The Gujarat based Intas Biopharmaceuticals Ltd (IBPL) will soon start clinical trials for filgrastim brand Neukine in Europe. The company has also planned its clinical trials of erythropoietin and interferon alpha in the European market next year.
The company has significant presence in North America with agreements and MoUs with three technology companies. Besides, North America, Europe is a crucial market for the company. The company is looking to strengthen its presence in the Europe, through alliances and exploring opportunities of clinical trials in the region. The process of clinical trials is mandatory and a pre-requisite for the company to develop the products and market them in Europe.
Speaking with Pharmabiz, Dr Dhananjay Patankar, chief technical officer and head (R&D), IBPL, said, "We are looking for newer opportunities in the regulated markets after receiving the EU-GMP certification. In Europe, the certification allows simplification of norms/procedures for product registration by significantly reducing the time required by the company to get the product registration. Moreover, Europe is an ideal market for IBPL to serve the goal of developing innovative research technologies/new molecules related to biopharmaceuticals; evaluate technology platforms; identify partnership opportunities, in-licensable IPs; and to build up Novel Drug Delivery System."
Filgrastim is in a class of drugs known as growth factors. It promotes the growth of white blood cells, which help to fight infections. Filgrastim also is used to increase white blood cell counts in adults with myelodysplastic syndrome (MDS) and to treat low white blood cell counts in adults with acute myeloid leukaemia who have received chemotherapy. Filgrastim has been used to increase white blood cell counts in people who have cancer, follow chemotherapy and take medications that lower white blood cell counts. While, Erythropoietin, a glycoprotein hormone produced by kidney, is used in treating anaemia, resulting from chronic renal failure, Interferon Alfa is a natural protein produced by the immune system cells are useful in fighting RNA-virus infection, and is especially useful for hepatitis B and C.
The company, in January 2007, invested Rs 13 crore towards conducting clinical trials and producing Factor IX, a drug used for treatment of Haemophilia-B, through novel transgenic platform. Thereafter, IBPL inked MoU with Canada-based Viropro Inc. for an undisclosed molecule and signed an agreement with US-based Virionics for co-development of HPV therapeutic vaccine.
Neukine was the first drug introduced by IBPL in India after which erythropoietin and interferon alfa in the domestic market and a few international markets. IBPL has also entered into several distribution and marketing agreements with reputed international companies in regulated and semi-regulated markets of Europe, Asia-Pacific, Middle East, Russia and CIS, South and Central America and Africa.
Talking about company's R&D expenditure Patankar said, "The company plans to spend Rs 10 crore a year for R&D. We are well prepared to launch one new product every year."