See below for BioMarin’s United States Privacy Policy. For more specific region/country versions, please select from the dropdown menu.

Privacy Policy And Notice Of Information Practices

Effective Date: October 1, 2018

BioMarin Pharmaceutical Inc. ("BioMarin," “we,” “us,” or “our”) respects the privacy of visitors to our websites and online services and values the confidence of our customers, partners, patients, and employees.

This Privacy Policy and Notice of Information Practices (“Privacy Notice”) sets forth BioMarin’s practices regarding the collection, use, and disclosure of information that you may provide through the websites and online services that we operate and that link to this Privacy Notice, as well as through any of our offline services that reference this Privacy Notice (collectively, the “Services”). Please read the entire Privacy Notice before using our Services.

Collection of Information

We may ask you for some or all of the following types of information when you register with our Services, access various content or features, submit photos and other content, or directly contact us with questions or feedback:

  • Contact information, such as name, email address, postal address, and telephone number;
  • User name and password;
  • Demographic information, such as age information and gender;
  • Communications preferences;
  • Search queries;
  • Stories, comments, photos, and other information posted in our interactive online features; and
  • Correspondence and other information that you send to us.

We also may collect certain information automatically when you visit the Services, including:

  • Your browser type and operating system;
  • Your Internet Protocol (IP) address, which is the number automatically assigned to your computer whenever you access the Internet and that can sometimes be used to derive your general geographic area;
  • Other unique identifiers, including mobile device identification numbers;
  • Sites you visited before and after visiting the Services;
  • Pages you view and links you click on within the Services;
  • Information collected through cookies, web beacons, and other technologies;
  • Information about your interactions with email messages, such as the links clicked on and whether the messages were opened or forwarded; and
  • Standard server log information.

We may use cookies, pixel tags, and similar technologies to automatically collect this information. Cookies are small bits of information that are stored by your computer’s web browser. Pixel tags are very small images or small pieces of data embedded in images, also known as “web beacons” or “clear GIFs,” that can recognize cookies, the time and date a page is viewed, a description of the page where the pixel tag is placed, and similar information from your computer or device. You can decide if and how your computer will accept a cookie by configuring your preferences or options in your browser. However, if you choose to reject cookies, you may not be able to use certain online products, services or features on the Services.

Response to “Do Not Track” Signals

Some Internet browsers include the ability to transmit “Do Not Track” signals. Since uniform standards for “Do Not Track” signals have not yet been adopted, BioMarin does not process or respond to “Do Not Track” signals.

Use of Information

Our legal basis to process your information includes processing that is necessary for legitimate business interests, including but not limited to the following examples:

  • Providing you with the products, promotions, services, and information you request;
  • Contacting you via email and otherwise about products, services, and events that we think might be of interest to you;
  • Maintaining or administering the Services, performing business analyses, or for other internal purposes to improve the quality of our business, the Services, and other products and services we offer;
  • Publishing stories, comments, photos, and other information posted in our interactive online features;
  • Processing employment applications and inquiries; and
  • Customizing and personalizing your use of the Services.

We may also process your information in order to comply with our legal obligations, perform a contract between us and you, establish and defend any legal claims, and in some cases our basis for processing will be because you have consented to our use of your information.

Sharing of Information

We are committed to maintaining your trust, and we want you to understand when and with whom we may share the information we collect.

  • Corporate Parents and Affiliates. We may share your information with our corporate parents and other affiliated entities for a variety of purposes, including business, operational, and marketing purposes. For more information on those entities, see www.biomarin.com/contact.
  • Service Providers. We may share your information with service providers that perform certain functions or services on our behalf pursuant to the purposes set out in this Privacy Notice (such as to host the Services, manage databases, perform analyses, or send communications for us).
  • Other Parties When Required By Law or as Necessary to Protect the Services. We may disclose your information to third parties in order to: protect the legal rights, safety, and security of BioMarin, our corporate parents and affiliates, and the users of our Services; enforce our Terms of Use; prevent fraud (or for risk management purposes); and comply with or respond to law enforcement, or legal process, or a request for cooperation by a government entity, whether or not legally required.
  • In Connection With a Transfer of Assets. If we sell all or part of our business, or make a sale or transfer of assets, or are otherwise involved in a merger or business transfer, or in the event of bankruptcy, we may transfer your information to one or more third parties as part of that transaction.
  • Other Parties With Your Consent. We may disclose to third parties information that does not describe or identify individual users, such as aggregate website usage data or demographic reports.
  • Aggregate Information. We may disclose to third parties information that does not describe or identify individual users, such as aggregate website usage data or demographic reports.

