Current Report Filing (8-k)
April 21 2015 - 4:37PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
April 21, 2015
VIVUS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-33389 |
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94-3136179 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
351 EAST EVELYN AVENUE
MOUNTAIN VIEW, CA 94041
(Address of principal executive offices, including zip code)
(650) 934-5200
(Registrants telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events
On April 21, 2015, VIVUS, Inc., or VIVUS, issued a press release titled VIVUS Announces Issuance of Two Additional U.S. Patents for Qsymia. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
99.1 |
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Press Release issued by VIVUS, Inc. dated April 21, 2015. |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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VIVUS, Inc. |
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Date: April 21, 2015 |
By: |
/s/ John L. Slebir |
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John L. Slebir |
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Senior Vice President, Business Development and General Counsel |
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EXHIBIT INDEX
Number |
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Description |
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99.1 |
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Press Release issued by VIVUS, Inc. dated April 21, 2015. |
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Exhibit 99.1
VIVUS ANNOUNCES ISSUANCE OF
TWO ADDITIONAL U.S. PATENTS FOR QSYMIA
MOUNTAIN VIEW, Calif., April 21, 2015 - VIVUS, Inc. (NASDAQ: VVUS), a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health, today announced that the United States Patent and Trademark Office has issued U.S. Patent Nos. 9,011,905 (link: 9011905; 905), covering compositions of Qsymia, and 9,011,906 (link: 9011906; 906), covering methods for effecting weight loss using Qsymia.
The newly issued patents are assigned to VIVUS and will be submitted for listing in the FDAs Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) and add to the existing patents listed in the Orange Book that provide market exclusivity for Qsymia.
Our efforts continue toward strengthening further the value of the Qsymia patent portfolio, said Seth H. Z. Fischer, CEO. The patents issued today reflect this ongoing activity.
About Qsymia
Qsymia® (phentermine and topiramate extended-release) capsules CIV is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia® (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
About VIVUS
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. For more information about the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties associated with enhancing and protecting our intellectual property and litigation in which we are involved or may become involved. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Investors should read the risk factors set forth in VIVUSs Form 10-K for the year ended December 31, 2014 as filed on February 25, 2015 and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.
VIVUS, Inc. |
Investor Relations: The Trout Group |
Dana B. Shinbaum |
Brian Korb |
Corporate Development & Investor Relations |
Managing Director |
shinbaum@vivus.com |
bkorb@troutgroup.com |
650-934-5200 |
646-378-2923 |
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