April 2008 - Mumbai: An agreement was signed between the Mumbai-based CRO, Vedic Lifesciences and Amarex, LLC, a clinical research organization headquartered at Germantown, MD, USA, early this year to collaborate on Clinical Development and Regulatory Affairs services for botanical drugs in the U.S. and India.

Kazem Kazempour, President & CEO, Amarex Clinical Research LLC was upbeat about the collaboration potential and offered: “Amarex’s focus on Phase 1 through Phase 4 clinical development is nicely complemented by Vedic’s pre-clinical development services and their focus on botanical compounds.” Mukesh Kumar head of Safety and
Regulatory Affairs at Amarex added: “Amarex’s growing involvement with botanical drug development is a good fit with Vedic’s special expertise with such compounds.

It is clear that having an Asian partner will provide certain advantages to our clients’ drug development needs.” Jayesh Chaudhary, Director & CEO, Vedic Lifesciences Pvt Ltd added, “Having completed over 2 dozen studies for compounds in recent years, Vedic has carved out a special niche in the Nutraceutical and Phytomedicine space. New regulations (year 2003) from FDA on Botanical Drugs give us an expanded opportunity in the U.S. market, and the agreement with Amarex greatly enhances Vedic’s access to the U.S. market and elsewhere outside Asia."

As per a recent report by McKinsey, the Indian clinical research industry is slated to reach a market size of $1.5B by the year 2010. Reliable estimates for Botanical Drug research are not readily available, however, since establishment of the 2003 regulations, there have been over 270 IND filings with FDA for Botanical Drug Products, which is already resulting in significant new expenditures on research services.

Contacts: http://www.amarexcro.com / http://www.vediclifesciences.com