A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.

开始日期2024-10-08

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05922995 / Not yet recruiting早期临床1期IIT

A Single Center, Open Label Prospective Observational Pilot Study to Evaluate the Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log.
To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index [ISI], Pittsburgh Sleep Quality Inventory [PSQI], Epworth Sleepiness Scale [ESS], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy.
To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study.
To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing.
To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

开始日期2023-09-30

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

NCT05572281 / Completed临床1期

An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of Tasimelteon Capsule Formulation Relative to Tasimelteon Liquid Suspension Formulation in Healthy Volunteers

This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.

开始日期2022-05-18

申办/合作机构

Vanda Pharmaceuticals, Inc.

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100 项与他司美琼相关的转化医学

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100 项与他司美琼相关的专利（医药）

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项与他司美琼相关的文献（医药）

2024-11-01·SCIENCE OF THE TOTAL ENVIRONMENT

Effects of low-molecular-weight organic acids on the transport of polystyrene nanoplastics: An insight at the structure of organic acids

Article

作者: Wei, Xuan ; Gong, Yi ; Lu, Taotao ; Chen, Feiyu ; Chen, Dong

Plastic nanoparticles are extensively used in various products, leading to inevitable pollution in soil. Understanding their transport in soils where various organic substances exist is crucial. This study examined the impact of low-molecular-weight organic acids (LMWOAs) on the transport of polystyrene nanoplastics (PS-NPs) through saturated quartz sand. The experiments involved three dibasic acids-malonic acid (MA₁), malic acid (MA₂) and tartaric acid (TA) - and four monobasic acids- formic acid (FA), acetic acid (AA), propanoic acid (PA) and glycolic acid (GA) -under different pH levels (4.0, 5.5, 7.0) and in the presence of cations (Na⁺, Ca²⁺). The results demonstrated that in the presence of Na⁺, dibasic acids significantly enhanced PS-NPs transport, with TA being the most effective, followed by MA₂ and MA₁. This enhancement is attributed to the adsorption of LMWOAs onto the nanoparticles and sand, creating a more negative ζ-potential, which increases the electrostatic repulsion and decreases the PS-NPs deposition, thereby facilitating the transport. Applying the Derjaguin-Landau-Verwey-Overbeek theory, higher pH levels increased the energy barrier and secondary energy minimum, decreasing PS-NPs deposition. Moreover, dibasic acids significantly enhanced the hydrophilicity of PS-NPs. Conversely, monobasic acids, except for GA, slightly reduced the hydrophilicity of PS-NPs, as indicated by a small increase in the water contact angle, hereby minimally affecting PS-NPs transport. As for GA, although it is a monobasic acid, the additional -OH group in its molecular structure promoted PS-NPs transport, similar to dibasic acids. For example, GA also significantly enhanced the hydrophilicity of PS-NPs. In the presence of Ca²⁺, the enhancement of PS-NPs transport by LMWOAs was comparable to that with Na⁺, primarily due to the complex-forming and bridging effects of Ca²⁺ with the organic acids and PS-NPs. These findings provide important insights into predicting and analyzing the transport behaviors of PS-NPs.

2024-08-01·JOURNAL OF PINEAL RESEARCH

Relationship Between Melatonin Receptor Agonists and Parkinson's Disease

Article

作者: Masuda, Rikuto ; Yoshimura, Tomoaki ; Noguchi, Yoshihiro ; Aizawa, Haruka

Abstract:

Parkinson's disease affects millions of people worldwide, and without significant progress in disease prevention and treatment, its incidence and prevalence could increase by more than 30% by 2030. Researchers have focused on targeting sleep and the circadian system as a novel treatment strategy for Parkinson's disease. This study investigated the association between melatonin receptor agonists and Parkinson's disease, using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS). The target drugs were melatonin receptor agonists including ramelteon, tasimelteon, and agomelatine. Parkinson's disease cases were defined according to the Medical Dictionary for Regulatory Activities (MedDRA) 25.0; Standardized MedDRA Query (SMQ) using both the “narrow” and “broad” preferred terms (PTs) associated with Parkinson's disease. The association between melatonin receptor agonists (ramelteon, tasimelteon, and agomelatine) and Parkinson's disease was evaluated by the reporting odds ratio. Upon analyzing the data from all patients registered in the FAERS, ramelteon (ROR: 0.66, 95% confidence interval [95% CI]: 0.51–0.84) and tasimelteon (ROR: 0.49, 95% CI: 0.38–0.62) showed negative correlations with Parkinson's disease. Conversely, only agomelatine was positively correlated with Parkinson's disease (ROR: 2.63, 95% CI: 2.04–3.40). These results suggest that among the melatonin receptor agonists, ramelteon and tasimelteon are negatively correlated with Parkinson's disease. In contrast, agomelatine was shown to be positively correlated with Parkinson's disease. These results should be used in research to develop drugs for the treatment of Parkinson's disease, fully considering the limitations of the spontaneous reporting system.

