Merck & Co has decided not to carry on paying for the development of its late-stage psoriasis drug tildrakizumab, choosing instead to license the treatment to Sun Pharmaceutical Industries.
Under terms of the agreement, the Indian drugmaker will acquire worldwide rights to tildrakizumab in exchange for an upfront payment of $80 million. Merck will continue all clinical development and regulatory activities, which will be funded by Sun, which will then be responsible for subsequent submissions, pharmacovigilance, post-approval studies, manufacturing and commercialisation.
Merck is eligible to receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties. The move is part of an initiative to “sharpen our commercial and R&D focus”, said Iain Dukes, head of business development and licensing at Merck Research Laboratories.
Tildrakizumab not a priority
He added that the initiative includes “prioritising our late-stage pipeline candidates” and the company feels Sun will help “realise the potential of tildrakizumab for patients with chronic plaque psoriasis”. Kirti Ganorkar, head of business development at Sun, added that “this collaboration is a part of our strategy towards building our pipeline of innovative dermatology products in a market with strong growth potential.”
Tildrakizumab, which is in Phase III for psoriasis, has shown efficacy in blocking inflammation by blocking IL-23. Other potential indications, which may be evaluated in future, include psoriatic arthritis and Crohn’s disease.
The late-stage products that Merck is prioritising include the osteoporosis drug odanacatib. Earlier this week, data from the eagerly-anticipated 16,700-patient LOFT outcomes study was presented which showed that the once-weekly pill significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo.
Although the rate of major adverse cardiovascular events was similar in the two arms, a numerically higher incidence of strokes was seen in the odanacatib group, although it was not deemed statistically significant. Also those on the Merck drug suffered more atypical femoral fractures and morphea-like skin lesions though the latter problem was resolved or improved after treatment was stopped.
Merck had initially planned to seek regulatory approval in the first half of 2013 but delayed filing until 2014. That has been put back again to 2015.
Omarigliptin comparable to Januvia
Meantime at the European Association for the Study of Diabetes meeting in Vienna, Merck presented Phase III data in a study involving Japanese patients which showed its once-weekly DPP-4 inhibitor omarigliptin was comparable to to its once-daily blockbuster Januvia (sitagliptin) for efficacy and tolerability.
The company plans to file omarigliptin, which also significantly reduced HbA1c levels compared to placebo in Japan by the end of the year, noting that its development programme for the drug involves ten Phase III trials and 8,000 patients.