RedHill Biopharma: RHB-204 Gets EU Orphan Drug Designation For NTM Infections

RedHill Biopharma Ltd. (RDHL), a specialty biopharmaceutical company focused on gastrointestinal and infectious diseases, announced Wednesday that the European Commission has granted Orphan Drug Designation to RHB-2041 for the treatment of nontuberculous mycobacteria or NTM disease.

In pre-market activity on Nasdaq, RedHill shares were gaining around 5.1 percent to trade at $1.03.

The designation was granted following a positive opinion recommendation by the European Medicines Agency's Committee for Orphan Medicinal Products or COMP.

RHB-204 was developed as the first stand-alone standard of care first-line therapy for NTM disease caused by Mycobacterium avium complex or MAC infection.

It is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM infections.

The EMA Orphan Drug Designation provides eligibility for 10 years post-approval EU market exclusivity. The company noted that the U.S. FDA Fast Track, Orphan and QIDP priority designations, previously granted to RHB-204, extend U.S. post-approval market exclusivity to a total of 12 years.

RHB-204 is also covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.

RedHill said it is advancing discussions with prospective partners for RHB-204 across multiple territories.

A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by MAC infection (NCT04616924).

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