The full results presentation for DECLARE has been confirmed as a late-breaker at AHA. In a recent AHA online planner posting, captured below, DECLARE will be presented on Saturday November 10 at 345pm CST by TIMI’s Stephen Wiviott. Javed Butler, the PI on the Jardiance EMPEROR-HF trials, has been invited as the discussant for DECLARE
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.
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.
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.
Novo Nordisk has entered into an R&D collaboration with Ossianix, a Philadelphia-based R&D company. Ossianix utilizes its single domain VNAR antibody to increase drug absorption across the blood brain barrier (BBB). According to the press release, Ossianix will deliver a predefined number of therapeutic agents to Novo for the treatment of diabetes and other metabolic diseases. Below, FENIX provides context of the R&D agreement as well as thoughts on potential targets that Novo is pursuing.
A Ph1 CT.gov record evaluating a new triplet FDC of empa+lina+met XR has been observed. Below, FENIX provides further details on potential triplet FDC filings and analysis, including pricing, based on read-through from the SGLT2i+DPP-IVi FDC market.
FDA issued a warning for the risk of a rare genital infection (necrotizing fasciitis of the perineum aka Fournier’s gangrene) with the use of SGLT2 inhibitors. FDA is also requiring label updates for the class. According to the FDA’s warning letter, there have been 12 cases (7 males and 5 females) of Fournier’s gangrene from March 2013 to May 2018.
Senseonics and Beyond Type 1 announced a collaboration to make the Eversense implantable CGM the “worldwide presenting sponsor of the Type One Run.” Beyond Type 1 is a patient advocacy organization primarily focused on providing patient education and resources through social media. Below, FENIX provides perspective on the partnership opportunity for Senseonics.