How Sciensus supported the launch of a breakthrough therapy in Europe and beyond

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.

Green_Two accounts

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

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Our multilingual customer service team is fluent in most European languages.

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We designed a Patient Support Program with face-to-face and remote nurse interventions. Read more at: Developing a comprehensive support program in Europe.

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The client entrusted Sciensus with responsibility for key issues such as processing orders and returns management, as well as customer credit checks and contracts.

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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.

Purple_Location

We offer a range of shipping solutions via our well established GDP-approved international delivery network.

Purple_Cash

We offer a full order to cash service. We take control of the complete supply process across warehousing, customer communications, delivery and cash collection.