Key Developments: VIVUS Inc (VVUS.O)
14.50USD
23 May 2013
$0.98 (+7.25%)
$13.52
$13.40
$15.04
$13.12
6,741,258
2,490,443
$31.21
$9.86
Latest Key Developments (Source: Significant Developments)
Vivus Inc Announces Pricing Of Offering Of $220 Million Of 4.50% Convertible Senior Notes
Vivus Inc announced the pricing of its offering of $220 million aggregate principal amount of 4.50% convertible senior unsecured notes due May 1, 2020 (the Notes) in a private placement pursuant to Rule 144A under the Securities Act of 1933, as amended (the Securities Act). VIVUS has granted to the initial purchasers a 30-day option to purchase up to an additional $30 million aggregate principal amount of the Notes. The offering is expected to close on or about May 21, 2013, subject to customary closing conditions. The net proceeds from this offering, after deducting discounts and commissions to the initial purchasers and other offering expenses, are expected to be approximately $213 million. VIVUS anticipates using approximately $30 million of the net proceeds from the offering to pay the cost of a capped call transaction described below to be entered into with an affiliate of one of the initial purchasers (the hedge counterparty), and the remainder of the net proceeds for continued commercialization of its products and development of its product candidates, and for general corporate purposes. If the initial purchasers exercise their option to purchase additional Notes, VIVUS may enter into an additional capped call transaction with the hedge counterparty. The Notes will bear interest at a fixed rate of 4.50% per annum, payable semiannually in arrears on May 1 and November 1 of each year, beginning on November 1, 2013, unless earlier purchased or converted. Full Article
Vivus Inc Announces Proposed Offering Of Convertible Senior Notes
Vivus Inc announced that it intends to offer, subject to market and other conditions, $200 million aggregate principal amount of convertible senior unsecured notes due May 1, 2020 (the Notes) through one or more initial purchasers in a private placement pursuant to Rule 144A under the Securities Act of 1933, as amended (the Securities Act). VIVUS also intends to grant the initial purchasers a 30-day option to purchase up to an additional $30 million aggregate principal amount of the Notes. VIVUS anticipates using a portion of the net proceeds from the offering to pay the cost of a capped call transaction described below to be entered into with an affiliate of one of the initial purchasers (the hedge counterparty), and the remainder of the net proceeds for continued commercialization of its products and development of its product candidates, and for general corporate purposes. If the initial purchasers exercise their option to purchase additional Notes, VIVUS may enter into an additional capped call transaction with the hedge counterparty. The Notes will be senior unsecured obligations of VIVUS and will accrue interest payable semiannually in arrears. Full Article
Vivus Inc Gets FDA Nod To Sell Diet Pill Via Retail Pharmacies-Reuters
Reuters reported that Vivus Inc said U.S. health regulators' approval to sell its diet pill Qsymia through retail pharmacies removed 'a major barrier' to the drug's adoption and paved the way for a direct-to-consumer campaign to be launched later this year. The U.S. Food and Drug Administration accepted Vivus's proposal to modify the REMS and allow Qsymia's sale through certified retail pharmacies. Full Article
Vivus Inc Announces Study Finds Improvements In Patients With Obstructive Sleep Apnea Treated With Phentermine And Topiramate Extended-Release Capsules
Vivus Inc announced that a study published in the journal SLEEP (2012; 35(11):1529-1539) found that patients with moderate to severe obstructive sleep apnea (OSA) taking phentermine and topiramate extended-release capsules achieved significant improvements in key measures of OSA and cardiovascular risk factors along with weight loss during the 28-week trial. OSA is a chronic and potentially serious sleep disorder in which breathing is abnormally shallow ("hypopnea") or stops altogether ("apnea") for at least 10 seconds. These In the study recently reported in SLEEP, 45 obese adults who were not using PAP were randomized to placebo or treatment with phentermine and topiramate extended-release capsules for 28 weeks. Both groups received intensive lifestyle modification counseling. The primary endpoint was change in the apnea-hypopnea index (AHI), a measure of the average number of breathing interruptions per hour during sleep. An AHI of 5-15 is considered mild, 15-30 moderate, and severe if >30. The average AHI at baseline in both treatment groups was about 45, indicating that, on average, subjects had severe OSA at the beginning of the study. By the end of the study, the number of apnea-hypopnea events in the phentermine and topiramate extended-release capsules group was reduced from an average of 44 events per hour (severe) to 14 events per hour (mild) at Week 28. The placebo-adjusted LS mean change Week 28 was -14.9 (p=0.0084). Full Article
