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Agreements

Date: 2011-04-26

Type of information: Licensing agreement

Compound: eprotirome

Company: Karo Bio (Sweden) Alkem (India)

Therapeutic area: Cardiovascular diseases - Genetic diseases - Metabolic diseases

Type agreement:

collaboration

licensing

Action mechanism:

This thyroid hormone analogue is liver-selective thyroid hormone receptor agonist.

Disease: heterozygous familial hypercholesterolemia

Details:

Karo Bio has entered into a collaboration and license agreement with the Indian pharmaceutical company Alkem Laboratories Ltd (Alkem). Under the agreement, Alkem will receive the exclusive rights to commercialize eprotirome in India and certain other markets in Asia-Pacific and Africa. Karo Bio is entitled to royalty on Alkem’s future sales of eprotirome. Alkem will conduct a pivotal clinical phase III trial in order to obtain marketing approval of eprotirome in India. The clinical trial will comprise up to 500 patients with primary hyperlipidemia with a high risk for cardiovascular disease, mainly patients with previous cardiovascular events. 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. Karo Bio’s phase III program for HeFH has previously been estimated to be an investment of SEK 400 million. As a consequence of the collaboration with Alkem, Karo Bio estimates that the investment will be reduced by approximately SEK 100 million. Eprotirome has in three clinical phase II trials been demonstrated to, when administered either as monotherapy or on top of ongoing statin or ezetimibe treatments, produce a profound and clinically meaningful lowering of several important risk factors for the development of cardiovascular disease in patients with high blood lipids.

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