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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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Insulin Tregopil

An oral insulin has long been considered the “Holy Grail” for treating diabetes. Biocon is developing Insulin Tregopil - a conjugated insulin molecule that is orally delivered and targeted towards liver which is a central organ in glucose metabolism. Insulin Tregopil thus provides a novel opportunity for effective postprandial control of glucose metabolism through the physiological route of the portal system.

Orally administered, a short while prior to meals, Insulin Tregopil is rapidly absorbed and reaches the liver within minutes through the normal physiologic route, the portal vein. The absorption of Insulin Tregopil is over within 60 to 90 minutes so that clinically significant postprandial hypoglycemia is negligible. Insulin Tregopil provides insulin treatment that primarily targets the liver without causing excessive peripheral hyperinsulinemia and this simulates normal insulin action. The two major complications of current insulin treatments, hypoglycemia and weight gain, could be potentially minimized by treatment with Insulin Tregopil. In addition, because it can be used in early diabetes, this approach holds the potential to protect beta cells and may thereby delay disease progression.

We believe Insulin Tregopil has the potential to effect a paradigm shift in the treatment of Diabetes Mellitus (DM).

Itolizumab- Novel anti-CD6 MAb

Itolizumab 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.

Itolizumab was approved by the Drugs Controller General of India for treatment of Psoriasis in India in 2013. Biocon launched Itolizumab as ALZUMAb for the treatment of psoriasis in India. It is the Second Novel Biologic from Biocon to be introduced for Indian patients.

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.

SiRNA - based Therapeutics
Biocon in collaboration with Quark Pharma, one of the leaders in small interfering RNA (siRNA) therapeutics, is developing novel assets for rare indications of ophthalmology and organ transplant based on the siRNA platform. These molecules could change the treatment paradigm for such orphan indications.

ADXS-HPV - Novel Cancer Immunotherapy
Biocon is co-developing ADXS-HPV with Advaxis Inc., a leader in developing the next generation of cancer immunotherapies. ADXS-HPV is a novel cancer immunotherapy for the treatment of human papillomavirus (HPV)-associated cervical cancer in women. This asset has tremendous potential in treating HPV-associated cervical cancer, a devastating disease seen primarily in developing countries.

Fusion Proteins Program
Biocon has an in-house program for developing a differentiated class of Fusion Antibody platform in Immuno-Oncology.

Anti-CD 20
Biocon has an in-house program for developing an oncology asset that is currently in Phase I of development.

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