Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies neoGAA and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease

The duration of the study per patient will be up to 3 years that will consist of a 14- day
screening period (may be extended up to 8 weeks in pre-specified situations), a 49-week
blinded treatment period, a 96-week open-label treatment period, and a 4-week post-treatment
observation period.

Inclusion criteria :

- The patient has confirmed GAA enzyme deficiency from any tissue source and/or 2
confirmed GAA gene mutations.

- The patient must provide signed, informed consent prior to performing any study
related procedures. Consent of a legally authorized guardian(s) is (are) required for
legally minor patients as defined by local regulation. If the patient is legally
minor, signed written consent shall be obtained from parent(s)/legal guardian and
assent obtained from patients, if applicable.

- The patient (and patient's legal guardian if patient is legally minor as defined by
local regulation) must have the ability to comply with the clinical protocol.

- The patient, if female and of childbearing potential, must have a negative pregnancy
test (beta-human chorionic gonadotropin) at baseline.

Exclusion criteria:

- The patient is <3 years of age.

- The patient has known Pompe specific cardiac hypertrophy.

- The patient is wheelchair dependent.

- The patient is not able to ambulate 40 meters (approximately 130 feet) without
stopping and without an assistive device.

- The patient requires invasive-ventilation (non-invasive ventilation is allowed).

- The patient is not able to successfully perform repeated forced vital capacity (FVC)
measurements in upright position of ≥30% predicted and ≤85% predicted.

- The patient has had previous treatment with alglucosidase alfa or any investigational
therapy for Pompe disease.

- The patient has prior or current use of immune tolerance induction therapy

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.