Ranbaxy Laboratories Limited has submitted an Investigational New Drug (IND) application to the Drug Controller General of India for permission to initiate phase-I human clinical trials.
The IND application is for the respiratory inflammation candidate that the joint GSK-Ranbaxy steering committee had identified earlier last year. Ranbaxy has successfully completed all the required regulatory safety and toxicity studies on the drug candidate and also plans to seek regulatory approval in other countries outside India in order to initiate phase-I human clinical trials at the earliest.
Dr Pradip Bhatnagar, senior vice president, New Drug Discovery Research (NDDR), Ranbaxy, said, “The long-standing vibrant collaboration between GSKs CEEDD and Ranbaxy has been the key for this success. This achievement also reflects the discovery and development capabilities of Ranbaxy’s R&D team.”
As per the multi-year R&D collaboration agreement, Ranbaxy will be responsible for conducting phase-I and phase-II clinical studies through Proof of Concept. GSK will then have the option to conduct further development through final registration and commercialization.
Ranbaxy could receive over $100 million in potential milestone payments for a product developed by Ranbaxy and subsequently launched by GSK in multiple indications and up to double digit royalties on worldwide net sales.
This is yet another major landmark in the GSK-Ranbaxy R&D collaboration, initiated in 2003, and further expanded in February 2007. The new milestone payments and royalties, as enumerated in the revised agreement, will apply to this current development programme and to future discovery programmes.
The Ranbaxy-GSK alliance envisages strong research workflow to emanate from a wide range of therapeutic areas of interest to Ranbaxy and GSK, including anti-infectives, respiratory, and oncology.
Ranbaxy Laboratories Limited, has continued to focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The company’s foray into Novel Drug Delivery Systems has led to proprietary ‘platform technologies’, resulting in a number of products under development. The company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.