Two New Exciting JDRF Partnerships Highlight Changing Landscape in Diabetes

by james s. hirsch and kelly l. close

The Juvenile Diabetes Research Foundation made two major announcements this month on corporate partnerships that highlight the changing landscape for diabetes care.

Specifically, the JDRF is partnering with Animas (part of Johnson & Johnson), to co-develop a first-generation artificial pancreas. It would allow an Animas insulin pump with a computer processing unit to wirelessly communicate with a continuous glucose sensor supplied by DexCom. The pump would automatically slow down or shut down the delivery of insulin when glucose levels dropped too low and would increase insulin delivery when blood sugar levels rose. Patients would still need to make insulin dosing decisions for meals. The JDRF and Animas hope to submit to the FDA a market-ready system, with clinical safety and efficacy trials, within four years. We’ve been hearing about the artificial pancreas for decades, and this movement is exciting because for this partnership to form, it all seems more likely to happen.

The JDRF is also partnering with Becton Dickinson to improve multiple aspects of insulin infusion pumps to improve the patient experience and to develop “microneedles” to speed insulin action. BD has long been the dominant player in the traditional delivery of insulin – syringes and pen needles – so its entrance into the pump market underscores its own expectations that pumps will play a larger role in diabetic care. Specifically, BD’s aims are to work toward less painful set insertion, less kinking, fewer infections, and overall “greater convenience.” In our experience, these kinds of problems have presented a deterrent to pump therapy, problems for some patients, and lower overall satisfaction with pump therapy. We applaud work coming to improve satisfaction in these areas.

For patients, these partnerships are significant on several levels. First, it underscores the JDRF’s efforts to support companies that can make a difference in the daily lives of people with diabetes. For most of the JDRF’s history (it was founded in 1970), its principal focus was on a cure. It is still focused on a cure, but in recent years it has recognized that breakthroughs short of a cure – and the artificial pancreas is on the top of its list – can still transform the lives of patients, and those breakthroughs should be aggressively pursued. Not coincidently, the JDRF’s new president, Alan Lewis, joined the organization last year after a career in industry and he clearly feels strongly about the JDRF working to improve life for patients today.

The partnerships are also important because of the size and power of the companies involved – Johnson & Johnson and Becton Dickinson. Breakthroughs aren’t cheap, and only those firms with the deepest pockets can afford the research and the lengthy regulatory process that is necessary to bring a product to market. J&J and BD would not be making those investments unless they believed the products can be developed and sold. Of course, their commitment is also a reminder that the size of the diabetes market is increasing every day.

The JDRF is contributing $8 million to the partnership with J&J/Animas and over $4 million to the BD project. The corporate investments were not disclosed, but we assume they are considerably larger, likely on the order of at least $20-$25 million each. Perhaps the biggest benefit is that other competing companies will increase their own investments in diabetes technology and increase innovation throughout the industry.

We also believe these partnerships are synergistic – both Animas and BD will benefit from the many scientists and researchers at JDRF, and JDRF will gain from the commercial experience of Animas and BD.

Some more detailed points about the two partnerships:

animas

• The goal of this first generation artificial pancreas will be to reduce many of the safety concerns of severe lows and highs, 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 the insulin if a threshold blood glucose level 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. Some of the features 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’s tempting to categorize this technology as the next incremental step toward a fully automated system, there is no question this would be a significant leap forward -- from one-way communication between a pump and CGM to two-way communication; that some of the decision making is automated is monumental. Such a system will be a “game-changer,” though still far short of a fully automated artificial pancreas.

• Finally, the press release notes explicitly that JDRF’s goal is to have many 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, the agency will be more positively disposed to approvals vs. “holds” on submissions that are correlated with it.

BD

• The goal of the JDRF/BD collaboration is twofold. The first is to reduce the stress of pump therapy through various means, including, as noted, improving convenience and minimizing pain, kinking, occlusions, and infections. We assume BD has decided that more and more people will be moving to pump therapy – likely more type 2s as well as type 1s, though this isn’t discussed in the release – and it presumably wants to be a major player in this shift rather than to be the dominant player only in the lower-tech (insulin syringe and pen needle) part of the market.

• The second major focus of BD/JDRF program is to validate the use of BD microneedle technology, which can be used to infuse insulin via pumps, and based upon past clinical experience, may improve the speed at which insulin works. Microneedles offer a minimally invasive and potentially less painful method of drug delivery; they are typically 1-2 mm in length and they introduce insulin into the top layer of the skin (intradermally), as opposed to the traditional sub-cutaneous space. This has been demonstrated to enhance the pharmacokinetics and bioavailability of insulin, which is very important for an artificial pancreas.

• With this partnership, BD has significant potential to improve insulin delivery by making it easier for more patients to deliver insulin more physiologically; this could expand the market significantly. According to JDRF, there are currently about 400,000 pumpers; we believe there is significant upside to expanding this market in both type 1 and type 2 patients as pumps become easier to use, as the user interface improves, and as other improvements like the ones identified by BD and JDRF emerge.

Broadly speaking, we believe far more innovation is coming to pump therapy and insulin delivery. This is an area where we believe patient perspective is incredibly important, and we look to our dQ&A patient panel to help us better understand this (thank you to many diaTribe readers for being part of this panel; if you are not currently and would like to be, please contact Richard Wood at richard.wood@d-qa.com). dQ&A measures satisfaction with diabetes therapy and technology in users in the US, via its research panel of people with diabetes. Around 2,000 people with diabetes take dQ&A's surveys every quarter, including approximately 700 pumpers (over 70% of type 1s in the panel wear pumps, and the panel also includes over 50 type 2 pumpers). Results vary considerably across the top six pumps for the twelve attributes we track - dQ&A's data show some top performers and some poor results too. But for the group as a whole, scores fall into three bands:

• The highest satisfaction scores are for overall safety, bolus calculation capabilities, ease of delivering insulin, and customer support.

• In the middle range are ease of setting up, inserting the cannula, reading the display, and frequency of occlusions.

• In the low range are comfort, integration with blood glucose measurement, setting alarms and alerts, and pump size, as well as overall satisfaction.

This data support the rationale behind the JDRF/BD partnership. Clearly, overall comfort with the infusion set is a concern, and pain with insertion is likely keeping some patients wearing sets longer than they otherwise would or keeping them from starting pump therapy.

In closing, we believe JDRF deserves enormous credit for continuing its innovative industry partnerships – there are now more than 30 in total. Certainly, these last two are exceptional – they are squarely aimed at accelerating the commercial development of important technologies for patients. We applaud both companies for creating what could be a very powerful public/private partnership; both want to make pump systems better and bring very different competencies. We look forward to reporting on milestones as early as next year – Dr. Aaron Kowalski has been on diaTribe’s advisory board since diaTribe began in 2006 and he has promised to help keep us in the loop! Kudos too to JDRF for raising over $1 billion since inception to find a cure and to improve life for patients like us ~ may companies and individuals keep supporting JDRF so the cure can emerge even faster.