Biocon now has come out with Cymgal (Valganciclovir), a post-transplant antiviral drug with a US Food and Drug Administration (FDA) grade active pharmaceutical ingredient (API). The company is the only player in the country with a US FDA API other than the drug innovator Roche.

Cymgal was introduced by the company in July 2012. The US FDA clearance for its API proves the high quality of the drug giving it an edge in terms of post-transplant outcomes.

Early this year, the company introduced Biosev C (Sevelamer Carbonate), which is an advanced phosphate binder for patients of chronic kidney disease (CKD).

These two products have taken the total nephrology portfolio of Biocon to 10 products for CKD and end stage renal disease (ESRD). “The effort is to ensure our products are affordable to patients still maintaining the highest quality standards,” - Dipankar Paul, associate director and head, nephrology division, Biocon Limited told Pharmabiz.

On the occasion of the World Kidney Day observed this year on March 14, the company has planned a massive awareness drive across hospitals on the importance of kidney health. Biocon started ‘NKompass’ a continuing medical education (CME) forum for Indian nephrologists and organised eight major programs across cities since November 2011. “Being one of the largest manufacturers of immunosuppressants in the world, drugs used in prevention of organ rejection in transplant patients, helps to bolster our presence in the segment,” he added.

Further, the company was also the first to introduce erythropoietin injections with a safety device to prevent needle stick injuries, which helps in preventing transmission of pathogens in dialysis units. Presently, its erythropoietin injections are available in vials, prefilled syringes, and safety devices, which cater to the needs of patients of all economic categories.

The market for post transplant drugs is on an upswing going by the number of ESRD patients requiring a transplant. There is a huge need for post transplant drugs to avoid rejection of the new kidney. Cymgal is estimated to have a market size of Rs.14 crore and Biocon is a major player in the space along with Roche besides other small players too, he added.

In the case of Biosev C with its active ingredient Sevelamer Carbonate is an advanced phosphate binder. In dialysis patients, the phosphorus levels should be maintained between 3.5 to 5.5mg/dl. This indicates the importance and indispensability of the drug. The innovator for Sevelamer Carbonate is Genzyme. Emcure is the other major player in the segment, stated Paul.

Indian nephrology market is valued at Rs.550 crore. The major players are Roche and Novartis representing global companies. From a national perspective the key companies are Biocon, Panacea Biotec and Emcure.

Biocon is estimated to have a market share of about eight per cent. Its products are ranked amongst the top three brands: Erypro, Tacrograf and Renodapt in the molecule category, said Paul.