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 14, 2015 (December 11, 2015)
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ENDO INTERNATIONAL PLC
(Exact Name of Registrant as Specified in Its Charter)
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Ireland | 001-36326 | 68-0683755 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland | Not Applicable |
(Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code 011-353-1-268-2000
Not Applicable
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:
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 1.01. Entry into a Material Definitive Agreement.
On December 11, 2015, the Registrant’s wholly owned subsidiary, Endo Ventures Limited (“Endo”) entered into a license and supply agreement (the “Agreement”) with and among Novartis AG, a Swiss corporation (“Novartis AG”) and Sandoz Inc., a Colorado corporation (“Sandoz”), to obtain the exclusive U.S. marketing and license rights to commercialize the prescription medicine Voltaren® Gel (diclofenac sodium topical gel) 1% (“Voltaren Gel” or the “Branded Licensed Product”) and, upon launch, the authorized generic of Voltaren Gel (the “Generic Licensed Product” and, together with the Branded Licensed Product, the “Licensed Product”). The Agreement supersedes and terminates the original license and supply agreement, dated as of March 4, 2008, by and among Endo Pharmaceuticals Inc., Novartis AG and Sandoz (by assignment from Novartis Consumer Health, Inc.) (the “2008 Agreement”). The 2008 Agreement will terminate on June 30, 2016, which is concurrent with the effective date of the Agreement.
Under the Agreement, Endo will pay royalties to Novartis AG or Sandoz (as designated by Sandoz) on annual net sales of the Branded Licensed Product, subject to certain thresholds specified in the Agreement. In addition, Endo has agreed to make certain guaranteed minimum annual royalty payments and contingent royalty payments, subject to certain limitations specified in the Agreement. The guaranteed minimum royalties will be creditable against royalty payments on an Agreement-year basis such that Endo’s obligation with respect to each Agreement year is to pay the greater of (i) royalties payable based on annual net sales of the Branded Licensed Product or (ii) the guaranteed minimum royalty for such Agreement year. Endo and Novartis AG or Sandoz (as designated by Sandoz) will share any profits relating to net sales of the Generic Licensed Product as specified in the Agreement. Novartis AG or Sandoz (as designated by Sandoz) is also eligible to receive a one-time milestone payment of $25 million if annual sales of the Licensed Product exceed $300 million.
During the term of the Agreement, Endo has agreed to purchase all of its requirements for the Licensed Product from Sandoz. The price of product purchased by Endo under the Agreement is fixed for the first year and is subject to annual changes based upon changes in the producer price index and raw materials as set forth in the Agreement. In addition, Endo will share in the costs of certain clinical studies and development activities initiated at the request of the FDA or as deemed appropriate by Endo.
The exclusive marketing and license rights do not include the right to commercialize over-the-counter (“OTC”) equivalent product in the United States. The OTC rights are held by GlaxoSmithKline Consumer Healthcare Holdings Limited (GSK”), who has agreed not to launch an OTC equivalent product prior to a specified time. In the event that GSK launches an OTC equivalent product before any person, other than GSK or its affiliates, launches either (i) an OTC version of 1% diclofenac gel product, or (ii) a generic to Voltaren Gel, then Endo will receive certain royalty payments on net sales of such OTC equivalent product in the United States as set forth in the Agreement; provided that, and subject to certain limitations and provisions as set forth in the Agreement, as a condition to the payment of any and all such royalties, net sales of the Licensed Product in the United States must have exceeded a certain threshold as defined in the Agreement prior to the launch of the OTC equivalent product.
The initial term of the Agreement will be seven (7) years, expiring on June 30, 2023. Thereafter, the Agreement will automatically be extended for successive one (1) year terms (each a “Renewal Term”) unless any Party provides written notice of non-renewal to the other Parties at least six (6) months prior to the expiration of any Renewal Term after the first Renewal Term.
Among other standard and customary termination rights granted under the Agreement, the Agreement can be terminated by any party upon reasonable written notice, if the other party has committed a material breach that has not been remedied within ninety (90) days from the giving of written notice. Endo may terminate the Agreement by written notice upon the occurrence of specified events, including the launch in the United States of a generic to the Licensed Product. Sandoz may terminate the Agreement upon reasonable written notice on or after the launch in the United States of an over-the-counter equivalent product by Sandoz, its affiliates or any third party that does not result in the declassification of the Licensed Product as a prescription product, following which net sales in any six (6) month period under the Agreement are less than a certain defined dollar amount.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by the full text of the Agreement, a copy of which will be filed with the exhibits to the Registrant’s annual report on Form 10-K for the year ended December 31, 2015.
A copy of the press release announcing the execution of the Agreement is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
Item 1.02. Termination of a Material Definitive Agreement.
The information set forth in Item 1.01 above is incorporated into this Item 1.02 by reference. On December 11, 2015, Endo, Novartis AG and Sandoz entered into the Agreement pursuant to which the 2008 Agreement will be terminated on June
30, 2016. The 2008 Agreement is being terminated in accordance with its terms and the termination will not give rise to any early termination fees or penalties.
Item 9.01. Financial Statements and Exhibits.
(d) | Exhibits. |
Exhibit No. | Description |
99.1 | Press Release of Endo International plc, dated December 14, 2015. |
SIGNATURES
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.
