Our client is a pharmaceutical company seeking US FDA and/or EMA approved Prescription (Rx) Drugs and Medical Foods for the Swiss market in Oncology, Hematology, Infectious Disease, Hepatology, Gastrology, Transplant, Hematology, and Hepatology.
Their main objective is to identify products that have yet to be registered in Switzerland.
This Swiss Shareholding Company (A.G.), established in 2013, is seeking approved or soon-to-be approved novel formulations, generics, biosimilars, and medical foods to market and distribute in Switzerland.
Their core activities include:
- Commercial Pharmaceutical/Biotech specialty care distribution and marketing
- Pharma focused Private Equity
- Investments in mid-to-late stage R&D companies shares with geographic rights
- High Level Strategic Advisory Services to high tech R&D companies
Their current portfolio includes:
- 70+ Finished Dosage Forms (In-licensed)
- 6 Biologics (In-licensed)
- 17+ Name Patient Access Products
- 160+ API’s Traded globally
Why Switzerland: Regulatory, Market Access, and Beyond?
- Switzerland prior to EU: First experience in Europe through Switzerland is the low risk, sustainable, high profit experience with minimal investment.
- 505(2b) Possible in Switzerland: Generic with innovation is a regulatory pathway nonexistent in EU.
- FDA Dossier Acceptable: Bio studies do not need to be repeated in most cases, like in EU. Local partner does investment for modifications to dossier.
- Highest Pricing in Europe: Highest pricing in Europe is in Switzerland and becomes reference to some countries in EU, uplifting average reimbursement prices.
- SwissMedic Data Protection: NCE (Generic or Original) by Swiss standards receive 10-year SMPC data protection. Orphan Drugs receive 15 Years data protection.
- Backdoor to EU: Register in Switzerland; sell to EU through Early NPS Access Program without EU approval. Entire continent in reach within 1 day and logistics/wholesaler hub.