Medusa® Biobetter Licensing Opportunities
| IFN-alpha XL | FT-105 | IL-2 XL | hGH XL | |
| Key characteristics | Non-modified interferon α-2b |
Non-modified insulin |
Non-modified interleukin-2 |
Non-modified somatropin |
|---|---|---|---|---|
| Competitive Advantages |
|
|
|
|
| Clinical Stage | Phase 2 | Phase 1 | Phase 1/2 | Preclinical |
| Indication | Hepatitis C | Diabetes | Renal Cell Carcinoma (RCC) | Growth Hormone Deficiency |
| Targeted Market * |
$6B (global HCV market) |
Injectable drugs > $15B Long-acting insulin > $6B |
$1.7B (global RCC market) |
$1.4B |
(* 2011 market estimates from various sources)
IFN-α XL
(two phase 1 studies successfully completed and currently in phase 2)
In a two-week Phase 1 study that compared the 18 MIU and 27 MIU doses of IFN-α XL with the standard dose of PegIntron, fewer adverse events were observed and, among the genotype I patients given the highest dose of IFN-α XL, there was a statistically significant, greater reduction in viral load after two weeks as compared with the patients given PegIntron. These results have been presented at the European Association for the Study of the Liver annual meeting in April 2008 (more info here).
A twelve-week Phase 2 study in genotype I patients to compare IFN-α XL with PegIntron®, in combination with ribavirin, is ongoing.
The primary endpoint is: viral load decrease at Week 4 and Week 12 of treatment with IFN-α XL 27 MIU, IFN-α XL 36 MIU and the marketed reference product (PegIntron 1.5μg/kg) in combination with ribavirin.
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Intermediate analysis of that study was presented in November 2011 at the AASLD’s “Liver Meeting” in San Francisco: improved safety profile of IFN-α XL versus PegIntron during a 3-month course of combined therapy with weight-based ribavirin was confirmed.
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Abstract “Medusa formulated Interferon-alpha-2b Shows a Favorable Efficacy / Tolerability Profile vs. PEGylated IFN-alpha-2b in Hepatitis C Patients in the Phase 2 Study ANRS HC23 COAT-IFN” (Christian Trepo et al.) will be presented at the 14th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD) that will be held on 22 – 25 June, 2012 in Shanghai.
IFN-α XL (PDF file) may potentially address the two greatest unmet medical needs in hepatitis C treatment: treatment of the virus in genotype I patients and reduction of serious adverse events associated with IFN α treatment.
The global interferon alpha market is valued at over $2.5 billion in 2010. PEGylated interferons Schering Plough’s (now Merck & Co) Pegintron® and Roche’s Pegasys® had sales of $0.7 billion and $1.6 billion in 2010, respectively.
FT-105
(Phase 1 successfully completed in healthy volunteers)
Flamel Technologies’ FT-105 (PDF file) is a Medusa microparticles-based once-daily formulation of non modified recombinant human insulin for the treatment of type I and II diabetes.
The original freeze-dried reconstituted formulation of FT-105 was successfully tested in a repeat dose administration study in rats versus Lantus. This formulation of FT-105 showed very significant advantages in reducing insulin levels with greatly reduced peak: trough ratios. FT-105 was then tested in Phase 1 clinical trial. The results obtained indicate that FT-105 has the potential to offer substantially better glucose control than currently-marketed long-acting insulin while providing true 24 hours coverage. Update of these results has been presented at the Tenth Annual Diabetes Technology Meeting (Bethesda, Nov. 11-13, 2010) (PDF document).
An improved liquid formulation of FT-105 is currently under development.
FT-105 would effectively treat 100% of patients with a single daily dose: in the U.S., approximately 25% or more of patients take other controlled release insulin more than twice a day.
The global market for insulin drugs has been estimated at $14 billion in 2010. Sales for Sanofi’ Lantus and Novo Nordisk’s Levemir, the two leading long-acting insulins, amounted to $4.7 and $1.2 billion, respectively.
Others Medusa-based Licensing Opportunities
- IL-2 XL (PDF file), a long-acting human interleukin-2 (IL-2) for the treatment of renal cell carcinoma, for which proof-of-concept has been obtained in a Phase 1/2 trial (comparison with Proleukin® in end-stage renal cell carcinoma patients);
- hGH XL (PDF file), a long-acting human growth hormone (GH) for the treatment of growth disorders (preclinical stage; proof-of-concept obtained in animal model); and,
- GLP-1 XL, long-acting human Glucagon-like peptide-1 analog for the treatment of type II diabetes (preclinical stage; proof-of-concept obtained in animal model).