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Active Discovery Programs

- Novel Molecules

Bringing path breaking proprietary products to global markets is Biocon’s long cherished objective. As drug development becomes an expensive, high risk endeavor, we are leveraging our robust R&D engine to deliver affordable innovation. Biocon’s global competitive edge rests on its high quality talent, process innovation, and high value licensable research assets.

Our Novel Molecules business capitalizes on in house expertise along the drug value chain to develop innovative therapies that address unmet medical needs in oncology, immunotherapy and diabetes.

Our promising pipeline has proprietary and partnered programs which are an outcome of cutting edge research that constantly pushes the boundaries of science.

We are pursuing several assets in diabetes, oncology and autoimmune diseases with enormous potential through development, licensing and commercialization.

To realize the full potential of our key advanced R&D assets, we plan to unlock value by taking our most promising novel molecules to proof-of-concept, before exploring global partnerships.

Novel Assets Under Clinical Development
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IN-105 (Oral Insulin)

Oral Insulin has long been considered the “holy grail” for treating diabetes. We believe our oral prandial insulin (IN-105) has the potential to effect a paradigm shift in the treatment of Diabetes Mellitus (DM). While subcutaneous Insulin is very effective in the treatment of diabetes, its prescription is generally delayed due to inconvenience of needle usage and potential hypoglycemia (caused by excess insulinisation). In contrast, Oral Insulin is simple, painless and 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 Millions of patients suffering from Diabetes Mellitus (DM) worldwide.

Biocon is developing IN-105 – a conjugated insulin molecule that is orally delivered and targeted towards liver which is a central organ in glucose metabolism. Biocon has successfully developed and scaled up the carefully selected formulation to give a consistent absorption from the GI tract. As a result, IN-105 shows predictable Pharmacokinetic and Pharmacodynamic profiles. Currently Biocon is engaged in further clinical development of this molecule for global markets with help from Bristol-Myers Squibb, its partner for this program. Bristol-Myer Squibb will have an exclusive option to further develop and commercialize IN-105, pending outcome of these clinical trials.

Anti-CD6 (T1h)

ALZUMAb is the World's first novel anti-CD6 antibody developed by Biocon to address a large unmet need for the treatment of Psoriasis in India

- Excellent safety and efficacy profile with very low opportunistic   infection rates and longer remission period

- Offers a new treatment option for Psoriasis with a less   aggressive dosing regimen and a longer treatment free period,   ensuring better patient compliance and convenience

- Is an innovative affordable treatment option with a promise to   offer a better quality of life for the patient

- Will provide an effective biologic treatment solution to 1-2% of   Indian population suffering from Psoriasis

- ALZUMAb (Itolizumab) has demonstrated preclinical   and/clinical evidence in treating other autoimmune diseases   like rheumatoid arthritis, psoriatic arthritis and multiple   sclerosis.

- Biocon is committed to offering this novel anti-CD6 biologic   from India to patients across the globe

Inflammatory autoimmune diseases like Psoriasis, Rheumatoid Arthritis  and Multiple Sclerosis require therapeutic intervention to modulate the immune system and alleviate disease symptoms. Autoimmune diseases are chronic in nature and patients require life long treatment. T-Cells found in the immune system which cause these diseases are a natural target for immunomodulation.

Itolizumab is the world’s 'first-in-class' humanized anti-CD6 monoclonal antibody (MAb) that has a unique mechanism of action (MOA) targeting the CD6 pathway. CD6 is a pan T-Cell marker involved in co-stimulation, adhesion and maturation of T-Cells, which have been found to play a leading role in autoimmune diseases. Itolizumab, by binding to CD6, down regulates T-Cell activation, causes reduction in synthesis of proinflammatory cytokines and possibly plays an important role by reducing T-Cell infiltration at sites of inflammation.

Emerging data shows that in addition to Th1, Th17 cells play a critical role in autoimmune diseases. Itolizumab is the world’s first anti-CD6 biologic addressing the Th17 pathway that has completed its 'Lab to Market' journey, making Biocon a front-runner in the race to develop biologics targeting the Th17 pathway.

Unlike other biologics like cytokine inhibitors which act downstream in the pro-inflammatory cascade, Itolizumab acts upstream inhibiting the formation of cytokines, resulting in lower infection rates and longer remission periods.

In addition to the Phase 3 TREAT-PLAQ study, two positive Phase 2a dose finding studies have been conducted one each in rheumatoid arthritis and psoriasis. A total of over 300 patients have been treated with Itolizumab, of these, about 100 patients have received the drug for 52 weeks with encouraging safety and tolerability profile. Itolizumab was approved by Drugs Controller General of India for treatment of Psoriasis in India in 2013.

Biocon has launched Itolizumab as ALZUMAbfor the treatment of psoriasis in India. It is the Second Novel Biologic from Biocon to be introduced for Indian patients.

MAb Fusion Protein Program

Biocon is also working on developing monoclonal antibody fusion proteins for oncology indications. This project is aimed at developing therapies that target multiple tumor types.

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