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Posted: November 24, 2009
Biolaxy Secures IND Approval for Nanoparticle Oral Insulin Delivery
(Nanowerk News) Shanghai Biolaxy announced the Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for its oral insulin project (Nodlin), an innovative insulin formulation to treat diabetes. This IND approval allows Biolaxy to initiate its first phase I clinical study.
Diabetes is a disorder characteristic of high blood glucose and poor metabolism. The complications of diabetes often result in severe micro- and macro-vascular diseases, loss of vision, kidney failure, and amputation. Insulin, as an effective diabetic treatment, can slow down diabetic disease progression. However, insulin is given by multiple daily injections at present, which significantly hinders its use.
Oral drug administration is a preferred route. However, the gastrointestinal (GI) tract is designed to digest nutrients like proteins and presents significant challenges for oral insulin including enzyme degradation and poor absorption. Currently, there is no approved oral insulin product despite intensive research in this field.
Nodlin is developed with NOD technology, a patented bio-adhesive nano-particle oral delivery technology, to overcome the barriers of oral insulin.
"IND approval is a significant milestone achievement for Biolaxy," quoted from William Lee, CEO. "We have experienced long delay in the approval process due to regulatory uncertainties, but we are very happy now Biolaxy is back on track in full speed to develop urgently needed drugs for the patients."
About Diabetes and Insulin Treatment
Diabetes has reached epidemic stage. It is estimated that there are 30-40 million diabetic patients in China with 1.2 million new cases each year. Insulin is a key diabetic treatment with worldwide market value close to $10 billion. Diabetic patients have to endure multiple daily injections for life and patients often are reluctant to use insulin despite the clinical proven benefits of early insulin treatment. Currently, insulin treatment in China particularly is under used.
Shanghai Biolaxy is a development stage biotech company and emerging leader in innovative delivery for biopharmaceuticals. Biolaxy was established in 2005 and is a wholly owned subsidiary of NOD Pharmaceuticals. Biolaxy uses patented platform technology, nano-particle oral delivery or NOD technology, to develop oral formulations for biopharmaceuticals, including insulin, exenatide, interferon, human growth hormone and more.
Nodlin is the first candidate developed with NOD technology and is positioned as basal insulin formulation based on the pre-clinical data. Nodlin possesses unique pharmacokinetic profile and is highly competitive.