We may allow third parties to place and read their own cookies, web beacons, Local Shared Objects, and similar technologies to collect information through the Services. For example, our third-party service providers may use these technologies to collect information that helps us with traffic measurement, research, and analytics. Local Shared Objects (sometimes referred to as “Flash Cookies”) are similar to standard cookies except that they can be larger and are downloaded to a computer or mobile device by the Adobe Flash media player. Please note that you may need to take additional steps beyond changing your browser settings to refuse or disable Local Shared Objects and similar technologies. For example, Local Shared Objects can be controlled through the instructions on Adobe’s Setting Manager page. If you choose to refuse, disable, or delete these technologies, some of the functionality of the Services may no longer be available to you.

Social Networking Services

BioMarin has worked with certain third-party social media providers to offer you their social networking services through our Services. For example, you can use third-party social networking services, including but not limited to Facebook, Twitter, and others, to share information about your experience on our Services with your friends and followers on those social networking services. These social networking services may be able to collect information about you, including your activity on our Services. These third-party social networking services also may notify your friends, both on our Services and on the social networking services themselves, that you are a user of our Services or about your use of our Services, in accordance with applicable law and their own privacy policies. If you choose to access or make use of third-party social networking services, we may receive information about you that you have made available to those social networking services, including information about your contacts on those social networking services.

You also may be able to link an account from a social networking service (e.g., Facebook, Twitter) to an account through our Services. This may allow you to use your credentials from the other site or service to sign in to certain features on our Services. If you link your account from a third-party site or service, we may collect information from those third-party accounts, and any information that we collect will be governed by this Privacy Policy.

Security and Retention

We maintain reasonable security procedures to help protect against loss, misuse or unauthorized access, disclosure, alteration or destruction of the information you provide through the Services. However, no data transmission over the Internet or stored on a server can be guaranteed to be 100% secure. As a result, while we strive to protect your information and privacy, we cannot guarantee or warrant the security of any information you disclose or transmit to us online and cannot be responsible for the theft, destruction, or inadvertent disclosure of your information. In the event that we believe that the security of your information may have been compromised, we will endeavor to give you appropriate notice as quickly as possible, including by email, and in accordance with applicable laws.

You are responsible for maintaining the confidentiality of your account password and for any access to or use of the Services using your password, whether or not authorized by you. Please notify us immediately of any unauthorized use of your password or account or any other breach of security.

Your information will be retained only for so long as reasonably necessary for the purposes set forth in this Privacy Notice, in accordance with applicable laws.

Children’s Privacy

BioMarin respects the privacy of children, and we are committed to complying with applicable legislation, including the US Children’s Online Privacy Protection Act (COPPA) and the EU General Data Protection Act (GDPR). The Services do not knowingly collect, use, or disclose personal information from children without prior parental consent, except as permitted by applicable legislation.

If you have questions concerning our information practices with respect to children, please contact us using the form located here.

Your rights, depending on where you live, may include the right to review, have deleted, or stop the further collection of your child’s personal information. If you would like to make such a request, please contact us using the form located here.

Your Choices and Your Information

If at any time you wish to stop receiving emails or other communications from us, or if you have submitted information through the Services and would like to have that information deleted from our records, please use the form found here to notify us.

Your rights, depending on where you live, may include the right to object to or request restriction of processing of your personal information, and request access to, erasure and/or portability of your information held by BioMarin, and you may make such a request by contacting us by completing the form found here or by telephone at (415) 506-6700.

