vanda pharmaceuticals inc (VNDA) Key Developments
FDA Accepts for Review Vanda's Filing of a Supplemental New Drug Application for Fanapt® Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults
Sep 15 15
Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review Vanda's filing of a supplemental New Drug Application (sNDA) for Fanapt® seeking approval as a maintenance treatment of schizophrenia in adults. Vanda is seeking approval based on the results of the REPRIEVE clinical study, which evaluated the long-term maintenance of efficacy and safety of Fanapt®. The FDA has set a user fee goal date under the Prescription Drug User Fee Act of May 27, 2016, which is the target date for the FDA to complete its review of the sNDA.
Vanda Pharmaceuticals, Inc. Appoints Richard Gulino as Senior Vice President, General Counsel and Secretary
Sep 14 15
Vanda Pharmaceuticals Inc. announced that it has named Richard Gulino as Vanda's Senior Vice President, General Counsel and Secretary. Mr. Gulino has over 20 years of strategic and legal experience representing life sciences and healthcare companies. Prior to joining Vanda, Mr. Gulino served as Vice President and General Counsel of Ameritox Ltd. Prior to this position, Mr. Gulino was Vice President and Deputy General Counsel at Cephalon, Inc. Before joining Cephalon, Mr. Gulino served as a senior commercial attorney at Zeneca, Inc.
Vanda Pharmaceuticals Inc. Names Gian Piero Reverberi as Senior Vice President and European General Manager
Sep 8 15
Vanda Pharmaceuticals Inc. announced that it has named Gian Piero Reverberi as Vanda's Senior Vice President, European General Manager. Mr. Reverberi has more than 20 years of experience in the pharmaceutical industry, holding senior management and regional leadership positions over the last 10 years. Prior to joining Vanda, Mr. Reverberi acted as a corporate advisor supporting several companies in the development of their commercial and geographical expansion strategies. Mr. Reverberi served as Senior Vice President, International Specialty Pharma at Shire Pharmaceuticals, with responsibility for Shire's specialty pharma business in EMEA, Canada, Australia, Japan, Asia Pacific and Latin America.
Vanda Pharmaceuticals, Inc. Announces Pivotal Trial Results Related to Patient Entrainment in the August Issue of the Lancet
Aug 5 15
Vanda Pharmaceuticals Inc. announced publication of pivotal trial results related to patient entrainment in the August issue of The Lancet. The published trial results are from the SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Sleep-Wake Disorder (Non-24)) Phase III studies of HETLIOZ® (tasimelteon), a circadian regulator for the treatment of individuals suffering from Non-24. Non-24 is a serious, rare and chronic circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception, and consequently cannot entrain (synchronize) their master body clock to the 24-hour day. Tasimelteon, marketed under the tradename HETLIOZ®, is currently approved for use in the United States and in the European Union. In the SET study, HETLIOZ® achieved the primary endpoints of entrainment of the melatonin rhythm as compared to placebo and clinical response as measured by entrainment plus a score of greater than or equal to 3 on the Non-24 Clinical Response Scale. HETLIOZ® also demonstrated significant improvement versus placebo across a number of sleep and wake parameters including measures of total sleep time, daytime sleep duration, and timing of sleep, as well as in the Clinical Global Impression of Change, an overall global functioning scale. In treated patients, daytime sleep decreased by 46 minutes per day in the worst 25% of days and nighttime sleep increased by 57 minutes per day during the worst 25% of nights. The RESET study demonstrated that continued treatment with 20mg of HETLIOZ® is required to maintain entrainment of the master body clock as measured by melatonin and cortisol circadian rhythms in individuals with Non-24. Patients treated with HETLIOZ® maintained their clinical benefits while patients who received placebo showed significant deterioration in measures of nighttime sleep, daytime sleep and timing of sleep. Furthermore, discontinuation of HETLIOZ® resulted in a rapid loss of circadian entrainment and a return to non-entrained circadian rhythms, reinforcing the importance of chronic therapy. Twenty-four-hour biological rhythms are regulated by interaction between environmental time cues and the internal circadian timing system. The environmental light-dark cycle interacts with the circadian timing system, and is the major time keeper for the master body clock which regulates many biological rhythms. Non-24 patients frequently struggle with severe disruptions to the sleep-wake cycle when the master body clock is out-of-sync with the 24-hour world.
Vanda Pharmaceuticals, Inc. Reports Consolidated Financial Results for the Second Quarter and Six Months Ended June 30, 2014; Provides Sales Guidance for the Full Year 2015
Jul 29 15
Vanda Pharmaceuticals, Inc. reported consolidated financial results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported total revenues of $27,582,000 against $10,862,000 a year ago. Loss from operations was $5,458,000 against $21,606,000 a year ago. Net loss was $5,386,000 or $0.13 per basic and diluted share against $21,575,000 or $0.64 per basic and diluted share a year ago. Non-GAAP net loss was $376,000 or $0.01 per basic and diluted share compared to $27,279,000 or $0.81 per basic and dilute share a year ago. Non-GAAP total revenues were $27,582,000 compared to $3,098,000 a year ago.
For the six months, the company reported total revenues of $49,732,000 against $20,005,000 a year ago. Loss from operations was $15,751,000 against $48,184,000 a year ago. Net loss was $15,607,000 or $0.37 per basic and diluted share diluted against $48,108,000 or $1.42 per basic and diluted share a year ago. Net cash used in operating activities was $60,569,000 against $17,168,000 a year ago. Non-GAAP net loss was $4,508,000 or $0.11 per basic and diluted share compared to $59,306,000 or $1.76 per basic and dilute share a year ago. Non-GAAP total revenues were $49,732,000 compared to $4,789,000 a year ago.
For the year 2015, the company expected net product sales from both HETLIOZ and Fanapt of between $100 million and $115 million, compared to prior guidance of $95 million to $110 million. The company expected HETLIOZ net product sales of between $40 million to $45 million. The company expected Fanapt net product sales of between $60 million to $70 million, compared to prior guidance of $55 million to $65 million.