India First Strategy Could Speed Up Data For FDA-EU Approvals
by Joshua Berlin
PharmAsia News
MUMBAI – Pharmaceutical companies may be able to take advantage of the relative speed to market in India to commercialize products earlier and obtain postmarketing data that could bolster drug approval applications filed later in the U.S. and Europe, according to Biocon Founder and Chairman Kiran Mazumdar-Shaw.
Speaking in Mumbai Nov. 19 during the Drug Information Association conference on Drug Discovery and Clinical Development in India, Mazumdar-Shaw noted that on average patient recruitment for clinical trials is roughly 75 percent faster in India than in the U.S. or Europe. This means that companies may advance compounds more quickly through clinical trials and reach the market first in India, she noted.
In an interview with PharmAsia News following her presentation, Mazumdar-Shaw predicted that companies like Biocon could accumulate roughly two years of postmarketing data in India prior to regulatory filing in the U.S. or Europe, where submissions would need to wait until completion of Western trials. The India postmarketing data could then be included as part of the product dossier, allowing companies to demonstrate real-world outcomes to Western regulators in an era of heightened concern about drug safety, she pointed out.
In addition, Mazumdar-Shaw told meeting attendees that the lower costs of clinical trials in India – which average roughly 30 percent to 50 percent less than in the U.S. or Europe – provide companies a strategic opportunity to study parallel indications for oncologics and other compounds in a cost-effective manner.
“What India brings to the table is the fact that failure is affordable” in drug development, she said. Drug R&D “is about making sure that you take big risks, but that they are not so expensive so you can afford to pay them and go on. This is really a true opportunity that India provides for R&D.”
Biocon has established itself as one of India's leading biopharmaceutical companies. In India, Biocon launched the first recombinant human insulin, Insugen in November 2004. The firm also markets BIOMAB-EGFR, a biologic to treat head and neck cancers, which launched in India in 2006.
In September, Biocon released positive Phase I results for its novel oral insulin product IN-105 during the European Association for Study of Diabetes meeting in Amsterdam. Biocon has completed all of the clinical development for the molecule at its headquarters in Bangalore, India. It recently received approval to begin Phase I trials in Switzerland, as well.
Biocon has several partnerships with multinational companies, including a preclinical deal signed earlier this year with Bristol-Myers Squibb focusing on medicinal chemistry, biology and drug metabolism (PharmAsia News, March 15, 2007).
Biocon also has rights to market breast cancer drug Abraxane (paclitaxel albumin-bound particles for injectable suspension) in India, Pakistan, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. The oncologic is scheduled to launch next year in India after receiving regulatory approval in October.
PharmAsia News is a regular contributor to BioHealth Investor
_________________
PharmAsia News
MUMBAI – Pharmaceutical companies may be able to take advantage of the relative speed to market in India to commercialize products earlier and obtain postmarketing data that could bolster drug approval applications filed later in the U.S. and Europe, according to Biocon Founder and Chairman Kiran Mazumdar-Shaw.
Speaking in Mumbai Nov. 19 during the Drug Information Association conference on Drug Discovery and Clinical Development in India, Mazumdar-Shaw noted that on average patient recruitment for clinical trials is roughly 75 percent faster in India than in the U.S. or Europe. This means that companies may advance compounds more quickly through clinical trials and reach the market first in India, she noted.
In an interview with PharmAsia News following her presentation, Mazumdar-Shaw predicted that companies like Biocon could accumulate roughly two years of postmarketing data in India prior to regulatory filing in the U.S. or Europe, where submissions would need to wait until completion of Western trials. The India postmarketing data could then be included as part of the product dossier, allowing companies to demonstrate real-world outcomes to Western regulators in an era of heightened concern about drug safety, she pointed out.
In addition, Mazumdar-Shaw told meeting attendees that the lower costs of clinical trials in India – which average roughly 30 percent to 50 percent less than in the U.S. or Europe – provide companies a strategic opportunity to study parallel indications for oncologics and other compounds in a cost-effective manner.
“What India brings to the table is the fact that failure is affordable” in drug development, she said. Drug R&D “is about making sure that you take big risks, but that they are not so expensive so you can afford to pay them and go on. This is really a true opportunity that India provides for R&D.”
Biocon has established itself as one of India's leading biopharmaceutical companies. In India, Biocon launched the first recombinant human insulin, Insugen in November 2004. The firm also markets BIOMAB-EGFR, a biologic to treat head and neck cancers, which launched in India in 2006.
In September, Biocon released positive Phase I results for its novel oral insulin product IN-105 during the European Association for Study of Diabetes meeting in Amsterdam. Biocon has completed all of the clinical development for the molecule at its headquarters in Bangalore, India. It recently received approval to begin Phase I trials in Switzerland, as well.
Biocon has several partnerships with multinational companies, including a preclinical deal signed earlier this year with Bristol-Myers Squibb focusing on medicinal chemistry, biology and drug metabolism (PharmAsia News, March 15, 2007).
Biocon also has rights to market breast cancer drug Abraxane (paclitaxel albumin-bound particles for injectable suspension) in India, Pakistan, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. The oncologic is scheduled to launch next year in India after receiving regulatory approval in October.
PharmAsia News is a regular contributor to BioHealth Investor
_________________
posted by Nico at
8:20 PM
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