Category Archives: Other

J&J Q3 ’18 Earnings Update

J&J hosted its Q3 ’18 earnings call but only briefly discussed the Invokana franchise. Senior management did not comment on the CANVAS/R review which is anticipated this month. Recall, in July 2018, J&J announced FDA extended the CANVAS/R sNDA review by 3 months. Below, FENIX provides thoughts on the CANVAS review as well as potential read-through from Lilly’s Ph2b dual agonist results to J&J’s dual agonist, JNJ-64565111.

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New Novo Stem Cell Manufacturing Facility

Novo Nordisk announced plans to establish a stem cell manufacturing facility in Freemont, California. The GMP-certified facility was previously operated by Asteria Biotherapeutics and Novo has signed an agreement with the company. According to the press release, the plant will be operational in 2019 at which time, it will be used to support Novo’s clinical development programs. Below, FENIX provides thoughts on Novo’s stem cell program.

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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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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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Livongo-Abbott Integration with Libre Pro

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.

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MannKind Partners for Pulmonary Hypertension; $MNKD up ~100%

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.

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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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Novo Partners for Cross BBB Drug Delivery

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.

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