ENDO INTERNATIONAL PLC | |
(Registrant) | |
By: | /s/ Matthew J. Maletta |
Name: | Matthew J. Maletta |
Title: | Executive Vice President, Chief Legal Officer |
Dated: December 14, 2015
INDEX TO EXHIBITS
Exhibit No. | Description |
99.1 | Press Release of Endo International plc, dated December 14, 2015. |
Exhibit 99.1
ENDO ANNOUNCES EXTENSION OF U.S. RIGHTS FOR VOLTAREN® GEL
Grants Exclusive License to Commercialize Branded Product
and any Future Authorized Generic Until 2023
and any Future Authorized Generic Until 2023
Voltaren® Gel is the Most Prescribed FDA-Approved Topical NSAID for the Relief of Osteoarthritis Pain
DUBLIN, December 14, 2015 -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) today announced the extension of its exclusive U.S. marketing rights for the currently marketed prescription medicine Voltaren® Gel (diclofenac sodium topical gel) 1% as well as for the product’s Authorized Generic, should Endo opt to commercially launch it in the future. Endo, through an indirect wholly owned subsidiary, has entered into a licensing agreement with Sandoz Inc. and Novartis AG through June 30, 2023.
“We are very proud of Voltaren® Gel’s market leading position and are therefore very pleased to extend our marketing rights and continue this successful commercialization,” said Rajiv De Silva, President and CEO of Endo. “Endo has a long-standing commitment to supporting the pain community. With this agreement, we can now continue to provide Voltaren® Gel as an important product in our innovative pain product portfolio.”
Under the terms of the seven-year agreement, Endo will make additional payments so long as there is no entry of a generic competitor product and the same minimum sales royalties and tiered, double-digit royalties on net sales of Voltaren® Gel in the U.S. as the current licensing agreement. Sandoz will continue to supply the product to Endo.
Endo will provide more detail regarding the anticipated financial impact of this license extension on its future performance when the Company provides full 2016 financial guidance.
About Osteoarthritis
Osteoarthritis (OA) is a chronic condition that occurs more frequently as people get older and can break down joints’ protective cartilage causing damage and pain. OA pain develops slowly and can gradually worsen over time.
About Voltaren® Gel
Voltaren® Gel is a non-steroidal anti-inflammatory drug (NSAID) used for the relief of joint pain of osteoarthritis in the knees, ankles, feet, elbows, wrists, and hands. Voltaren® Gel has not been studied for use on the spine, hip, or shoulder. Voltaren® Gel received regulatory approval in October 2007 from the U.S. Food and Drug Administration. Voltaren® Gel provides 1% diclofenac sodium in a topical gel formulation. According to IMS (Health NPA, 2009-2015), Voltaren® Gel is the most prescribed non-steroidal anti-inflammatory (NSAID) medication
Exhibit 99.1
indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.
Important Safety Information About Voltaren® Gel
NSAID medicines, like Voltaren® Gel, may increase the chance of a heart attack or stroke that can lead to death. This chance increases:
• | with longer use of NSAID medicines |
• | in people who have heart disease |
NSAID medicines, like Voltaren® Gel, should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
NSAID medicines, like Voltaren® Gel, can cause ulcers and bleeding in the stomach and intestines at any time during treatment.
• | Ulcers and bleeding can happen without warning symptoms and may cause death |
• | The chance of a person getting an ulcer or bleeding increases with older age |
NSAID medicines should only be used:
• | at the lowest dose possible for your treatment |
• | for the shortest time needed |
Do not use Voltaren® Gel if you are allergic to diclofenac (the active ingredient in Voltaren® Gel) or if you have had asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs.
Tell your healthcare provider:
• | if you have a history of ulcers or bleeding in the stomach or intestines, or kidney or liver problems, or heart failure |
• | about all of your medical conditions |
• | about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects |
• | if you are pregnant or breastfeeding. Voltaren® Gel should not be used late in pregnancy |
NSAIDs, including Voltaren® Gel, can lead to high blood pressure or worsening of high blood pressure, which may add to the increased risk of heart attack and stroke.
Possible serious side effects include life-threatening skin and allergic reactions.
Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing, chest pain, weakness in one side of your body, slurred speech, or
Exhibit 99.1
swelling of the face or throat. Stop using Voltaren® Gel and call your healthcare provider right away if you have: skin rash or fever with blisters.
Do not use Voltaren® Gel on the same skin site that was treated with other topical products, such as sunscreens, cosmetics, lotions, moisturizers, or insect repellents.
Other information about NSAIDs:
• | Aspirin, which is an NSAID, can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines |
You should not use Voltaren® Gel with oral NSAIDs.
The most common side effects reported in studies using Voltaren® Gel were application site reactions, including dermatitis (reported in 7% of treated patients).
Use Voltaren® Gel exactly as prescribed by your healthcare provider.
• | Apply Voltaren® Gel to clean, dry skin that does not have any cuts, infections, or rashes |
• | Avoid exposing skin where you apply Voltaren® Gel to sunlight and artificial light, such as tanning booths |
• | Do not get Voltaren® Gel in your eyes, nose, and mouth |
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional information about Voltaren® Gel, please see the full prescribing information at http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=60045fc6-f0d9-4f67-ba91-c3b317596437, including the Medication Guide.
About Endo International plc
Endo International plc (NASDAQ: ENDP) (TSX: ENL) is a global specialty pharmaceutical company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation, including the statements by Mr. De Silva and other statements regarding market and product potential. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations
Exhibit 99.1
and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with the Securities and Exchange Commission ("SEC") and with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval ("SEDAR"), including under the caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K filings, and as otherwise enumerated herein or therein, could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.
CONTACTS:
Investors/Media: Keri P. Mattox, (484) 216-7912
Media: Heather Zoumas-Lubeski, (484) 216-6829
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