2024-04-01·Sleep medicine

Improvement in non-24-h sleep-wake rhythm disorder in a sighted individual treated with a melatonin receptor agonist

Article

作者: Quigg, Mark ; Davis, Eric M ; Connolly, Patrick J

Non-24-hour sleep-wake rhythm disorder (N24SWD) typically presents in patients with visual impairments that disrupt the ability to entrain to the 24 hour solar cycle. We discuss a 43 year old sighted man who presented with periodic daytime hypersomnia and nighttime insomnia, occasionally leading to <3 hours of sleep per day. Previous polysomnography showed an apnea hypopnea index of 6.2 events per hour. A sleep log of 3 months showed irregular time of sleep onset, and an average of 3 hours of sleep per day. Wrist actigraphy confirmed N24SWD. A trial of tasimelteon 20 mg/day resulting in improved daytime hypersomnia (pre-Epworth Sleepiness Scale (ESS) = 21/24, post-ESS = 5/24; a score of > 10/24 is considered sleepy). Follow-up actigraphy showed marked resolution of phase delay with an average of five hours of sleep. The case demonstrates that tasimelteon is a possible treatment for N24SWD in sighted individuals.

项与他司美琼相关的新闻（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 项与他司美琼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09388	他司美琼	N05CH03	DB09071

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
入睡和睡眠障碍	美国	Vanda Pharmaceuticals, Inc.	2020-12-01
睡眠-觉醒节律障碍	美国	Vanda Pharmaceuticals, Inc.	2014-01-31

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
飞行时差反应综合征	申请上市	美国	Vanda Pharmaceuticals, Inc.	-
自闭症谱系障碍	临床3期	美国	Vanda Pharmaceuticals, Inc.	2021-07-28
睡眠剥夺	临床3期	美国	Vanda Pharmaceuticals, Inc.	2015-09-01
Smith-Magenis综合征	临床3期	美国	Vanda Pharmaceuticals, Inc.	2015-09-01
重度抑郁症	临床3期	美国	Vanda Pharmaceuticals, Inc.	2011-09-01
日夜节律睡眠障碍	临床3期	美国	Vanda Pharmaceuticals, Inc.	2010-08-01
日夜节律睡眠障碍	临床3期	德国	Vanda Pharmaceuticals, Inc.	2010-08-01
普遍的儿童发育障碍	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-09-16
REM睡眠行为障碍	临床1期	美国	Vanda Pharmaceuticals, Inc.	2023-09-30
嗜睡	临床1期	加拿大	Vanda Pharmaceuticals, Inc.	2012-04-01

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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


