In a major effort to protect the safety of both the nephrologists and the kidney patients, Biocon has developed an innovative pre-filled syringe (PFS) containing Erythropoietin, a recombinant DNA.

PFS is a safety device that helps prevent infection transmission to both the nephrologists and patient during the subcutaneous epoetin therapy. It is a novel product developed in association with a US company.

"PFS will now help contain the infection and we have taken into consideration the safety of both the nephrologists and the patients. The device can allow a patient to inject himself under the guidance of a doctor. The procedure of administrating Erythropoietin becomes more simple", Rakesh Bamzai, president, marketing, Biocon Limited told Pharmabiz.

On the World Kidney Day observed on March 13, the company is keen to protect both the nephro specialist and the patient.

Biocon is the only company in the country to launch the device. This provides the company with a first mover advantage for the chronic renal failure therapy. This is the sixth drug in the nephrology portfolio, stated Bamzai.

The company which entered the nephrology drug market with the launch of five products in March 2007 on World Kidney Day is known to offer the drugs at around 40 percent lower. "Even PFS is competitively priced," he informed.

The other five immunosuppressant drugs for chronic kidney disorders (CKD) are Renodapt (Mycophenolate Mofetil), Tactograf (Tacrolimus), Cyclophil ME (Cyclosporine Micro Emulsion USP), Rapacan (Sirolimus) and Erypro (rHuEPO).

The five drugs have generated a positive response. The entire range is registered in many countries including Middle East, South East Asia and Europe.

In India, over 1.2 lakh patients suffer from CKD and only 20 per cent can afford the treatment. Annually only 3500 transplants are conducted and 7000 patients take dialysis.

In the US, around 20 million adults suffer from CKD which is about one in nine adults. Over 71 per cent of the CKD cases are due to diabetes, and hypertension. By 2015, CKD and cardiovascular diseases will result in 36 million fatalities. Globally over 1.5 million CKD cases survive with either hemo or peritoneal dialysis or transplantation. The numbers of cases are expected to double within the next decade.

In India the nephrology drug market is Rs 300 crore and growing at 25 per cent. Companies which have a nephrology drug portfolio include two multinational Roche and Novartis. Among Indian companies are Panacea Biotech and Wockhardt. Biocon has a comprehensive portfolio in the segment.

The key issue in India is that the medical insurance providers do not support CKD patients. Unless a comprehensive insurance is extended, it will be difficult for patients to access the drugs which are expensive, pointed out Bamzai.

Biocon is gearing up to garner 20 per cent market share over the next three years with the nephrology formulations with its high quality and affordable prices. It also markets active pharmaceutical ingredient MMF Mycophenolate mofetil used for treating nephrotic syndrome.