trending Market Intelligence /marketintelligence/en/news-insights/trending/lGnUm68wvdM3RmXrUbNkHA2 content esgSubNav
In This List

Endo partner Novitium gets FDA nod for copy of Sobi's metabolic disease drug

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Endo partner Novitium gets FDA nod for copy of Sobi's metabolic disease drug

Endo International PLC said Novitium Pharma LLC received the U.S. Food and Drug Administration's approval for the first generic version of Swedish Orphan Biovitrum AB (publ)'s medicine Orfadin to treat a rare inherited metabolic disorder.

East Windsor, N.J.-based Novitium is a partner of Endo subsidiary Endo Ventures Ltd.

Orfadin is used to treat adult and pediatric patients with hereditary tyrosinemia type 1, or HT-1, in combination with dietary restriction of the amino acids tyrosine and phenylalanine.

HT-1 is a rare and serious inherited metabolic disease caused by the inability to metabolize the amino acid tyrosine, which leads to elevated levels of the acid. The condition — which can lead to liver, kidney and peripheral nerve damage — affects at least 1 in 100,000 patients worldwide, with about 150 patients in the U.S., the company said in a Sept. 4 press release.

Endo unit Par Pharmaceutical Inc. plans to distribute the generic drug through specialty pharmacies from September.

Global sales of Orfadin for the past four quarters were about $85 million.