Memorandum
Executive Highlights
- AstraZeneca and Mitsubishi Tanabe Pharma Corporation announced the formation of a three-year research collaboration to develop novel therapies for diabetic nephropathy.
- The agreement aims to speed development of candidates from both companies’ pipelines.
AstraZeneca and Mitsubishi Tanabe Pharma Corporation (MTPC) announced the formation of an inventive three-year research collaboration to develop novel therapies for diabetic nephropathy. The partnership encompasses candidates from both companies’ pipelines and all phases of the drug development process, from target selection to the delivery of small molecule drugs. Research will occur in parallel at MTPC’s Japan-based facilities and at AZ’s facility in Sweden. The agreement does not include any specific financial commitments – each company will contribute equal resources at its own cost. MTPC’s diabetic nephropathy candidate (MT-3995) is a selective mineralocorticoid receptor antagonist in phase 1 in the US and in phase 2 in Europe and Japan (four trials are currently listed as recruiting or ongoing on ClinicalTrials.gov). Meanwhile, AZ’s pipeline includes the phase 3 compound roxadustat (hypoxia-inducible factor inhibitor) for treatment of anemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD), as well as the phase 2 candidate tempanor (AZD1722) for ESRD/CKD associated with type 2 diabetes (neither compound is currently part of the collaboration with MTPC). We hope that the collaboration will indeed yield “high-quality candidate drugs much faster than working alone,” as there is an enormous need for diabetic nephropathy treatments. Recent notable developments in this area include Kyowa Hakko Kirin’s announcement in July that it would resume development of bardoxolone methyl “with a particular emphasis on patient safety” (Reata’s phase 3 BEACON trial of the compound was terminated in 2012 due to safety concerns) and the initiation of the CREDENCE renal outcomes trial investigating whether J&J’s SGLT-2 inhibitor Invokana (canagliflozin) could potentially slow the progression of nephropathy. See the table below and read our AbbVie 2Q14 report for a more complete overview of the competitive landscape for diabetic nephropathy.
Table 1: Diabetic Nephropathy Competitive Landscape
|
Company |
Drug Name |
Class |
Status/ |
Other Remarks |
|
AbbVie |
Atrasentan |
Endothelin-receptor antagonist |
Phase 3 |
Primary completion expected 2017 |
|
J&J |
Invokana (canagliflozin) |
SGLT-2 inhibitor |
Phase 3 |
Already marketed for type 2 diabetes; being investigated for diabetic nephropathy in CREDENCE trial |
|
NephroGenex |
Pyridorin |
Oxidation inhibitor |
Phase 3 |
Recently entered phase 3 |
|
AZ |
Roxadustat |
2-OG inhibitor |
Phase 3 |
Recently entered phase 3 |
|
AZ |
AZD1722 |
NHE3 inhibitor |
Phase 2 |
Phase 3 expected in 2015 |
|
Bayer |
Finerenone |
MR (mineralcorticoid receptor) antagonist |
Phase 2 |
Primary completion of safety/efficacy trial with different oral doses expected this month (Identifier: NCT01874431) |
|
Concert Pharmaceuticals |
CTP-499 |
Inhibitor of inflammation, oxidation, and fibrosis to be used with standard CKD therapies |
Phase 2 |
|
|
Kyowa Hakko Kirin |
Bardoxolone methyl |
Inhibitor of inflammation |
Phase 2 |
Reata’s phase 3 BEACON trial terminated due to safety concerns; Kyowa Hakko Kirin recently acquired the candidate |
|
Lilly |
LY2382770 |
TGF-beta monoclonal antibody |
Phase 2 |
Primary completion expected this month (Identifier: NCT01113801) |
|
Lilly |
LY3016859 |
TGF-alpha/epiregulin monoclonal antibody (inhibitor of two epidermal growth factor receptor ligands) |
Phase 2 |
Currently recruiting, primary completion expected August 2015 (Identifier: NCT01774981) |
|
Pfizer |
PF-00489791 |
Phosphodiesterase inhibitor |
Phase 2 |
Trial completed August 2013 (Identifier: NCT01200394); management mentioned “encouraging clinical performance” in 4Q13 update |
|
Pfizer |
PF-04634817 |
C-C chemokine receptor type 2/5 antagonist |
Phase 2 |
Primary completion expected September 2014 (Identifier: NCT01712061); also being investigated for diabetic macular edema |
|
Vascular Pharma |
VPI-2690B |
Targets insulin-like growth factor-1 signaling pathway |
Phase 2 |
Initiating phase 2 trial in September 2014, according to company website |
|
Daiichi Sankyo |
CS-3150 |
Oral MR antagonist |
Phase 2 |
Expected to enter phase 3 by early 2015 |
|
Lilly |
Undisclosed small molecule |
Undisclosed |
Phase 1 |
None |
-- by Emily Regier, Adam Brown, and Kelly Close