Active Development 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.
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.
Inflammatory autoimmune diseases like Psoriasis, Rheumatoid Arthritis (RA) and Multiple Sclerosis (MS) 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 is a natural target for immunomodulation.
T1h suppresses T cell proliferation in vitro. Two clinical trials completed by Biocon, in Psoriasis and Rheumatoid Arthritis patients has clearly established the role of CD6 in these diseases and targeting CD6 with T1h is causing significant improvement in symptoms in these diseases. T1h was safe and well tolerated. A Phase III efficacy clinical trial in Psoriasis was initiated in May 2010.
The positive results from the Phase 3, TREAT-PLAQ Study with Itolizumab for chronic plaque psoriasis, were declared in early 2012. Successfully met the pre-specified primary endpoint and multiple secondary endpoints after 12 and 28 weeks of treatment;
Itolizumab represents a significant advancement in the treatment of psoriasis and potentially other autoimmune diseases with an excellent risk-benefit profile. This could possibly become the first novel biologic developed and approved from India and is an important milestone for Biocon in its pursuit of affordable innovation.
Biocon has recently received marketing authorization from the Drugs Controller General of India (DCGI) for its novel biologic Itolizumab used for the treatment of psoriasis. It is on track to introduce this product as Alzumab™ in India later in FY14. This will become Second Novel Biologic from Biocon to be introduced for the Indian patients.
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 humanized Monoclonal Antibody that binds to CD20, a protein located on both normal and malignant B-cells. After binding, BVX -20 is targeted to kill 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. Proof of concept has been shown in animal studies and GLPtox studies in relevant animal models is complete. This molecule has entered phase I of Clinical development.
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.