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

  • 55%
 

PNI23*

* in silico modeling

  • 7%

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