Question

Please write down a short plan (1-2 pages) for pharmaceutical marketing and gearing-up sales of Eucreas 50mg/850 mg or 50mg/1000mg (active ingredients: Vildagliptin & Metformin) and taking into consideration the products of the competitors in the Pharmaceutical Selling (local or international products).

Is Eucreas cost effective? This means paying its prices with getting better health outcome. Better health outcomes mean improving patient compliance (adherence) and glycemic control.

Answer 1

Eucreas tablets are a combination of two active ingredients: vildagliptin and metformin. Metformin belongs to a group of antidiabetic medication called biguanide. It helps in decreasing the sugar level in the blood. It not only helps in reducing the level of sugar produced by liver cells, it also helps in increasing the sensitivity of the muscle cells towards insulin. This substance also helps in delaying sugar absorption from the intestines into the bloodstream after having a meal. Vildagliptin belongs to the category of antidiabetic medication called dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by preventing the breakdown of two incretin hormones, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) and reduces the sugar level in blood. It is a prescription medicine. Eucreas is indicated in the treatment of type 2 diabetes mellitus:

- Eucreas is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.

- Eucreas is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.

There have been no formal interaction studies for Eucreas. The following statements reflect the information available on the individual active substances.

Vildagliptin

Vildagliptin has a low potential for interactions with co-administered medicinal products. Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.

Results from clinical trials conducted with the oral antidiabetics pioglitazone, metformin and glyburide in combination with vildagliptin have shown no clinically relevant pharmacokinetic interactions in the target population.

Drug-drug interaction studies with digoxin (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after co-administration with vildagliptin.

Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin. In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin. However, this has not been established in the target population.

- Eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.

Metformin

Metformin must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable.