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Intarcia and Numab Announce Achievement of Key Research and Development Milestones

Intarcia and Numab Announce Achievement of Key Research and Development Milestones

  • Numab’s antibody fragment leads achieve all predetermined success criteria and have been successfully formulated in Intarcia’s proprietary formulation technology.
  • R&D progress opening up new potential once or twice-yearly therapies and combo regimens beyond ITCA 650 – the late stage therapy for type 2 diabetes
  • Intarcia is progressing multiple Numab antibody-fragment based therapies and proprietary peptide-based therapies and combinations in Diabetes, Obesity and Auto-Immune Diseases

Boston, MA, and Wädenswil, Switzerland, June 2, 2016 – Intarcia Therapeutics, Inc., and Numab AG, today announced the achievement of several key milestones in the development of a multi-specific antibody targeting inflammatory / autoimmune diseases. This is an important step towards realizing the potential of combining Numab’s antibody-based therapeutics with Intarcia’s unique delivery and formulation technologies.

Numab applied its novel discovery and optimization platform to identify two highly potent, highly selective antibody fragment based leads. The chemical and biological profiles of the lead molecules have met or exceeded all of the success criteria that were established upon the initiation of the licensing collaboration early last year.

David Urech Ph.D., CSO and co-CEO of Numab AG, commented: “Achievement of this milestone for Intarcia further confirms the power of Numab’s discovery platform to produce next-generation antibody-based therapeutics, as well as our commitment to exceed expectations with our strategic partners.”

In addition, Intarcia has successfully formulated multiple lead molecules produced by Numab. Results confirm the robust stability of the Numab molecules, demonstrate the versatility of the Intarcia formulation technology, and are a testimony to the powerful synergies of the companies’ respective technology platforms.

Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics, said: “Our Numab collaboration continues to progress with cutting-edge science and technologies capable of delivering important new medicines and combinations in our therapeutic areas of focus. The progress brings us one step closer to delivering very promising and important new once or twice-yearly medicines in large and serious chronic diseases where we are uniquely positioned to address unmet needs.”

About Numab
Founded in 2011, Numab discovers and develops innovative antibody-based therapeutics. Applying proprietary rabbit-based antibody discovery and engineering technology, Numab generates highly potent and stable antibody-based molecules that serve as building blocks to create multi-specific antibody-based therapeutics with tailored pharmacokinetic properties. Numab’s therapeutic antibodies are designed to improve on existing therapies in terms of effect size, effect duration and safety. For further information, visit www.numab.com.

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 continuous and consistent manner via Intarcia's proprietary technology platform. Intarcia has successfully completed its FREEDOM Phase 3-stage development program for type 2 diabetes, which consisted of four separate clinical trials. 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.

About ITCA 650
ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s proprietary technology platform, 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 peptides above human body temperature for extended periods of time. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. When approved, ITCA 650 will be the first injection-free GLP-1 therapy that can deliver up to a full year of treatment from a single placement of the osmotic mini-pump. ITCA 650 is currently being evaluated in the FREEDOM global Phase 3 clinical trial program. All four FREEDOM trials have been successfully completed. FREEDOM-2 demonstrated head-to-head superiority in glucose control after 52 weeks over the market-leading oral therapy, Januvia® (sitagliptin). The fourth and last of the FREEDOM clinical trials, the FREEDOM-CVO trial, began close-out procedures in 4Q15 after reaching the target number of major cardiovascular events. The FREEDOM-CVO trial now has met its primary and secondary endpoints and succeeded in delivering the clinical results necessary for regulatory filings.

Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.

 

INVESTOR CONTACT

Intarcia Therapeutics, Inc.
James Ahlers
james.ahlers@intarcia.com
(510) 782-7800

MEDIA CONTACTS

Intarcia Therapeutics, Inc.
Paulina Bucko
paulina.bucko@intarcia.com
(857) 880-1442

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