fosun pharma and dova pharmaceuticals sign an exclusive distribution agreement for avatrombopag, an oral drug candidate for treatment of thrombocytopenia-凯发k8娱乐app下载

fosun pharma and dova pharmaceuticals sign an exclusive distribution agreement for avatrombopag, an oral drug candidate for treatment of thrombocytopenia-凯发k8娱乐app下载

2018-03-19

fosun pharma and dova pharmaceuticals sign an exclusive distribution agreement for avatrombopag, an oral drug candidate for treatment of thrombocytopenia

mar. 16, 2018, 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 and hkg: 02196) and dova pharmaceuticals, inc. (dova), through its wholly owned subsidiary akarx inc. (akarx) signed a distribution agreement, which provides fosun pharma industrial the right to exclusively develop and commercialize and to assist dova with the registration of avatrombopag (trademark: doptelet® , the product) in china mainland and hong kong. avatrombopag is an orally administered drug candidate for the treatment of thrombocytopenia.


according to the agreement, fosun pharma industrial will make an upfront payment, pay fixed payments if certain developmental milestones are met and a fixed transfer price for any product supplied.


dova is a clinical-stage pharmaceutical company and is committed to identifying, acquiring, developing and commercializing drug candidates. as dova targets rare diseases where the unmet need is high, dova is also looking beyond to ensure its drug candidates help as many as patients as possible.


“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 china mainland and hong kong.”

    

thrombopoietin receptor (tpo-r) agonist is the conventional therapeutic drug for the treatment of thrombocytopenia in the european countries and the us. avatrombopag, developed by akarx, is a second generation of oral tpo-r agonist. the planned indications for avatrombopag includes for the treatment of thrombocytopenia in patients with chronic liver disease (cld) undergoing a procedure, idiopathic thrombocytopenic purpura (itp), and chemotherapy-induced thrombocytopenia (cit). in the two phase iii studies completed in the us for the cld indication, avatrombopag met all efficacy endpoints with high statistical significance, showed a similar safety profile to the placebo and had low risk of having portal vein thrombosis. avatrombopag was granted orphan drug designation by us fda for the itp indication, and its new drug application for the cld indication has been submitted and been accepted by us fda with priority review. the phase iii study for itp has been completed while the phase iii study for cit is being initiated.

 

according to ims midastm, as of december, 2016, the sales of rhtpo, the first generation of anti-thrombocytopenia drug in china, is rmb 676 million, and globally, the market size of the second generation of tpo-r agonist, for itp alone, is usd 1.26 billion.


thrombocytopenia is a hemorrhagic disorder. patients with severe thrombocytopenia, such as cld and itp patients, have relatively high risk of spontaneous bleeding, and in extreme conditions this disorder can be life-threating. cit is a frequent dose-limiting toxicity of chemotherapy regimen, and its occurrence can weaken the efficacy of chemotherapy by requiring dose reductions or delays. currently the palate infusion, glucocorticoid and rhtpo are the most frequently used therapeutics in clinic for itp and cit in china. the second generation of tpo-r activator is a beneficial complement to the existing therapeutics which are accompanied by risks and poor efficacy.


        “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 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 regulatory approval in the us, and the ultimate introduction of this treatment to patients with thrombocytopenia in mainland china and hong kong.”

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about dova

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.for more information about dova pharmaceuticals, please visit http://dova.com/.