DURHAM, N.C., March 19, 2018 (GLOBE NEWSWIRE) -- Dova Pharmaceuticals, Inc. (NASDAQ:DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, entered into an agreement through its wholly owned subsidiary, AkaRx, Inc., granting Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., (Fosun Pharma Industrial), a wholly owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) (SHA:600196) (HKG:02196), the exclusive development and distribution rights of avatrombopag in mainland China and Hong Kong.
Terms of the transaction include an upfront payment, milestone payments, and a fixed transfer price for product supplied. Under the agreement, Fosun Pharma Industrial has the right to exclusively develop and commercialize and to assist AkaRx with the registration of avatrombopag for chronic liver disease (CLD) patients with thrombocytopenia in mainland China and Hong Kong. Further, Fosun Pharma Industrial will also support the development of avatrombopag for expanded indications in mainland China and Hong Kong.
“Fosun Pharma is a highly qualified partner, and we are excited to work with them as we look to expand avatrombopag internationally,” said Alex Sapir, President and Chief Executive Officer of Dova. “Fosun Pharma is a strong pharmaceutical company in China and a growing international player. They have the resources and experience to assist us with the marketing authorization process in order to maximize the distribution of avatrombopag in mainland China and Hong Kong.”
“We are pleased to collaborate with Dova on avatrombopag as a potential therapeutics for Chinese patients inflicted by diseases such as CLD, ITP or CIT," said Yifang Wu, president and chief executive officer of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., the parent company of Shanghai Fosun Industrial Development Company Limited. "The data from the two pivotal Phase 3 clinical studies of avatrombopag for its initial indication CLD were impressive, and we believe avatrombopag has a bigger potential for its expanded indications. We look forward to Dova’s regulatory approval in the US, and the ultimate introduction of this treatment to patients with thrombocytopenia in mainland China and Hong Kong.”
Avatrombopag is a second generation orally administered thrombopoietin receptor agonist (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. The New Drug Application (NDA) for treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure has been accepted for priority review by FDA with a PDUFA date of May 21, 2018. Dova is also working on expanded indications in chemotherapy induced thrombocytopenia (CIT) and immune thrombocytopenia purpura (ITP). Dova holds the worldwide intellectual property 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, is owned by AkaRx, Inc, a wholly owned subsidiary of Dova Pharmaceuticals. 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 been accepted for priority review by FDA for this initial indication with a PDUFA goal date of May 21, 2018.
Cautionary Notes 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 “anticipated”, “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 Dova’s potential commercialization of avatrombopag, both in the United States and internationally, and Dova’s clinical development of avatrombopag for additional indications. 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, increased regulatory requirements, 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 Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission (SEC), 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.
Mark W. Hahn
Chief Financial Officer
Source:Dova Pharmaceuticals, Inc.