Bioton takes on insulin giants


Polish company Bioton S.A (Warsaw) and Swiss-headquartered generics giant Actavis (Zug) have joined forces to shake up the €12bn world market for recombinant insulins and insulin analogues. At the end of January, Bioton Chairman Ryszard Krauze and Actavis CEO Claudio Albrecht announced that their companies have formed a joint venture for the development and registration of recombinantly produced insulins. While Bioton will develop and produce the insulins, the fourth largest generics producer will sell them in all EU countries, the US, Japan, Switzerland, Norway, Albania, Bosnia & Herzegovina, Croatia, Iceland, Kosovo, Liechtenstein, Montenegro and Macedonia. In Poland, both companies will market the products under their repective brands.

Facing off with the big boys

Under the terms of the agreement, Bioton will receive €22.25m upfront and a further €33.25m in milestones. Both companies expect revenues to reach €1.5bn in the seven years following the market launches of Bioton’s human recombinant insulin, short-acting insulins and long-acting insulins, the first step of which will commence at the end of 2012. The companies will share profits on a 50/50 basis. Actavis also secured an option to market Bioton’s insulins in 24 further markets, paying the Polish bioech firm €1m up front and €0.9m in milestone payments for the privilege.
For Bioton, which is the fourth firm globally to manufacture a human recombinant insulin (“gensulin”), the deal is a unique opportunity for expansion into the global market, which is currently dominated by three big players: Danish Novo Nordisk, French Sanofi and US pharma giant Eli Lilly. “For Bioton, the collaboration with Actavis will fuel faster expansion into high-margin markets,” commented the firm’s CEO Slawomir Ziegert. Albrecht said the deal involved more than just the sale of insulins and insulin analogues. “We are encountering competitor giants when it comes to insulin, and we have to maximise the competitive advantage that we clearly have.”
Bioton wants to be the first company on the market to offer biosimilar versions of recombinantly-produced human insulins, which will be much cheaper than IP-protected originator products. But Pfizer and its Indian manufacturing partner Biocon are hard on the heels of the Polish. Some insulins – such as Lilly’s Humulin, Novo Nordisk’s Novalin or Sanofi’s Lantus – have already lost patent protection. Others, like Levemir (Novo Nordisk) or the fast-acting insulins Humalog (Eli Lilly) and Novalog (Novo Nordisk) will follow in the next two years.
But Actavis also has plans beyond insulin. Albrecht announced the firm intends to launch a biosimilar for bestselling drugs every month during the first eight months of 2012. Bioton can benefit from the generics expert’s plans. Together with the initial announcement of the diabetes pact, which dates back to November 2010, Actavis said it will carry out a due diligence to acquire a 51% stake in Bioton’s Swiss subsidiary Biopartners – a biosimilar specialist.



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