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)

December 30, 2015

 


 

VIVUS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-33389

 

94-3136179

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

351 EAST EVELYN AVENUE

MOUNTAIN VIEW, CA 94041

(Address of principal executive offices, including zip code)

 

(650) 934-5200

(Registrant’s 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 1.02.  Termination of a Material Definitive Agreement.

 

On October 10, 2013, VIVUS, Inc., or VIVUS or the Company, entered into a license and commercialization agreement, or the License Agreement, and a commercial supply agreement, or the Supply Agreement, with Auxilium Pharmaceuticals, Inc., or Auxilium. Auxilium was acquired by Endo International, plc in January 2015. On December 30, 2015, Auxilium provided the Company with notice of termination of the License Agreement pursuant to Section 12.2(c) of the License Agreement and of Auxilium’s desire to abandon and relinquish all rights with respect to the Auxilium License (as defined in the License Agreement) as of December 30, 2015. Section 12.2(c) of the License Agreement provides that at any time following the one (1) year anniversary of the Product Launch (as defined in the License Agreement) in the United States, Auxilium shall have the right to terminate the License Agreement for any reason upon one hundred eighty (180) days prior written notice to VIVUS. In addition, on December 30, 2015, Endo Ventures Limited, or Endo, provided the Company with notice of termination of the Supply Agreement pursuant to Section 9.3 of the Supply Agreement. Section 9.3 of the Supply Agreement provides that either party may also terminate the Supply Agreement upon written notice to the other party if the License Agreement is terminated in accordance with its terms. Auxilium and Endo, along with Endo International, plc, determined to provide notice of termination of the License Agreement and Supply Agreement to focus their commercial resources on a recently FDA approved pain medication. Given this, the License Agreement and Supply Agreement will terminate on June 30, 2016. The parties are currently negotiating the terms and conditions of a Transition Services Agreement.

 

Under the terms of the License Agreement, Auxilium received an exclusive license to commercialize and promote VIVUS’s drug STENDRA® (avanafil) for the treatment of erectile dysfunction in the United States and Canada and their respective territories. Under the License Agreement, VIVUS received an upfront license fee of $30 million, certain milestone payments, plus royalty payments on STENDRA sales. VIVUS also received a regulatory milestone payment of $15 million upon approval by the FDA of the 15 minute time of onset claim for STENDRA in the United States.

 

Under the terms of the Supply Agreement, VIVUS agreed to supply Endo with STENDRA bulk drug product until December 31, 2018 at the latest.  For 2015 and each subsequent year during the term of the Supply Agreement, if Endo failed to purchase an agreed minimum purchase amount of STENDRA from VIVUS, Endo agreed to reimburse VIVUS for the shortfall as it relates to VIVUS’s out of pocket costs to acquire the active pharmaceutical ingredient (API) needed to manufacture bulk STENDRA.

 

Item 7.01.  Regulation FD Disclosure.

 

In a press release issued on December 31, 2015, the Company announced its receipt of notice of termination of the License Agreement and Supply Agreement.  A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

The information in this Form 8-K and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

 

Item 9.01.  Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1              Press Release issued by VIVUS, Inc. dated December 31, 2015.

 

2



 

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.

 

 

 

VIVUS, Inc.

 

 

Date: December 31, 2015

By:

/s/ John L. Slebir

 

 

John L. Slebir

 

 

Senior Vice President, Business Development and
General Counsel

 

3



 

EXHIBIT INDEX

 

Number

 

Description

 

 

 

99.1

 

Press Release issued by VIVUS, Inc. dated December 31, 2015.

 

4




Exhibit 99.1

 

GRAPHIC

 

VIVUS, Inc. Announces Intent to Reacquire U.S. and Canadian Rights for Stendra® (Avanafil)

 

MOUNTAIN VIEW, CA — (Marketwired) — December 31, 2015 — VIVUS, Inc. (NASDAQ: VVUS) (the “Company”), announced today that it has been notified by Auxilium Pharmaceuticals, Inc., a subsidiary of Endo International, plc., of Auxilium’s intention to return the U.S. and Canadian commercial rights for STENDRA® (Avanafil) to VIVUS. Auxilium has provided its contractually obligated six-month notice of termination which, absent an agreement between Auxilium and VIVUS for an earlier date, will result in the termination of the license and supply agreement on June 30, 2016.

 

“We are excited to reacquire the U.S. and Canadian commercial rights for STENDRA. We appreciate Endo’s efforts to build the STENDRA brand and understand their decision to focus their resources on BELBUCATM,” said Seth Fischer, VIVUS Chief Executive Officer. “With STENDRA’s 15 minute onset-of-action, efficacy, ability to be taken with food and alcohol, and safety profile, we remain confident in STENDRA’s long-term prospects.  We are in the process of evaluating ways for maximizing the value of STENDRA and expect to make an announcement by the end of the first quarter of 2016 with our decision. As part of this process, we are working closely with Auxilium to ensure a smooth transition of STENDRA back to VIVUS.”

 

Any forward-looking statements in this press release are based on current information as of the date of this press release, and VIVUS does not undertake any obligation to update any forward-looking statements to reflect new information or future developments or events, except as required by law. The reader is cautioned not to rely on these forward-looking statements.

 

The announcements contained in this press release were made pursuant to Rule 14e-2 under the Securities Exchange Act of 1934, as amended.

 

About Avanafil

 

STENDRA (avanafil) is approved in the U.S. by the FDA for the treatment of erectile dysfunction. Auxilium Pharmaceuticals, Inc. has exclusive marketing rights to STENDRA in the U.S. and Canada. In January 2015, Auxilium was purchased by Endo International, plc., or Endo.

 

STENDRA is available through retail and mail order pharmacies. Auxilium currently offers programs that help patients with out-of-pocket costs.

 

SPEDRA, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.

 

VIVUS has granted an exclusive license to Sanofi to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia.

 

Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. VIVUS is in discussions with other parties for the commercialization rights to its remaining territories.

 

For more information about STENDRA, please visit www.Stendra.com.

 



 

Important Safety Information

 

STENDRA® (avanafil) is prescribed to treat erectile dysfunction (ED).

 

Do not take STENDRA if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure.

 

Discuss your general health status with your healthcare provider to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help.

 

STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following; medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®); some types of oral antifungal medicines, such as ketoconazole (Nizoral®), and itraconazole (Sporanox®); or some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin.

 

In the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

 

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including STENDRA) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor right away.

 

Sudden decrease or loss of hearing has been rarely reported in people taking PDE5 inhibitors, including STENDRA. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you experience sudden decrease or loss of hearing, stop taking STENDRA and contact a doctor right away. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers or other anti-hypertensives, your doctor may start you on a lower dose of STENDRA.

 

Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure.

 

STENDRA in combination with other treatments for ED is not recommended.

 

STENDRA does not protect against sexually transmitted diseases, including HIV.

 

The most common side effects of STENDRA are headache, flushing, runny nose and congestion.

 

Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.

 

About VIVUS

 

VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea and sexual health. For more information about the Company, please visit www.vivus.com.

 

VIVUS, Inc.
Mark Oki
Chief Financial Office

oki@vivus.com

650-934-5268

 

Investor Relations: The Trout Group
Brian Korb
Managing Director
bkorb@troutgroup.com
646-378-2923

 


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