Key Developments For Vivus Inc
Vivus Inc (VVUS.W) (NASD ADF)
Vivus, Inc. Announces Positive Results From Phase 3 Study Of Avanafil In Erectile Dysfunction; Data Demonstrate Robust Efficacy, Favorable Side-Effect Profile
Vivus, Inc. announced positive results from REVIVE (TA-301), a phase 3 pivotal study evaluating the safety and efficacy of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED), in 646 patients. The REVIVE study met all primary endpoints across the three doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. The pivotal study, conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), also demonstrated successful intercourse in 30 minutes or less, and a favorable side-effect and safety profile. The REVIVE study was a randomized, double-blind, placebo-controlled efficacy and safety study that evaluated three doses of avanafil in men with a history of general ED. The results of the phase 3 study showed; Patients achieved an overall improvement in erectile function, as measured by improvement in the International Index of Erectile Function (IIEF). IIEF scores range from 0-30 and measure the severity of erectile dysfunction as follows: severe dysfunction is less than or equal to 10; moderate is 11-16; and mild/minimal is 17-25.
Vivus, Inc. Shares Dive Following Q3 2009 Report-AP
The Associated Press reported that shares of Vivus, Inc. fell sharply after the Company reported a third-quarter loss, though analysts maintained their focus on the Company's potential obesity treatment Qnexa. Vivus announced a quarterly loss of $21.1 million, or $0.30 per share, compared with profit of $266,000, or less than a penny per share, during the same period a year prior. Revenue plunged to $4.4 million from $25.5 million recorded in the 2008 quarter, when the company reported deferred revenue from the sale of its spray-on hot flash treatment Evamist. The Company said it remains on track to ask for Food and Drug Administration approval of Qnexa by the end of 2009. The development of Qnexa is part of a surge in obesity treatment development from the biotechnology sector. If approved, Qnexa would likely compete with other treatments including Arena Pharmaceuticals Inc.'s lorcaserin and Orexigen Therapeutics Inc.'s Contrave.
Vivus, Inc. Announces Promotion Of Peter Tam To President
Vivus, Inc. announced the promotion of Peter Tam to President of VIVUS. Leland Wilson, formerly President and Chief Executive Officer (CEO), will remain CEO of VIVUS. Mr. Tam was also appointed to the Board of Directors.
Data On Vivus, Inc.'s Qnexa To Be Featured At European Association For The Study Of Diabetes Annual Meeting
Vivus, Inc. announced that data on Qnexa, an investigational new drug, will be presented this October 2, 2009 at the annual meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria. The data being presented is from the previously announced year-long phase 2 trial (DM-230) evaluating Qnexa in patients with type 2 diabetes. The study demonstrated that Qnexa significantly reduced patients' hemoglobin A1c (HbA1c), a key indicator of blood sugar control, by 1.6% and helped patients achieve and maintain significant weight loss. The study also showed that Qnexa had a positive impact on other risk factors associated with diabetes.
Vivus, Inc. Announces Closing of Public Offering And Exercise of Over Allotment Option
Vivus, Inc. announced the closing of its previously announced underwritten public offering. Prior to closing, the underwriters exercised in full their option to purchase an additional 1,350,000 shares of common stock. As a result, the Company sold a total of 10,350,000 shares of its common stock at a price to the public of $10.50 per share. The gross proceeds from the sale of the shares, before underwriting discounts and commissions and other offering expenses, were approximately $108,675,000. The Company anticipates using the net proceeds from the offering to fund its research and development efforts, including manufacturing activities and clinical trials for its proprietary product candidates and investment in select pre-commercial and commercial activities, and for general corporate purposes, including working capital. J.P. Morgan Securities Inc. acted as sole book running manager of the offering.
