How Sciensus supported the launch of a breakthrough therapy in Europe
Overview
Sciensus has more than 30 years’ experience supporting pharmaceutical companies with the launch and distribution of orphan drugs outside the US, providing a customisable, fully managed service.
The client, US-based Eiger BioPharmaceuticals, has developed a pioneering therapy for an ultra-rare paediatric disorder that causes rapid ageing and early death.
Using our expertise we designed and implemented a turnkey solution tailor-made to meet the company’s needs, from early access to patients in Europe through to acquiring market authorisation.
We helped our client access and support new patients.
We helped them navigate complex regulatory and licensing challenges.
We provided market-leading support throughout the process.
The objective
Reaching patients globally with a first-to-market life-extending therapy.
Studies have shown the client’s innovative treatment significantly extends the average life expectancy of individuals with this condition.
With no other drug available in Europe, this breakthrough therapy has the power to transform the lives of young people with this debilitating disease.
The company required our support to license and obtain approval for the distribution of its life-extending drug in Europe.
The challenge
In order to access EU markets, the company not only required EMA approval but also compliance with regulatory and healthcare systems within individual countries in Europe, making it an extremely complex process.
Supporting with the application for an Early Access Program (EAP) – where the healthcare system supports and funds the treatment pre-EMA approval – was key to ensuring the quick and efficient delivery of this drug to patients. However, this was also a challenge as some countries follow EMA guidelines whilst others have their own national systems around early access, or Compassionate Use Programs (CUP).
The solution
Partnering with Sciensus enabled the company to extend the reach of its pioneering treatment.
Sciensus supported the Client to:
- Import the product into EU using its Wholesale Distribution Authorisation (WDA) and Manufacturing and Import License (MIA).
- Navigate through the complexity of setting up an Early Access Program in France. This allowed people to benefit from the unlicensed medication.
- Establish a new EU-based entity and successfully obtaining EU marketing authorisation.
- Facilitate the first official licensed launch of the drug in Germany in as little as 4 months following EMA approval.
Delivering the best results for our client
To enable both companies to continue to deliver the highest level of service to patients, Sciensus provided:
- a complete tailor-made European infrastructure package – effectively a ‘one stop shop’, adapting to any challenges and obstacles that were encountered
- a dedicated rare disease account director who implemented tried and tested governance approach which consists of:
- Quarterly Business Reviews, face to face with Senior Teams, Operations, Commercial, Finance, Quality and Legal when required
- Monthly Team KPI review sessions
- Bi-Weekly Quality, Operational, and Customer Service meetings with appropriate individuals.
Sciensus is our trusted partner of choice: thanks to their international orphan disease market expertise and guidance, we were able to overcome expansion challenges into new markets. Their personalised solutions enabled us to find a viable way to grow our business in Europe and beyond.
Chief Commercial Officer at Eiger BioPharmaceuticals, Inc
Delivering the best results for our client
Here are some examples of how our partnership achieved and exceeded Eiger’s expectations
Our multilingual customer service team is fluent in most European languages.
We designed a Patient Support Program with face-to-face and remote nurse interventions. Read more at: Developing a comprehensive support program in Europe.
The client entrusted Sciensus with responsibility for key issues such as processing orders and returns management, as well as customer credit checks and contracts.
We were able to take care of tender management in different countries, as well as auditing, and managing all of the legal and regulatory requirements.
We offer a range of shipping solutions via our well established GDP-approved international delivery network.
We offer a full order to cash service. We take control of the complete supply process across warehousing, customer communications, delivery and cash collection.
You may be interested in…
Blogs/Articles
Accessing and supporting EU rare disease patients: a quick guide
Overcoming challenges in finding rare disease patients in Europe Rare diseases mean rare patients. In Europe ‘rare’ is defined as…
Case Studies
Developing a comprehensive support program in Europe
Overview Sciensus is a leading provider of Patient Support Programs (PSPs). These bespoke programs are delivered by highly qualified Healthcare…
Blogs/Articles
Early access programs – benefits, challenges and the Sciensus solution
You have a novel therapy making significant progress in clinical trials and are already receiving requests for access from various…