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Finding Transformational Solutions to the Global Diabetes Epidemic


Today, Janssen Pharmaceuticals announced that it will develop and commercialize oxyntomodulin-based therapies, including HM12525A, a novel biologic that is expected to enter phase 2 studies next year for the treatment of diabetes and obesity.[1] Janssen has obtained worldwide rights, excluding China and Korea, as part of an agreement with Hanmi Pharmaceutical Co., Ltd.  The deal and contract negotiations were facilitated by Johnson & Johnson Innovation – Janssen Business Development.
According to the International Diabetes Federation, an estimated 387 million people worldwide are living with diabetes and this number is expected to grow to 592 million by 2035.[2] The majority of these cases (90% - 95%) are comprised of type 2 diabetes, which is a chronic disease that affects the body's ability to metabolize sugar (glucose) and is characterized by insulin resistance and inadequate pancreatic beta cell function.[3] Furthermore, it has been estimated that one-half of the adults living in the U.S. has either diabetes or pre-diabetes.[4]
In addition to diet and exercise, there are a number of medications (e.g., metformin, sulfonylureas glinides) and insulin therapies on the market to help control blood glucose levels. Unfortunately, even with the growing list of therapies, nearly half of adults with type 2 diabetes do not achieve the recommended levels of glucose control.[5],[6],[7] And if left uncontrolled, these patients will ultimately develop life-threatening complications, including heart attack, stroke, and end-stage kidney disease.
New approaches are needed to transform the way diabetes is treated.
The oxyntomodulin-based therapy HM12525A is a GLP-1/glucagon receptor dual agonist that holds great promise for improving the therapeutic options for people living with metabolic diseases. Oxyntomodulin is a naturally occurring peptide hormone that is released from the gut after eating to activate both the glucagon-like peptide-1 receptor and the glucagon receptor. HM12525A has already shown evidence of improving multiple metabolic parameters that lead to improved blood glucose, body weight, and insulin sensitivity.
This novel large molecule broadens and strengthens Janssen’s portfolio of therapies to treat metabolic diseases. Janssen’s existing therapy, INVOKANA® (canagliflozin), was approved in March 2013, and is the number one branded non-insulin type 2 diabetes medication prescribed by U.S. endocrinologists. This oral medication selectively inhibits sodium glucose co-transporter 2 (SGLT2), a cell transporter responsible for the reabsorption of glucose by the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with this disease. Janssen continues to study INVOKANA® in several ongoing clinical trials.
I am very excited about this agreement with Hanmi and the potential of HM12525A to improve therapuetic options for people living with metabolic diseases.  There are limited clinical stage therapeutics against novel targets for metabolic diseases, and I am proud that Janssen was the partner Hanmi selected.
This deal is a good illustration of the value that I believe can be found by investing in therapies that can potentially transform the way diabetes is treated, and make a real impact on the lives of patients around the world.

Patrick Verheyen, Global Head, Johnson & Johnson Innovation – Janssen Business Development

[1] Janssen Pharmaceuticals. (2015). Janssen Announces Global License and Development Rights Agreement with Hanmi Pharmaceutical for Novel Clinical Stage Biologic to Treat Diabetes and Obesity [Press Release]. Retrieved from:  http://janssen.com/janssen-announces-global-license-and-development-rights-agreement-hanmi-pharmaceutical-novel

[2] Centers for Disease Control and Prevention, National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014. Available at: http://www.cdc.gov//diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.

[3] Cefalu T, Leiter L, Yoon K-H, Arias P, Niskanen L, Xie J, Balis D, Canovatchel W,  Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50.

[4] Menke, A., Casagrande, S., Geiss, L., Cowie, C.C. Prevalence of and Trends in Diabetes Among Adults in the United States, 1988-2012. JAMA, 2015; 314 (10): 1021

[5] Bailey CJ. Renal glucose reabsorption inhibitors to treat diabetes. Trends Pharmacol Sci. 2011;32(2):6371.

[6] Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988–2010. Diabetes Care. 2013 Feb 15. Epub ahead of print.

[7] World Health Organization, Media Centre, Diabetes, Fact sheet Number 312. Available at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed April 1, 2013.