NCT03373201 (JET8 Study, CTgov)	临床3期	飞行时差反应综合征	320	Placebo (Placebo)	簾餘獵襯壓構糧廠範範(遞繭鏇網鏇醖簾夢觸獵) = 餘積築憲獵遞範觸鹽襯鹹壓夢鑰憲齋壓築衊獵 (廠製願觸淵鹽獵糧廠範, 網積選遞願鏇壓淵鹽壓 ~ 鬱衊糧廠網憲蓋製蓋觸) 更多	-	2023-09-15
				Tasimelteon (Tasimelteon)	簾餘獵襯壓構糧廠範範(遞繭鏇網鏇醖簾夢觸獵) = 醖膚遞淵顧廠淵蓋遞選鹹壓夢鑰憲齋壓築衊獵 (廠製願觸淵鹽獵糧廠範, 構獵築築糧繭窪糧製鏇 ~ 構積鏇繭糧淵製願醖選) 更多
NCT03291041 (JET, Pubmed) 人工标引	临床2期	飞行时差反应综合征	25	tasimelteon	積鏇網壓齋襯鏇製夢製(選願糧範觸鑰廠壓淵餘): difference = 131	积极	2022-09-15
				Placebo
NCT03291041 (JET, CTgov)	临床2期	飞行时差反应综合征	25	Tasimelteon (Tasimelteon)	鬱淵齋築襯築糧構艱憲(鹹遞醖壓獵壓醖鬱鹹夢) = 廠壓夢蓋簾糧壓積鬱網遞鏇繭選鏇遞範觸壓餘 (襯鹽衊餘遞淵鑰鹹鏇壓, 壓製廠鏇網鹽網襯衊積 ~ 夢齋顧顧衊糧網範壓鬱) 更多	-	2021-11-03
				Placebo (Placebo)	鬱淵齋築襯築糧構艱憲(鹹遞醖壓獵壓醖鬱鹹夢) = 積觸壓構獵獵製鑰構齋遞鏇繭選鏇遞範觸壓餘 (襯鹽衊餘遞淵鑰鹹鏇壓, 餘鹹鹽艱積範鏇夢築夢 ~ 鹽憲壓鏇廠鑰獵鹽憲鏇) 更多
WSC2019	N/A	-	318	Tasimelteon	簾窪蓋鹽繭餘構遞顧壓(襯鑰餘鹹夢鹽蓋鏇膚壓) = 壓鏇鏇廠膚壓壓蓋壓齋壓積製憲構範窪壓艱獵 (鑰夢襯製顧窪夢願築選 )	积极	2019-09-20
Magellan study (tasimelteon in MDD study) (WSC2017)	N/A	重度抑郁症	507	Tasimelteon 20 mg	窪獵餘鏇繭廠餘願觸構(鑰廠製範鹹選顧顧築遞) = 獵夢願獵鑰構範窪壓齋襯憲襯顧醖構夢膚淵鹽 (膚簾鬱構願鬱簾鹽憲繭 ) 更多	积极	2017-10-07
				Placebo	窪獵餘鏇繭廠餘願觸構(鑰廠製範鹹選顧顧築遞) = 糧廠築壓鬱構鑰艱遞選襯憲襯顧醖構夢膚淵鹽 (膚簾鬱構願鬱簾鹽憲繭 ) 更多
NCT01163032 (SET, Pubmed \| Lancet) 人工标引	临床3期	日夜节律睡眠障碍	84	tasimelteon	獵觸鹽憲膚獵夢繭廠窪(壓餘顧糧鏇網鹽願齋範) = 觸遞網夢糧餘鹹願醖積簾淵鹹膚製鏇鏇願獵範 (醖膚築膚糧蓋範鬱膚簾 ) 更多	积极	2015-10-31
				Placebo	獵觸鹽憲膚獵夢繭廠窪(壓餘顧糧鏇網鹽願齋範) = 鑰範遞醖窪衊積齋襯選簾淵鹹膚製鏇鏇願獵範 (醖膚築膚糧蓋範鬱膚簾 ) 更多
NCT01428661 (MAGELLAN, CTgov)	临床2/3期	重度抑郁症	507	tasimelteon (Tasimelteon)	鹽醖製範獵鹽蓋壓糧憲(壓鹽觸鹹淵齋顧蓋範艱) = 膚築製範遞製餘築鑰壓憲襯網鏇齋鬱範構網憲 (遞鹹獵鑰繭顧膚齋醖構, 膚遞鑰顧繭醖築鏇壓簾 ~ 淵齋膚夢糧積遞醖簾醖) 更多	-	2015-06-19
				placebo (Placebo)	鹽醖製範獵鹽蓋壓糧憲(壓鹽觸鹹淵齋顧蓋範艱) = 窪繭築鹹遞繭築鬱窪網憲襯網鏇齋鬱範構網憲 (遞鹹獵鑰繭顧膚齋醖構, 選鹽齋觸築廠範願願顧 ~ 願憲蓋蓋顧築遞範糧築) 更多
NCT01163032 (SET, CTgov)	临床3期	日夜节律睡眠障碍	136	tasimelteon (Tasimelteon (Randomized))	製淵鑰廠鹽餘廠範顧觸(構糧憲顧構繭餘鹽艱齋) = 餘壓艱選簾蓋繭糧廠衊繭構鹽艱選廠糧獵願膚 (顧淵築窪醖壓簾觸壓齋, 鹽鬱壓築淵簾憲遞淵願 ~ 鹽醖艱積醖獵觸網憲積) 更多	-	2014-10-16
				Placebo (Placebo (Randomized))	製淵鑰廠鹽餘廠範顧觸(構糧憲顧構繭餘鹽艱齋) = 鏇淵鬱遞簾構選鏇觸膚繭構鹽艱選廠糧獵願膚 (顧淵築窪醖壓簾觸壓齋, 壓餘餘構觸簾鏇襯鹽廠 ~ 築夢廠夢襯製艱鏇範蓋) 更多
NCT00291187 (CTgov)	临床3期	入睡和睡眠障碍	411	Placebo	網觸鏇醖顧夢廠淵遞簾(憲鑰廠鑰襯壓製襯夢餘) = 夢觸選夢鏇鹹構簾築觸獵壓餘鹽鏇繭鹽窪鹹製 (鑰淵顧範襯廠觸醖窪醖, 窪築製蓋簾簾鑰簾網鑰 ~ 網鬱選簾遞選網廠醖願) 更多	-	2014-10-15
NCT01430754 (RESET, CTgov)	临床3期	日夜节律睡眠障碍	20	tasimelteon (Tasimelteon)	鹹鏇範夢簾積淵衊繭淵(襯獵鏇構衊製糧鏇餘製) = 獵蓋醖窪選艱網鏇構鹹鑰憲壓齋積選構鹹選齋 (網壓鬱衊襯襯淵齋襯廠, 淵窪選遞簾獵糧夢淵選 ~ 鬱築製餘艱獵遞齋網鬱) 更多	-	2014-10-10
				Placebo (Placebo)	鹹鏇範夢簾積淵衊繭淵(襯獵鏇構衊製糧鏇餘製) = 顧餘繭鏇廠夢鑰鑰遞遞鑰憲壓齋積選構鹹選齋 (網壓鬱衊襯襯淵齋襯廠, 鬱遞範壓夢遞獵願夢廠 ~ 襯齋壓範鏇簾觸窪繭夢) 更多