Welcome to

CarthaGenetics^®

focuses on rare diseases area with unmet needs,
we are committed to providing patients and physicians with innovative Orphan Drugs in development.

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Early Access Programs

CarthaGenetics® is your partner to start your successful EAP and prelaunch in Europe.

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Patient Identification

CarthaGenetics® will accelerate your recruitment for such patients through its strong relationships with KOLs, local scientific societies and local patient groups.

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Biosimilars

CarthaGenetics® has recently developed this new pole of expertise dedicated to the introduction of orphan drugs biosimilars in emerging countries

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CarthaGenetics® has direct presence in Algiers, Düsseldorf, Lausanne, Madrid, Milan, Paris, and Tunis.

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Who we are

Founded by Philippe Carteron de Balmont in 2004, CarthaGenetics® has focused on finding innovative early patients access to Orphan Drugs and is now a pioneer with one of the broadest experiences in the field of Rare Diseases.

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.

Our offices

SWITZERLAND Tel: +41 22 575 31 31

ALGERIA Tel: +213 21 98 51 36

FRANCE Tel: +33 660 23 54 36

GERMANY Tel: +49 176 620 77 849

ITALY Tel: +39 331 987 74 07

SPAIN Tel: +34 93 245 4353

TUNISIA Tel: +216 71 160 421

TURKEY Tel: +90 532 224 00 44

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.

EAP / NPS

Named Patient Sales (NPS) / Early Access Program or Expended Access Program (EAP)

Why setting up an EAP ?

Early access programs in Europe: a regulatory tool with pre-marketing impact.

Is your product eligible for EAP ?

To be eligible for an EAP, your drug candidate must fulfill several criteria

When to plan an Early Access Program ?

Planning for your managed access program should be considered as early as possible from Phase II trials onwards.

EAP / NPS

Named Patient Sales (NPS) / Early Access Program or Expended Access Program (EAP)

Why setting up an EAP ?

Early access programs in Europe: a regulatory tool with pre-marketing impact.

Is your product eligible for EAP ?

To be eligible for an EAP, your drug candidate must fulfill several criteria

When to plan an Early Access Program ?

Planning for your managed access program should be considered as early as possible from Phase II trials onwards.

Which countries are allowing Named Patients Sales?

Due to difference in legislation, EAPs to Orphan Drugs vary much across Europe.

Who 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).

Working 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.

Which countries are allowing Named Patients Sales?

Due to difference in legislation, EAPs to Orphan Drugs vary much across Europe.

Who 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).

Working with CarthaGenetics on your EAP/NPS

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.