Biolaxy Secures IND Approval for Oral Insulin
By Shanghai Biolaxy, PRNEMonday, November 23, 2009
SHANGHAI, November 24 - 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."
Notes for Editors
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. Currently, insulin treatment in China particularly is under
used.
About Biolaxy
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.
More information can be found at www.biolaxy.com .
William Lee, Ph.D., CEO, +86-21-6194-0758, info at biolaxy.com
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