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): April 13, 2018
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
| Delaware | ||
| (State or other jurisdiction of incorporation) | ||
| 001-34186 | 03-0491827 | |
| (Commission File No.) | (IRS Employer Identification No.) | |
2200 Pennsylvania Avenue NW
Suite 300E
Washington, DC 20037
(Address of principal executive offices and zip code)
Registrant’s 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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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. ☐
| Item 8.01. | Other Events. |
On April 13, 2018, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware (the “Delaware District Court”) that West Ward Pharmaceuticals (“West Ward”), a subsidiary of Hikma Pharmaceuticals, infringed Vanda Pharmaceuticals Inc.’s (“Vanda”) U.S. Patent number 8,586,610 (the “’610 Patent”) for Fanapt®. As previously disclosed, the Delaware District Court previously ruled that Vanda was entitled to a permanent injunction against West Ward enjoining West Ward from infringing the ‘610 Patent, including the manufacture, use, sale, offer to sell, distribution or importation of any generic iloperidone product described in West Ward’s Abbreviated New Drug Application for a generic version of Fanapt® until the expiration of the ‘610 Patent in November 2027.
A press release announcing the decision of the U.S. Court of Appeals for the Federal Circuit is attached hereto as Exhibit 99.1 and incorporated by reference herein.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release of Vanda Pharmaceuticals Inc. dated April 13, 2018. | |
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.
| VANDA PHARMACEUTICALS INC. | ||||||
| Dated: April 13, 2018 | By: | /s/ Richard L. Gulino | ||||
| Name: | Richard L. Gulino | |||||
| Title: | Senior Vice President, General Counsel | |||||
Exhibit 99.1
Vanda Wins Appeal Case on Fanapt®
U.S. Court of Appeals Affirms District Court’s Decision
WASHINGTON, April 13, 2018 /PRNewswire/ – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced today that the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of Delaware’s decision that West Ward Pharmaceuticals, a subsidiary of Hikma Pharmaceuticals, infringed Vanda’s U.S. Patent number 8,586,610 (the ‘610 Patent) for Fanapt®. The ‘610 Patent is set to expire November 2, 2027.
About Vanda Pharmaceuticals Inc.
Vanda is a 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.
About Fanapt®
For full U.S. Prescribing Information for Fanapt®, including indication, Boxed Warnings and Important Safety Information, visit our Web site at www.fanapt.com.
Investor Contact:
Jim Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
SOURCE Vanda Pharmaceuticals Inc.