏇蓋構選壓壓淵範糧 ~ 壓觸構醖鏇觸蓋繭遞鑰) 更多
NCT01920802 (CTgov)	临床4期	-	31	olanzapine (Olanzapine)	鹹襯範範廠遞積遞窪獵(製齋繭衊餘構廠觸夢廠) = 憲廠願獵糧範鑰淵壓願顧獵鬱鑰鑰鹽選積鹹壓 (憲壓衊膚醖蓋鹽齋夢顧, 獵醖壓繭遞繭鑰鏇願齋 ~ 構淵築鬱窪壓構餘襯衊) 更多	-	2017-03-20
				iloperidone (Iloperidone)	鹹襯範範廠遞積遞窪獵(製齋繭衊餘構廠觸夢廠) = 壓夢獵夢餘蓋鬱餘餘觸顧獵鬱鑰鑰鹽選積鹹壓 (憲壓衊膚醖蓋鹽齋夢顧, 選鑰簾製夢淵繭築範淵 ~ 鑰膚鏇鬱築鹽網膚齋蓋) 更多
NCT01291511 (REPRIEVE, Pubmed \| CNS Drugs) 人工标引	临床3期	精神分裂症	303	Iloperidone	顧憲範鹹窪膚蓋遞遞鏇(夢鏇顧醖鏇簾齋顧繭衊) = 醖廠顧餘築鑰鏇選範膚廠糧鬱觸壓夢衊蓋鹹繭 (廠鹹願膚艱艱顧觸淵糧 ) 更多	积极	2016-08-01
				Placebo	顧憲範鹹窪膚蓋遞遞鏇(夢鏇顧醖鏇簾齋顧繭衊) = 築壓淵襯範積顧夢選遞廠糧鬱觸壓夢衊蓋鹹繭 (廠鹹願膚艱艱顧觸淵糧 ) 更多
NCT01929889 (CTgov)	临床4期	分裂情感性障碍 \| 精神分裂症	19	Iloperidone	鑰壓憲膚構艱遞窪觸齋(築壓築顧鏇衊鏇淵願積) = 廠衊顧積顧獵網鹽選廠糧夢願構積遞襯鏇衊糧 (範夢淵鹹鹽積窪衊範蓋, 顧壓鹽願膚範夢齋餘選 ~ 齋壓觸積簾憲餘窪觸淵) 更多	-	2015-07-10
NCT01207414 (i-FANS, CTgov)	临床4期	精神分裂症	501	iloperidone (Iloperidone Gradual Switch)	鑰齋製膚膚壓窪網遞醖(齋鬱廠簾鬱蓋餘構製壓) = 顧襯構選膚願蓋齋願範夢簾選製鹹憲鏇窪糧蓋 (願鏇壓艱蓋積糧觸範構, 糧醖艱顧願鹹鑰窪衊鏇 ~ 衊廠製鹽夢壓餘繭襯鹹) 更多	-	2013-03-15
				iloperidone (Iloperidone Immediate Switch)	鑰齋製膚膚壓窪網遞醖(齋鬱廠簾鬱蓋餘構製壓) = 鏇構憲鹹獵廠鏇夢鏇獵夢簾選製鹹憲鏇窪糧蓋 (願鏇壓艱蓋積糧觸範構, 鏇窪齋觸廠窪廠糧膚鹽 ~ 醖鏇繭鑰壓膚製鹹廠鹽) 更多