Micropump Pipeline

COREG CR™

Flamel licensed the worldwide rights for the application of Micropump® to GlaxoSmithKline (GSK) for a beta blocker used for the treatment of hypertension, heart failure and heart attack.

COREG CR is unique in that it permits once daily dosing for patients, with no increase in Cmax or Cmin. Click here to see the Coreg CR pharmacokinetic curve.

GSK announced on March 22, 2007 nationwide availability of once-a-day Coreg CR™ for the treatment of three key cardiovascular conditions

To learn more about COREG CR, please click here.

ACE inhibitor

Flamel announced in 2002 a licensing agreement with Servier Monde for the application of Micropump to an undisclosed ACE inhibitor. The agreement provided for an initial payment of $3 million upon signing of the agreement. During the second quarter of 2003, Flamel received a milestone payment of $0.5 million from Servier and has received to date over $12 million from Servier with respect to this agreement.

Trigger Lock™, application of MICROPUMP for pain management

Opioid analgesics are used to treat patient suffering from severe and chronic pain. A major problem faced by the industry is the growing abuse and misuse of its drugs by drug abusers, who extract the active ingredient from the drugs and achieve their immediate release. We have applied our MICROPUMP technology to address this issue in creating Trigger Lock.

Trigger Lock products cannot be crushed to extract the active ingredients. We believe that other methods commonly employed by drug abusers to liberate the active ingredient are also ineffective as against Trigger Lock.

On June 14, 2005, Flamel Technologies filed its fifth PCT (Patent Cooperation Treaty) patent application with the European Patent Office regarding its Trigger Lock technology.

This product was developed internally and is available for licensing.

Augmentin SR

Flamel Technologies is developing multiple formulations of Augmentin, an amoxicillin/clavunate potassium antibiotic, for the treatment of various conditions.

This product was developed internally and is available for licensing.

Proton Pump Inhibitors (PPI)

Proton pump inhibitors prevent the creation of acid in the stomach, which may cause heartburn and can lead to a condition known as acid-reflux disease, caused when stomach acid backs up into the esophagus.
The market for that class of drugs is estimated at $23 billion in 2006.
The Micropump® platform is effective in improving efficacy of these drugs. Our clinical trial of Omeprazole SR demonstrated significantly greater efficacy than Nexium®.

Genvir™ (controlled-release acyclovir)

The Company is developing Genvir,™ a controlled-release formulation of acyclovir for the treatment of genital herpes.
The worldwide sales of herpes treatment (including branded and generic acyclovir and prodrugs such as valacyclovir and famcyclovir) totaled an estimated $2.2 billion in 2006 (source: companies public information and reports, Flamel estimates).
The results from the phase III study in acute herpes treatment proved the efficacy and safety of the product, with significant potential dosing and compliance advantages over formulations of acyclovir. The results were also competitive with the results seen in phase III trials of Valtrex® (GSK) and Famvir® (Novartis).
Link to the summary of the study.

Metformin XL

This product is a controlled-release formulation of metformin, an oral anti-diabetic drug for the treatment of type II diabetes.
According to Visiongain ("The World Diabetes Market, 2005– 2011,” March 2006), the global market for oral antidiabetic drugs in 2004 exceeded $7 billion, with a growth rate of 9%.
Metformin XL’s competitive advantage relies on the ease of swallowing 2 gram per day doses of the drug (this microparticle-based formulation can be manufactured as oro-dispersible tablets, sachets and syrup). Based on modified size and type of tablet, Flamel’s formulation of metformin should improve patient compliance with a once-a-day regimen.

The product is available for licensing.