Ranbaxy Laboratories Limited (Ranbaxy) has launched a New Chemical Entity (NCE), Lulifin (Luliconazole), in the Indian dermatology market. This follows a strategic in-licensing agreement with Summit Pharmaceuticals International Corporation, Japan (SPI) allowing Ranbaxy, exclusive marketing rights, for India. The introduction of this NCE, significantly strengthens Ranbaxy’s presence in the Dermatological segment.
Commenting on the development, Sanjeev Dani, senior vice president & regional director – Asia, CIS & Africa, Ranbaxy, said, “It is well recognized that in the post patent era, licensing would be the key strategy to bring New Chemical Entities to India. Dermatology is one of the top priority therapeutic areas for us and we are pleased to introduce Lulifin in the Indian market. We would be manufacturing the product in India under licence from SPI, Japan.”
Luliconazole was discovered by Nihon Nohyaku Co Ltd (Nihon Nohyaku) and was approved and launched in Japan in 2005. Based on SPI’s licensing know-how and strong network abroad, SPI in-licensed the rights for luliconazole in certain territories from Nihon Nohyaku, to expand its reach in overseas markets. In India, SPI has entered into a licensing agreement with Ranbaxy to market the product exclusively.
Lulifin is a topical imidazole and is indicated for Cutaneous mycoses caused by Tinea pedis, Tinea corporis, Tinea cruris. Currently, topical imidazoles and allylamines are used for the treatment of Cutaneous mycoses with disadvantages like long duration of therapy, which leads to poor compliance and a high relapse rate. Clinical trials conducted by Nihon Nohyaku with Pola Chemical Industries, Inc. (currently Pola Pharma Inc Tokyo), in Japan and by Ranbaxy, in India, confirm the at par efficacy with other topical imidazoles but with the added advantage of shorter therapy duration and once a day application. This greatly improves patient compliance with significantly better outcomes.
Ranbaxy already has a strong presence in the Dermatology market with products such as Zole-F, Minoz, Suncros, Fucidin and Teczine, among others.
SPI is a 100 per cent daughter subsidiary company of Sumitomo Corporation (SC) and is an integrated service company specializing in the area of pharmaceutical research and development. SPI has a good track record in activities such as, exclusive agent of ATCC (the world’s largest gene/cell bank for research) of the USA, support of discovery research through distribution/sales of compound libraries for HTS (High Throughput Screening – high-speed technology for early drug candidate compounds selection in discovery research), supply of starting materials, intermediates and bulk drug substances for pharmaceuticals, and intermediation/consultation services in license/co-research arrangements of promising drugs/diagnostics/technologies originating from domestic and foreign bio-ventures, pharmaceutical companies, universities and institutes.
Nihon Nohyaku Co Ltd is an agrochemical company listed on the Tokyo Stock exchange and has been working to revolutionize technology in its core area of business involving manufacture and sale of safe and superior agrochemicals. Furthermore, working from the basis of agrochemical research, development and manufacturing, Nihon Nohyaku have been expanding the business in fields such as chemical products, pharmaceuticals, animal health products, and organic intermediates.