Roche Scientific Company India is planning to launch anaemia drug, CERA, developed by its parent company, Hoffmann-La Roche Ltd, in India by 2007. The company is awaiting US FDA approval for CERA. If it gets FDA approval this year, it is likely to hit Indian market next year.
CERA (Continuous Erythropoietin Receptor Activator) is a new drug for the treatment of anaemia in chronic kidney disease patients. CERA, the long-acting anti-anaemia agent, is the first and only continuous erythropoietin receptor activator and the only anti-anaemia drug to have ever studied long dosing intervals of once every four weeks in all patients for its initial filing.
It is a distinct molecule with a unique mechanism of action which promises to deliver rapid, sustained and stable correction of anaemia. In November last year, the company had finished its phase III trials for CERA in the US.
A senior company official of Roche India told Pharmabiz, "We are expecting the approval for CERA in the US this year and once get US FDA approval, we will apply for DCGI approval and hope it will be approved in 2007 itself."
The market for erythropoietin (a protein produced by the kidneys) is lucrative. The erythropoietin market in India is growing at a rate of 20 percent. The EPO market is estimated at about Rs 75 crore. At the end of 2004, the world market for erythropoietin was valued at $11.1 billion, a growth of 8% over 2003. The market has been growing at an average annual growth rate of 18% over the previous 5 years.
The companies that are marketing EPO in India include Shantha Biotechnics (Shanpoietin), LG Life Sciences India (LG Espogen Inj), Ranbaxy (Ceriton), Johnson & Johnson (Eprex), Emcure Pharma (Vintor for Nephrology and Epofer for Haematinics), Wockhardt (Wepox), Zydus Biogen (Zyrop), Hindustan Antibiotics (Hemax) and Intas Pharmaceuticals (Epofit and Erykine).
On its clinical trials for CERA, a Roche release says, the aims of the phase III programme were to confirm the efficacy of CERA at extended administration intervals for the correction of anaemia and the maintenance of Hb levels and to demonstrate its long-term safety and tolerability. The phase II - III programme is the largest programme undertaken for a drug treating renal anaemia, and involving more than 2,700 patients from 29 countries.
The maintenance studies met their primary endpoints and show that both intravenous and subcutaneous CERA, when given at extended dosing intervals, was effective in maintaining Hb levels. Generally, the safety profile is characteristic of the population under study. The full review of the benefit-risk assessment of CERA will be made by the health authorities after filing in 2006, added the release.
In the field of anaemia therapy, NeoRecormon (epoetin beta) is Roche's leading treatment for patients with kidney disease and cancer with over one million patient have undergone treatment.