US-based X4 Pharmaceuticals has entered an exclusive agreement with United Arab Emirates (UAE)-based pharmaceutical products wholesaler taiba rare to distribute and commercialise oral Xolremdi (mavorixafor) in select Middle Eastern countries for the treatment of warts, hypogammaglobulinemia, infections and myelokathexis (WHIM) syndrome.
The agreement covers Bahrain, Egypt, Kuwait, Oman, Qatar, Saudi Arabia and the UAE, and is contingent upon receiving regulatory approvals in these regions.
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taiba, collaborating with X4 on strategic decisions, is set to manage the distribution, promotion, marketing and sales of the therapy in the Middle East.
The therapy’s local regulatory filings will be based on X4’s US Food and Drug Administration (FDA) registration dossier.
Once regulatory approvals are obtained, taiba will make the therapy available to WHIM patients via a named-patient programme, which allows for the use of medicines approved in other nations for local subjects who lack alternative treatment alternatives.
X4 Pharmaceuticals CEO and president Paula Ragan stated: “We are very pleased to collaborate with taiba rare, an ideal partner for X4 due to their dedication to and experience providing access to innovative rare disease treatments throughout the region.
“We look forward to working together to further expand the global reach of Xolremdi for people with WHIM syndrome.”
Xolremdi is a selective CXC chemokine receptor 4 (CXCR4) antagonist and gained the US Food and Drug Administration (FDA) approval in April 2024 for individuals aged 12 and above with WHIM syndrome.
It is the only treatment specifically approved for WHIM syndrome in the US.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use is currently reviewing the marketing authorisation application for mavorixafor for this condition.
X4 is exploring further applications in addition to WHIM. A pivotal Phase III trial is being conducted by the company to investigate the therapy for the treatment of specific chronic neutropenic disorders.
