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Notice of meeting Combined Shareholders' Meeting Friday

Key Takeaway: Shareholders' Meeting Friday June 26, 2015 At 11.00 Flamel Technologies S.A. I Flamel.com CONTENTS 1 NOTICE & AGENDA 2 HOW TO PARTICIPATE IN THE MEETING 4 Management Report By The Board Of Directors To The Shareholders' Meeting To Be Held On June 26, 2015 5 APPENDIX 1 TABLE OF

Full Press Release Details

Shareholders' Meeting
Friday June 26, 2015 At 11.00
Flamel Technologies S.A. I Flamel.com
CONTENTS 1
NOTICE & AGENDA 2
HOW TO PARTICIPATE IN THE MEETING 4
Management Report By The Board Of Directors To The Shareholders' Meeting To Be Held On June 26, 2015 5
APPENDIX 1 TABLE OF EARNINGS FOR THE LAST FIVE FINANCIAL YEARS 25
APPENDIX 2 REPORT CONCERNING DELEGATIONS MADE TO THE BOARD 26
Presentation Of The Resolutions - Report By The Board Of Directors To The Combined Shareholders Meeting To Be Held On June 26, 2015 27
Proposed Resolutions Presented At The Combined General Meeting To Be Held On June 26, 2015 34
REQUEST FOR ADDITIONAL DOCUMENTS AND INFORMATION 49
We are pleased to invite you to attend
the Combined Ordinary and Extraordinary General Meeting of Flamel Technologies, SA that will be held on Friday, 26th June 2015
at 11:00 am (Paris time), at Company headquarters, located at 33, avenue du Dr Georges L vy, 69693 V nissieux, France,
in order to deliberate on the following agenda:
Within The Competence Of The
Ordinary General Shareholders' Meeting
Within The Competence Of The
Extraordinary General Shareholders' Meeting
The present Notice of Meeting includes:
A voting form, to be used to vote by post
Information about how to participate in
the General Meeting is provided hereafter.
The required quorum for extraordinary resolutions
is one fourth (25%) of the total outstanding shares with voting rights, upon first call of the shareholders' meeting. If such quorum
is not met, the Board of Directors will give a second notice of Shareholders' Meeting. At this second Meeting, which shall
take place within two months after the first meeting, the required quorum is one fifth (20%) of the total outstanding shares with
IF THE QUORUM FOR THE ORDINARY MEETING
IS NOT MET ON JUNE 26, 2015, SHAREHOLDERS WILL BE INVITED TO VOTE AT A MEETING WHICH WILL BE HELD ON JULY 3, 2015 ON THE SAME AGENDA,
AS DESCRIBED IN THIS NOTICE.
TO PARTICIPATE IN THE MEETING
All shareholders and bearers of voting
right certificates may take part in the General Meeting by attending the Meeting in person, appointing a proxy of their choosing
to represent them or voting by post.
Nevertheless, if you expect to be present
at the meeting, please note that shareholders will be admitted to the General Meeting whatever the number of shares they hold provided
they are owner of registered shares and their shares have been registered in a share account held by the Company at least one day
prior to the date of the meeting.
will need to provide evidence of share ownership
Holders of registered shares need only
register their shares in a registered share account, as specified above, to be able to take part in the General Meeting. Caceis
Corporate Trust will therefore issue proof that they are shareholders.
American Depositary Shares (ADS)
Holders of ADS shall take part in the General
Meeting by voting by post provided that their shares have been registered in a bearer share account held by an accredited banking
or financial intermediary. The accredited banking or financial intermediary that holds the share account will therefore be responsible
for issuing proof that they are shareholders and producing a certificate of share ownership, as specified above, to the General
Meeting coordinator (centralisateur), i.e. The Bank of New-York - BNY Mellon.
The record date for ADS Owners entitled
to vote at the Combined General Meeting is May 19, 2015.
If you wish to appear and vote at any meeting
of the holders of Shares, you must surrender your receipts and become registered on the registry maintained by or on behalf of
Flamel Technologies S.A. at least (i) one (1) Paris Business Day prior to the date of the relevant shareholders' meeting to appear
and vote at such meeting.
are requested to cast a postal vote
Your postal voting form or proxy form
will be provided by your broker. You must complete and sign the voting form and return it to the General Meeting coordinator
via the banking or financial intermediary that holds your share account, along with the certificate of share ownership referred
Voting forms will only be taken into
consideration if received by the General Meeting coordinator by June 18, 2015 at the latest.
