Biocon Ltd. (BIOS), India’s largest publicly traded biotechnology company, is in talks with U.S. drugmakers to co-develop and sell a psoriasis treatment that may rival Johnson & Johnson’s Stelara.
Managing Director Kiran Mazumdar-Shaw, 60, is seeking a partner to help with expertise and funding for the tests needed for approval in the U.S., she said in an interview. Biocon plans to file for permission in the year ending March to sell in the North American nation, and aims to start marketing Alzumab in that country two to three years later, she said.
Alzumab would provide a novel therapy for a plaque-causing form of the immune disorder that would compete with best-selling products from Johnson & Johnson, AbbVie Inc. and Pfizer Inc. (PFE) The biologic psoriasis treatment, made from living cells, will help Biocon enter a market that it estimates will be valued at $8 billion by 2016.
“The proof of the pudding is if they’re able to license it out to a major pharma company; if they can find someone to foot the cost of global trials,” said Nitin Agarwal, an analyst at IDFC Securities Ltd. in Mumbai, who has a buy rating on the stock. “That would be the litmus test of whether this product is going to succeed globally.”
The molecule, licensed by Biocon in 2003 from a Cuban researcher, was approved for use in moderate to severe plaque psoriasis after mid- and late-stage trials in India, the company said in a statement in January.
Treatments for the disorder include injected medicines such as Amgen Inc. and Pfizer’s Enbrel, AbbVie’s Humira and Johnson & Johnson’s Stelara. (JNJ) Together, the three medicines, which may also treat other autoimmune diseases, had a total of more than $14 billion in sales last year.
Analysts estimate sales of Johnson & Johnson’s best-selling Remicade, which is also used to treat diseases such as rheumatoid arthritis and ulcerative colitis, as well as psoriasis, will increase to $6.4 billion this year.
If Alzumab is “approved for the other indications like rheumatoid arthritis, that would be significant,” said Ajaykumar Sharma, associate director of health care practice at Frost & Sullivan in Mumbai. “It would be a much bigger market.”
Psoriasis is a chronic skin disease of scaling and inflammation that affects more than 5 million, or 3 percent, of adult American, though children are afflicted as well, according to the National Institutes of Health.
It occurs when cells rise from their origin below the surface of the skin and amass on the surface before they have matured. Normal turnover of skin cells takes about a month, though can occur in only a few days in people with psoriasis, resulting in patches of thick, inflamed skin covered with silvery scales.
Alzumab is in a new class of treatment based on a humanized monoclonal antibody that selectively targets the CD6 type of white blood cell to reduce inflammation. Monoclonal antibodies are made in the lab to mimic natural substances that stimulate a patient’s immune system to attack disease-causing cells.
Biocon’s drug, also known as itolizumab, yielded statistically significant improvement after 12 weeks of treatment in a study of more than 200 patients, Biocon reported last year.
“There are some studies that show Alzumab is better than the other biologics, but more trials need to be done, with a wider group of people around the world, to show its full impact,” said Umashankar Nagaraju, consultant dermatologist at Apollo Hospitals in Bangalore.
Biologic treatments for psoriasis can lower a body’s ability to fight infection, Mazumdar-Shaw said. Johnson & Johnson’s website for Remicade warns that some patients have had serious infections caused by viruses, fungi and bacteria that have spread throughout their bodies, including tuberculosis.
Biocon’s Alzumab exhibited an “excellent safety and tolerability profile with very low rates of infection,” the company said in a statement in January 2012. That suggests “a favorable risk benefit profile compared to currently available biologic treatments.”
The Indian drugmaker plans to seek approval this year with the U.S. Food and Drug Administration to conduct further tests investigating the drug’s safety and efficacy in treating psoriasis and other immune disorders, such as rheumatoid arthritis, Mazumdar-Shaw said.
“We have such long remission rates, compared to all the other drugs,” Mazumdar-Shaw, who started Biocon in 1978, said in an interview in Bangalore last week. “We don’t even have relapse in many of the patients. After 24 weeks, we’re still not seeing relapse for a large percentage. That’s why we’re excited, that’s why this is a crown jewel for us.”
Alzumab is the second-most advanced novel molecule in Biocon’s pipeline of drugs in development, according to an investor presentation. The leader is nimotuzumab, a cancer drug.
“They’ve created an interesting pipeline,” said IDFC’s Agarwal. “Now it’s about the last mile, whether they are able to commercialize this pipeline. That would affect the rerating of the stock. People are waiting to see what happens.”
Biocon’s shares have dropped 0.5 percent this year, compared with a 10.7 percent increase in the S&P BSE Healthcare index. The company’s stock rose 2.4 percent to 285.30 rupees in Mumbai, the most since April 11.
Sales in the U.S. will also help boost revenue, which expanded 6.9 percent to 6.3 billion rupees ($112 million) in the three months ended March 31, the slowest pace in a year.
Rapid commercialization of Alzumab “will be transformational for us,” Mazumdar-Shaw said.
A U.S.-based partner will help Biocon plan and design clinical trials in the U.S., where patient studies are often of a longer duration and more expensive to conduct that in India, and assist with the drug’s marketing and promotion, she said.
A partnership with Pfizer to sell insulin made by Biocon under the Univia and Glarvia brands ended last year after “individual priorities” on copied biologics changed. Mazumdar-Shaw forecasts the planned venture to sell Alzumab will be different.
“We’ve got all the safety, efficacy, immunogenicity” data, Mazumdar-Shaw, who trained as a brewmaster, said. “All we need to do now is to identify how we’re going to do the trial in the U.S. and what is the shortest trial you can do to get it into the market.”
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