Memorandum

J&J Animas partners with JDRF to bring first-generation artificial pancreas to market – January 13, 2010

Executive Highlights

  • The JDRF is partnering with J&J’s Animas to co-develop a first-generation artificial pancreas.
  • The partially automated system will include an Animas insulin pump possessing a sophisticated computer-processing unit that will communicate wirelessly with a CGM sensor by DexCom – creating a “hyperglycemic/hypoglycemic minimizer” systemThe system will be designed to reduce the time spent in severe hyperglycemia and hypoglycemia by automatically slowing down or shutting down the insulin pump when glucose drops towards hypoglycemic levels and automatically re-starting the pump and increasing insulin infusion if necessary when it approaches hyperglycemic levels; patients will still need to make insulin-dosing decisions in complex situations such as mealtime.
  • The partnership is hoping to submit a market-ready system, supported by clinical safety and efficacy trials, to the FDA within four years.

The JDRF and Johnson and Johnson’s Animas have announced they will partner to develop a commercial-grade first-generation artificial pancreas. The objectives of the partnership are to develop the automated sensor-algorithm-insulin pump system, conduct clinical safety and efficacy trials, and to submit a market-ready product to the FDA for approval. The FDA has designated the artificial pancreas as one of its “critical path” initiatives, signaling the eager anticipation of this technology. In addition to the years of research conducted by the JDRF allowing this endeavor to be feasible, the JDRF is contributing $8 million in funding to the project, which is designed to culminate in the creation of a partially automated system composed of an insulin pump (to be designed by Animas) that wirelessly communicates with a CGM sensor (supplied by DexCom), and a computer system (within the pump) designed to regulate basic insulin dosing based on CGM output and control algorithms in development. We imagine Animas’ investment is several times larger, all in, but these terms were not disclosed.

  • The goal of this first generation artificial pancreas will be to reduce many of the safety concerns of severe hypoglycemia and hyperglycemia, especially at nighttime. The computer processor will be designed to slow down or shut off the insulin pump if the CGM suggests impending hypoglycemia and will restart insulin therapy if a threshold blood glucose level or pre-set delay is reached. Additionally, the automated processor will be designed to increase insulin delivery if the CGM indicates severe hyperglycemia and to automatically return to preset basal rates once glucose levels fall appropriately. In this first iteration, patients will still have to control their insulin dosing “manually” for both standard and complex situations, such as meals, correction doses, etc. The partnership is aiming to have a system ready for the FDA to review within the next four years. We believe this partnership will prompt faster innovation throughout industry; some of the features of this system remind us of Medtronic’s low-glucose suspend sensor-integrated pump the Paradigm Veo, which is not available in the US at this time.
  • While it is tempting to think of this technology as just the next natural incremental step towards a fully automated system, there is no question the system in development itself will go well beyond the current technology -- the leap from one-way communication between pump and CGM to two-way communication and some automated decision making is monumental. Such a system will be a “game-changer” in the diabetes world, despite the distant twinkle in our eyes of a fully automated artificial pancreas. We think this is incredibly exciting news and believe such a device could be revolutionary for both adults and children with type 1 diabetes.
  • Finally, the press release notes explicitly that JDRF’s goal is to have multiple versions of an artificial pancreas available for people with diabetes, with multiple industry leaders. We believe the “JDRF halo” will serve the industry well and that with JDRF set to support FDA submissions, we believe the agency will be more positively disposed to approvals vs. “holds” to submission that are correlated with it. We also believe the partnership is very synergistic – Animas will benefit from the many scientists and researchers at JDRF and JDRF will gain from the commercial experience of Animas and indeed, that of JDRF as a whole.

--by Jessica Swienckowski & Kelly Close