ZUG, Switzerland, November 29 /PRNewswire/ -- BioPartners, a global biopharmaceuticals company and one of the leaders in the emerging field of competitively priced biosimilar products has submitted a marketing authorisation application (MAA) to the European Medicines Evaluation Agency (EMEA) for Valtropin(TM) (somatropin), its recombinant human growth hormone developed in collaboration with LG Life Sciences (LGLS) of Korea.
The application for Valtropin in the treatment of paediatric and adult growth hormone deficiency (GHD) and other growth disorders is currently under regulatory review.
Commenting on the submission Professor Paul Saenger, Professor of Paediatrics at the Albert Einstein College of Medicine in New York, USA and Principal Investigator for BioPartners' Phase III study in GHD children said "Valtropin has been shown to be as safe and efficacious as other growth hormones preparations on the market. If approved it will provide endocrinologists with a cost-effective solution for the treatment of various growth disorders."
Valtropin is the second biosimilar product submitted by BioPartners to the EMEA. Earlier this year, the company submitted an application for its interferon alpha product, which is also currently being evaluated by the agency. "This, as far as we are aware, makes us the only company with two biosimilar products under regulatory review in Europe." stated Mr Jean-Noel Treilles, CEO of BioPartners. "This is a great step forward as biologic drugs can be costly and in some countries this limits their usage. The approval of competitively priced biosimilar products may provide cost-savings for healthcare systems and facilitate the treatment of more patients." he added.
As part of its commitment to the treatment of GHD, BioPartners is co-developing a sustained release formulation of its human growth hormone with LGLS. This innovative formulation, which is currently in Phase II clinical development, offers a more convenient once weekly dose regimen. A product with less frequent administration compared to current daily administered treatments may aid compliance and would therefore be a significant step forward for patients requiring treatment with recombinant human growth hormone.
Human growth hormone is produced in the pituitary gland and exerts its actions both through direct effects on tissues (e.g. through bone and cartilage) and via a family of molecules known as somatomedins, such as insulin-like growth factor 1 (IGF-1). Paediatric human growth hormone deficiency may occur at any time during infancy or childhood, with the most obvious sign being noticeable slowing of growth. The worldwide prevalence of cases is one in 4,000. Growth hormone deficiency in adults is the continuation of a process that began in infancy or childhood, or it may have its onset after adulthood is reached. It is estimated to affect 10 people per million annually worldwide. In both cases, physicians recommend a therapy with growth hormone replacement therapy produced by recombinant technology.
Headquartered in Zug, Switzerland, BioPartners (http://www.biopartners.com/) is a global biopharmaceuticals company and a leader in the emerging field of multi-source biopharmaceuticals. BioPartners' mission is to develop patentable and innovative formulations of "first generation" biopharmaceuticals as well as advanced delivery systems that may improve patient compliance to its product portfolio. BioPartners is developing a comprehensive range of biopharmaceutical products that may offer life-saving therapeutic benefits across many therapeutic areas, including oncology, virology, haematology, endocrinology and neurology.
Notes to Editors:
BioPartners was founded by Global Healthcare Partners and Credit Suisse First Boston. Global Health Care Partners currently consists of some of the most respected and recognised figures in the international pharmaceutical industry. These include Henry Wendt, former Chairman of SmithKline Beecham and current Non-Executive Director of BioPartners and Ted Roberts, former Head of Pharmaceuticals of Merck KGaA and current Chairman of BioPartners.
BioPartners has partnered with LG Life Sciences, the global biopharmaceutical company based in South Korea and German manufacturer Rentschler Biotechnologie, for the development and manufacture of its portfolio of drugs.