Armed with the European Union’s good manufacturing practices (GMP) certification, Intas Biopharmaceuticals Ltd will soon start clinical trials of its filgrastim brand Neukine in Europe. Filgrastim helps the bone marrow make new white blood cells and thus offset the side effects of chemotherapy. Neukine was the first drug introduced by Intas in India.
It has also scheduled clinical trials of erythropoietin and interferon alpha in the European market next year.
While erythropoietin, a glycoprotein hormone produced by kidney, is used in treating anemia resulting from chronic renal failure, interferon alpha is a natural protein produced by the immune system cells are useful in fighting RNA-virus infection.
Dhananjay Patankar, head of research & development at Intas, said: “We are looking at newer opportunities in the regulated markets after we got the EU-GMP recently.”
The EU’s GMP certification would enable Intas to strengthen existing alliances and look forward to possible agreements with other pharmaceuticals and biotech companies in Europe. It will also simplify the procedure for product registration in different countries of the world.
Intas had already launched erythropoietin and interferon alpha in the domestic market and a few international markets.
The company plans to spend Rs 10 crore a year for R&D. “The target is to produce one product every year,” said Patankar. It has also lined up Rs 250 crore to build manufacturing facilities.
Earlier this year, Intas forged a research agreement with US-based Virionics Corp to co-develop a vaccine for human papilloma virus (HPV-16 & HPV-18), which causes cervical cancer.