GSK submits its first application for daprodustat in Japan; Two drugmakers part with $15M to avoid opioid trial
→ Just as Hal Barron planned, GSK $GSK has submitted its first regulatory application for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat, in Japan for patients with renal anemia due to chronic kidney disease (CKD). The application is based on positive Phase III data conducted in Japan on anemic patients across the spectrum of CKD from stages 3-5 — which included patients on and not on dialysis, regardless of prior anemia treatment with erythropoiesis-stimulating agents (ESAs). If approved, daprodustat will be exclusively distributed in Japan by Kyowa Kirin Co.
→ Two drugmakers — Endo $ENDP and Allergan $AGN — have agreed to part with $15 million altogether to avoid going to trial in October in a landmark case by two Ohio counties, who have accused a raft of drug manufacturers and distributors of stoking the opioid crisis, Reuters reported on Tuesday. Other drug firms embroiled in the multidistrict litigation include Purdue, Teva and J&J as well as drug distributors such as McKesson $MCK, Cardinal Health $CAH and AmerisourceBergen $ABC.
“(T)he Endo settlement in two OH counties would extrapolate to a potential national settlement of $1.8B for Endo, <50% of our published estimate,” SVB Leerink analysts wrote in a note. “The Endo settlement provides a positive readthrough for Mylan and Amneal indicating that the settlement numbers for them could end up being <50% of our published estimates of $0.8B and $1.2B, respectively. For Teva and Mallinckrodt, the readthrough is less clear and varies depending on whether we use sales mix or volume mix as our basis…a key piece of the puzzle in addition to the city/county lawsuits is the state AG lawsuits which remain a wild card, and we understand that trials for these cases will not be held until 2020.”
→ Cerecor‘s $CERC oral formulation of D-mannose — a naturally occurring monosaccharide — called CERC-802 has been granted fast track status by the FDA to treat Mannose-Phosphate Isomerase Deficiency (MPI-CDG). CDG’s are rare, inherited, metabolic disorders with high infant morbidity and mortality and no FDA-approved treatments. The overall estimated occurrence of MPI-CDG globally is less than 50 cases, although researchers suspect it is under-diagnosed.
→ Tetra Bio-Pharma — a company focused on developing cannabinoid-based therapeutics — is joining forces with Thorne Research and Onegevity to form a joint venture, CB2 Therapeutics. CB2 will focus on developing compounds for chronic inflammatory conditions with high unmet needs that aren’t adequately served with current therapies. The joint venture is targeting an initial raise of $10,000,000 to start its Phase II clinical trials for irritable bowel syndrome (IBS) and the commercialization of its dietary supplements for interstitial cystitis.
→ Cadent Therapeutics — currently in collaboration with Novartis $NVS to develop a negative allosteric modulator, now in Phase II for the treatment of treatment-resistant depression — welcomed John McBride on board as CFO. McBride jumps over from the same role at Syntimmune, where he helped with the company’s acquisition to Alexion $ALXN. Prior to his time at Syntimmune, McBride served as the COO and CFO at Tokai Pharmaceuticals and had stints at Gloucester Pharmaceuticals, Pharmacia, CytoTherapeutics and Phytera. In addition, the company announced the appointment of several other hires, including Minnie Mildwoff, Vice President, Regulatory Affairs and Quality Assurance; Robert Gaffey, Vice President, Finance and Administration; Nicole Luosey, Vice President, Strategic and Program Operations and Noah Goodman, Executive Director, Business Development.