Current Report Filing (8-k)
October 04 2018 - 4:33PM
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 4, 2018 (October 3, 2018)
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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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 3, 2018, the U.S. Food and Drug Administration publication, Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as
the Orange Book, updated its listing for the Vanda Pharmaceuticals Inc. (Vanda) new chemical entity patent, number 5,856,529, for HETLIOZ
®
(the 529 Patent) to reflect the receipt of the
full five-year extension of the expiration date under the Hatch-Waxman Act. Prior to receipt of the five-year Hatch-Waxman extension, the 529 Patent was set to expire in December 2018 following an interim
one-year
extension granted in 2017. With the five-year extension, the 529 Patent is now set to expire in December 2022 absent any other applicable patent term extensions. Including the 529 Patent,
Vanda currently has a total of 8 patents covering HETLIOZ
®
listed in the Orange Book, the latest of which has an expiration date of February 2035.
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 4, 2018
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By:
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/s/ Timothy Williams
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Name:
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Timothy Williams
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Title:
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Senior Vice President, General Counsel and Secretary
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