Any questions related to voting by ADS
holders should be addressed directly to your broker.
Management Report By The
Board Of Directors To The Shareholders' Meeting To Be Held On June 26, 2015
1. The Company's activities in 2014 6
2. Financial Results for 2014 10
3. Goals and Prospects for the Company for 2015 13
4. Research and Development activities 14
5. Share Capital 17
6. Group Structure 20
7. Management and Directorship of the Company 21
8. Important events occurring between the end of the financial year and the date of the present report 24
APPENDIX 1 TABLE OF EARNINGS FOR THE LAST FIVE FINANCIAL YEARS 25
APPENDIX 2 REPORT CONCERNING DELEGATIONS MADE TO THE BOARD 26
The auditor reports, the annual financial statements, as well as all documents relating thereto have been made
available to you at the Company's registered office according to legal and regulatory requirements.
The annual financial statements presented
to you have been established in accordance with French accounting laws, principles and methods.
Please note that the accounting methods
used to prepare these annual financial statements are the same as the ones used for previous financial years.
Flamel Technologies SA is a specialty pharmaceutical
company utilizing core competencies in drug delivery and formulation to develop safer and more efficacious pharmaceutical products
to address unmet medical needs and/or reduce overall healthcare costs. Flamel has a balanced business model consisting of a successful
previously Unapproved Marketed Drugs ("UMDs") business with two marketed products in the USA, Bloxiverz
and Vazculep , and a branded business, focusing on the development of products utilizing Flamel's proprietary drug
delivery platforms. The branded products are based on proprietary drug delivery platforms and target high-value solid oral and
alternative dosage forms using 505(b)(2) and Biosimilar pathways where the Company can develop strong intellectual property positions
and deliver meaningful patient benefits. Flamel's business model allows the Company to select, develop, seek approval for,
and commercialize niche branded and generic products, initially targeted for the U.S. market. The Company is able to self-fund
the development of most product development opportunities.
Flamel is headquartered in Lyon, France
and has operations in St. Louis, Missouri, USA, and Dublin, Ireland.
As of December 31, 2014, Flamel had 109
full-time employees based in France and an average of 210 full-time employees over 2014. The divestiture of the Pessac Facility
resulted in the transfer of 107 employees on December 1, 2014 to Recipharm Pessac SAS.
Both products are commercialized in the
USA by Flamel's subsidiary clat:
Bloxiverz (neostigmine
methylsulfate injection), Flamel's first NDA approval. Bloxiverz's NDA was filed in August 2012 and approved by
the FDA on May 2013. The launch of Bloxiverz (10mL multiple dose vial at 0.5 and 1.0 mg/mL strengths) commenced in July
2013. Bloxiverz is a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular
blocking agents after surgery. Bloxiverz is the first and only FDA-approved version of neostigmine methylsulfate, even though
other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug and Cosmetic Act
of 1938. Compared with the remaining unapproved marketed products, Bloxiverz has proven and approved safety, efficacy and
quality. Today, neostigmine is the most common agent used for the reversal of the effects of other agents used for neuromuscular
blocks. There are approximately 5 million vials sold annually in the U.S. The volume of sales of Bloxiverz is dependent
upon, as per FDA guidance the FDA removing all unapproved products from the market in a timely manner (typically one year post
approval). All manufacturers of unapproved versions of neostigmine methylsulfate have been notified by the FDA to cease manufacturing
of the unapproved product as of July 30, 2014. On January 8, 2015, the FDA approved Fresenius Kabi USA ("Fresenius")'s
NDA for neostigmine methylsulfate (for both 0.5 mg/1mL and 1 mg/1mL strengths). On January 15, 2015, Flamel's increased the
WAC for Bloxiverz to $98.75 (from the previous WAC of $35.80) per vial for both the 0.5 and 1.0 mg/mL strengths.
In the future, the volume of sales of Bloxiverz is dependent upon the competitive landscape between Eclat, APP,
and any subsequent ANDA approvals that may occur.
Vazculep (phenylephrine hydrochloride
injection), Flamel's second NDA approval. On June 28, 2013, the Company filed an NDA for a second product developed by
clat and later identified as Vazculep (phenylephrine hydrochloride injection). The product was approved by the FDA
Last updated: Mar 22, 2016