Beta Bionics partners with Novo Nordisk, receives $5 million investment (complementing Lilly!); pivotal trial timelines slip slightly; two R&D team additions – February 1, 2017

Beta Bionics’ CEO Dr. Ed Damiano and VPs Ed and Serafina Raskin just shared an update with Close Concerns on the public benefit corporation’s recent progress:

1. Beta Bionics has entered into a strategic partnership with Novo Nordisk, which includes a $5 million investment from the Danish pharmaceutical giant. This announcement is remarkable because Lilly made a similar $5 million investment about a year ago, and both companies now hold a seat on the Board of Directors – virtually unprecedented:

• Lilly’s Global Brand Development Leader Deirdre Ibsen;
• Novo Nordisk’s Corporate Project VP Dr. Martin Lange;
• Other key BOD members are Ed Raskin and Children with Diabetes Founder Jeff Hitchcock.

This is an impressive vote of confidence from Novo Nordisk and a testament to Beta Bionics’ goal to be a “platform” for better drug delivery. The integrated iLet Bionic Pancreas will be compatible with both Lilly’s Humalog and Novo Nordisk’s NovoLog (in a manual fill glass insulin cartridge) and in Novo Nordisk’s prefilled NovoRapid PumpCart cartridge in Europe.  Commercial use of glucagon in the iLet will only be available in a prefilled cartridge.

2. Timelines for trials have slipped slightly since the last update in October: The six-month insulin-only pivotal trial is now slated for the end of 2017 or early 2018 (back from “2H17”), and the bihormonal pivotal trial is now expected to start in mid-2018 (back from “1H18”). The insulin-only device could be approved as early as the end of 2018, as Beta Bionics will submit the PMA with their three-month clinical data first, and follow with six-month clinical data in a PMA supplement. Dr. Damiano hopes that the FDA review could be as short as four or five months, in line with Medtronic’s three-month MiniMed 670G review.

3. Beta Bionics just added three new members to its R&D and Quality Assurance teams: VP of Research and Development, Mr. Mike Rosinko (formerly VP of R&D at Tandem), R&D Program Manager, Mr. Don Ludolph (also formerly of Tandem), and Director of Quality Assurance, Mr. Joe Conkey (formerly of Covidien, now part of Medtronic). Dr. Damiano was very excited to share this news, highlighting that the three will be critical to success moving forward, and may allow things to be done with the iLet device that he probably wouldn’t have considered for gen 1, but with minimal impact to the timeline.

4. Beta Bionics has obtained B Corp certification, meaning it meets “the highest standards of verified, overall social and environmental performance, public transparency, and legal accountability.” The status is granted by B Lab, a non-profit with a vision “… that one day all  companies compete not only to be the best in the world, but the best for the world.”

Detailed Highlights

1. Beta Bionics has entered into a strategic partnership with Novo Nordisk, which includes a $5 million investment from the Danish pharmaceutical company. This move is a clearly a strong vote of confidence from Novo Nordisk and shows the company’s increasing interest in diabetes tech (see below). Dr. Damiano emphasized that, like Lilly, Novo Nordisk is interested in the research and commercial aspects of the iLet Bionic Pancreas: from the research angle, the dual-chamber pump will provide scientists a platform upon which to study new drugs and new autonomously delivered dual-drug interactions, and from the commercial angle, it would help to optimize delivery of Novo Nordisk insulins. Dr. Damiano pointed out that these two strategic partners value the iLet as a device that will “make their great drugs even better.” In addition to capital, Beta Bionics will be able to leverage Novo Nordisk’s connections and expertise, particularly with regard to European regulatory pathways and experience with the prefilled NovoRapid PumpCart with Roche and Ypsomed.

• This announcement is all the more remarkable because Lilly made a similar $5 million investment about a year ago, and BOTH companies now hold a seat on the Board of Directors (Lilly’s Global Brand Development Leader, Deirdre Ibsen, and Novo Nordisk’s Corporate Project VP, Dr. Martin Lange, who notably join Ed Raskin and Children with Diabetes Founder Jeff Hitchcock). As far as we know, this kind of arrangement is unheard of in diabetes, and we’re elated to see competitors coming together to support technology that can improve both of their products. Said Dr. Damiano: “We feel like the United Nations of Medtech.”
• Beta Bionics has been using both Novolog and Humalog in most of its outpatient studies, and the intent is to make the iLet compatible with the prefilled NovoRapid PumpCart in Europe. A manual fill option for insulin will also be available.
• Dr. Damiano added that the progress with glucagon partner Zealand Pharma continues to be very encouraging. In December, Zealand announced that it has initiated a phase 2a feasibility study of dasiglucagon, a liquid-stable glucagon, in the bionic pancreas. This study is being conducted under the direction of Dr. Steven Russell at MGH. We met with Zealand during JPM and were inspired by our conversation with CEO Britt Meelby Jensen (formerly of Novo Nordisk!) and Chief Medical and Scientific Officer Adam Steensberg.
  
  • Lilly has a phase 1 stable glucagon, while Novo Nordisk has not shared any updates on a stable glucagon recently. Both are obviously clear candidates for providing soluble glucagon for the iLet, and if not in the first bihormonal version, perhaps in a subsequent version. Of course, both companies have the current reconstituted glucagon rescue products
• Novo Nordisk has made significant moves into diabetes tech over the last two years – in addition to this partnership, it also has its IBM Watson partnership announced in late 2015 and the Glooko partnership announced last month. On an exciting note, Novo Nordisk will pilot a connected pen in Europe this year – we believe there is so much potential to improve insulin delivery in people with diabetes and we are very excited about the opportunity of smarter delivery devices.
• For 2016, Beta Bionics raised $11 million in dilutive funding (including the $1 million WeFunder equity crowdfunding raise) and $12 million in non-dilutive funding from NIH to support the bihormonal pivotal trial. As of October, Beta Bionics was seeking $7 million for the insulin-only pivotal trial. Dr. Damiano and team are still exploring additional resources, including other crowdfunding paths.

