Biocon Launches Psoriasis Drug In India; To File IND Application With US FDA This Fiscal

 
on August 10 2013 1:07 PM
Kiran Mazumdar-Shaw
India's Biocon on Saturday launched ALZUMAb, a novel biologic for the treatment of psoriasis, in India. Sreeja/IB Times

Bangalore, India-based Biocon (NSE:BIOCON) announced Saturday the launch of its first biologic drug for the treatment of chronic psoriasis in India, and said it would file an investigational new drug, or IND, application with the U.S. Food and Drug Administration, or FDA, by the end of this fiscal year.

The drug, Alzumab, is the second biologic -- a medicine created through a biological process and not through a chemical process -- launched by the company, and is expected to serve about 1 percent to 2 percent of India's population estimated to suffer from the ailment.

“Alzumab is a path-breaking novel biologic and offers high efficacy and safety profile with lower infection rates compared to similar biologics used in the treatment of psoriasis,” said Kiran Mazumdar-Shaw, Biocon's chairperson and managing director, at a press conference.

Psoriasis, an auto-immune disease, also affects an estimated 2 percent to 3 percent of populations in the U.S. and Europe, and the global psoriasis drug market is expected to exceed $8 billion by 2016.

Biocon, which spends 10 percent of its revenues on research and development, is in talks with various companies for finalizing a partnership to take the product to global markets, including the U.S., over the next few years. Biocon earned almost 20 billion rupees (about $330 million) in annual revenues in the last fiscal year.

“We have short-listed a few companies for partnering in the launch of Alzumab in the U.S. We will be filing for IND application by this fiscal,” Rakesh Bamzai, president of marketing at Biocon, told International Business Times on the sidelines of the press conference.

Alzumab functions by acting earlier in the inflammation process unlike other biologic drugs, resulting in longer remission periods and lower rates of infection.

Alzumab is the "the world’s first anti-CD6 antibody drug" for treating psoriasis and it has been tested to produce a long remission period ranging from 25-28 weeks, compared to other existing therapies which have a remission period of five-15 weeks, according to Mazumdar-Shaw.

A longer remission period is crucial as it can reduce long-term medication costs. A 24-week course, with bi-weekly injections could cost anywhere between $3,000 to $5,000 in India. The company also said it would consider a "compassionate-pricing policy" for patients from low-income groups.

The prescription drug is priced at 7,950 rupees ($131) for each vial, making it 50 percent cheaper than existing biologics that are sold in the same class, Mazumdar-Shaw said.

The three-phase clinical trial for Alzumab was conducted among 400 patients in India, making it one of the largest drug trials in the country. 

According to Mazumdar-Shaw, the drug could be used in treating other auto-immune diseases such as rheumatoid arthritis, psoriatic arthritis and multiple sclerosis. And, the first phase of clinical trials for the treatment of rheumatoid arthritis has been completed, she added.

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