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 16, 2018
Eagle Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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001-36306 |
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20-8179278 |
(State or other jurisdiction |
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(Commission File Number) |
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(IRS Employer Identification No.) |
of incorporation) |
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50 Tice Boulevard, Suite 315 |
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07677 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (201) 326-5300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 8.01 Other Events.
On April 16, 2018, Eagle Pharmaceuticals, Inc., or the Company, issued a press release announcing that the Company has submitted and the U.S. Food and Drug Administration has accepted for filing its abbreviated new drug application (ANDA) for vasopressin injection, 1ml.
A copy of the press release referenced above is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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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.
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Eagle Pharmaceuticals, Inc. | |
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Dated: April 16, 2018 |
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By: |
/s/ Scott Tarriff |
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Scott Tarriff |
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Chief Executive Officer |
For Immediate Release
Eagle Pharmaceuticals Vasopressin ANDA Accepted for Filing by the FDA
WOODCLIFF LAKE, N.J., April 16, 2018 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (Eagle or the Company) today announced that it has submitted and the U.S. Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for vasopressin injection, 1ml. This product is the generic version of Endo International plcs original Vasostrict® formulation, which is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Vasostrict had approximately $400 million in brand sales in 2017.
We are pleased that the FDA has accepted our vasopressin injection formulation for filing. We look forward to the FDAs decision and intend to work closely with them through the review process, stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagles strategy is to utilize the FDAs 505(b)(2) regulatory pathway. Additional information is available on the companys website at www.eagleus.com.
Forward-Looking Statements
This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as will, may,, believe, intends, anticipate(s), plan, enables, potentially, entitles, and similar expressions are intended to identify forward-looking statements. These statements include statements regarding future events including, but not limited to: the impact, if any, of Eagles success in gaining timely FDA approval of the vasopressin product; the timing and level of success of a future launch of the vasopressin product; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; the commercial success of Eagles commercial portfolio, including vasopressin once launched; the ability of Eagle to deliver sustained shareholder value over time; and other factors that are discussed in Eagles Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the U.S. Securities and Exchange Commission (SEC) on February 26, 2018, and its other filings with the U.S. Securities and Exchange Commission (SEC). All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagles control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to whether Eagles management and/or board of directors will be effective in managing Eagles business and future growth, as well as the other risks described in Eagles filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any
obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com