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.
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.
Oramed announced FDA cleared its IND application for ORMD-0901, an oral GLP-1RA believed to be using exenatide. According to the press release, Oramed is planning to initiate a Ph1 PK study in Q3 ’18 with intentions to move into Ph2 in 2019. The Ph1 study has not yet been posted on CT.gov, but the press release said the Ph1 study will be a 4-way crossover vs. Byetta in 15 healthy subjects. Below, FENIX provides thoughts on ORMD-0901 in the context of Novo’s oral semaglutide.
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.
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.
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.
Livongo announced a partnership with Abbott to integrate the FreeStyle Libre Pro into the Livongo for Diabetes program. The integration with a professional (retrospective) CGM makes sense given Livongo’s focus on patient education and behavior-based treatment. Below, FENIX provides a unique perspective that the Abbott partnership could signal a limitation in Livongo’s diabetes solution.
Yesterday, MannKind announced a partnership with United Therapeutics for dry powder delivery of treprostinil (pulmonary hypertension) and another non-disclosed R&D project. MannKind will receive $45M in an upfront payment and is eligible for up to $50M in additional milestones as well as “low double-digit” royalties” for the tresprostinil development and commercialization. Since the partnership announcement, $MNKD is up ~100% (+89% on Sept 4 and an additional +10% in Sept 5 pre-market trading shown below). Interestingly, the news came 21 years after treprostinil first became available through the MiniMed 407c, a pump created in part by Al Mann.
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.
ADA has issued an updated position statement on the treatment of pediatric patients with T1DM.