Ranbaxy Laboratories Limited and GSK have submitted a joint investigational new drug (IND) application for respiratory inflammation candidate to the Drug Controller General of India for permission to initiate Phase-I human clinical trials.
Earlier this year, GlaxoSmithKline approved further development of the respiratory drug by Ranbaxy under a research and development collaboration pact between the two companies, signed in April 2007. The two companies are collaborating on two research programmes - one in chronic obstructive pulmonary disease (COPD) and the other in anti-infectives. (See: Ranbaxy-GSK alliance to develop respiratory drug)
Chronic obstructive pulmonary disease (COPD), which encompasses both chronic bronchitis and emphysema, is one of the commonest respiratory disorders of adults in the developed world.
A committee of senior members from GSKs Center of Excellence for External Drug Discovery (CEEDD) and Ranbaxy's New Drug Discovery Research (NDDR) team had last year identified the compound to advance into preclinical investigation.
Dr Pradip Bhatnagar, senior vice president, New Drug Discovery Research (NDDR), Ranbaxy, said, "The long-standing collaboration between GSK's CEEDD and Ranbaxy has been the key for this success."
Ranbaxy plans to seek regulatory approval in other countries outside India in order to initiate Phase-I human clinical trials, after it has successfully completed the necessary regulatory safety and toxicity studies on the drug candidate in India.
As per the multi-year R&D collaboration agreement, Ranbaxy will be conducting Phase I and Phase II clinical studies through Proof of Concept while GSK will have the option to conduct further development through final registration and commercialisation.
Ranbaxy expects to receive over $100 million in potential milestone payments for the product developed by Ranbaxy and subsequently launched by GSK in multiple indications. It expects a double-digit royalty on worldwide net sales.
The GSK-Ranbaxy R&D collaboration was initiated in 2003, and further expanded in February 2007. The new milestone payments and royalties will be per the revised agreement and will also apply to this current development program and to future discovery programmes.
In July 2007 the two companies reached an agreement to settle their dispute over a US patent covering GSK's herpes pill Valtrex (valacyclovir hydrochloride tablets), under which Ranbaxy will introduce its generic copies of Valtrex in the US in the latter part of 2009 and will have 180 days of exclusivity to sell the product there, highlighting a trend where top multinational patent holders have started collaborating with their generic rivals, while simultaneously competing in the same markets.(See: Ranbaxy, GSK to settle valacyclovir patent case in US)
Even as the two clashed over certain drugs, they continued their collaboration in other areas and three months before settling the Valtrex dispute, in April 2007, Ranbaxy and GSK agreed to join hands on their anti-inflammatory drug research programme, under which Ranbaxy would also be responsible for conducting Phase I and Phase II clinical studies, while GSK would have the option to conduct further development through to final commercialisation.
In January this year, Ranbaxy Laboratories Ltd announced the settlement of "all matters relating to possible patent litigation with GlaxoSmithKline relating to Sumatriptan Succinate tablets", the generic version of GlaxoSmithKline's Imitrex tablets. The terms of the settlement, allowed Ranbaxy to distribute a generic version of Sumatriptan Succinate tablets in the 25mg, 50mg and 100mg strengths in the United States with an expected launch date in December 2008. (See: Ranbaxy announces settlement of possible Imitrex litigation with Glaxosmithkline)
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 also has a joint venture in the field of product development is Merck & Co., Inc, which was signed in May this year, for a drug discovery and clinical development collaboration for new products, in the anti-infective field.(See: Ranbaxy to develop new drugs for Merck & Co) While Merck will identify the drug leads, potential molecules that can be developed into new drugs, Ranbaxy will develop the drug to the stage of human trials, with the right to co-commercialise the products in India in addition to royalties and milestone payments over product sales.