Servier in licensing deal potentially worth more than $1 billion for Intarcia's implantable GLP-1 agonist

Servier entered a licensing deal potentially worth more than $1 billion for rights outside the US and Japan to Intarcia Therapeutics' investigational therapy ITCA 650 for the treatment of type 2 diabetes, the companies announced Wednesday. Tupinon-Mathieu, head of Servier's Metabolism Innovative Center, remarked "this disruptive injection-free GLP1 could reshape the treatment of type 2 diabetes in the very near future and corresponds to our objectives for patient care in metabolic diseases."

ITCA 650, which is currently in late-stage development, employs Intarcia’s technology platform involving a matchstick-size, miniature osmotic pump that is placed sub-dermally to provide continuous and consistent delivery of exenatide for up to a year. The therapy also uses Intarcia’s formulation technology designed to maintain stability of therapeutic proteins and peptides at human body temperatures for extended periods of time. According to the drugmakers, if approved, ITCA 650 could become "the world’s first and only injection-free GLP-1 agonist given just once or twice yearly in a small, matchstick sized mini-pump placed sub-dermally."

Last month, Intarcia reported top-line results showing positive primary endpoints from two of its four Phase III trials of ITCA 650. Intarcia said that it will continue to lead the global Phase III studies, which are on track to support global filings for ITCA 650 in the first half of 2016. Under the agreement, Servier and Intarcia will share future global development-related investments for the lifecycle management of ITCA 650, including head-to-head superiority studies against other drugs, as well as planned combination regimens.

The companies noted that Servier will make an upfront payment of $171 million to Intarcia, with the latter eligible to receive early regulatory milestones of $230 million, as well as $650 million in additional development, regulatory and sales milestones. Intarcia, which retains full control of ITCA 650 in the US and will seek a partner in Japan, also stands to receive tiered net sales-related payments ranging from the low double digits to the mid-30s as a percentage of sales of product supplied through a manufacturing and supply agreement. In addition, the drugmakers will co-invest in an additional manufacturing site outside the US.

Exenatide is currently marketed by AstraZeneca as Byetta and Bydureon, which are injected twice-daily and once-weekly, respectively, for patients with type 2 diabetes. "When we talk to patients...there is a huge burden of the treatment for them on their daily lives," commented Pascal Touchon, Servier’s vice president of scientific cooperation and business development. Touchon noted that the company’s investment reflects its belief "about how important the innovation will be for patients and how large the potential might be if the innovation reaches patients."

According to Intarcia CEO Kurt Graves, the deal with Servier was the result of a six-month process that involved talks with 11 drugmakers. Graves said that Servier was a good fit, in part, because "they’re the one party that was happy to leave us in full control of the US." Servier previously signed diabetes-focused deals with Intercept Pharmaceuticals, related to the development of TGR5 agonists, and Celladon for the discovery and development of SERCA2b modulators.

For related analysis on the GLP-1 class of medicines, read ViewPoints: Sanofi touts oral GLP-1 opportunity, but competition from Novo Nordisk will be difficult to overcome, and for more information on the diabetes market, see Diabetes -- KOL Insight and Consensus Outlook.

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