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http://www.vivus.com/
http://www.vivus.com/main.taf?p=2
http://finance.yahoo.com/q/ks?s=VVUS
http://finance.google.com/finance?client=ob&q=VVUS

VIVUS, Inc., a pharmaceutical company, engages in the development and commercialization of therapeutic products to treat obesity, post-menopausal, and sexual health in women and men in the United States. Its investigational product pipeline includes Qnexa, which has completed a Phase II clinical trial for treating obesity; Testosterone MDTS that has completed Phase II study to treat hypoactive sexual desire disorder; Avanafil, which has completed Phase II clinical trial for the treatment of erectile dysfunction; and ALISTA that has completed Phase IIb study for the treatment of female sexual arousal disorder. The company also markets MUSE for the treatment of erectile dysfunction. The company was founded in 1991 and is headquartered in Mountain View, California. 

Qnexa is not a brilliant developped drug, its rather a combination therapy of available generic drugs. In past dealing the company has bought an available drug as well for 15mln, ran trials for new indications and sold it in 2008 for 150mln. So although no great scientific endeavour, they do know how to run trials and a very business savvy management. The interesting part is the the sheer size of the potential market, with a lot of bigger competitors like Pfizer and Merck discontinuing their obesitas trials due to side effects and risks. Only a few competitors left now, of whihc Qnexa is one. And the company does intend to partner upon favourable data, likely after phase III results.     


Clinical Trial details

http://www.drugs.com/clinical_trials/results-phase-3-equate-trial-vivus-qnexa-highlighted-european-congress-obesity-7185.html

Answers to FAQ about the SPA

1. What is an SPA
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
2. Does VVUS have an SPA for Qnexa?

VIVUS Completes Special Protocol Assessment Process for Qnexa Phase 3 Studies
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Nov. 5, 2007--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has successfully concluded communications with the U.S. Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process regarding key elements of the pivotal phase 3 clinical trials of Qnexa for the treatment of obesity and weight-related co-morbidities. The company and the FDA have reached agreement on study design features that will be employed throughout the entire phase 3 program including the co-primary endpoints of the study, scope and size of the patient population, specific safety assessments, inclusion/exclusion criteria, duration of the trials and the statistical method for analyzing the co-primary study endpoints.
"We are pleased by the FDA's supportive attitude toward our pivotal phase program for Qnexa. The dialog we have had with the FDA throughout the End of Phase 2 (EOP2) and SPA process has provided valuable guidance, especially on the FDA's current attitude about potential safety issues and the need for the sponsor to thoroughly assess safety issues prospectively. The SPA process has provided us with guidance that will help us navigate today's complex regulatory landscape," commented Wesley Day, Vice President Clinical Development of VIVUS. "We are not looking at the cosmetic effects of obesity; rather, we have designed our trials to study patients that are severely obese or that have co-morbidities which increase their risk of cardiovascular disease. We believe weight loss treatments that have minimal impact on co-morbidities such as blood pressure and blood glucose levels will have limited appeal to the medical community. Our study design will allow us to
properly characterize the safety and tolerability profile of Qnexa and to capture the benefits of treatment on obesity and weight-related co-morbidities."
About the Phase 3 Program
The phase 3 Qnexa program will include two pivotal, double blind, placebo-controlled, multi-center studies in distinct populations that will compare Qnexa to placebo during a 56-week treatment period. The studies are designed to proactively demonstrate the safety of Qnexa. The first study, known as EQUIP (OB-302), will enroll morbidly obese adult subjects with a body mass index ("BMI") of 35 or greater with controlled co-morbidities. The second trial, known as CONQUER (OB-303), will enroll overweight and obese adult subjects with BMI's from 27 to 45 and at least two co-morbid conditions, such as hypertension, dyslipidemia and type 2 diabetes. The co-primary endpoints for these studies will evaluate the differences between treatments in mean percent weight loss from baseline to the end of the treatment period, and the differences between treatments in the percentage of subjects achieving weight loss of 5% or more.
The phase 3 program will also include a six-month confirmatory factorial study, known as EQUATE (OB-301), in obese subjects with BMI's from 30 to 45. This trial will evaluate two dose levels of Qnexa, compared to both placebo and the individual constituents of the combination. The primary endpoints will be similar to those evaluated in the pivotal studies.
Safety and tolerability of Qnexa will be determined by reporting adverse events, physical exam, clinical laboratory data, electrocardiogram, cognitive function tests, psychological assessments, and clinical assessment of clinical laboratory variables. The phase 3 studies will enroll approximately 4,500 subjects.


About a Special Protocol Assessment
A Special Protocol Assessment is a regulatory procedure by which the FDA can provide advice on the current thinking at the FDA regarding the evaluation of issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies associated with the development of products in human drug applications as defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 379g(1)) (PDUFA products). The advice given by the FDA is not binding. For more information about the Agency's Special Protocol Assessment process see http://www.fda.gov/cder/guidance/3764fnl.htm.
About VIVUS
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products. The current portfolio includes investigational products addressing obesity and sexual health. VIVUS has three products that are positioned to enter phase 3 clinical trials. The pipeline includes: Qnexa™, for which a phase 2 study has been completed for the treatment of obesity; Testosterone MDTS®, for which a phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); and avanafil, for which a phase 2 study has been completed for the treatment of erectile dysfunction (ED). MUSE® is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company's web site at http://www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals
and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that the EvaMist NDA submission will be approved in a timely basis, or at all. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10- K for the year ended December 31, 2006 and periodic reports filed with the Securities and Exchange Commission.
CONTACT: VIVUS, Inc.
Timothy E. Morris, 650-934-5200
Chief Financial Officer
or
Trout Group
Ian Clements (SF), 415-392-3385
or
Brian Korb (NYC), 646-378-2923
SOURCE: VIVUS, Inc.
 

