Programas de acceso gestionado

Professionals walking at a Ferrer event on the PAA expanded access to medicines program.

R & D

MANAGED ACCESS PROGRAMS

We believe in a different way of doing things, using Ferrer as a force for change

In our quest to bring significant differential value to people suffering from serious diseases, we are directing our efforts to the development of products in two main therapeutic areas: vascular and interstitial lung diseases and rare neurological diseases. Both areas include rare or low-prevalence diseases that often lack adequate or licensed treatments.

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We are committed to research and development

For this reason, Ferrer's commitment to research and development of possible solutions in these areas through clinical trials is essential to improve the lives of affected people, as well as to efficiently manage health resources. And our commitment goes even further.

At Ferrer we also offer eligible candidates the possibility of benefiting from therapies prior to regulatory approval through Managed Access Programs (PAG).

What is a Managed Access Program?

Managed Access Programs (including "Compassionate Use," "Early Access," "Expanded Access," and "Patient Nominal Programs," among others), are potential pathways for people with a serious condition or disease to access an investigational drug for treatment outside of clinical trials when there are no comparable or satisfactory alternative therapeutic options.

Who can join a PAG?

Extended access may be appropriate when all of the following conditions are met:

• The person has a life-threatening, long-lasting, or severely debilitating illness.

• The disease cannot be satisfactorily treated with any currently licensed medicine.

• It is not possible to enroll the patient in a clinical trial.

• There is sufficient evidence to consider that the potential benefit of treatment outweighs the potential risks in the context of the disease to be treated.

• Ferrer has an adequate supply of the medicine and the provision of expanded access will not interfere with ongoing clinical trials or product development.

• The provision of such access is permitted in accordance with applicable local laws and regulations.

Process for requesting a PAG

The treating physician may request information on how to request access to investigational or non-approved products in your country by contacting Ferrer's Medical Information Department by email at medinfo@ferrer.com.

Ferrer's experts will review all access requests in a careful and equitable manner, taking into account the criteria described above, as well as the applicable local laws and regulations.

In addition, specific information on the extended access programs available for certain Ferrer products can be found below.

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Managed Access Program for Pulmonary Hypertension Associated with Interstitial Lung Disease

Interstitial lung disease (PH-ILD)1,2 consists of a group of lung diseases characterized by marked scarring or fibrosis of the bronchioles and alveolar sacs of the lungs. Increased fibrotic tissue in PID prevents oxygenation and free gas exchange between the pulmonary capillaries and alveolar sacs, and the condition can present with a wide range of symptoms, including shortness of breath during activity, labored breathing, and fatigue.

WHO group 3 pulmonary hypertension (PH) frequently complicates the outcome of patients with interstitial lung disease and is associated with poorer functional status, as measured by exercise capacity, increased need for supplemental oxygen, lower quality of life, and poorer outcomes.

Ferrer works to ensure the correct execution of the program safely for suitable candidates.

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DISCLAIMER: The fact that a program exists does not guarantee that it will be available in all countries. Each country has its own regulatory mechanisms to facilitate programmes for new medicines and any access prior to approval of these must always comply with the specific laws and regulations of each territory, including the requirements for the importation of medicines from abroad.

Managed Access terminology encompasses a variety of locally defined pathways to access medicines prior to commercial authorization or availability, including, but not limited to, Compassionate Use (CU), Expanded Access Programs (EAPs), Named Patient Programs (NPPs) as well as Post-Trial Access (PTS) programs. PTA).

References:

1. Behr J, Nathan SD. Pulmonary hypertension in interstitial lung disease: screening, diagnosis and treatment. Curr Opin Pulm Med. 2021 Sep 1; 27(5):396-404.

2. King CS, Shlobin OA. The trouble with group 3 pulmonary hypertension in interstitial lung disease: dilemmas in diagnosis and the conundrum of treatment. Chest. 2020; 158(4):1651-1664.