The research based pharmaceutical company Glenmark Pharmaceutical Ltd is making huge investments in the biology segment. Its three new biologics entities (NBEs) are at the discovery stage and two NBEs are expected to complete phase I trial by FY 2009-10. The company has already built a strong pipeline for its six molecules.
Glenmark is planning to invest close to US $20 million every year on research and development against US$15 million during the last fiscal. The company is aggressively working towards the biology segment and willing to invest huge amount.
Speaking to the Pharmabiz, Glenn Saldanha, managing director and CEO, said, "We are a research driven company. Our continued efforts in research have helped us to build a strong NCE pipeline of six molecules and given us confidence for the future. In a span of seven years, we have developed a pipeline of 11 molecules three of which are in clinical development and other eight are at various stages of preclinical development and discovery".
Inflammatory conditions, diabetes, oncology and obesity are key disease segment being currently researched at Glenmark. Its North American partner has commenced phase II testing on oglemilast (GRC3886), a PDE-4 inhibitor for the indications of Asthma and COPD.
The company has concluded an agreement for GRC-8200 with Merck KgaA, where Merck will develop and commercialise the molecule for markets in North America, Europe and Japan. Glenmark will retain exclusive rights for the Indian markets and will co-commercialise in the rest of the countries. Its lead candidate for pain GRC-6211 will enter in phase II clinical trails in Europe and the other three molecules are into preclinical stages of development. These three molecules will enter the clinics before the end of FY 2008. The company has purchased all the rights to two NBE's CHR-1103 and CHR-1201 from Chromos Molecular System Inc., of British Columbia, Canada.
Currently, it is spending around five per cent of total sales revenue on R&D. The strength of the manpower in its Indian R&D centre is 450, whereas at Switzerland is around 40. All the biology works is mostly carried out at Switzerland. Till date, Glenmark has filled 700 dossiers for marketing approvals and received over 500 approvals for its products in the semi regulated markets. Glenmark has commenced commercial supplies to the US for several products and also filed 11 US DMFs, eight European DMFs, five Certificate of European Pharmacopoeias (CEPs) and three Canadian DMFs. It targets to file 12-14 US DMFs during the current fiscal and several in Europe, Canada and other markets. Till now the company has filled 40-50 patents and willing to file more patents in both sides.
The company's new manufacturing facility at Baddi has upgraded with a lotion line and additional ointment line. The company also commissioned its oncology solid dosages products manufacturing facility at its plant in Kundiam, Goa and the oral dosage facility at the Goa plant expanded in line with US FDA guidelines and GMP requirements.
Talking about future plans, Saldanha, said, "The growth plan is focusing more on new registration, launches and expansion of commercial operation into newer countries. We aim to be a global speciality company with the launch of at least two proprietary molecules through a product pipeline by own research and in-licensing/buyouts of NCEs and NBEs. The long term plan is to establish specialty front ends in the US, key European and semi regulated markets".