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.