Category Archives: Psoriasis

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BANGALORE: Indian biotech major Biocon has announced that it has received marketing authorization from the Drugs Controller General of India (DCGI) for its novel biologic Itolizumab used for the treatment of psoriasis.

This is the second novel biologic, a medicinal preparation created by a biological process, developed by Biocon at its research and development unit in Bangalore. Biocon's first biologic to enter the market was BioMab EGFR, used in the treatment of cancer.

The company said Itolizumab is a first in class therapy for the treatment of moderate-to-severe psoriasis and has an excellent safety profile as indicated during the 52-week phase III multi-centric clinical study that was conducted in India.

Biocon will market the novel biologic under the name Alzumab in India, during the latter half of 2013. Alzumab will be manufactured and formulated as an infusion drug at Biocon's manufacturing facility at Biocon Park in Bangalore.

Psoriasis is a socially debilitating disease affecting 2% to 3 % of the Indian population. Global estimates suggest that the treatment of psoriasis will have a market value of $8 billion by 2016.

Commenting on the regulatory approval, Kiran Mazumdar-Shaw, CMD, Biocon, said, "This approval paves the way for us to extend clinical development for other indications like rheumatoid arthritis, multiple sclerosis and vitiligo." The biologic Itolizumab has shown promising pre-clinical and clinical efficacy in other auto-immune diseases like rheumatoid arthritis and multiple sclerosis, Biocon said.

Shaw added, "We also intend to file a US IND (Investigational New Drug) filing shortly to enable us to embark on a global clinical development plan. This is a defining moment for Biocon as it reaches a significant milestone in its mission of delivering affordable innovation to patients worldwide."

Biocon plans to develop Itolizumab with a global partner for various markets across the world.

Excerpt from:
Biocon's Itolizumab drug for psoriasis gets DCGI approval

Biocon gets nod to sell psoriasis drug in India This approval paves the way for the launch of Biocon?s Alzumab in India, later during 2013 Raghuvir Badrinath / Bangalore Jan 08, 2013, 10:38 IST

Biocon, the publicly held biotechnology company, on Tuesday announced that it has received marketing authorisation from the Drugs Controller General of India (DCGI) for Novel Biologic Itolizumab, an anti CD6 molecule, for the treatment of chronic plaque Psoriasis.

Itolizumab is a first in class therapy with a unique Mechanism of Action (MOA) and has an excellent safety profile as indicated during the 52 week Phase III multi-centric clinical study conducted in India.

This approval paves the way for the launch of Biocons Alzumab in India, later during 2013. Alzumab is a differentiated biologic drug with a better safety profile compared to other approved biologic therapies given its low opportunistic infection rates.

A novel biologic indicated for the treatment of Moderate-to-Severe Psoriasis, Alzumab will be marketed by Biocons Immunotherapy Division.

Alzumab, will be manufactured and formulated as an infusion drug at Biocons Biopharma manufacturing facility at Biocon Park, Bangalore.

Commenting on this development, Kiran Mazumdar-Shaw, CMD, Biocon, said, We are excited to receive this marketing authorisation for Itolizumab from DCGI which will enable Biocon to introduce this novel, first in class biologic for the treatment of psoriasis patients in India. This is our Second novel biologic that we have developed in India, BioMab EGFR, an anti-cancer monoclonal antibody, being the first."

"This approval paves the way for us to extend clinical development for other indications like Rheumatoid Arthritis (RA), Multiple Sclerosis (MS) and Vitiligo. We also intend to file a US IND shortly to enable us to embark on a global clinical development plan. This is a defining moment for Biocon as it reaches a significant milestone in its mission of delivering affordable innovation to patients worldwide, she added.

Alzumab is expected to provide a safe and effective treatment option for Psoriasis, a socially debilitating disease affecting 2-3% of Indian population.

The global market size for Psoriasis is estimated to cross $8 bn by 2016.

