X4 Pharmaceuticals has partnered with Taiba Rare for Xolremdi (mavorixafor) distribution and commercialisation in select Middle East countries.
Xolremdi is a once-daily oral treatment for warts, hypogammaglobulinaemia, infections, and myelokathexis (WHIM) syndrome.
The exclusive agreement covers Saudi Arabia, the UAE, Qatar, Oman, Kuwait, Bahrain, and Egypt. The agreement is subject to regulatory approvals in these MENA countries.
X4 Pharmaceuticals aims to improve the lives of those with rare immune system diseases.
Taiba Rare brings expertise in specialty and orphan drug marketing, sales, and distribution.
Mavorixafor received US Food and Drug Administration (FDA) approval in April 2024 for WHIM syndrome treatment in patients aged 12 and older. It helps increase circulating mature neutrophils and lymphocytes.
The European Medicines Agency (EMA) is currently reviewing the Marketing Authorisation Application (MAA) for the drug for WHIM syndrome. The EMA has previously granted orphan designation to mavorixafor for the condition.
Last month, X4 Pharmaceuticals announced a licensing and supply agreement with Norgine to commercialise mavorixafor in Europe, Australia, and New Zealand.
X4 Pharmaceuticals president and CEO Paula Ragan said: “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.”
Under the agreement, Taiba Rare will lead the distribution, promotion, marketing, and sales of Xolremdi in the region, collaborating with X4 Pharmaceuticals on key strategies.
Local regulatory filings will reference X4 Pharmaceuticals’ FDA registration dossier.
Pending regional approvals, Taiba Rare plans to offer mavorixafor through a named-patient (compassionate use) programme for local WHIM patients who have no other treatment options.
Taiba Healthcare CEO Saif Al Hasani said: “Xolremdi is the first and only treatment approved for patients with WHIM syndrome.
“We are proud to partner with X4 to bring Xolremdi to those with this rare primary immunodeficiency in the Middle East region.
“Having been granted Orphan Drug Designation in both the US and the European Union, Xolremdi fits well into our portfolio of innovative therapies for those with the highest unmet needs.”
Massachusetts-based X4 Pharmaceuticals is also evaluating additional uses of mavorixafor and conducting a global Phase 3 trial (4WARD) for chronic neutropenic disorders.
