Intarcia Therapeutics and French pharmaceutical research company Servier have established a $1 billion strategic partnership for the development of ITCA 650 outside the United States and Japan. The drug is Intarcia’s phase 3 investigational therapy for the treatment of type 2 diabetes, and is expected to become the first injection-free GLP-1 agonist in the world, to be administrated only once or twice a year.
The two companies will now join forces to enhance the development of the therapeutic, which is administered through a small, matchstick sized mini-pump placed sub-dermally, making it a major advancement in the treatment of type 2 diabetes if it successfully passes the remaining phase 3 trials. ITCA 650 can be inserted into a patient by a qualified physician, nurse, or physician’s assistant in a simple, fast procedure.
The partnership agreement stipulates that Intarcia will receive more than $1 billion in an upfront payment, regulatory and sales milestone payments, and tiered sales-related payments from worldwide revenues, excluding the U.S. and Japan. Both of the companies will contribute to future global investments associated with the development of the life cycle management of the ITCA 650, which includes new head-to-head superiority research to evaluate it against leading diabetes medications and planned novel combination regimens.
“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 the chairman, president and CEO of Intarcia Therapeutics, Kurt Graves. “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.”
The phase 3 clinical trial program for the technology, called FREEDOM, is expected to result in the filing of global submissions in the first half of 2016, and will continue to be conducted by Intarcia. The company will also manage the registration of the treatment in the United States. Servier will be in charge of seeking regulatory approvals in other countries, as the company believes that “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,” according to Isabelle Tupinon-Mathieu, head of the Metabolism Innovative Center at Servier.
“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,” said Pascal Touchon, vice president of business development and collaboration at Servier. “We will collaborate closely with Intarcia, with whom we share a common vision and urgency to bring such benefits to patients with diabetes.”
The purpose of the investigational therapy is to offer continuous and consistent drug treatment through the ongoing subcutaneous delivery of exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist currently recommended globally for diabetes in the form of self-injection twice a day or once a week, depending on the prescription. The company believes that, in addition to the reduction of medication regularity, using the osmotic pump may improve the treatment by maintaining therapeutic protein and peptide stability at normal body temperatures for a sustained period of time.
“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,” added Graves. “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 has recently presented the primary endpoint of two of its four phase 3 trials to assess the medication, which have revealed positive outcomes. In addition, “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,” explained the investigator Robert Henry, M.D. “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,” added Henry, who also serves as professor of Medicine, in Residence, UC San Diego and Chief, Diabetes & Metabolism VA San Diego Healthcare System.