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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 confident 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 2007-2008 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 program that is expected to enter preclinical development later this year is BVX-20 (a novel human anti- CD20).
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 and initial dose-range-finding Phase II trials. Data from the Phase II study was presented at EASD, Rome in September, 2008. Phase III long term HbA1c lowering studies in type 2 DM subjects are being initiated in Q1, 2009.
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. Two Phase II clinical trials have been started one in RA and one in Psoriasis in India and are expected to be completed in 2009.
BVX-20
Non-Hodgkin's Lymphoma (NHL) is the most common cancer of the lymphoid organs. Its incidence in western countries varies from 6 to 16/100,000 and in the EU specifically, an approximate 50,000 new cases are diagnosed each year. Biocon’s BVX-20 is a novel human Monoclonal Antibody that binds to CD20, a protein located on both normal and malignant B-cells. After binding, BVX -20 kills B-cells by recruiting the body’s own immune system. BVX-20 is intended for use in the treatment of patients with relapsed or chemotherapy resistant follicular B-cell NHL and CD20 positive diffuse large B-cell NHL in combination with chemotherapy. This Monoclonal Antibody was also developed in collaboration with Vaccinex using their ActivMab technology. Proof of concept has been shown in animal studies and the molecule is expected to start clinical trials in 2009.
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