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news.Karo Bio and Alkem Laboratories have signed a collaboration and licensing pact for eprotirome, a novel, liver-selective thyroid hormone receptor agonist, intended for the treatment of dyslipidemia.
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Under the agreement, Alkem will get commercialization rights for Karo Bio’s eprotirome across India and other countries in Asia-Pacific and Africa..
In connection to receive Indian marketing approval for eprotirome, Alkem will organize a pivotal Phase III trial to determine further safety profile of the drug.
Data from the Indian study will be included in Karo Bio’s application for marketing approval of eprotirome for the treatment of high-risk patients with heterozygous familial hypercholesterolemia (HeFH) in the EU.
The partnership entitles Karo Bioto receive a royalty on Alkem’s future sales of eprotirome.
Karo Bio president and CEO Fredrik Lindgren said the collaboration represents a substantial financial value, since their investment in eprotirome’s Phase III program will decrease from about SEK400m to SEK300m as a consequence of Alkem conducting one of the studies.