 

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VVUS News: Statement of Changes in Beneficial Ownership (4) 09/19/2016 05:04:44 PM
VVUS News: Statement of Changes in Beneficial Ownership (4) 09/19/2016 05:03:54 PM
VVUS News: Statement of Changes in Beneficial Ownership (4) 09/19/2016 05:03:54 PM
VVUS News: Current Report Filing (8-k) 09/06/2016 04:09:28 PM
VVUS News: Statement of Changes in Beneficial Ownership (4) 09/02/2016 04:41:16 PM
PostSubject
#1918   VVUS DAY TREND1 07/28/16 12:44:28 PM
#1917   How did such potential go so wrong? pphm_mike 07/24/16 04:25:34 PM
#1916   ***** Vivus Begins Q3 With Underwhelming Qsymia Sales TREND1 07/23/16 11:50:37 AM
#1915   ***** VVUS MONTHLY 3 line break TREND1 07/22/16 07:28:07 PM
#1914   VVUS DAY TREND1 07/22/16 06:40:15 PM
#1913   EPS = - .90 TREND1 07/22/16 06:33:31 PM
#1912   Inst % Owned =42% TREND1 07/22/16 06:32:04 PM
#1911   FLOAT = 90 MILLION TREND1 07/22/16 06:31:07 PM
#1910   Vivus Announces Positive Ruling In Qsymia Litigation - TREND1 07/22/16 06:28:36 PM
#1909   If this just hit $3.15 stock_risk 04/14/16 06:19:48 AM
#1908   I hope we see $2.5 soon stock_risk 04/06/16 10:32:28 AM
#1907   Tick Tick ;) europtiger 04/06/16 09:45:42 AM
#1906   Soon soon stock_risk 04/04/16 09:45:15 AM
#1905   shooting up, directly. Northwest 12 04/04/16 09:34:55 AM
#1904   Lets Break 2,50$ First ;) europtiger 04/04/16 09:33:37 AM
#1903   $4? stock_risk 04/04/16 09:14:11 AM
#1902   Exactley my thoughts... I have a Big load europtiger 04/04/16 02:35:39 AM
#1901   1.085.300 shares have been accumulated during the last Northwest 12 04/03/16 04:34:30 AM
#1900   Wth is North Tide doing with all those shares? Northwest 12 04/03/16 04:31:45 AM
#1899   * * $VVUS Video Chart 03-31-16 * * ClayTrader 03/31/16 05:19:20 PM
#1898   Looking good here europtiger 03/29/16 02:01:24 PM
#1897   Cooking????? With Gas??? Could be....Could be!!!! Wyatt Earp 03/14/16 07:54:21 PM
#1896   Maybe something cooking europtiger 03/14/16 03:46:19 PM
#1895   Puzzling how this is moving especially after earnings pretzelLOGIC 03/14/16 03:18:10 PM
#1894   Bought in today... Lets see europtiger 03/14/16 01:46:35 PM
#1893   Well we are waiting stock_risk 02/18/16 03:40:24 AM
#1892   Up 0.09 nine cents, I smell BUY OUT seamop 02/12/16 11:33:57 AM
#1891   OoooooooooooooO stock_risk 11/18/15 11:50:24 AM
#1890   Hi to mee stock_risk 11/12/15 09:12:11 AM
#1889   No. Many of us here lurking!! Wyatt Earp 11/06/15 08:18:37 AM
#1888   Im the only freak here? stock_risk 11/05/15 10:05:34 PM
#1887   No body in the house stock_risk 11/03/15 12:32:30 PM
#1886   Hello stock_risk 11/02/15 12:00:43 PM
#1885   Should be about to run.. Kylef 10/24/15 08:15:17 AM
#1884   carl icahn investing ~ http://www.insidermonkey.com/blog/vivus-inc-vvus-tender WarChest 10/09/15 08:45:07 AM
#1883   * * $VVUS Video Chart 10-08-15 * * ClayTrader 10/08/15 05:02:22 PM
#1882   have a great day all ... WarChest 10/08/15 02:20:54 PM
#1881   take it down on this fake cross WarChest 10/08/15 01:41:01 PM
#1880   lines have to go thru within 10 min ~ WarChest 10/08/15 01:35:49 PM
#1879   fake out on mac 60 back off WarChest 10/08/15 01:30:08 PM
#1878   pinch ~ pinch WarChest 10/08/15 01:28:37 PM
#1877   so easy its like taking candy from a WarChest 10/08/15 01:25:16 PM
#1876   mac curling up give it to me ~ WarChest 10/08/15 01:18:12 PM
#1875   nice churning today ~ Icahn news WarChest 10/08/15 01:13:15 PM
#1874   grabbed dip $1.95 buy trigger about to WarChest 10/08/15 01:10:53 PM
#1873   VVUS 2.17 setting up to explode PAC 10/08/15 11:35:39 AM
#1872   STILL???? wOW MONEYMADE 10/08/15 10:40:52 AM
#1871   Going UP! Short Covering Spike. jimmac 10/08/15 10:14:16 AM
#1870   Great, We have a serious BREAKOUT NOW! jimmac 10/08/15 10:13:01 AM
#1869   200 ma boom coming ~ balamidas 10/08/15 09:59:20 AM
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