As part of its innovation-led business strategy, Biocon has gone in for series of licensing pacts. To begin with, it has entered into an exclusive licensing agreement with a global biopharmaceutical company to develop and market a bio-similar version of G-CSF (granulocyte-colony stimulating factor) in North America and the European Union. However, Biocon did not disclose the name of the company.
Under the terms of the agreement, Biocon will receive an upfront licensing fee and, following approval in the licensed territories, royalties from sales.
The second initiative by the company is an exclusive licensing agreement with Invitrogen to market insulin to the global cell culture market.
The company also has filed an investigational medical product dossier (IMPD) for IN105 to conduct a phase I clinical trial in Sweden. The trial will be conducted at Karolinska University Hospital, Stockholm which marks its first step in the international development plan for IN105.
Its discovery led research programs particularly oral insulin (IN105) and anti-CD6 monoclonal antibody (T1h) has made major progress with the N105 completing phase IC human clinical "proof of concept" trials. T1h will commence phase II human clinical trials during Q2 FY08.
In its bio-similar manufacture project, the company received regulatory approval from DCGI for bio-similar Streptokinase and GCSF.
"We see licensing as a strong affirmation of our innovation led business strategy and expect to realize even greater licensing revenues in the future," stated Dr Kiran Mazumdar-Shaw, chairman and managing director, Biocon.