GSK lets exclusivity period on TPR100 expire
agreement with UK sexual health specialist Futura Health for its
transdermal pain relief product, TPR100.
Prior to its decision, GSK was in talks with Futura regarding a potential development and distribution deal for TPR100. However, while these discussions are continuing, the exclusivity period covering them expired at the end of March. Futura said that it will seek additional non-exclusive partners to develop TPR100. Last summer, GSK handed back development rights to Futura's erectile dysfunction treatment candidate, MED2002 following the expiration of a similar exclusivity arrangement. At the time, GSK cited a change in strategic priorities as the reason for its decision. MED2002 contains the nitric oxide generating prodrug glyceryl trinitrate that has been used to treat angina for over a century. The product is now being developed in partnership with SSL International, the UK-headquartered multinational consumer products group that owns the Durex and Scholl brands. Phase I trial extended TPR100 is being developed as a topical non-prescription agent for the treatment of muscular and joint pain for potential application in the osteoarthritis and sports injury markets. The drug uses the solvent gel-based DermaSys delivery technology that Futura originally developed in conjunction with MED2002. In addition to its plans to look for more partners, Futura announced that Phase I clinical studies of TPR100 had been extended. The firm said that this was to enable the completion of work on certain aspects of formulation development and optimization. Among industry observers the general response to the delay was that, while unfortunate, it is not disastrous for Futura. Collins Stewart analyst Navid Malik commented that: "it's a little bit disappointing that [Futura] haven't managed to finish the work and get something concluded but I think it should be seen as a positive that GSK is still there on a non-exclusive basis." Malik went on to suggest that GSK may still choose to exercise its licensing option when the extended study is completed, depending on the data which emerges. Meanwhile, analysts at Edison Investment Research said that Futura is in a strong position with TPR100. They suggested that the drug has considerable market potential, particularly because of the perceived limitations of currently available transdermal pain medications and the well documented GI problems associated with the long-term use of oral non-steroidal anti-inflammatory agents. Edison also cited last year's $302m deal for US rights to a similar transdermal pain product, Diractin, between Germany's Idea AG and Alpharma, as further indication of the demand for such products.