Melinta Therapeutics has signed a licence agreement with Cidara Therapeutics to facilitate a strategic collaboration for marketing the latter’s rezafungin in the US.
Rezafungin is a new, once-weekly echinocandin antifungal being developed by Cidara to treat and prevent serious fungal infections such as candidemia and invasive candidiasis in adults.
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It is also being developed for invasive fungal infection prophylaxis in adults who undergo allogeneic blood and marrow transplantation.
The collaboration comes after Cidara filed a New Drug Application (NDA) for rezafungin to treat candidemia and invasive candidiasis.
In more than ten years, no new treatments have been approved for these infections.
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Rezafungin for injection received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) earlier, which gives the NDA priority review.
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By GlobalDataIf the regulatory agency accepts to review the NDA, Cidara anticipates a decision on the approval in the first quarter of next year.
According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway.
The company will also lead the regulatory works for obtaining approval for rezafungin in the treatment and prophylaxis indications.
At the time points mentioned in the deal, the NDA will be transferred to Melinta.
Melinta Therapeutics president and CEO Christine Ann Miller said: “The addition of rezafungin expands and diversifies our existing portfolio and serves as fuel for accelerating our long-term growth strategy.
“By leveraging our expansive commercial infrastructure, we will provide the resources needed to optimise the commercialisation of rezafungin and ensure patient access to this life-saving medicine in the US.
“We will continue to aggressively pursue portfolio expansion that aligns with our mission of providing innovative therapies for acute and life-threatening illnesses.”
