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): September 22, 2017

 

Dova Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

 

001-38135
(Commission
File Number)

 

81-3858961
(IRS Employer
Identification No.)

 

240 Leigh Farm Road, Suite 245
Durham, North Carolina

(Address of Principal Executive Offices)

 

27707
(Zip Code)

 

Registrant’s telephone number, including area code: (919) 748-5975

 

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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

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. x

 

 

 



 

Item 8.01              Other Events

 

On September 22, 2017, Dova Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the submission of a new drug application to the U.S. Food and Drug Administration for avatrombopag.

 

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K, the contents of which are incorporated herein by reference. The information contained in this Current Report on Form 8-K speaks only as the date hereof. While the Company may elect to update the information in this Current Report on Form 8-K in the future, the Company disclaims any obligation to do so except to the extent required by applicable law.

 

Item 9.01              Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

 

 

Number

 

Exhibit Description

99.1

 

Press Release, dated September 22, 2017.

 

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.

 

 

Dova Pharmaceuticals, Inc.

 

 

 

 

Date: September 22, 2017

/s/ Douglas Blankenship

 

Douglas Blankenship

 

Chief Financial Officer

 

3


Exhibit 99.1

 

 

DOVA PHARMACEUTICALS ANNOUNCES NEW DRUG APPLICATION SUBMISSION TO FDA FOR AVATROMBOPAG, A SECOND GENERATION THROMBOPOIETIN RECEPTOR AGONIST

 

DURHAM, NC, September 22, 2017 — Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a specialty pharmaceutical company, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avatrombopag, a second generation orally administered thrombopoietin receptor agonist (TPO-RA) for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

 

“Submission of the NDA for avatrombopag represents a significant milestone and a major advancement towards potentially bringing this novel therapy to patients, including the approximately 1.1 million CLD patients in the United States affected by thrombocytopenia, of whom approximately 70,000 have severe thrombocytopenia,” said Alex Sapir, President and CEO of Dova. “The treatment of thrombocytopenia represents an important unmet need in this patient population, as significant limitations impact the use of platelet transfusions, the current standard of care.”  Risks associated with platelet transfusions include antibody development, bacterial infections, short duration of effect, limited supply, and inconvenience of administration.  Currently there is no drug treatment approved by FDA or the European Medicines Agency (EMA) for the treatment of thrombocytopenia in patients with CLD who are scheduled to undergo a procedure.

 

Primary safety and efficacy data supporting the NDA submission were provided by the results of two pivotal Phase 3 clinical trials, ADAPT-1 and ADAPT-2, that evaluated the efficacy and safety of avatrombopag for the treatment of severe thrombocytopenia (defined as <50,000 platelets per microliter of circulating blood) in patients with CLD.  In both trials, avatrombopag met the primary and secondary efficacy endpoints with high statistical significance. Avatrombopag treatment was well tolerated with a safety profile that was generally comparable to that of placebo, with the frequency, severity, and types of adverse events reported being consistent with those expected in patients with CLD.  There will be an oral presentation of these two pivotal Phase 3 trials at the upcoming American Association for the Study of Liver Diseases (AASLD) Meeting in Washington, DC on October 23rd at 3PM (EDT).

 

About Avatrombopag

 

Avatrombopag is a second generation orally administered TPO-RA which is intended to address the limitations of other existing treatments for thrombocytopenia. In two identically-designed Phase 3 clinical trials, ADAPT 1 and ADAPT 2, avatrombopag met all primary and secondary endpoints with high statistical significance.  Avatrombopag is initially being studied for its potential for the acute treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure. Dova is also planning to explore the potential use of avatrombopag in a broader population of patients with thrombocytopenia, including in patients undergoing surgical procedures associated

 



 

with a high risk of bleeding, and patients who develop thrombocytopenia after receiving chemotherapy. In addition, Dova is exploring a potential regulatory approval pathway for avatrombopag for the treatment of adults with chronic immune thrombocytopenic purpura (ITP) based on results from a completed Phase 3 trial in this patient population. Dova holds the worldwide rights to avatrombopag for all current and future indications.

 

About Dova Pharmaceuticals, Inc.

 

Dova is a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, with an initial focus on addressing thrombocytopenia. Dova’s lead drug candidate, avatrombopag, has successfully completed two pivotal Phase 3 clinical trials for the treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure and an NDA has now been submitted to FDA for this initial indication.

 

Cautionary Note Regarding Forward-Looking Statements

 

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Dova’s current beliefs and expectations. These forward-looking statements include expectations regarding the regulatory development of avatrombopag. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Dova’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Dova’s Quarterly Report on Form 10-Q for the quarter ended June 30th, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on August 14, 2017, and Dova’s other periodic reports filed with the SEC.  Any forward-looking statements speak only as of the date of this press release and are based on information available to Dova as of the date of this release, and Dova assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

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Contacts

 

Doug Blankenship

(919) 748-5975

dblankenship@dova.com

 

Westwicke Partners

John Woolford

(443) 213-0506

john.woolford@westwicke.com