GS provides diabetes pipeline update.
double by 2030, with treatments currently falling way short of
medical needs. The focus falls on impending products offering novel
therapies to diabetics and for healthcare companies.
Current treatments and practices have vastly improved from initial insulin therapy and "fingersticks." That said, unwanted side effects such as weight gain and oedema coupled with discomfort (needles) are characteristic of basic insulin therapy.
The new generation of drugs should offer significantly better options. Such is the demand that the value of potential pharmaceutical pipeline for diabetes could be the largest of all major therapeutic categories.
According to the report a number of companies have come into the frame that could alter the severity and complications of the disease. Insulin pumps and continuous monitoring, inhaled insulin, and new pills that increase insulin sensitivity offer significant potential advances.
Improvements on existing diabetes drugs as well as entirely new compounds are being offered to allow less frequent dosing and/or less use of insulin. Bristol Myer/Merck's Pargluva should be a more efficacious than current Thiazolidinedione's (TZD).
Glucagon-like-peptide compounds such as Lilly/Amylin's Byette only respond when blood glucose levels increase, and reduce the need to recalculate the correct amount of insulin by meal.
Amylin's strong prescence in the diabetes market should also drive growth in the environment of rising demand. The core of Amylin revolves around two products: Byetta (50/50 partnership with Lilly) may address a $1 billion (€813 million) commercial opportunity and Symlin may address a $200-£00 million opportunity.
The initial lift-off for Byetta has been quite strong owing to its efficacy and weight loss benefits, despite the need for twice daily injections. Early phase II data indicates that a once a week formulation may also be effective, which could further expand the target market.
In addition, Lilly's Arxxant, a new class of drug called kinase C-beta inhibitors, is currently being tested to reduce the progression of diabetic eye and kidney disease.
Companies are involved in a serious way, responding to the growing worldwide need for effective therapies. Novo Nordisk, Sanofi Aventis and Eli Lilly are the primary makers of varying forms of insulin.
Also, Bristol-Myers and Merck are co-developing a next generation TZD, along with Novartis and Merck, which both have DPP-IV inhibitors in development.
The rundown of the pharmaceutical industry's progress within this field is highlighted in Goldman Sachs' (GS) latest report: "Global Themes - Perspectives on Diabetes - addressing a pandemic problem."
As for big pharma, GlaxoSmithKline's diabetes franchise, Avandia, is only one of the only two commercially successful TZD's in the market, and its sales now account for 7 per cent of the company's revenues. GlaxoSmithKline is also developing other follow on products such as a dual/pan PPAR, or next generation TZD, and a DPP-IV inhibitor, which may see proof of concept data soon.
Meanwhile, Pfizer's diabetes exposure comes with potential of Exubera (inhaled insulin), which Pfizer is co-developing with Sanofi Aventis and Nektar. Importantly, they will present to an FDA panel on September 8, 2005, and a successful outcome could lead to significant revisions to the current $500 million peak sales estimate.
Merck is on the forefront in diabetes treatment development with both a dual/pan (Pargluva, a new TZD muraglitizar with BMY) and a DPP-IV inhibitor (sitagliptin) in its pipeline.
Roche's claim in the diabetes field is limited in pharmaceuticals with potential in the pipeline. However, Roche is a major participant in the diagnostic end of diabetes with Accu-Chek blood glucose monitors, data management systems, insulin pumps and lancets.
Sanofi Aventis has multiple points of interest in diabetes. First, it is one of three leading insulin makers, and analogue Lantus has been highly successful. Secondly, it is co-developing Exubera with Pfizer and Nektar. Finally, the developmental anti-obesity compound Accomplia also reduces blood sugar - it has estimated peak sales of $1.5 billion.
GS said that the global problem of diabetes was important to understand. From a revenue perspective, diabetes in developing economies presents a double-edged sword. Growth in both the disease and in income in countries such as India and China could offer significant potential revenue opportunities for healthcare companies.
However, the regulatory environment, the lack of intellectual property rights, and the challenge of drug getting paid all pose potential hurdles.
According to the International Diabetes Federation, diabetes is the fourth main cause of death in most developed countries. At least 50 per cent of all people with diabetes do not know of their condition. By 2025, the number of diabetics is forecast to double in Africa, the Middle East, and Southeast Asia, and rise 20 per cent in Europe, 50 per cent in North America, and 85 per cent in central and South America.