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Biocon gets nod to sell psoriasis drug in India

Biocon gets nod to market psoriasis drug in India Drugs Controller General allows marketing of Bangalore-developed Itolizumab BS Reporter / Bangalore Jan 09, 2013, 00:53 IST

Publicly-held biotechnology major Biocon announced on Tuesday that it has received marketing authorisation from the Drugs Controller General of India ( DCGI) for its novel biologic Itolizumab, anti CD6 molecule, for the treatment of chronic plaque psoriasis.

Itolizumab is a first-in-class therapy and the second novel biologic developed by Biocon at Asias largest biotech hub in Bangalore.

Commenting on this development, Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said, This is our second novel biologic that we have developed in India, BioMab EGFR, an anti-cancer monoclonal antibody, being the first. This approval paves the way for us to extend clinical development for other indications like rheumatoid arthritis, multiple sclerosis and vitiligo.

She added that the company will file an IND (investigational new drug) in the US shortly to embark on a global clinical development plan. She termed the approval for Itolizumab a defining moment for Biocon.

Alzumab is expected to provide a safe and effective treatment option for psoriasis, a socially debilitating disease affecting two-three per cent of Indias population. The global psoriasis market size is estimated to cross $8 billion by 2016.

Biocons share price dropped 2.3 per cent on the National Stock Exchange to close at Rs 294.70 per share on Tuesday.

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Biocon gets nod to market psoriasis drug in India

BOUDRY, Switzerland--(BUSINESS WIRE)--

Celgene International Srl, a subsidiary of Celgene Corporation (CELG), today announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving apremilast 30 mg BID monotherapy in both the ESTEEM 1 & 2 phase III studies. ESTEEM 1 & 2 are the two pivotal phase III, randomized, placebo-controlled studies evaluating apremilast, the companys oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with moderate to severe chronic plaque psoriasis.

Patients on apremilast also achieved a statistically significant benefit over placebo in the major secondary endpoint, Static Physician Global Assessment (sPGA).

Psoriasis is a common immune-mediated skin disease affecting nearly 125 million people worldwide, said Kim Papp, M.D., Ph.D. of Probity Medical Research, Canada. Despite advances in treatment over the last decade, a significant proportion of moderate to severe psoriasis patients remain inadequately treated. The primary reason for psoriasis patients not receiving adequate therapy is the burden associated with available treatment options. As a consequence, there is a high unmet medical need for an efficacious, safe, oral option that patients can take long-term.

An NDA submission for psoriasis, based on ESTEEM 1 & 2 data, is expected in the second half of 2013. The company previously announced it expects to file an NDA for psoriatic arthritis (PsA) in the first quarter of 2013 and a combined MAA for psoriasis and psoriatic arthritis in Europe in the second half of the year.

The Phase III safety and tolerability data are improved over previously observed phase II psoriasis data and consistent with results from the phase III psoriatic arthritis trials. The overall psoriasis safety database includes nearly 2,000 patients to date. ESTEEM 1 & 2 are ongoing trials. Subjects are being evaluated for safety and efficacy in the long-term extension studies for up to an additional four years. Approximately one-third of the study population was treatment-nave and two-thirds had prior exposure to either systemic and/or phototherapy; approximately one-third of the overall study population had prior biologic therapy.

To date, the five positive phase III studies from the ESTEEM and PALACE programs represent the most comprehensive clinical data for submission for patients with psoriatic disease. Clinical data from ESTEEM 1 & 2 are planned for presentation at upcoming major medical meetings.

About ESTEEM 1 & 2

ESTEEM 1 & 2 are two pivotal phase III randomized, placebo-controlled study evaluating apremilast in subjects with a diagnosis of moderate to severe chronic plaque psoriasis for at least 12 months prior to the screening, and at baseline, and who are also a candidate for phototherapy and/or systemic therapy. Approximately 1,250 patients were randomized 2:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks, followed by a maintenance phase from weeks 16-32 in which placebo subjects were switched to apremilast 30 mg BID through week 32, and a randomized withdrawal phase for responders from Week 32-Week 52 based on their initial randomization and PASI response.

About Apremilast

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Apremilast ESTEEM Program Meets Primary and Major Secondary Endpoint in Pivotal Phase III Psoriasis Trials

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