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Intarcia and Servier sign ex-U.S. partnership for ITCA 650 in diabetes; Intarcia retains independence & full control of the U.S. & Japan12/11/2014
- Intarcia upfront and potential milestone payments total more than $1B; Includes $401M near-term with an upfront payment of $171M and three early stage regulatory milestones of $230M; with $650M in additional development, regulatory and sales milestones.
- Intarcia will receive tiered net sales-related payments with commercial success ranging from the low double digits to the mid-30s as a percentage of sales of product supplied through the manufacturing and supply agreement. Both parties will co-invest in an additional manufacturing site outside the U.S.
- Both parties will share global development costs on new superiority studies and combination regimens planned and agreed upon. Servier will wholly fund any territory-specific trials required for marketing approvals.
BOSTON, MA, November 12, 2014 – Intarcia Therapeutics, Inc. today announced the successful start of a strategic partnership with Servier outside the United States and Japan, to develop and commercialize ITCA 650, Intarcia’s phase 3 investigational therapy for the treatment of type 2 diabetes. If successful in its remaining phase 3 trials, ITCA 650 would 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. A qualified physician, nurse or physician’s assistant can place ITCA 650 in a simple five-minute procedure in a doctor’s office. Under the agreement, Intarcia is to receive an upfront payment and total potential development, regulatory and sales milestone payments totaling more than $1 billion. Intarcia will also receive ex-U.S./Japan tiered sales-related payments. The parties will also share future global development-related investments for the life cycle management of ITCA 650, including new head-to-head superiority studies against leading diabetes medications, as well as planned novel combination regimens. Intarcia will continue to lead the global ITCA 650 phase 3 pivotal trials, which are on track to support global filings in the first half of 2016. Intarcia also will continue its lead role in the potential registration of ITCA 650 in the U.S., while Servier will seek regulatory approvals outside the U.S. and Japan, with the support of Intarcia.
"As one of the largest ex-U.S. partnering deals ever in the biotechnology industry, our collaboration with Servier is yet another major milestone in a series of significant achievements over the last few years that are truly transformational for Intarcia and our stakeholders,” stated Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics. “We are already the highest valued private biotech company in history with world-class investors, and now we are firmly set up to retain full control of the U.S. operations as we continue on our path to build a fully capable and disruptively innovative biotech company with a pipeline of game changing, once-yearly medicines. We are very pleased to partner with Servier, who shares our passion and vision for ITCA 650, and the goal of leveraging our technologies to open up a totally new way of delivering important GLP-1 therapy to patients with type 2 diabetes. Truly disruptive technologies and products tend to come from smaller, faster, more flexible, and more innovative companies not tied to the business models of the largest pharmaceutical firms. Servier brings a unique combination of financial strength, deep diabetes expertise with no competitive conflicts, and a track record of innovation and excellent performance in the EU and emerging markets. We placed high value on those factors and their partnering mindset when we made our final decision to select Servier over other major diabetes firms competing for months to be our partner.”
Intarcia recently announced top-line results showing positive primary endpoints from two of its four phase 3 clinical trials. “With continued success in the remaining phase 3 trials, and additional outcomes studies planned to start next year, ITCA 650 represents the promise of a very important and totally novel therapeutic approach for patients with type 2 diabetes. ITCA 650 phase 3 data show the potential to provide robust glucose reductions and weight loss together with potentially game-changing compliance and adherence that comes with just once- or twice-yearly dosing. Thus, ITCA 650 holds the potential to deliver the intended GLP-1 benefits earlier in therapy where injections don’t typically get used, while also addressing the poor compliance and adherence rates that all too often lead to poor control and treatment outcomes over time,” said Robert Henry, M.D., Professor of Medicine, in Residence, UC San Diego and Chief, Diabetes & Metabolism VA San Diego Healthcare System.
Dr. Isabelle Tupinon-Mathieu, Head of the Metabolism Innovative Center at Servier, stressed: “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.” Pascal Touchon, Vice President Business Development and Scientific Collaboration at Servier added: “This strategic partnership shows our commitment to bring innovative therapies to people with type 2 diabetes in most countries around the world where Servier has a strong presence and where we demonstrate our extensive know-how and experience in this field. We will collaborate closely with Intarcia, with whom we share a common vision and urgency to bring such benefits to patients with diabetes.”
About ITCA 650
ITCA 650 (a once or twice-yearly continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s proprietary technology platform involving a matchstick-size, miniature osmotic pump that is placed sub-dermally to provide continuous and consistent drug therapy, and the company’s proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver up to a full year of treatment from a single placement. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM.
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. In addition, delivering medicines just once or twice yearly has the potential to ensure improved patient adherence and compliance, which is very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a constant and consistent manner via Intarcia's proprietary technology platform. Intarcia is conducting a phase 3-stage development program for type 2 diabetes that consists of four separate clinical trials, two of which have been completed. Intarcia continues to conduct research and development, utilizing its platform technology, to treat other chronic serious disorders in the field of diabetes and obesity. For more information on the Company, please visit www.intarcia.com.
Founded in 1954, Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular, metabolic, neurologic, psychiatric, bone and joint diseases as well as cancer. In 2013, the company recorded a turnover of 4.2 billion euros. Ninety-one percent (91%) of Servier drugs are consumed outside France. Twenty-seven percent (27%) of turnover from Servier drugs were reinvested in Research and Development in 2013. With a strong international presence in 140 countries, Servier employs more than 21,000 people worldwide. More information is available at: www.servier.com
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. Wholepoint Communications
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