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Agreements

Date: 2012-01-30

Type of information: Collaboration agreement

Compound: insulins and analogue insulins

Company: Actavis (Switzerland) Bioton (Poland)

Therapeutic area: Metabolic diseases

Type agreement:

joint-venture

Action mechanism:

Disease: diabetes

Details:

Actavis and Bioton have formed a joint venture company for the development and registration of insulins, including analogue insulins. Within the framework of the joint-venture, Bioton will be responsible for the development and manufacture of insulin products, while Actavis will be granted an exclusive licence to commercialise those products under the Actavis brand throughout the European Union and the United States of America, as well as in Albania, Bosnia & Herzegovina, Croatia, Iceland, Japan, Kosovo, Lichtenstein, Macedonia, Montenegro, Norway, Serbia and Switzerland. In Poland, both companies will offer the insulin products under their respective brands, Bioton being a Polish company. Bioton is the Polish manufacturer of modern recombinant human insulin, which is on offer to patients on almost 20 markets worldwide, including Poland, Russia, China, Thailand, Vietnam and India. With respect to the sale of insulins, Bioton cooperates with GlaxoSmithKline and Bayer HealthCare, as well as other local foreign distributors, leading on particular markets. Bioton's insulin are manufactured in its biotechnology facility in Macierzysz near Warsaw.

Financial terms:

Actavis has agreed to remunerate Bioton with the aggregate amount of €55.5 million, of which € 22.25 million at signing. The remainder (€ 33.25 million) will be paid in instalments in accordance with agreed milestones relating to the registration process involving recombined human insulin (RHI). Based on the sales volumes estimated by the parties, Actavis\' revenues from the sale of the Insulins by Actavis into the markets in the initial period of 7 years from launch are expected to exceed € 1.5 billion. Pursuant to the agreement, the parties will share on an equal \'50/50\' basis the profits from the sale of the insulins performed by Actavis, as well as the development and registration costs related to Bioton insulins.
In addition, the Bioton Group have also signed memoranda of understanding with Actavis for the sale of insulins in 24 additional territories, including Turkey and Australia. Actavis will pay an additional consideration of up to € 1,900,000, including € 1,000,000 at signing. Both parties expect that sales of Bioton\'s recombinant human insulin by Actavis into some of the additional territories shall commence on the turn of 2012 and 2013. The profits from the sale of the insulins in these additional territories will again be shared on an equal basis (50/50). Formal documentation of these arrangements is expected to be concluded in the following weeks.




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