Flamel Technologies to Begin Clinical Study of Basulin™
LYON, France, October 4, 1999 -- Flamel Technologies
S.A. (Nasdaq: FLML) announced today that the Medical
Ethics Committee in Manchester, United Kingdom, approved its protocol for a
Phase I study of Basulin™, Flamel's long-acting insulin product.
Basulin™ is a long-acting, once-a-day formulation of
human insulin that is administrated subcutaneously. Extensive preclinical
testing has shown this product could reliably maintain a constant hypoglycemic
effect for 24 hours, significantly longer than currently available commercial
products.
Long-acting insulin is complementary to fast-acting
insulin in the treatment regimens for both Type I and Type II diabetics. The
worldwide market for long-acting insulin is growing and is currently estimated
to account for half of the $2.5 billion total insulin market.
"A once-a-day Basulin™ product would be a great
improvement in the treatment of diabetes," explained Dr. Gerard Soula, President
and Chief Executive Office of Flamel Technologies. "Not only should Basulin™
result in improved patient compliance and comfort, but, more importantly, it
should result in better overall control of the patients' insulin levels. Such
improved control has the potential to reduce the medical complications
associated with diabetes."
The randomized, double-blind, placebo-controlled
study is designed to compare the pharmacokinetic properties, the hypoglycemic
effect, and the safety of the drug in single doses in healthy male volunteers.
The study will begin in the next few weeks in Manchester, England, and will be
completed by year-end 1999.
Discussing the pending study, Dr. Soula said, "Our
business strategy is to move Basulin™, Flamel's primary product, through the
clinical development stage of R&D as quickly as possible. Receipt of this
go-ahead from the Ethics Committee is a key milestone in that strategy." Dr.
Soula further commented that one of the major clinical and competitive
advantages of this product, which should facilitate its approval, is the use of
naturally occurring human insulin rather than modified insulin analog.
"Basulin™ is the first application of Flamel's
Medusa® delivery system for proteins, peptides, and small molecules. Positive
results from this study will validate the Medusa® system. Anticipation of this
further increases our excitement about this study," added Dr. Soula.
Flamel Technologies is engaged in the development of
advanced polymer technologies for unique life science applications. To meet
important medical needs and develop commercially valuable products, the Company
is building on its principal technology platforms: the controlled release of
therapeutic drugs and proteins with its Micropump® and Medusa® systems; the
efficient delivery of agrochemical active ingredients with its Agsome™ system;
ColCys™ biomaterial-based medical devices; and photochromic materials for
eyeglass lenses.
Agsome™, Basulin™, and ColCys™ are
trademarks, and Micropump® and Medusa® are registered trademarks of Flamel
Technologies. NOTE: This document contains a
number of matters, particularly as related to the status of various research
projects and technology platforms, that constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. The
presentation reflects the current views of Flamel's management with respect to
future events and is subject to risks and uncertainties that could cause actual
results to differ materially from those contemplated in such forward-looking
statements. These risks include risks that products in the development stage
may not achieve scientific objectives or milestones or meet stringent regulatory
requirements, uncertainties regarding market acceptance of products in
development, the impact of competitive products and pricing, and the risks
associated with Flamel's reliance on outside parties and key strategic
alliances. These and other risks are described more fully in Flamel's Form 20-F
dated December 31, 1998.