Key Developments: VIVUS Inc (VVUS.OQ)

VVUS.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Vivus and Auxilium announce FDA approval of STENDRA sNDA
Thursday, 18 Sep 2014 06:00am EDT 

Vivus Inc and Auxilium Pharmaceuticals Inc:Says U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for STENDRA A (avanafil).  Full Article

Vivus announces acquisition of Topiramate-related Patents from Janssen Pharmaceuticals
Monday, 25 Aug 2014 07:00am EDT 

Vivus Inc:Says the acquisition of a group of patents from Janssen Pharmaceuticals, Inc. covering uses of topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions.Patents acquired includes U.S. 6,071,537 (Shank), U.S. 6,362,220 (Cottrell) and others -- are directed to methods of using topiramate to treat obesity, lower blood pressure and lipid parameters, and reduce blood glucose.  Full Article

Vivus files lawsuit against actavis for infringement of Qsymia Patents
Thursday, 12 Jun 2014 04:32pm EDT 

Vivus Inc:Files a lawsuit in the U.S. District Court for the District of New Jersey against Actavis Laboratories FL, Inc., Actavis, Inc., and Actavis PLC, collectively referred to as Actavis.Lawsuit was filed in response to an Abbreviated New Drug Application, or ANDA, filed by Actavis.Actavis seeks to market and sell generic versions of the currently approved doses of Qsymia capsules CIV prior to the expiration of U.S.  Full Article

Vivus Inc collaborates with aetna to test first comprehensive weight management program integrating weight loss medication
Tuesday, 14 Jan 2014 07:00am EST 

Vivus Inc:Says it has joined with Aetna to integrate Qsymia (phentermine and topiramate extended-release) capsules CIV into a pilot program designed to evaluate the benefits of prescription medication combined with lifestyle support for weight loss.Says the program is the first of its kind involving Qsymia and a health care benefits provider.  Full Article

Vivus Inc announces license and commercialization agreement with Sanofi SA
Thursday, 12 Dec 2013 07:07am EST 

Vivus Inc:Says it has entered into a license and commercialization agreement with Sanofi SA to commercialize avanafil on an exclusive basis in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia.Says Sanofi will be responsible for obtaining regulatory approval in its territories.Sanofi intends to market avanafil under the tradename SPEDRA or STENDRA.Under the terms of the agreement, Vivus is eligible to receive up to $61 million in upfront payments, regulatory and sales milestones and will also receive escalating royalties based on net sales over the life of the agreement.  Full Article

Vivus Inc Announces Issuance of Two Key U.S. Patents for Qsymia
Wednesday, 13 Nov 2013 07:00am EST 

Vivus Inc announced that the United States Patent and Trademark Office has issued U.S. Patent Nos. 8,580,298 covering compositions of Qsymia, and 8,580,299, covering methods for effecting weight loss using Qsymia. The newly issued patents are assigned to VIVUS and are an addition to the existing foundational patents - listed in the U.S. Food & Drug Administration (FDA) Orange Book - that provide market exclusivity for Qsymia. Prior to issuance of these new patents, patent protection for Qsymia in the U.S. was expected to expire in June 2020. With the addition of the two new patents, both of which have been submitted for listing in the FDA Orange Book, patent exclusivity for Qsymia in the U.S. is expected to extend to June 2029.  Full Article

Vivus Inc Announces Appointment Of Interim CFO - Form 8-K
Tuesday, 5 Nov 2013 04:06pm EST 

Vivus Inc reported in its Form 8-K that on November 5, 2013, the Board of Directors of the Company appointed Svai Sanford, the Company’s Corporate Controller, as interim Chief Financial Officer (CFO) effective November 5, 2013, or the Effective Date. As of the Effective Date, Mr. Sanford has assumed the duties of the Company’s principal financial officer on an interim basis.  Full Article

Auxilium Pharmaceuticals Inc Announces License Agreement With Vivus Inc For Marketing Rights To STENDRA In The United States And Canada
Friday, 11 Oct 2013 07:00am EDT 

Auxilium Pharmaceuticals Inc announced the signing of an agreement with Vivus Inc providing Auxilium with the exclusive right to market VIVUS's product, STENDRA (avanafil), in the United States and Canada. The parties also simultaneously signed a Commercial Supply Agreement pursuant to which VIVUS will be initially responsible for the manufacture and supply of STENDRA to Auxilium. Under the license, Auxilium will pay VIVUS a one-time license fee of $30 million. Auxilium may make a $15 million regulatory milestone payment to VIVUS if the FDA approves the STENDRA label to reflect a 15 minute or less onset of action efficacy claim and up to $255 million in potential milestone payments based on the achievement of certain sales targets. VIVUS will also receive royalties on product sales. Auxilium expects to begin its commercial launch of STENDRA by the end of 2013, first with shipments of STENDRA in December 2013.  Full Article

Vivus Inc Announces Resignation Of President-Form 8-K
Friday, 27 Sep 2013 05:22pm EDT 

Vivus Inc reported in its Form 8-K that on September 25, 2013, Peter Y. Tam tendered his resignation from his position as President of VIVUS, Inc., or the Company, effective October 12, 2013.  Full Article

Vivus Inc Names New Chief Executive Officer
Tuesday, 3 Sep 2013 07:00am EDT 

VIVUS, Inc announced that Anthony P. Zook has resigned as Chief Executive Officer and from the VIVUS Board of Directors, effective September 3, 2013, due to recurring issues associated with a previously-diagnosed medical condition. The VIVUS Board of Directors has appointed Seth H. Z. Fischer, a former senior executive at Johnson & Johnson, to serve as its Chief Executive Officer, effective today. Mr. Fischer will also join the VIVUS Board of Directors.  Full Article

CORRECTED-UPDATE 1-Vivus' Stendra gets FDA approval for use 15 minutes before sex

(Corrects headline and first paragraph to make clear that Stendra was already approved for use 30 minutes before sex, and has now been approved for use as little as 15 minutes before sex)

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