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DISCOVERY PIPELINE
PHARMACEUTICALS
Small molecule pharmaceuticals play an important role in Biocon’s R&D programs. We are leveraging our expertise in fermentation and chemical synthesis to improve manufacturing productivity for existing products and introduce new generics into our pipeline. Under development are several generics for the anti-infective, oncology and immunosuppressive domains. Additionally, we are looking to advance our expertise in API
manufacture to develop value-added capabilities in dosage formulation.
BIOSIMILAR PROGRAMS
Numerous innovative Biotherapeutics have started to go off patent and are facing the introduction of a wave of similar biological medicinal products, known as biosimilars. In the face of escalating healthcare costs, biosimilars represent a tremendous opportunity to provide cost-effective drugs. However, the molecular complexity of biotechnology-derived products requires a high level of quality control over manufacturing of the active substance and the finished product, as well as clinical safety and efficacy data for registration and evaluation.
Biocon has in progress, several biosimilar programs that are of strategic importance not only to our future but also that of affordable medicine. Our R&D is in a unique position to capitalise on the biosimilar opportunity due to the investments we have made in developing a high level of expertise in characterisation and process validation. We are confi dent that we have in place the technical skills and regulatory knowledge to overcome the challenge of getting biosimilars such as Insulin approved for key markets of the US and EU.
DISCOVERY MOLECULES
Our most significant R&D thrust during the year 2006-2007 has been to develop discovery molecules. Our focus on novel biologics, primarily Monoclonal Antibodies (MAbs) have resulted in a robust and rapidly advancing pipeline. Biocon’s most exciting programs include the development of Oral Insulin (IN -105) in the treatment of diabetes mellitus and a new MAb (T1h) targeted against CD6 in the treatment of rheumatoid arthritis. Other programs that are expected to enter preclinical development later this year are BVX-10 (a novel human anti - TNF/), BVX-20 (a novel human anti- CD20) and oral BNP – (BN-054).
IN -105 (Oral Insulin)
Subcutaneous Insulin is very effective in the treatment of diabetes but its prescription is generally delayed due to inconvenience of needle usage and potential hypoglycemia (caused by excess insulinisation). In contrast, Oral Insulin (ie. Insulin in tablet form) is simple and painless to administer. Additionally, it is delivered through the portal vein, mimicking the natural physiology of the body. If successful in the clinic, Oral Insulin could become a very important therapy for intervention in earlier stages of diabetes.
Biocon is developing IN -105, a conjugated Insulin molecule that is orally delivered and targeted towards the treatment of diabetes. During the last year, we have made significant progress along its development lifecycle. Biocon’s R&D group has successfully developed a tablet for oral delivery of IN -105, its formulation carefully selected to give consistent absorption and glucodynamic (glucose-lowering) effect. In the clinic, this molecule has completed Phase I trials and is expected to enter Phase II in India later this year. The encouraging results of the Phase Ia and Ib studies represent a vital hurdle crossed in the development of IN -105 as a product. IN -105 will enter Phase I trials in Europe towards the end of next year.
Anti-CD6 (T1h)
Rheumatoid Arthritis (RA) is a chronic, inflammatory, systemic disease in which the immune system attacks the joints and causes its destruction. RA also impacts multiple systems in the body, including the heart, skin, blood vessels and lungs.
The introduction of biologics that target the signaling molecules and different cell types in the immune system has significantly advanced the treatment of RA. While joint damage is hard to reverse, the inflammatory conditions that are present during RA have been greatly reduced, causing an improvement in patient quality of life.
T1h is a novel humanised Monoclonal Antibody that blocks the activity of CD6, a specific antigen found on the surface of an important cell type in the immune system, T cells. T1h suppresses T cell proliferation in vitro and is expected to modify the course of arthritic disease in the clinic by modulating T cell behaviour.
Biocon’s T1h has completed a Phase I study in patients with RA. The product was found to be safe and well tolerated. A Phase II dose-range finding study, designed to evaluate the safety and efficacy of T1h in patients with severe RA, is expected to start in 2007.
BVX -10Another promising target for therapeutic intervention in RA is the Tumor Necrosis Factor Alpha TNFa, a cytokine that has multiple biologic actions, including mediation of inflammatory responses and modulation of the immune system. There is evidence that TNFa plays a central role in autoimmune and inflammatory diseases, contributing to the progression of both inflammation and joint destruction.
Biocon’s BVX -10 is a novel human Monoclonal Antibody directed against TNFa. It was developed in collaboration with our partner Vaccinex, a biotechnology company in Rochester NY, using their unique and proprietary ActivMab platform technology. Phase I trials are expected to start in Q1 2009.
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