India-based pharmaceutical firm Alkem Laboratories negotiated rights to commercialize Karo Bio’s Phase III-stage dyslipidemia therapy eprotirome in India and certain other countries. As part of the deal Alkem will carry out a 500-patient pivotal Phase III study to support approval of the drug in India. Karo will then be able to use data from the Indian study to support its own submission of the drug in the European Union for the treatment of high-risk patients with heterozygous familial hypercholesterolemia, the lead indication for eprotirome.
Karo is carry out a global development program for eprotirome. The drug is in Phase II development in the U.S. and poised for Phase III studies in the EU. The firm says the deal with Alkem means it will be able to reduce the costs of its own investment in Phase III development of the drug from SEK 400 million (roughly $64 million) to about SEK 300 million ($48 million).
Eprotirome is a liver-selective thyroid hormone receptor agonist that Karo claims reduces a number of independent risk factors of the development of atherosclerotic cardiovascular disease. Three Phase II studies have shown that when used as monotherapy or in combination with statins or ezetimibe, eprotirome leads to clinically meaningful reductions in risk factors for the development of cardiovascular disease in patients with high blood lipids.