Liraglutide
Indications:
- As monotherapy or in combinations with other medicinal products for the treatment of type 2 diabetes
- Weight management
Liraglutide:
- Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist also known as incretin mimetic
- 97% similarity with human glucagon-like peptide-1
- By binding to GLP-1 receptors, Liraglutide stimulates insulin secretion
- Liraglutide inhibits glucagon production, inhibits gastric motility and stimulates the hypothalamic satiety center
- Solution for injection in multi-dose disposable pre-filled pen (subcutaneous administration)
- Originator - Victoza by Novo Nordisk
- Off-patent
Key Facts
Liraglutide packs were sold in 2021*
*MIDAS Data by IQVIA
Total market in 2021 in USD*
*MIDAS Data by IQVIA
MA in Europe MA in USA
AVVA`s
Technology
AVVA’s Liraglutide API Technology was developed in cooperation between AVVA Pharmaceuticals Ltd (Cyprus), and the Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry (Russia).
Know-how and patent protected IP rights:
- Recombinant plasmid DNA for fusion protein expression
- E. coli strain
- Recombinant fusion protein production method
- Liraglutide production method
Main Technology Features:
- Specific Kanamycin – resistant E. coli strain:
- Reduced contamination risk
- Does not require dedicated production
- Increased protein yield: result of producing strain genetic construct
- Reduced fermentation cycle
- Scalable technology
- Specific impurities lower detection limits
- Optimized purification process
AVVA’s Technology Advantages and Completed Milestones
| № | Advantage | AVVA | NOVO Nordisk | AVVA’s Advantage |
|---|---|---|---|---|
| 1 | Strain-based technology | E. coli | S.cerevisiae |
More robust technology, lower possibility of target protein degradation |
| 2 | Reduced fermentation cycle | ~8 hours | ~5 days | Faster production cycle |
| 3 | Process nutrient demand | less | more | Cost effective |
| 4 | Target protein yield | up to 5.3 g/l | - | Generally higher than S.cerevisie-based technology |
| 5 | Impurity profile | 2 identified impurities* | 3 identified impurities* | Higher purity product |
Completed Milestones:
-
Specific E. coli strain creation
-
Master bank and Working bank
-
Similarity to originator
-
Analytical method
-
Manufacturing:
- 25 Pilot batches: 20 L – reactor with protein yield up to 3.7 g/l
- 5 Scale up batches: 100 L reactor with protein yield up to 5.3 g/l
Established Similarity
AVVA`s Liraglutide VS Victoza
AVVA`s Liraglutide
Victoza
Pre-Clinical Study in db/db mice
Victoza (300 μg/kg) and AVVA’s Liraglutide (300 μg/kg) show similar decrease on blood glucose levels at 4, 24 and 48 hours after administration, p> 0.9*
*data analysis by LSD test
Victoza 300 μg/kg
Liraglutide AVVA 300 μg/kg
Control group
Additional studies performed for establishing similarity
- Peptite mapping
- N-terminal sequencing
- Mass spectrometry
- Biological activity
- Isoelectric focusing
- SEC HPLC
License Conditions
Conditions
- Exclusive rights within the Territory
- Patent validity within the Territory
- License Fee:
- Territory based
- Milestone Payments:
- Upon signature
- On Dossier disclosure
- Upon successful tech transfer completion
- Upon M.A. grant
- Tech Transfer expenses:
- Covered by the licensee
- Time to market:
- Within 5 years post successful tech transfer
- Royalties:
- For 15 years post commercialization
Diabetes.
Overview
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood glucose.
Hyperglycaemia is common in uncontrolled diabetes and may lead to a number of acute and chronic complications
Health impact
- Acute complications:
- Hyperosmolar Hyperglycaemic State (HHS)
- Diabetic ketoacidosis (DKA)
Chronic complications
- These are long-term problems that can develop gradually, and can lead to serious damage if they go unchecked and untreated.
- Retinopathy
- Heart attack / Stroke
-
Nephropathy
-
Diabetic foot syndrome
-
Kidney failure
Diabetes Key Facts
Adults are living with diabetes. This number is predicted to rise to 643 million by 2030 and 783 million by 2045.
death every 5 seconds. 6.7 million deaths in 2021 from diabetes
Type 2 diabetes represents more than 95% of total cases