RedHill enters manufacturing deal with Cosmo for two key products
pharmafile | February 19, 2021 | News story | Medical Communications | RedHill Biopharma
RedHill Biopharma has announced agreements with Cosmo Pharmaceuticals to manufacture two of RedHill’s key products.
Cosmo will manufacture Movantik, RedHill’s best-selling product in the US, and RHB-204, currently in a Phase III US study as a stand-alone, first-line, orally-administered treatment for pulmonary nontuberculous mycobacteria (NTM) disease.
Movantik is the leading prescribed oral peripherally acting mu-opioid receptor antagonist in the US specifically designed to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. OIC is the most common and debilitating gastrointestinal adverse effect associated with opioid therapy, affecting an estimated 40 to 80% of the millions of patients taking chronic opioid therapy each year.
RHB-204 is an investigational proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed as a stand-alone first-line treatment for pulmonary NTM disease caused by Mycobacterium avium Complex. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world. In 2017, there were an estimated 110,000 pulmonary NTM disease patients in America, with US market potential estimated at over $500 million.
RHB-204 has received FDA Fast Track, Orphan Drug, and QIDP designations aimed at accelerating development and FDA review and extending US market exclusivity to a potential total of 12 years, to be granted at the time of FDA approval.
Steven Thomasian, RedHill’s Vice President of Supply Chain Management, said: “Movantik is currently our biggest commercial product. This agreement strengthens our qualified supply base and capacity moving forward and solidifies our ongoing strategic relationship with Cosmo.”
Davide Malavasi, Cosmo’s Head of Manufacturing, commented: “We are happy to strengthen our partnership with RedHill with the manufacturing of these two important products and therefore to further expand Cosmo’s production capacities and capabilities.”
Darcy Jimenez
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