Tag Archives: Announcements

Tandem to Pioneer iPump Regulatory Pathway; Shares Close to $50

Tandem hosted its 2018 Institutional Investor & Analyst Day as well as announcing an increase to its 2018 sales guidance. Of note, Tandem disclosed plans to create a new pump category called iPump (via the de novo regulatory pathway), interoperable insulin delivery algorithms, and plans to accelerate development of its t:sport pump. Below, FENIX provides highlights from the investor event with insight into the potential market impact of Tandem’s pipeline, including how iPump could work for Medtronic.

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Dance Biopharm Raises $24.5M for Inhaled Insulin Development

Dance Biopharm announced it has raised $24.5M in private equity financing to help support the development of its inhalable insulin, Dance 501. According to the press release, Dance Biopharm plans to initiate Ph3 studies in 2019. Below, FENIX provides thoughts on Dance 501 including potential read through from Afrezza.

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Novo Cuts 400 Jobs in Denmark/China and Confirms Shift in R&D Strategy

Novo Nordisk announced plans to restructure its R&D organization which includes cutting 400 R&D jobs in Denmark and China. Novo is also establishing a new BD unit in Cambridge, MA to help facilitate additional R&D collaborations. This news comes as no surprise and is consistent with FENIX’s previous insight regarding Novo’s shift in R&D strategy as evidenced by 7 external R&D collaborations/acquisitions thus far in 2018. Below, FENIX provides thoughts on Novo’s new R&D strategy.

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Beta Bionics Raises $50M, but No Lilly Investment

Beta Bionics announced it has secured $50M thus far in a Series B round. Interestingly, the press release states Novo has participated in the Series B, but there was no mention of Lilly. Recall, Both Novo and Lilly previously invested $5M each in the Series A financing. Zealand also committed $5M to the Series B fresh off its $205M cash injection from the sale of Soliqua/Lyxumia royalties. Below, FENIX provides thoughts on the Beta Bionics financing including Lilly’s apparent decision to refrain from further investment.

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New Lilly Academic Collaboration to Help Compete with Novo/Oxford

Lilly and the Indiana Bioscience Research Institute (in collaboration with Indiana University School of Medicine) have partnered to create the “Lilly Diabetes Center of Excellence” (LDCE). According to the press release, the LDCE will support “cutting-edge research in diabetes, diabetic complications, and related metabolic disorders.” Lilly’s decision to create the LDCE appears to be (at least in part) driven by a need to keep up with Novo’s collaboration with The University of Oxford. Below, FENIX provides thoughts on the LDCE including a comparison with a similar program between Novo and University of Oxford.

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Sanofi Restructures GBUs; Stefan Oelrich Moves to Bayer

Less than 3 years after reorganizing the company into 5 Global Business Units (GBUs), Sanofi is once again restructuring the organization. Now, Sanofi is creating Primary Care and China & Emerging Markets GBUs, which will replace the Diabetes and Cardiovascular (DCV) and General Medicines & Emerging Markets (GEM) GBUs. As part of the transition, Stefan Oelrich, head of the DCV business, is leaving Sanofi to join Bayer’s Board of Management and lead its Pharmaceuticals Division. The transition is set to take effect by the beginning of 2019. Below, FENIX provides thoughts Sanofi’s reorganization with insight on the potential impact on its diabetes business.

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One Drop Now Integrates with Apple Watch

One Drop announced its blood glucose management platform now integrates directly with the Apple Watch. Previously, One Drop’s Apple Watch app required users to manually input BG data. Below, FENIX provides thoughts on the One Drop/Apple Watch integration as a source of new patients for One Drop.

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Insulet CEO Succession

Insulet announced that as of January 1, 2019, Shacey Petrovic (pictured below) will succeed Patrick Sullivan as Insulet’s CEO. For the last two years, Petrovic has served as the company’s President and Chief Operating Officer. Below, FENIX provides thoughts on the CEO succession and impact to Insulet moving forward.

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Zealand Lixi Royalty Sale May Indicate BD Challenges

Last week, Zealand sold its rights to Soliqua and Lyxumia future revenue streams to Royalty Pharma for $205M. While Zealand said it will use the funding to continue its pipeline progression, the sale could also indicate Zealand is having difficulty in some of its near-term business development initiatives, including finding a global commercialization partner for dasiglucagon in hypo rescue. Although speculative, it was likely easier for Zealand to sell its future Soliqua/Lyxumia royalty streams than to raise operational proceeds from the public markets. Below, FENIX provides thoughts on the sale and potential read-through to a dasiglucagon partnership.

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Sanofi DCV CMO Leaves

Riccardo Perfetti (pictured below), Sanofi’s VP Medical Affairs and Head of the DCV Global Medical Team, has reportedly left Sanofi to serve as the CMO of Applied Therapeutics. Perfetti had been with Sanofi since October 2007.

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