Current Report Filing (8-k)
January 09 2017 - 4:57PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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):
January 9, 2017
Egalet Corporation
(Exact name of Registrant as specified in its charter)
Delaware
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001-36295
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46-3575334
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(State or Other Jurisdiction
of Incorporation or Organization)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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600 Lee Road, Suite 100
Wayne, Pennsylvania 19087
(610) 833-4200
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrants Principal Executive Offices)
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01
Regulation FD Disclosure.
As reported under Item 8.01 of this current report on Form 8-K, Egalet Corporation (the Company) issued a press release on January 9, 2017 announcing the United States Food and Drug Administrations (FDA) approval of ARYMO ER. During a conference call and webcast scheduled to be held at 8:15 P.M. Eastern Time on January 9, 2017, Company management will discuss the FDA approval. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated into this Item 7.01 by reference.
The information in this Item 7.01 of this current report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed filed for purposes of Section 18 of the Securities Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing 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 8.01
Other Events.
On January 9, 2017, the Company announced that the FDA has approved ARYMO ER (morphine sulfate) extended-release tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The label for ARYMO ER is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
In connection with the FDAs approval of ARYMO ER, the Company intends to deliver notice triggering the second $40,000,000 tranche of the Companys senior secured debt financing previously announced on August 31, 2016. In connection with the funding of the second tranche, the note purchasers will also receive a royalty right, representing a right to receive an aggregate 1.5% royalty payment on net sales of ARYMO ER. The terms of the senior secured debt financing and royalty rights are further described in the Companys current report on form 8-K filed on September 1, 2016.
Item 9.01 - Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number
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Description
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99.1
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Press Release, dated January 9, 2017 (furnished herewith).
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99.2
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Label for ARYMO ER (filed herewith).
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: January 9, 2017
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Egalet Corporation
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By:
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/s/ Stan Musial
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Name: Stan Musial
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Title: Chief Financial Officer
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EXHIBIT INDEX
Exhibit Number
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Description
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99.1
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Press Release, dated January 9, 2017 (furnished herewith).
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99.2
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Label for ARYMO ER (filed herewith).
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