Flamel Technologies Announces Profitable First Quarter Results; Increased Cash Levels

Flamel Technologies Announces Profitable First Quarter Results;

Increased Cash Levels

LYON, France May 11, 2009 Flamel Technologies (Nasdaq: FLML) today announced its financial

results for the first quarter of 2009. First quarter highlights included:

For the first quarter 2009, Flamel reported total revenues of $12.1 million versus $10.9 million in

the year-ago period. License and research revenues during the quarter were $7.1 million and

included a $4 million milestone from GSK; license and research revenues during the year-ago quarter

were $3.5 million and included a 500,000 ($0.75 million) milestone from Merck Serono. Product

sales and services, pursuant to the Company s supply contract with GlaxoSmithKline declined in the

first quarter to $2.4 million from $4.7 million in the year-ago quarter. Other revenues in the

quarter were $2.5 million, as compared to $2.6 million in the year-ago quarter.

Operational expenses in the first quarter 2009 declined 22% from $15.8 million in the year-ago

quarter to $12.4 million. Costs of goods and services sold were $2.1 million, as compared to $2.4

million in the first quarter of 2008. Costs and expenses of Flamel s research and development were

$7.4 million, compared to $9.3 million in the first quarter of 2008. SG A expenses during the

quarter declined from $4.1 million in 2008 to $2.9 million in the first quarter 2009.

Net income for the first quarter 2009 was $1.2 million as compared to a net loss of ($3.7) million

in the first quarter of 2008. Net income per share (basic) for the first quarter of 2009 was $0.05,

compared to a net loss per share (basic) in the year-ago period of ($0.15). Net income per share

(diluted) for the first quarter of 2009 was $0.05. Cash and marketable securities at the end of

the first quarter totaled $39.1 million and did not include receipt of the $4 million milestone

from GSK. Cash and marketable securities as of December 31, 2008 were $37.1 million.

Stephen H. Willard, Flamel s Chief Executive Officer, stated, During the first quarter, we made

continued progress in expanding our partnership model. We are beginning to enjoy the fruits of

work that we have undertaken over the past few years, such as with the announced license agreement

with Merck Serono. There are numerous additional feasibility studies that could serve as potential

catalysts for further license agreements. The strength of our technology and the success of our

scientists in creating value for our partners are driving this process, which we believe may

in the remainder of this year. Our financial strength is an especially important asset

to us as we negotiate these potential license agreements and as we work to develop new feasibility

studies to fuel our future growth.

Flamel Technologies, S.A. is a biopharmaceutical company principally engaged in the development of

two unique polymer-based delivery technologies for medical applications. Micropump is a

controlled release and taste-masking technology for the oral administration of small molecule

drugs. Flamel s Medusa technology is designed to deliver controlled-release

formulations of therapeutic proteins.

A conference call to discuss earnings is scheduled for 8:30 AM EDT May 11, 2009. To participate in

the conference call, investors in the US and Canada are invited to dial 1-800-860-2442.

International callers are invited to call 1-412-858-4600. The Conference ID number is: 430430. The

webcast of the conference call will be available on the Company s website: www.flamel.com.

Charles Marlio, Director of Strategic Planning and Investor Relations

FRANCE: 33 (0) 4 7278-3434

Fax: 33 (0) 4 7278-3435

This document contains forward-looking statements within the meaning of the Private Securities

Litigation Reform Act of 1995, including certain plans, expectations, goals and projections

regarding financial results, product developments and technology platforms. All statements that

are not clearly historical in nature are forward-looking, and the words anticipate, assume,

believe, expect, estimate, plan, will, and similar expressions are generally intended to

identify forward-looking statements. All forward-looking statements involve risks, uncertainties

and contingencies, many of which are beyond our control, 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 Annual Report on the Securities and Exchange Commission Form 20-F for the year

ended December 31, 2007. All forward-looking statements included in this release are based on

information available at the time of the release. We undertake no obligation to update or alter

our forward-looking statements as a result of new information, future events or otherwise.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of dollars except share data)