2. Timelines for trials have slipped slightly since the last update in October: the six-month insulin-only pivotal trial is now slated for the end of 2017 or early 2018 (back from “2H17”), and the six-month pivotal trial of the bihormonal iLet is now expected to start in mid-2018 (back from “1H18”). Dr. Damiano believes the insulin-only system could be approved as early as the end of 2018, since the company plans to submit the PMA in tranches (primary three-month pivotal data so that FDA can begin to evaluate it, followed by full six-month data). With this design in mind, and assuming a 4-5 month review by the FDA, Dr. Damiano hopes that the insulin-only approval could come within 12 months from the start of the study (so roughly 24 months from now). This small team is ambitious, but there is a trend over the past couple years of changing pivotal/submission/commercialization timelines as things evolve – e.g., after the iLet was unveiled at FFL 2015, the plan (at the time) was to use Xeris glucagon in a bihormonal pivotal study running from 1Q17-1Q18. Obviously things have changed a lot since then (!) – there is now an insulin-only device and three new drug partners – though there are still several steps to complete from here. Will the company hit this updated timing? On the plus side, an end of 2018 insulin-only launch would put Beta Bionics on track with several other automated systems (e.g., Tandem/TypeZero, Bigfoot, and possibly Animas). 

• Beta Bionics plans to submit IDEs for the insulin-only and bihormonal iLet bridging studies by the end of May, start the studies by mid-July, and run them into September. As a reminder, these are NIH funded, and this keeps pace with previously expected mid-2017 timing. These trials will show that the integrated iLet device works equivalent to the iPhone-driven, two-Tandem-pump research platform that has been used in prior outpatient studies.       
  
  • The bihormonal bridging study will likely be designed to provide eight weeks of drug exposure in the bihormonal study arm, instead of just two. This study will provide a picture of the effects of longer glucagon exposure, and will also allow Beta Bionics to learn how well the iLet works in the bihormonal setting, including the custom dual-cannula infusion set, cartridge changes, human factors, etc. Dr. Damiano emphasized that Beta Bionics is willing to put off the pivotal timeline if it finds any issues from the bridging studies, but the hope is that any issues that might be identified would be limited to the graphical user interface, which could be addressed with software revisions.

3. Beta Bionics has added three new members to its management team: VP of Research and Development, Mr. Mike Rosinko (formerly VP of R&D at Tandem), R&D Program Manager, Mr. Don Ludolph (also formerly of Tandem), and Director of Quality Assurance, Mr. Joe Conkey (formerly of Covidien, now part of Medtronic). Dr. Damiano was very excited to share this news, saying that the three will be critical to our success moving forward, and may allow things to be done with the iLet that he probably wouldn’t have considered for gen 1, but with minimal impact to the timeline. The latest additions are all located in Irvine, CA, where Ed and Serafina Raskin live, forming a “Beta Bionics East” in Boston and a “Beta Bionics West” (five employees in Irvine and eight in Boston). Mr. Raskin added that having presence in both Boston and Southern California has several advantages, as it allows recruiting from two medtech-rich regions and the West location brings close proximity to Dexcom’s San Diego headquarters.

4. Beta Bionics has obtained B Corp certification, meaning it meets “the highest standards of verified, overall social and environmental performance, public transparency, and legal accountability.” The status is granted by B Lab, a non-profit with a vision “…that one day all companies compete not only to be the best in the world, but the best for the world.” Beta Bionics joins 2,013 other companies in 50 countries and 130 industries as B Corp certified, though Mr. Raskin believes that Beta Bionics may be the only medical device company in diabetes to enjoy the distinction of being both a benefit corporation (in the Commonwealth of Massachusetts) and a certified B Corp. Beta Bionics received a qualifying score quite quickly in its first year of operations (unusually fast), and certification lasts two years. What does it take to be a B Corporation? Mr. Raskin stressed that Beta Bionics focuses on the global community, accountability, social justice principles, and environmental concerns (packaging, recycling, etc.) – it took roughly 60-80 hours to complete the verification and auditing process with B Lab.

Close Concerns Questions

Q: Will Beta Bionics hit the pivotal timing? How will the insulin-only version stack up to other systems when it comes out?

Q: Can Beta Bionics scale manufacturing, quality, and customer service? Can it succeed in a very fragile pump ecosystem?

Q: Will Novo Nordisk or Lilly advance a stable glucagon for inclusion in the iLet? Will Zealand’s stable glucagon work out? Where is Xeris in all of this?

Q: Will Beta Bionics pursue a traditional pump business model or seek a new one to come to market?

Q: Are there plans for an iLet CE Mark submission?

Q: If disputes arise on the board between Novo Nordisk and Lilly, how will they be resolved?

Q: How are “Beta Bionics East” and “Beta Bionics West” likely to expand? Which is likely to be bigger? More active?

Q: Does Beta Bionics envision partnering with other insulin manufacturers (Merck, Sanofi, MannKind, Biocon, others?)

-- by Brian Levine, Adam Brown, and Kelly Close