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印度百康(Biocon)推出全球首个CD6单抗药Alzumab

来源:生物谷 2013-08-13 17:45

2013年8月13日讯 /生物谷BIOON/ --亚洲最大的生物技术公司—印度百康(Biocon)8月10日宣布,在印度推出首创新药(first in class)Alzumab(Itolizumab),这是全球首个抗CD6单克隆抗体,用于治疗慢性斑块型银屑病(chronic plaque psoriasis)。

银屑病(Psoriasis)俗称牛皮癣,是一种常见的慢性炎症性皮肤病,属于多基因遗传的疾病,多种激发因素(如创伤、感染、药物等)均可能在易感个体中诱发该病。全球银屑病市场在2016年的规模将超过80亿美元。

T细胞已被发现在自身免疫性疾病中发挥着主导作用,而CD6是一种泛T细胞标记物,涉及T细胞的共刺激、粘附、成熟。越来越多的研究数据显示,除了Th1细胞,Th17细胞在自身免疫性疾病中也发挥了关键作用。目前,Biocon公司是开发生物制剂靶向Th17细胞通路竞赛中的领跑者。

其他生物制剂,如细胞因子抑制剂,通过作用于前炎症(pro-inflammatory)级联反应的下游发挥作用,Alzumab则作用于上游,抑制细胞因子的合成,从而降低感染率并取得较长的缓解期。

Alzumab通过结合CD6,下调T细胞的激活,导致促炎性细胞因子合成的减少,同时通过减少T细胞在炎症部位的浸润,来发挥重要的作用。

Alzumab具有的这种独特作用机制(MOA),与现有其他疗法相比,提供了卓越的安全性和相似的疗效属性,具有一个长期的缓解期,以及非常低的机会感染率(opportunistic infection rate)。

Alzumab已在临床前/临床试验中表现出治疗其他自身免疫性疾病的证据,如类风湿性关节炎、银屑病关节炎、多发性硬化症等。(生物谷Bioon.com)

英文原文:Biocon Launches ALZUMAb(TM)- a 'First in Class' Novel Biologic Treatment for Psoriasis Patients in India...

August 10, 2013

- ALZUMAb(TM) 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(TM) (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

Biocon, Asia's premier biotechnology company, today announced the launch of its 'first in class' novel biologic ALZUMAb(TM)(Itolizumab), the world's first anti-CD6 monoclonal antibody to be introduced for treating patients with chronic plaque psoriasis, in India.

ALZUMA(TM) with a unique Mechanism of Action (MOA) offers superior safety and similar efficacy profile compared to other existing therapies, and has a long remission period with very low opportunistic infection rate. Psoriasis is a socially debilitating disease affecting 2-3 % of world population. The global Psoriasis market size is estimated to cross $8 bn by 2016.

Commenting on this development Ms. Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon said, "Biocon's ALZUMAb(TM) (Itolizumab) is the first anti-CD6 monoclonal antibody to be commercialized, an outcome of path breaking research in India .This new line of treatment will usher in a paradigm shift in the management of psoriasis. We are proud that this will be the first instance of a breakthrough innovation from India with a potential to treat multiple autoimmune diseases and making a difference to a much larger patient population across the world."

Mr. Rakesh Bamzai President-Marketing, Biocon said: "Biocon is committed to address the huge unmet need of patients suffering from Psoriasis through its 'first in class' biologic ALZUMAb(TM) Compared to existing therapies, ALZUMAb(TM) offers a better safety and efficacy profile to the patients with longer remission periods and lower infection rates that will lead to better patient compliance and overall reduction in the cost burden to the patient."

Indicated for the treatment of Moderate-to-Severe Psoriasis, ALZUMAb(TM) is being introduced in India by Biocon's Immunotherapy Division. Formulated as an infusion drug it is manufactured at Biocon's Biopharma manufacturing facility at Biocon Park, Asia's largest biotech hub in Bangalore.

Biocon: Front runner in introducing a biologic based on TH 17 pathway

ALZUMAb(TM)is the world's first anti-CD6 biologic addressing the Th 17 pathway that has completed its 'Lab to Market' journey. Emerging data shows that in addition to Th 1, Th17 cells, play a critical role in autoimmune diseases, and Biocon is a front-runner in the race to develop biologics targeting the Th17 pathway with ALZUMAb(TM)(Itolizumab).

This differentiated MOA positions Itolizumab as a potentially 'best-in-class' treatment for psoriasis, and other autoimmune diseases.

Itolizumab: A high potential biologic for a range of autoimmune diseases

ALZUMA(TM) is an outcome of breakthrough innovation at Biocon which has the potential to transform the treatment options for several autoimmune diseases besides psoriasis like rheumatoid arthritis, multiple sclerosis and others. It is potentially a pipeline within a product.

Its launch in India for psoriasis is the first milestone on a promising and exciting journey towards new treatment options for life-changing autoimmune diseases. Biocon is committed to taking ALZUMA(TM) (Itolizumab) from India to patients worldwide with a global partner.

Notes to the Editor:

ALZUMAb(TM) (Itolizumab) Unique MOA

ALZUMAb(TM) (Itolizumab) is the world's 'first-in-class' humanized anti-CD6 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.

ALZUMA(TM) (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. 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.

Clinical Development

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 ALZUMAb(TM) (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

About Biocon Limited

Established in 1978, Biocon Limited, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India's largest and Asia's leading biotechnology company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide. Biocon's robust product portfolio includes the world's first Pichia-based recombinant human Insulin, INSUGEN(R), Glargine, BASALOG(R) and India's first biologic BioMAb-EGFR(TM) for head and neck cancer. It has now successfully developed its second novel biologic Itolizumab, a 'first in class' anti-CD6 monoclonal antibody, introduced as ALZUMAb(TM) for psoriasis in India, in 2013.

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