Wednesday December 8, 8:04 am Eastern Time
Company Press Release
SOURCE: Flamel Technologies S.A.
Flamel Technologies Announces $42 Million
Development and Licensing Agreement with Novo
Nordisk for Long-acting Insulin
LYON, France, Dec. 8 /PRNewswire/ -- Flamel Technologies (Nasdaq: FLMLY - news) announced today they have
entered into a development and licensing agreement with Novo Nordisk (NYSE: NVO - news) for Basulin(TM), Flamel's
long-acting basal insulin product for Type I and Type II diabetes.
Under the terms of the agreement, Novo Nordisk acquires exclusive worldwide development and marketing rights to
Basulin(TM). In return, Flamel Technologies receives up-front licensing fees of $5 million including $1 million received earlier
this month, potential $37 million in milestone payments and royalties on future product sales. Novo Nordisk will fund the
clinical trials and product development. In addition, Flamel Technologies will supply Novo Nordisk with Medusa©
nanoparticles for Basulin(TM). Further details of the agreement were not disclosed.
Basulin(TM) is a long-acting, once-a-day formulation of human insulin utilizing Flamel's Medusa© controlled delivery system
for subcutaneously administered therapeutic proteins and peptides. In preclinical tests, Basulin(TM) provided continuous,
24-hour coverage compared to standard 12-hour coverage provided by marketed products. A Phase I clinical trial of the
product is currently underway in the United Kingdom. Results are expected in the first quarter of next year.
``In addition to the convenience of a once-a-day product, Basulin(TM) may also provide an overall improvement in glucose
control and a reduction in the longer-term complications often associated with diabetes.' said Dr. Philippe Vivet, Flamel's
Medical Director. He also explained that diabetics typically require two formulations of insulin to maintain the ideal level of
glucose in their blood: one fast-acting and one long-acting. Long-acting insulin provides continuous therapy to ensure blood
glucose levels do not rise or fall to dangerous levels that can lead to serious medical complications.
Gerard Soula, Flamel's President and Chief Executive Officer, commented, ``As a leading provider of insulin products for the
treatment of diabetes, Novo Nordisk is the ideal development and marketing partner for Basulin(TM). Their commitment and
enthusiasm for this project are gratifying and we consider these further validation of our innovative Medusa© technology that
provides the foundation for Basulin(TM).' 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. Dr. Soula added that Basulin(TM) is the first application of Flamel's
Medusa© delivery system for therapeutic proteins, peptides and small molecules.
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(TM) system; ColCys(TM) biomaterial-based medical
devices; and photochromic materials for eyeglass lenses.
Agsome(TM), Basulin(TM) and ColCys(TM) are trademarks, and Micropump© and Medusa© are registered trademarks of
Flamel Technologies.
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 for the period ended December 31, 1998.
SOURCE: Flamel Technologies S.A.
More Quotes
and News:
Flamel Technologies SA (NasdaqNM:FLMLY - news)
Novo Nordisk A/S (NYSE:NVO - news) |
