Medusa Pipeline

IFN alpha-2b XL (Interferon alpha-2b XL)

As a whole, interferons totaled more than $6.9 billion in estimated sales in 2006, an increase of 10% compared to the previous year. Use of the Medusa^® platform for this compound has been validated in monkey and other animal studies. Flamel’s IFN XL appears to maintain the full activity of native IFN alpha, whereas PEG-ylated IFN (from Schering-Plough and Roche) shows a strong reduction of activity compared with native IFN. This project is being developed internally and is available for licensing.



On April 25, 2008, Flamel Technologies announced the presentation of results of two week study of interferon alpha XL at the European Association for the Study of the Liver.
Click here to access the presentation entitled "Antiviral activity and tolerance of a novel interferon-alpha-2b sustained release(IFN-alpha-2bXL) compared to Peg-IFN-alpha-2b:a phase Ib trial in HCV patients".

FT-105

The Diabetes Market

Worldwide insulin sales in 2006 are estimated at $8.9 billion (Sources: companies press releases and reports; Flamel estimates)

The International Diabetes Federation (IDF) estimates that approximately 194 million people have diabetes in the adult population, or 5.1% (in the age bracket of people aged 20-79) of people in all IDF member countries.

The American Center for Disease Control (CDC) estimate for the same year is that 18.2 million US citizens, or 6.3% of the total population, have diabetes in the USA.

Evolution of the Diabetes Market

Due to the evolution of lifestyle (i.e., more sedentary with greater fat and sugar intake), the number of patients affected with type II diabetes will continue to grow. These patients mainly need basal insulin. For these reasons, long-acting insulin is expected to command an increasing share of the market for insulin.

Therapeutic Need

Insulin serves to regulate the glucose level in the blood. In a non-diabetic person, the body produces insulin in large quantities after each meal to reduce the resulting high glucose level. The body also produces a small quantity of insulin every 15 minutes to ensure that a basal level of insulin is maintained throughout the day. For type II diabetic patients, who represent 90% of the market, there is a need for basal insulin as they often do not produce sufficient quantities themselves.

Flamel's Solution: FT-105

FT-105 is Flamel's next generation basal insulin. Phase I results suggest that FT-105 has the potential to offer substantially better glucose control than currently-marketed long-acting insulins while providing true 24 hour coverage. Moreover, because FT-105 uses Flamel's MEDUSA technology, the recombinant insulin that patients receive is not denatured or chemically modified. A phase I glucose clamp trial was completed in September.
Please click here for top-line results of the Phase I study.

IL-2 XL

As a whole, interleukin sales totaled an estimated $213 million in 2006.
Due to toxicity issues, interleukins are not approved for use in as many applications as they theoretically could be. Interleukin-2 (IL-2) is used for the treatment of certain types of cancer, such as renal cell carcinoma and metastatic melanoma, and is being studied for the treatment of acute myelogenous leukaemia, non-Hodgkin’s lymphoma and HIV/AIDS infection.

IL-2 is the only therapy offering complete remission for the treatment of late stage renal cancer or metastatic melanoma.
For IL-2 to be effective in fighting against cancer, high doses are required. This has limited the potential applications for the compound, due to safety issues. We feel that a significant increase in the approved applications of this compound can be achieved with a reduction of its toxicity through the use of an appropriate drug delivery system.

The Medusa^® platform has been validated in monkey and other animal studies for this compound. Our initial studies show an increase of the response of the immune system, with an increase of CD4, CD8 and CD25 compared with Proleukin® (aldesleukin, from Chiron), a decrease of the blood concentration of the drug after injection (which limits toxicity), and an increase in the duration of action. This project is being developed internally and is available for licensing.

Flamel Technologies presented at the 2006 ASCO (American Society of Clinical Oncology) Annual meeting (June 2-6, 2006) the preliminary results of the phase I/II of its controlled-released formulation of interleukin-2 (IL-2 XL). Click here to access the document.
Link to the graphs

hGH XL

This therapeutic drug used in the treatment of growth disorders were estimated at more than $5.5 billion in 2006.

Growth hormones are usually released from the pituitary gland. They are metabolized by the liver, which causes the production of numerous growth factors. In turn, the growth factors act on various cells in the body, causing them to rejuvenate and repair. The efficacy of hormones in treating their respective diseases is well established, since they were among the first therapeutic proteins to be used in the form of natural hormones extracted from human or animal tissues.

This project is being developed internally and is available for licensing.