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Biocon Announces Positive Efficacy Data with its Novel Monoclonal Antibody Itolizumab in a Pivotal Psoriasis Study...
January 09, 2012
Bengaluru, India /San Francisco, USA: January 9, 2012:

Biocon, Asia's premier biotechnology Company today, announced positive results from its Double Blind, Placebo Controlled, Phase 3, TREAT-PLAQ Study with Itolizumab in chronic plaque psoriasis. Itolizumab, the first humanized anti CD-6 monoclonal antibody, successfully met the pre-specified primary endpoint of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo. It also met multiple secondary endpoints after 12 and 28 weeks of treatment.

This 52 week study conducted in India, had a 12 week placebo controlled phase, 16 week consolidation and 24 week randomized withdrawal phase. It enrolled over 200 patients across placebo and two active treatment regimens. In this 28 week interim analysis, both treatment regimens were statistically significantly better than placebo with the fixed dose regimen of 1.6 mg/kg every two weeks for 12 weeks followed by 1.6 mg/kg every 4 weeks for 16 weeks demonstrating response rate of 36% (p<0.0043) at Week 12 and 46% at Week 28. The response rates for patients with PASI> 20 at baseline was 43% and 54% at Week 12 and 28 respectively. The molecule also exhibited an excellent safety and tolerability profile with very low rates of infection (~10%) in active treatment arms suggesting a favorable risk benefit profile compared to currently available biologic treatments. Biocon plans on presenting the safety and efficacy data from the entire 52 week study at an upcoming scientific meeting.

Expressing her excitement at the outcome of the study Ms. Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon said, "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. We look forward to taking this molecule to the market across multiple indications with a global partner to ensure that affordable innovation reaches patients worldwide in a timely manner." "We strongly believe in this molecule and are pleased with the results from the TREAT-PLAQ study. The low opportunistic infection rate despite the study being conducted in India validates the preclinical findings and along with novel mechanism of action opens new treatment paradigms for treatment of psoriasis and other autoimmune diseases. We are looking forward to accelerating clinical development in other autoimmune conditions like MS (Multiple Sclerosis) and RA (Rheumatoid Arthritis)" said Abhijit Barve, M.D., Ph.D., President Research and Development, Biocon. "We would like to sincerely thank all the patients and their families, investigators and colleagues at Biocon, Clinigene and other partners for their participation in this complex study"

About Itolizumab

Itolizumab is a 'first-in-class' investigational humanized IgG1 monoclonal antibody that selectively targets CD6 cells. CD 6 is a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation. In addition to TREAT-PLAQ study, two positive Phase 2a dose finding studies have been conducted one each in RA and psoriasis. A total of about 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.

About Biocon Limited

Established in 1978, Biocon Limited (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India's largest biotechnology Company by revenue. The Group, promoted by Ms. Kiran Mazumdar-Shaw, is a fully-integrated, innovation-driven healthcare enterprise with strategic focus on biopharmaceuticals and research services. Biocon's value chain traverses the entire length of discovery, development and commercialization of novel therapeutics. Biocon's robust product offering includes the world's first Pichia-based recombinant Human Insulin, INSUGEN(R) and India's first indigenously produced monoclonal antibody BIOMAb-EGFR(TM)

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