VIVUS,INC. (NASDAQ:VVUS) Files An 8-K Other Events

ME Staff 8-k
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VIVUS,INC. (NASDAQ:VVUS) Files An 8-K Other Events
Item 8.01.  Other Events

On January 3, 2017, VIVUS, Inc., or the Company, entered into a Settlement Agreement with Hetero USA, Inc., Hetero Labs Limited Unit III and Hetero Labs Limited, collectively referred to as Hetero. The Settlement Agreement resolves the lawsuit, brought by the Company in the U.S. District Court for the District of New Jersey (Case No. 16-4560 (KSH)(CLW)) on July 27, 2016, in response to Hetero’s filing of an Abbreviated New Drug Application, or ANDA, seeking to market and sell generic versions of the currently approved doses of STENDRA® (avanafil) tablets prior to the expiration of U.S. Patents 6,656,935 and 7,501,409, collectively referred to as the Asserted Patents. Under the Settlement Agreement, Hetero was granted a license to manufacture and commercialize the generic version of STENDRA described in its ANDA filing in the United States as of the date that is the later of (a) 180 days prior to the expiration of the last to expire of the Asserted Patents or (b) the date that Hetero obtains final approval from the FDA of the Hetero ANDA. The Settlement Agreement provides for a full settlement of all claims that were asserted in the suit, subject to the Court’s acceptance of the stipulation of dismissal. As required by law, the Settlement Agreement will be submitted to the U.S. Federal Trade Commission and U.S. Department of Justice.



About VIVUS, INC. (NASDAQ:VVUS)

VIVUS, Inc. is a biopharmaceutical company. The Company operates in the development and commercialization of therapeutic products segment. It provides over two therapies approved by the Food and Drug Association (FDA), which include Qsymia (phentermine and topiramate extended-release) for chronic weight management and STENDRA (avanafil) for erectile dysfunction (ED). The Company has completed the Phase II studies of Qsymia for the indication of Obstructive Sleep Apnea (OSA) and diabetes. Its Qsymia is available in over 40,000 certified retail pharmacies across the country. Its STENDRA is also approved by the European Commission (EC), under the name, SPEDRA, for the treatment of ED in the Europe. The United States Food and Drug Association approved a Supplemental New Drug Application (sNDA) for STENDRA. STENDRA is indicated to be taken approximately 15 minutes before sexual activity.

VIVUS, INC. (NASDAQ:VVUS) Recent Trading Information

VIVUS, INC. (NASDAQ:VVUS) closed its last trading session up +0.02 at 1.27 with 278,247 shares trading hands.