Biocon's Kiran Mazumdar-Shaw has been one of the leaders in India attempting to build a biotech community capable of developing drugs for worldwide markets. Now the company has a test case on its hands. After gaining an approval in India for the homegrown psoriasis drug Alzumab, Mazumdar-Shaw has set out to find a pharma partner capable of pulling off the clinical trials needed for U.S. and European approvals.
The anti-inflammatory antibody, also known as itolizumab, was approved in the sub-continent based on data from a Phase III clinical trial with only 200 patients. And Mazumdar-Shaw has been touting it to Bloomberg as a likely competitor to some mega-blockbuster competition like Humira, Enbrel and Stelara.
"We have such long remission rates, compared to all the other drugs," Mazumdar-Shaw gushed to the business news wire. "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." And she noted that the antibody has even bigger potential in rheumatoid arthritis.
But Biocon, like the rest of the Indian biotech community, has found it tough to land--and keep--Big Pharma partners. Bristol-Myers Squibb ($BMY) picked up an option on its oral insulin program last fall. But deals have been hard to come by, with Pfizer ($PFE) dropping a partnership on insulin biosimilars in 2012. The company reportedly landed the psoriasis drug 10 years ago from a Cuban investigator, leaving plenty of time for Biocon to strike a deal before now. And analysts want to see a big name on the dotted line before they buy the company line.
"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," IDFC Securities' Nitin Agarwal told a credulous Bloomberg. "That would be the litmus test of whether this product is going to succeed globally."
- here's the feature from Bloomberg
Kiran Mazumdar-Shaw - The 25 most influential people in biopharma today -2012 | Kiran Mazumdar-Shaw - Women in Biotech 2011