vanda pharmaceuticals inc (VNDA) Key Developments
Vanda Pharmaceuticals, Inc. Receives Positive CHMP Opinion for Hetlioz (Tasimelteon) for the Treatment of Non-24-Hour Sleep-Wake Disorder in the European Union
Apr 24 15
Vanda Pharmaceuticals, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of HETLIOZ(tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults in the European Union (EU). The CHMP positive opinion will be reviewed by the European Commission (EC). If approved, the EC grants a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the EU, as well as European Economic Area members Iceland, Liechtenstein and Norway. The EC usually issues a final decision within two months of a CHMP opinion.
Vanda Pharmaceuticals, Inc. Announces Tom Gibbs as Senior Vice President, Chief Commercial Officer
Apr 20 15
Vanda Pharmaceuticals Inc. announced that it has named Tom Gibbs as Senior Vice President, Chief Commercial Officer of the company. Prior to joining Vanda, Mr. Gibbs served as Vice President of Worldwide Commercial Operations at Bristol Myers Squibb. Prior to this position, Mr. Gibbs held other senior roles at Bristol Myers Squibb including Vice President of US HIV Franchise and Vice President Global Commercialization and FDT Leader HCV Portfolio and HCV Small Molecules. Before joining Bristol Myers Squibb, Mr. Gibbs held the position of Vice President of US Sales for Novartis Vaccines and Diagnostics. Earlier in his career, Mr. Gibbs held positions at Endo Pharmaceuticals, Johnson & Johnson Corporation, George Weiss Associates and SmithKline Beecham PLC.
Vanda Pharmaceuticals Inc. Announces Nominating/Corporate Governance Committee Changes
Mar 20 15
Vanda Pharmaceuticals Inc. announced that on March 16, 2015, Steven K. Galson, M.D., M.P.H. notified the Board of Directors of the company that he did not intend to stand for re-election at the company's 2015 Annual Meeting of Stockholders so that he may devote his full time efforts to his other commitments. The Board has appointed Richard Dugan, a current director, to succeed Dr. Galson as a member of the Nominating/Corporate Governance Committee of the Board, effective upon the expiration of Dr. Galson's term.
Vanda Pharmaceuticals Inc. Announces Top-Line Results of the Phase II Proof of Concept Clinical Study
Mar 6 15
Vanda Pharmaceuticals Inc. announced top-line results of the Phase II proof of concept clinical study investigating the safety and efficacy of tradipitant as a monotherapy in the treatment of chronic pruritus in patients with atopic dermatitis. Tradipitant, formerly known as VLY-686, is a neurokinin 1 receptor antagonist under clinical investigation for the treatment of chronic pruritus in patients with atopic dermatitis. The pre-specified primary endpoint of the Phase II proof of concept clinical study was the change from baseline on the Visual Analog Scale (VAS) for itch. Due to high placebo effect, there was no significant difference from placebo on this pre-specified endpoint, however, Vanda believes this proof of concept study was informative, in that through subsequent analyses, it has discovered an exposure response relationship and further observed a significant and clinically meaningful response across several pruritus related outcomes evaluated in individuals with higher blood plasma levels of tradipitant. This is not unexpected given that all the assessments related to pruritus are significantly associated with the itch sensation the patient is experiencing at that time. Based on the data Vanda examined across the study, lower blood plasma levels of tradipitant may be below a threshold of efficacy to ameliorate the itch sensation in patients.
Vanda Pharmaceuticals Inc. Announces Consolidated Financial Results for the Fourth Quarter and Full Year Ended December 31, 2014; Provides Sales Guidance for the Year 2015
Feb 19 15
Vanda Pharmaceuticals Inc. announced consolidated financial results for the fourth quarter and full year ended December 31, 2014. For the quarter, the company’s total revenues were $15.4 million, compared to $8.8 million for the fourth quarter of 2013. Net income was $69.7 million compared to a net loss of $7.7 million for the fourth quarter of 2013. Diluted net income per share was $1.77, compared to a net loss per share of $0.23 for the fourth quarter of 2013. Non-GAAP total revenues were $7.6 million, compared to $2.0 million for the fourth quarter of 2013. Non-GAAP net loss was $13.5 million compared to $12.7 million for the fourth quarter of 2013. Non-GAAP diluted net loss per share was $0.36, compared to $0.38 for the fourth quarter of 2013. Income from operations was $69.693 million against loss from operations of $7.791 million a year ago.
For the year, the company’s total revenues were $50.2 million, compared to $33.9 million for 2013. Net income was $20.2 million compared to a net loss of $21.1 million for 2013. Diluted net income per share was $0.55, compared to a net loss per share of $0.69 for 2013. Non-GAAP total revenues were $19.4 million, compared to $7.1 million for 2013. Non-GAAP net loss was $80.0 million compared to $40.9 million for 2013. Non-GAAP Diluted net loss per share was $2.30, compared to $1.35 for 2013. Income from operations was $20.062 million against loss from operations of $21.200 million a year ago.
The company expects ombined net product sales from both HETLIOZ and Fanapt of between $95 million and $110 million for the year 2015. HETLIOZ net product sales of between $40 million to $45 million and Fanapt net product sales of between $55 million to $65 million.