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): November 27, 2018

 

Eagle Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-36306

 

20-8179278

(State or other jurisdiction

 

(Commission File Number)

 

(IRS Employer Identification No.)

of incorporation)

 

 

 

 

 

50 Tice Boulevard, Suite 315
Woodcliff Lake, NJ

 

07677

(Address of principal executive offices)

 

(Zip Code)

 

  Registrant’s 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 November 27, 2018, Eagle Pharmaceuticals, Inc. issued a press release announcing positive results of a pre-clinical study conducted to evaluate the effects of RYANODEX® (dantrolene sodium) in Acute Radiation Syndrome.

 

A copy of the full text 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.

 

Description

99.1

 

Press Release dated November 27, 2018

 

2


 

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.

 

 

Eagle Pharmaceuticals, Inc.

 

 

 

 

Dated: November 27, 2018

 

 

By:

/s/ Scott Tarriff

 

 

Scott Tarriff

 

 

Chief Executive Officer

 

3


Exhibit 99.1

 

 

For Immediate Release

 

Eagle Pharmaceuticals Announces Positive Results of Pre-clinical Study Conducted to Evaluate Effects of RYANODEX in Acute Radiation Syndrome (ARS)

 

—Eagle to explore ARS indication to treat individuals exposed to high doses of radiation such as nuclear power plant leakage or nuclear weapons; additional research ongoing to evaluate hematopoietic syndrome in certain cancer patients undergoing radiation therapy—

 

WOODCLIFF LAKE, N.J., November 27, 2018 — Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced positive results of a proof-of-concept (POC) study in a Total-Body Radiation Animal Model. The objective of the study was to evaluate the efficacy of intravenous administration of RYANODEX® to prevent or mitigate Acute Radiation Syndrome (ARS) in a total body irradiated C57BL/6 male mouse hematopoietic model.

 

Animals in each treatment group received a well-characterized, high-dose of radiation to their whole body and also received randomly-assigned RYANODEX in different treatment modalities. In this study, the RYANODEX treatment group had overall less mortality post-treatment than non-treated animals with ARS. Additional details will be provided when available.

 

Based on the study results to date, Eagle intends to further explore an investigational indication for RYANODEX for the treatment of hematopoietic syndrome in individuals exposed to high doses of radiation, such as nuclear power plant leakage or nuclear weapons. Due to its nature, this indication is likely to be developed under the U.S. Food and Drug Administration’s “Animal Rule”.

 

The Company plans to conduct further research for treatment of post-irradiation hematopoietic syndrome, which could include treating the hematological side effects in certain cancer patients undergoing radiation therapy.

 

“This initial data provides the basis for better characterization of the underlying mechanisms of ionizing-radiation bone marrow suppression and the radioprotective effects of RYANODEX,” said Adrian Hepner MD, Chief Medical Officer of Eagle.

 

“We believe these study data support further investigation of RYANODEX as a therapy in patients with ARS exposed to high doses of radiation. We plan to focus additional research efforts in specific cancer populations

 


 

undergoing radiation therapy, a significant area of unmet medical need and look forward to reporting our progress,” said Scott Tarriff, Chief Executive Officer of Eagle.

 

About Acute Radiation Syndrome

 

Acute Radiation Syndrome (ARS), also known as radiation toxicity or radiation sickness, is an acute medical condition caused by irradiation of the whole body (or a significant portion of the body), by a high dose of penetrating radiation in a short period of time, generally minutes. The leading cause of ARS is depletion of pluripotent cells in specific tissues.  ARS generally follows a predictable clinical course and is characterized by signs and symptoms that are manifestations of cellular deficiencies and the reactions of various tissues and organs to ionizing radiation. High-dose ionizing radiation exposures to the whole or substantial parts of the body often result in life-threatening injuries, primarily to those radiosensitive, self-renewing tissues, but most markedly to the hematopoietic systems. The survival rate of patients with the hematopoietic syndrome decreases with increasing radiation exposure. The primary cause of death is the destruction of the bone marrow, resulting in infection and hemorrhage.

 

About RYANODEX

 

RYANODEX® (dantrolene sodium) for injectable suspension is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.

 

Important Safety Information

 

RYANODEX® is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia, including:

 

Discontinuing triggering anesthetic agents

 

Increasing oxygen

 

Managing the metabolic acidosis

 

Instituting cooling when necessary

 

Administering diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX® is insufficient to maintain diuresis).

 

Precautions should be taken when administering RYANODEX® preoperatively for the prevention of malignant hyperthermia, including monitoring vital signs, avoiding known triggering agents, and monitoring for early clinical and metabolic signs of malignant hyperthermia that may indicate additional treatment is needed.

 

The administration of dantrolene sodium is associated with loss of grip strength and weakness in the legs, as well as drowsiness, dizziness, dysphagia, dyspnea, and decreased inspiratory capacity. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Care must be taken to

 


 

prevent extravasation of RYANODEX® into the surrounding tissue due to the high pH of the reconstituted RYANODEX® suspension and potential for tissue necrosis.

 

RYANODEX® full Prescribing Information can be found at www.RYANODEX.com

 

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. Eagle’s strategy is to utilize the FDA’s 505(b)(2) regulatory pathway.  Additional information is available on the Company’s 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 and phrases such as “anticipated,” “forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including, but not limited to: Eagle’s ability to advance RYANODEX in the treatment of ARS; Eagle’s plans to continue to evaluate the data with respect to RYANODEX in the treatment of ARS; and Eagle’s plans to conduct further research with respect to RYANODEX in the treatment of ARS. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s 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 the Company can successfully advance its product candidates, including RYANODEX; the risks inherent in the early stages of drug development and in conducting pre-clinical studies and clinical trials; the possibility that the study results with respect to RYANODEX in the treatment of ARS may be inaccurate or incomplete; and other factors that are discussed in Eagle’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on February 26, 2018 and its other 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 the Company does 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.

 

Contact:

Investor Relations

Lisa M. Wilson

In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

 

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