European Regulators Reject Vivus Inc Obesity Drug-Reuters
Reuters reported that Vivus Inc said European regulators Vivus Inc said recommended that its obesity pill not be approved, citing potential safety concerns related to the long-term use of the drug. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) raised concerns over heart risks and birth defects and the drug Qsiva's use by patients for whom it was not indicated. Vivus, which announced in late September that it was expecting a negative response, said it intends to appeal the panel opinion and request a re-examination of the decision by the CHMP Full Article
Vivus Inc Wins Dismissal Of Federal Securities Class Action Lawsuit
Vivus Inc announced the dismissal of a putative class action lawsuit captioned Kovtun v. Vivus, Inc., et al., Case No. 4:10-CV-04957-PJH, filed in November 2010 against the Company and two of its officers alleging securities fraud. On September 27, 2012, Honorable Phyllis J. Hamilton of the U.S. District Court for the Northern District of California granted, with prejudice, VIVUS's motion to dismiss all claims asserted against VIVUS and its officers for failure to state a claim. In October 2011, Judge Hamilton had dismissed an earlier version of the Plaintiffs' complaint, but at that time granted the plaintiffs leave to file an amended complaint, which Judge Hamilton has now dismissed without leave to amend. Plaintiffs have a period of 30 days from the entry of Judge Hamilton's order in which to appeal the decision. Full Article
Vivus Inc Announces FDA Approval of Once Daily Qsymia (Phentermine and Topiramate Extended-release) Capsules CIV
Vivus Inc announced that the U.S. Food and Drug Administration (FDA) has approved Qsymia (pronounced Kyoo sim ee' uh) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). The safety and efficacy of Qsymia were evaluated in two multicenter, phase 3 trials that included severely obese patients (the EQUIP study), and overweight or obese patients with at least two weight-related comorbidities, such as hypertension, hypertriglyceridemia, type 2 diabetes, or central adiposity (the CONQUER study). The average weight loss in EQUIP was 10.9% on Qsymia 15 mg/92 mg and 1.6% for placebo (ITT-LOCF, p<0.0001). The average weight loss in CONQUER was 9.8% on Qsymia 15 mg/92 mg, 7.8% on Qsymia 7.5 mg/46 mg and 1.2% for placebo (ITT-LOCF, p<0.0001). The most common adverse reactions for patients treated with Qsymia included tingling sensation of hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth. Full Article
Vivus Inc Announces FDA Approval Of STENDRA Tablets For Treatment Of Erectile Dysfunction
Vivus Inc announced that the U.S. Food and Drug Administration (FDA) has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S. STENDRA (avanafil) is licensed from Mitsubishi Tanabe Pharma Corporation. VIVUS has development and commercial rights to STENDRA for the treatment of sexual dysfunction worldwide with the exception of certain Asian Pacific Rim countries. In South Korea, STENDRA is approved and is marketed by JW Pharma under the brand name Zepeed. Full Article
Vivus Inc Diet Drug Approval Decision Delayed Three Months-Reuters
Reuters reported that U.S. health regulators have extended by three months their deadline for making an approval decision on Vivus Inc's diet drug Qnexa, the Company said on Monday, marking the latest delay to bring a new obesity treatment to market. The Food and Drug Administration informed Vivus that it will decide whether to approve Qnexa by July 17 as it needs more time to review the Company's risk evaluation plan for the drug. The previous FDA action date for Qnexa had been April 17. Full Article
Vivus, Inc. Announces Proposed Public Offering Of Common Stock
Vivus, Inc. announced that it is offering to sell, subject to market and other conditions, 8,500,000 shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering. VIVUS also intends to grant the underwriters a 30 day option to purchase up to an aggregate of 1,275,000 additional shares of common stock to cover over-allotments, if any. All of the shares in the offering are to be sold by VIVUS. J.P. Morgan Securities LLC is acting as sole book-running manager of the proposed offering. Full Article
Denner added as nominee to Vivus board by activist investor
- First Manhattan Company (FMC) added some heavyweight muscle on Thursday to its bid to shake up the board of drugmaker Vivus Inc by naming former Carl Icahn top lieutenant Alex Denner and two others to its slate of proposed nominees.
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