Medivir AB (Nasdaq Stockholm: MVIR) is a Swedish biotech company that focuses on innovative pharmaceuticals to address unmet medical needs in oncology. Quotient Sciences has partnered with Medivir over the past several years, most recently with formulation development activities and drug product manufacturing of fostroxacitabine bralpamide (fostrox). Today, Medivir announced that an updated formulation of fostrox that is suitable for commercial manufacture has been finalized.
Fostrox is currently under evaluation as a potential treatment for hepatocellular carcinoma (HCC), a potentially life-threatening form of liver cancer that is the third leading cause of cancer-related death worldwide. Fostrox received a positive opinion on orphan medicinal drug designation by EMA and was granted orphan drug designation by the FDA for the treatment of HCC.
The development of an updated commercial formulation is a milestone towards fostrox becoming a treatment option for HCC patients worldwide. A Phase 1b/2a study is still ongoing to evaluate fostrox in combination with Lenvima®, a tyrosine kinase inhibitor used to treat certain kinds of cancer.
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LENVIMA® is a registered trademark by Eisai R&D Management Co., Ltd.