vivus inc (VVUS) Key Developments
VIVUS and Auxilium Announce FDA Approval of STENDRA sNDA
Sep 18 14
VIVUS Inc. and Auxilium Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for STENDRA(R) (avanafil). STENDRA is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity. STENDRA is a prescription medication in a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors approved for the treatment of ED in men 18 years or older. STENDRA is available in multiple dosage strengths (50, 100 and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks). In clinical studies, when compared to placebo, STENDRA helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse. ED is the inability to attain or maintain a penile erection for sufficient sexual performance. Men may experience ED differently. Many men with ED experience one or more of the following: trouble achieving an erection; difficulty achieving an erection firm enough for penetration; or erections not lasting long enough to have successful intercourse. In the Massachusetts Male Aging Study, it is estimated that 52% of men over 40 years of age experience some degree of ED. In addition to advanced age, recognized risk factors for erectile dysfunction include cardiovascular disease (hypertension, atherosclerosis, and hyperlipidemia), diabetes, depression, alcohol use, smoking, pelvic/perineal surgery or trauma, neurologic disease, obesity, pelvic radiation, and Peyronie's disease. The sNDA filed by VIVUS was based on results from Study TA-501 entitled, 'A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction.' The study was designed to assess the efficacy of two dosage strengths of STENDRA as early as approximately 15 minutes after dosing. In this 440-patient study conducted at 30 sites in the U.S., patients treated with STENDRA had a significantly higher proportion of attempts that enabled an erection sufficient for successful sexual intercourse as early as approximately 15 minutes following administration compared to placebo. The previously approved prescribing information recommended administration approximately 30 minutes before sexual activity.
VIVUS Announces Acquisition of Topiramate-Related Patents from Janssen Pharmaceuticals
Aug 25 14
VIVUS, Inc. announced 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. Janssen has agreed to dismiss the lawsuit it brought against VIVUS on August 22, 2014 in the U.S. District Court for the District of Delaware (Case No. 1:14-cv-01088 UNA). The patents acquired by VIVUS - including 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. VIVUS also assumed all rights under Janssen's license for U.S. 6,323,236 (McElroy), owned by the University of Cincinnati, and will be responsible for all future financial obligations under that license. The McElroy patent is directed to methods of using topiramate to treat impulse control disorders. VIVUS will pay a one-time upfront fee and a royalty to Janssen on Qsymia product sales for an assignment of these topiramate-related patents owned by Janssen. VIVUS has an option to buy out the royalty for a predetermined amount.
Michael J. Astrue Announces Not to Stand for Re-Election for the Board of VIVUS, Inc
Aug 15 14
Michael J. Astrue notified VIVUS Inc. that he will not stand for re-election to the company's Board of Directors at the next annual meeting of stockholders.
VIVUS Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014
Aug 7 14
VIVUS Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported total net revenue of $21.9 million compared to $5.534 million a year ago. Net loss was $25.83 million, or $0.25 per basic and diluted share compared to $55.512 million or $0.55 per basic and diluted share a year ago. Loss from operations was $17.5 million against $51.45 million a year ago. Loss from continuing operations before income taxes was $25.83 million against $55.63 million a year ago. Loss from continuing operations was $25.83 million or $0.25 per basic and diluted share against $55.64 million or $0.55 per basic and diluted share a year ago.
For the six months, the company reported total net revenue of $58.6 million compared to $9.65 million a year ago. Net loss was $41.4 million, or $0.40 per basic and diluted share compared to $109.1 million or $1.08 per basic and diluted share a year ago. Loss from operations was $25.414 million against $105.242 million a year ago. Loss from continuing operations before income taxes was $41.813 million against $109.4 million a year ago. Loss from continuing operations was $41.4 million or $0.40 per basic and diluted share against $109.403 million or $1.08 per basic and diluted share a year ago.
VIVUS Inc. to Report Q2, 2014 Results on Aug 07, 2014
Jul 31 14
VIVUS Inc. announced that they will report Q2, 2014 results at 5:00 PM, Eastern Standard Time on Aug 07, 2014