LipoNova AG is a leading developer of effective therapies for non-metastatic renal cell carcinoma (RCC), a serious disease with a high unmet medical need. We are pioneers in the development of autologous tumour vaccines, a new class of compounds for combating diseases of this type. We have successfully completed a Phase-III clinical study on adjuvant RCC with Reniale®, our lead product and the world’s first autologous treatment with demonstrated efficacy and safety as an adjuvant therapy in non-metastatic RCC.

Within five years, we see LipoNova AG as an integrated biopharmaceutical company, delivering Reniale®, after its approval, to patients worldwide through a global distribution network. Our product pipeline will include promising candidates for further development and drug registration.

LipoNova AG aims to become a successful biopharmaceutical company by pursuing effective therapeutic approaches and developing product candidates with a high potential for technical and commercial integration.

Primarily we are focused on enhancing patient health and creating value for our shareholders by gaining approval for and launching Reniale®, as well as by expanding our clinical stage oncology drug pipeline via partnering or Mergers & Acquisition:

Seeking approval and launching Reniale®


• In September 2007, LipoNova AG was given the go-ahead by the FDA to initiate the final phase of the Reniale® development program following a pre-IND meeting. LipoNova AG will announce its scientific phase III clinical trial internationally in compliance with regulatory standards. LipoNova AG believes that the data of this trial will be sufficiently robust and compelling that the FDA will award the drug US registration. This final international phase III study is planned for 2008.
  
  
• Ahead of approval and licensing a “named-patient” use programme, LipoNova AG will make Reniale® available to patients. Named-patient programmes are a legal and ethical way to respond to demands for an unlicensed medicine to meet the special needs of individual patients when a suitable alternative does not exist. In some countries, named-patient sales are carried out via compassionate use programmes.
  
  
Expanding our pipeline of clinical stage compounds in oncology


• Expanding the pipeline of clinical stage compounds in oncology via partnering or mergers & acquisition or building strategic and commercial partnerships with international pharmaceutical companies.
  
  
Assure funding for company development


• To assure the achievement of our strategic goals, LipoNova AG is assuring its financial resources from assessing funds from capital markets.