Bentley Pharmaceuticals has entered into an agreement with Dong Sung Pharmaceuticals for the development of an intranasal spray formulation of insulin for the South Korean market with the view of extending this deal into additional territories.
The specialty pharmaceutical and drug delivery company, which has a growing branded and generic product line in Europe, reported the results of a Phase II trial of the formulation, called CPE-215, in December last year.
This study was the first intranasal insulin trial conducted in a target population of diabetic patients and was intended to assess absorption of insulin and timing of dosing.
Under the agreement, the two companies have agreed to conduct Phase II and Phase III studies designed to comply with international standards that would be applicable for regulatory submissions in South Korea and possibly in other countries.
The agreement would see a joint working team consisting of Bentley and Dong Sung employees guiding the development process in Korea. Dong Sung will fund the appropriate studies and submit the regulatory documents required for their licensed territory. Bentley will provide clinical and commercial supplies of insulin formulations, as well as metered administration devices.
"The generation of more advanced clinical data through this collaboration could be valuable in supporting other developmental strategies for Asia, the EU and the US. The development of this product has also given us encouragement that our platform technology may be used to deliver other peptides," said James Murphy, chairman and CEO of Bentley Pharmaceuticals.
Dong Sung have been working on the development of non-parenteral administration of insulin and other therapeutic agents since 1997, underlying the time and resources allocated to this area of research.
Scientists have known for years that the intranasal route of administration of therapeutic agents was a highly efficient route, but success in this route of administration has been difficult due to low delivery payload, poor reproducibility and/or mucosal irritation.
"We are excited by the potential to bring this intranasal insulin product to those suffering from Type I diabetes. If the study lives up to our expectations then the product will receive the regulatory clearances needed in the Republic of Korea, Asia, Europe and the Americas," added Yang-Gu Lee, president of Dong Sung.
A number of inhaled products are already in late-stage clinic and one, Pfizer and Sanofi-Aventis' Exubera, is already under regulatory review. However, fear of side effects seen with inhaled products - the result of lung function testing in animals - could limit the use of these products and leave room for other delivery approaches.
The agreement is Bentley's first to develop and license its intranasal spray formulation of insulin. Bentley previously announced that it will report the results of its initial Phase II clinical trial in an abstract, entitled "Intranasal Insulin Administration in Type I Diabetic Patients Utilizing CPE-215 Technology" at the American Diabetes Association 65th Scientific Sessions, June 10-14, 2005, in San Diego, California.
Previous reports of Bentley's intranasal insulin development program were published in Diabetes Technology and Therapeutics, Vol. 7 (1): 124-130, 2005.