Biocon is evaluating the safety and efficacy of its three drugs for oncology, rheumatoid arthritis and psoriasis. This pipeline of discovery-led research products in oncology, inflammatory conditions and auto immune diseases have been developed after a technology transfer from global majors

The company is engaged in conducting the randomized, open label, four arms parallel phase-II clinical study of anti-CD6 monoclonal antibody (T1hmAb) in combination with Methotrexate in patients with Active Rheumatoid Arthritis at seven investigation sites.

For its novel psoriasis drug, phase-II clinical trial will start at five sites before the end of the year. The study will evaluate the pharmacokinetics of anti-CD6 monoclonal antibody (T1h mAb) in patients with active moderate to severe Psoriasis. These clinical trials will enable Biocon to establish Proof of Concept for T1h to add value to its licensing potential.

In order to consolidate its oncology drug development expertise, Biocon has commenced the phase-IIb trials for Glioma and NSCLC for BioMAb EGFR (Nimotuzumab). The open label, multi-centric study includes induction and maintenance therapy in combination with radiotherapy with Temozolomide (concomitant & adjuvant) in Indian patients with Glioblastoma Multiformeis is on at eight investigational sites in India.

The third open-label, randomized, comparative, multi-centric study is being initiated at 11 sites in India with Nimotuzumab in combination with Chemotherapy versus Chemotherapy alone in the treatment of patients with Stage IIIB / IV Non Small Cell Lung Cancer (NSCLC). This study will enable our Oncotherapeutics division to expand its market share through label extensions, stated Kiran Mazumdar-Shaw, chairman and managing director, Biocon.

The alliances for tech-transfer have been carried out with Cuban Institute CIMAB in monoclonal antibodies (MAbs) and cancer vaccines. The partnership and minority stake with the Baltimore-based IATRICa Inc will allow co-development of an exclusive new class of immunoconjugates for targeted immunotherapy of cancers and infectious diseases. The collaboration with Vaccinex Inc is for development of fully-humanized antibodies focused on cancer, inflammation and autoimmune diseases.

In addition the company also has a licensing agreement with Bentley Pharmaceuticals, Inc for its intranasal spray formulation for insulin administration.

Biocon has many molecules in licensing stage which will be released as and when the market is open for the product. Going by the current global financial scenario, the bio-pharma sector is highly risk prone. However, the company is insulated to face the crisis because of its sound business model across the value chain built over the last three decades, said Shaw.