CHICAGO, May 9 /PRNewswire/ -- Alveair(TM), Coremed, Inc.'s unmodified "needleless" yet inhalable insulin, is now the focus of a global pharma consortium's plans that soon could introduce the fast-onset, long-lasting nano-technology drug delivery system around the world, it was announced.

A privately held drug-delivery company, Coremed, Inc., exclusively focuses on the development of inhalable and oral insulin technology.

Over the past several years, the company has conducted an intensive pre- clinical trial of its insulin nano-technology, which is a major breakthrough in the delivery of macromolecules and protein drugs. The technology formulates unmodified protein molecules into sub-micron particles that resist enzymatic degradation and promote permeability and absorption.

Current injectable insulins on the market include Novolog (TM), Humalog (TM) and Aprida (TM), which are fast-onset and of short duration. Alveair (TM) is both fast-onset and long-duration. Delivered by inhalation, Alveair is "needleless."

Based on pre-clinical trials, Alveair is distinctively advanced in technology and different in market potentials for the following reasons:

- It has fast onset comparable to subcutaneous Aspart analog insulin injection. - It achieves efficacy comparable to injected insulin. - It has sustained efficacy of at least eight hours' duration. - Significant therapeutic blood levels of insulin were achieved for 12 hours. - It has minimal or nearly no residue. - Based on HPLC studies, Alveair insulin is unmodified; therefore, it is much less likely to induce immune abnormalities. - The inter- and intra-group data were tight and compact. - Positive results have been reported in its preliminary human trial. - In its limited human trial, there is not a single incidence of coughing in both smokers and non-smokers. - It has a dual platform of analog and regular insulins.

"Alveair's long-acting duration and efficacy is clearly an advantage," Frank K. Leung, M.D., F.A.C.E., Coremed's founder, said. "It also makes sense to minimize the risks and exposure of pulmonary delivery. Alveair will be in two clinical development directions: regular pathway and fast-track in different countries."

A global consortium of major international diabetes companies in both the United States and overseas is currently taking shape, he said. Based on Alveair's insulin technology, this global partnership has the potential to encompass the largest global diabetes market share under the current market network.

Its partners are capable of producing bulk insulin API at costs that are much lower than current suppliers. With its technological know-how and capabilities, the consortium could offer up-to-date diabetes care to countries around the globe, and worldwide market share for the companies beyond their regional network and distributions.

In another development, Leung announced that Coremed's Intesulin (oral insulin) is in its initial trial of diabetic human subjects. In a limited number of patients, the data are positive from the delivery of a single gel- capsule. There are no reported gastrointestinal irritations, metabolic abnormalities or hypoglycemia thus far, he said. Data were unpublished.

Coremed, Inc., is to present a company overview at BIO2005's annual international convention in Philadelphia on June 21. The company has presented over 40 abstracts of its experimental data at numerous professional scientific meetings of the American Diabetes Association and Endocrine Society from 2000- 2005.
Source: Coremed, Inc.