Current Report Filing (8-k)
October 18 2017 - 7:02AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 17, 2017
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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001-34186
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03-0491827
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(Commission File No.)
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(IRS Employer Identification No.)
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2200 Pennsylvania Avenue NW
Suite 300E
Washington,
DC 20037
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (202)
734-3400
Not Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check the appropriate box below
if the
Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to
Rule 14a-12
under the Exchange Act (17 CFR
240.14a-12)
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☐
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Pre-commencement
communications pursuant to
Rule 14d-2(b) under
the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to
Rule 13e-4(c) under
the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or
Rule 12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this
chapter).
Emerging growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the
Exchange Act. ☐
On October 17, 2017, Vanda Pharmaceuticals Inc. (Vanda) reached a
pricing agreement with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband or
GSK-SV)
for the treatment of totally blind individuals with
Non-24-Hour
Sleep-Wake Disorder with HETLIOZ
®
(tasimelteon) after an Arbitration Board decision.
Under the German Pharmaceuticals Market Reorganization Act (AMNOG), a pricing agreement was reached after an Arbitration Board was called to
reach a final HETLIOZ
®
price. The outcome of the Arbitration Board is legally binding. The
ex-factory
price of HETLIOZ
®
in Germany is expected to be approximately EUR 69,000 (sixty-nine thousand euros) per year, with an effective date of August 1, 2017.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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VANDA PHARMACEUTICALS INC.
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Dated: October 18, 2017
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By:
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/s/ Richard L. Gulino
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Name:
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Richard L. Gulino
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Title:
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Senior Vice President, General Counsel
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