California-based BioMarin Pharmaceutical Inc, which had sued Dr Reddy’s Laboratories last November for allegedly infringing patents covering its phenylketonuria drug Kuvan, has agreed to resolve the patent litigation. BioMarin is a global biotechnology company that develops and commercialises innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases.
According to a statement issued by BioMarin, the US drugmaker said it will grant Dr Reddy’s a non-exclusive licence to its patents on Kuvan (sapropterin dihydrochloride) allowing Dr Reddy’s to market a generic version of Kuvan 100 mg tablets in the US at a later stage, which is expected to be more than five years from now. Phenylketonuria (PKU) is a genetic disorder and is caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH), which is required for the metabolism of phenylalanine (PHE), an essential amino acid found in most protein-containing foods. Kuvan, which has clocked $203 million revenues for the company in 2014, is used for the treatment of hyperphenylalaninemia (HPA) in adults and children with phenylketonuria (PKU).
However, as per the statement, it can be done earlier under certain circumstances which were kept confidential. “The settlement agreement recognises the strength of the intellectual property related to Kuvan and helps ensure that patients who depend on Kuvan to manage their phenylketonuria (PKU) will continue to receive the medication,” executive V-P and CCO BioMarin, Jeff Ajer said.