Pipeline
„Auxilius Pharma focuses on adding clinical value and building strong IP position for all its assets”
Lead Asset Cardiovascular Portfolio
Auxilius Pharma projects have been carefully selected and focus on medicines addressing the high unmet clinical needs, bringing solutions and value to patients, health care providers, and payers.
Formulation
Manufacturing
Preclinical
Clinical
Registration
PNI19
PNI23*
* in silico modeling
Value-added Medications
Molecules with well-established clinical efficacy and safety profiles that have undergone some form of modification to improve the product for the benefit of patients, healthcare providers and/or payers are known as Value-added medicines or VAMs. The value is usually added in one of the three areas:
Adapted from: Redesigning Medicines – New Options for Patient-centric Treatment. Sandoz, A NOVARTIS Company.
Regulatory Pathway
Our development approach makes use of the 505(b)2 regulatory pathway in the United States. This pathway has been created for pharmaceutics for which the safety and efficacy have previously been demonstrated. This targeted approach can considerably cut the amount of clinical work necessary to get a product to market, shorten the development cycle, and lower costs and risks.
Typical Value-added medication development pathway
New drug
application pathway
New chemical entity
Clinical study requirements
Development timeline
Review
timeline
Market exclusivity
Investment average
505(b)2
Value-added medication
+*
partial
3-6 years
10-12 months
3-7 years
<$10-15MM
* – new chemical entity designation is granted for active substances not yet listed in the USP
505(b)2 key advantages
The pathway permits the sponsor to use existing safety and efficacy data, which translates into shorter time-to-market and significantly reduced development costs
- Accelerated and simplified market authorization
- Shorter R&D process
- Low clinical studies cost
- Patenting available
- Up to 5 years US market exclusivity