Sanofi’s Head of Global R&D Retiring
Sanofi announced that Elias Zerhouni, the company’s Head of Global R&D, is retiring and will be succeeded by John Reed, the former Global Head of Roche Pharma Research & Early Development.
Sanofi announced that Elias Zerhouni, the company’s Head of Global R&D, is retiring and will be succeeded by John Reed, the former Global Head of Roche Pharma Research & Early Development.
A new Ph3 trial (AWARD-11) evaluating 3.0 and 4.5mg Trulicity has been observed on CT.gov. The trial is projected to complete in Q4 ’19. If no additional trials are required, launch could occur as early as Q1 ‘21 (assuming a full 10-month review).
Lexicon hosted its R&D Day and provided an overview of clinical and regulatory activities for its diabetes portfolio including sotagliflozin and LX2761 (selective SGLT1i). Below, FENIX provides highlights of the R&D day as well as thoughts on the impact of sotagliflozin on the T1DM and T2DM markets.
Mylan hosted its Investor Day and provided updates on biosimilar Lantus and Novolog, as well as disclosing for the first time its intentions to develop biosimilar versions of Toujeo, Victoza, and Saxenda. Below, FENIX provides analysis and market implications for each of the biosimilar programs.
AZ has announced FDA approval of Bydureon as an add-on to basal insulin for T2DM based on the results of the DURATION-7 study. The corresponding label update may help strengthen a Bydureon message of broad use including first-injectable therapy and treatment intensification.
AZ has begun actively promoting Bydureon BCise, the new autoinjector device which became available in US pharmacies in January 2018. Below, FENIX has conducted a launch analysis in the context of the broader GLP-1RA market including assessment of prescription data trends.
Novo Nordisk began actively promoting Ozempic (sc QW semaglutide) in the field in early February 2018, two months after the December 2017 approval. Below, FENIX has conducted a launch analysis, including thoughts on promotional materials, sampling strategy, and early insights from NRx trends.
AZ hosted their Q4 ’17 earnings call (press release) and briefly discussed their diabetes portfolio, with a particular focus on Farxiga and Bydureon.
In early January AZ announced the availability of Bydureon BCise autoinjector in US pharmacies after receiving FDA approval in Oct 2017. FENIX has conducted GLP-1RA market, pricing, and co-pay card analyses.
Sanofi has reportedly announced a round of 400 layoffs for the diabetes and cardiovascular business unit sales team. In a separate news release, it was also announced that Sanofi has appointed Dominique Carouge, former VP of Administration & Management for Global R&D, as a new EVP Head of Business Transformation.