Despite new pricing rules, France still offers opportunities for Early Access to Orphan drugs
Since March 2021, there have been some changes in the pricing of pharmaceuticals in France, leading progressively to a s...
08 September, 2022
we are committed to providing patients and physicians with innovative Orphan Drugs in development.
Our Commitment
CarthaGenetics® focuses on Orphan Drugs and Advanced Therapies areas with unmet needs. Good health is vital to all of us, and finding sustainable access to innovative treatments is our motto. That’s why we are committed to providing patients and physicians with innovative drugs in development.
Early Access Programs
CarthaGenetics® is your partner to start your successful EAP and prelaunch in Europe. CarthaGenetics® offers an efficient and cost-effective approach to managing global EAP and is aware of local variability within the programs and works within the boundaries of local regulations.
Why setting up an EAP ?
Early access programs in Europe: a regulatory tool with pre-marketing impact.
Read MoreIs your product eligible for EAP ?
To be eligible for an EAP, your drug candidate must fulfill several criteria
Read MoreWhen to plan an Early Access Program ?
Planning for your managed access program should be considered as early as possible from Phase II trials onwards.
Read MoreWhy setting up an EAP ?
Early access programs in Europe: a regulatory tool with pre-marketing impact.
Read MoreIs your product eligible for EAP ?
To be eligible for an EAP, your drug candidate must fulfill several criteria
Read MoreWhen to plan an Early Access Program ?
Planning for your managed access program should be considered as early as possible from Phase II trials onwards.
Read More
Which countries are allowing Named Patients Sales?
Due to difference in legislation, EAPs to Orphan Drugs vary much across Europe.
Read MoreWho will pay for your product during NPS/EAP phase?
Usually, hospitals and/or national insurance, or insurances systems bear the costs of Named Patient Sales in most countries (France, Italy, Turkey, Switzerland and Spain).
Read MoreWorking with CarthaGenetics on your EAP/NPS
Implementation and management of your EAP requires significant knowledge, experience and resources. Your company may not have all the specific experience in this highly regulated environment nor the dedicated resources.
Read MoreWhich countries are allowing Named Patients Sales?
Due to difference in legislation, EAPs to Orphan Drugs vary much across Europe.
Read MoreWho will pay for your product during NPS/EAP phase?
Usually, hospitals and/or national insurance, or insurances systems bear the costs of Named Patient Sales in most countries (France, Italy, Turkey, Switzerland and Spain).
Read MoreWorking with CarthaGenetics on your EAP/NPS
Implementation and management of your EAP requires significant knowledge, experience and resources. Your company may not have all the specific experience in this highly regulated environment nor the dedicated resources.
Read MorePatient identification
Patient identification and patient recruitment for your clinical trials:
• For a rare lysosomal disorder, CarthaGenetics® has been able to obtain clinical approvals in 2 months in Turkey with a strong collaboration with the global CRO picked up by our customer.
• Due to its network, CarthaGenetics® found for another ultra rare disorder 58 patients in one country, where a big pharma with a competitive treatment and many sales reps in the field has only identified 5 !
• For another Ultra rare disorder, CarthaGenetics® helped some European patients relocation in the US for the duration of a phase III in the USA.
Biosimilars
Biosimilars are copies of approved innovator biotherapeutic products that have been demonstrated to be comparable to the corresponding original product in terms of quality, safety and efficacy. They offer improved affordability since they come on the market at a significantly reduced price compared to the original product.
For Orphan Drugs, despite the specific « enlarged » patent protection given by Orphan Drug status, biosimilars constitute the beginning of a brand new era, by fostering access to all patients in need, especially in emerging countries.
Biosimilars
Biosimilars are copies of approved innovator biotherapeutic products that have been demonstrated to be comparable to the corresponding original product in terms of quality, safety and efficacy. They offer improved affordability since they come on the market at a significantly reduced price compared to the original product.
For Orphan Drugs, despite the specific « enlarged » patent protection given by Orphan Drug status, biosimilars constitute the beginning of a brand new era, by fostering access to all patients in need, especially in emerging countries.
We Have Great Skills
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Latest News / Events
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CarthaGenetics is attending the SSIEM congress
CarthaGenetics is attending the SSIEM congress (Scientific Society for Inborn Errors of Metabolism) in Freiburg in Breis...
31 August, 2022 -
The revision of EU orphan drugs’ policy, what to expect?
For patients with rare diseases, time to access has been always the greatest challenge....
09 August, 2022
Companies we worked with
We have worked for international biopharmaceutical companies from around the world who wish to start clinical trials and/or commercial operations (prelaunch and Early Access Program) in Europe (incl. Turkey) & North Africa.
