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Vanda Pharmaceuticals Announces Initiation of "CALYPSO" to Study the Role of Genetic Variation in COVID-19 Infections in Collaboration With University of Washington Medicine

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WASHINGTON, April 15, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the initiation of the CALYPSO program to study the role that human genetic variations play in SARS-CoV-2 ("COVID-19") infection and disease progression. As a part of the CALYPSO program, Vanda will collaborate with University of Washington School of Medicine and its Virology Lab on a pharmacogenetics study in patients with COVID-19. The study will focus on the sequencing of the genome of individual patients, as well as the COVID-19 virus, and the identification of genetic factors that correlate with disease progression and outcomes.

In support of this study, Vanda and UW Medicine plan to collect Whole-Genome Sequencing ("WGS") data from over 1,000 patients with COVID-19 infection, and perform Viral Genome Sequencing, which should enable Vanda and the UW Medicine Virology Lab to explore host susceptibility, associations of WGS with clinical outcomes and severity of disease, as well as host-virus interactions. The study is scheduled to begin enrollment in the coming weeks and will be open to patients in hospitals and clinics around the United States.

"We look forward to the advancement of our program and the opportunity to work with and leverage the expertise of UW Medicine to expand our understanding of the COVID-19 infection mechanism," said Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer of Vanda.

"The study has the potential to provide new insights into virus–host interactions that could lead to more effective public health strategies and the design and development of vaccines and therapeutics," said Sandra P. Smieszek, Ph.D., Head of Genetics at Vanda. "With the vast amount of data we expect to collect, the team will aim to discern the factors associated with severity and other critical, clinical characteristics of the infected individuals."

"By leveraging our sequencing expertise and capabilities in collaboration with Vanda, we will be able to provide the necessary insight for potentially life-saving solutions for patients," said Alex Greninger M.D., Ph.D., M.S., M.Phil., Assistant Professor, Laboratory Medicine, Assistant Director, Virology Division at the University of Washington School of Medicine. "We believe this collaboration will help answer critical questions and hopefully outcomes in the fight against COVID-19."

"We are grateful to collaborate with Vanda as we try to find better ways to care for people currently suffering from COVID-19, and as we develop plans for the next phase of the national response," said Keith R. Jerome, M.D., Ph.D., Head of Virology Division at the University of Washington School of Medicine. "The approach of combining host and viral genomics to identify the most promising treatments may serve as a model for future efforts around the world. This unique agreement positions UW Medicine and Vanda for potentially changing the course of the COVID-19 pandemic."

"This is the type of collaboration we need to bring solutions to patients suffering in this time of crisis," said Dr. Greninger. "We look forward to getting this important work underway."

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 www.vandapharma.com and follow us on Vanda's Twitter and LinkedIn.

About UW Virology

The UW Virology is one of nine divisions comprising the Department of Laboratory Medicine at the University of Washington School of Medicine. The UW Medicine Virology Clinical Laboratories perform diagnostic testing for a full range of human pathogens including respiratory viruses, herpes group viruses, HIV, hepatitis, and enteric viruses, and was one of the earliest providers of COVID-19 testing. The Division provides the highest quality patient care and serves as a model of excellence for clinical laboratories across the nation. Its UW Virology Lab is also recognized as a worldwide leader in virology research. UW Medicine Virology's research programs integrate the latest in computational, laboratory, and clinical research methods to advance the understanding of infectious diseases. Many past and current faculty members in the Virology Division have received prestigious awards recognizing their scientific achievements.

Vanda Contact:

AJ Jones II
Chief Corporate Affairs and Communications Officer
Vanda Pharmaceuticals Inc.
202-734-3400

pr@vandapharma.com

UW Medicine Contact:

Susan Gregg
Director, Media Relations
206-616-6730

sghanson@uw.edu

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this release are "forward-looking statements" under the securities laws. These forward-looking statements include, without limitation, statements regarding the design, enrollment and anticipated findings of the CALYPSO program, the promotion of more effective public health strategies and the design and development of vaccines and therapeutics. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions 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 enroll patients for, and successfully conduct, the study described in this press release; the ability of Vanda, either alone or with its partners, to process the data collected and subsequently develop effective vaccines or therapeutics; the ability to obtain FDA approval of any such vaccines or therapeutics; and other factors that are set forth in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2019, which is on file with the SEC and available on the SEC's website at www.sec.gov. Additional factors may be set forth in those sections of Vanda's annual report on Form 10-Q for the fiscal quarter ended March 31, 2020, to be filed with the SEC in the second quarter of 2020. In addition to the risks described above and in Vanda's annual report on Form 10-K and quarterly reports on Form 10-Q, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. 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 release is provided only as of the date of this 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.

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SOURCE Vanda Pharmaceuticals Inc.