You may also have the right to lodge a complaint with the relevant data protection supervisory authority if you believe that our use of your information violates applicable law.

International Transfers

Some of the parties to whom we disclose your information are located in countries that may not provide the same level of data protection as your home country. We take appropriate steps to ensure that such recipients of your information are bound to duties of confidentiality, and BioMarin implements measures such as the EU standard data protection contractual clauses to ensure that any transferred personal information remains protected and secure.

Links to Third-Party Content

As a convenience to our visitors, the Services may link to a number of sites, services, and other content that are operated and maintained by third parties. These third parties operate independently from us, and we do not control their privacy practices. Such links do not constitute an endorsement by BioMarin of the content or the persons or entities associated therewith. This Privacy Notice does not apply to third-party content. We encourage you to review the privacy policies of any third party to whom you provide information.

Policy Updates

This Privacy Notice may be revised from time to time as we add new features and services, as laws change, and as industry privacy and security best practices evolve. We display an effective date on the policy in the upper left corner of this Privacy Policy so that it will be easier for you to know when there has been a change. If we make any material change to this Privacy Notice regarding use or disclosure of personal information, we will provide advance notice through the Services. Small changes or changes that do not significantly affect individual privacy interests may be made at any time and without prior notice.

Contact Us

If you have any questions about this Privacy Notice, you may contact us using the form found here or at:

BioMarin Pharmaceutical Inc.
105 Digital Drive
Novato, CA 94949
Phone: (415) 506-6700

Indication
Brineura® (cerliponase alfa) injection for intraventricular use is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Important Safety Information
Brineura is contraindicated in patients with any sign or symptom of acute, unresolved localized infection on or around the device insertion site (e.g. cellulitis or abscess); or suspected or confirmed CNS infection (e.g. cloudy CSF or positive CSF gram stain, or meningitis), any acute intraventricular access device-related complications (e.g., leakage, extravasation of fluid, or device failure), and with ventriculoperitoneal shunts.
Brineura must only be administered via the intraventricular route using aseptic technique to reduce the risk of infection. Prior to each infusion, inspect the scalp for signs of intraventricular access device leakage, failure or potential infection. Brineura is contraindicated if there are acute intraventricular access device-related complications (e.g., leakage, extravasation of fluid, device failure, or bulging of the scalp around or above the intraventricular access device); or sign or symptom of acute, unresolved localized infection on or around the device insertion site (e.g. cellulitis or abscess); or suspected or confirmed CNS infection (e.g. cloudy CSF or positive CSF gram stain, or meningitis). Consultation with a neurosurgeon may be needed to confirm the integrity of the device. In case of intraventricular access device complications, discontinue the Brineura infusion and refer to the device manufacturer’s labeling for further instructions. Prior to each infusion of Brineura and when clinically indicated, send cerebrospinal fluid (CSF) samples for testing of cell count and culture.
Material degradation of the intraventricular access device reservoir was reported after approximately 4 years of administration, which may impact the effective and safe use of the device. During benchtop testing such material degradation was recognized after approximately 105 perforations of the intraventricular access device. The intraventricular access device should be replaced prior to 4 years of single-puncture administrations, which equates to approximately 105 administrations of Brineura.
Monitor vital signs before infusion starts, periodically during infusion, and post-infusion in a healthcare setting. Perform electrocardiogram (ECG) monitoring during infusion in patients with a history of bradycardia, conduction disorder, or with structural heart disease. In patients without cardiac abnormalities, regular 12-lead ECG evaluations should be performed every 6 months.
Hypotension was reported in 2 patients during or up to 8 hours after Brineura infusion. Patients did not require alteration in treatment, and reactions resolved spontaneously or after intravenous fluid administration.
One patient experienced hypoxia 8 hours after Brineura infusion, followed by a low mean arterial pressure at 15 hours post infusion. Symptoms resolved after oxygen administration, airway repositioning, and normal saline infusion. One patient reported decreased oxygen saturation, 45 minutes after starting Brineura, with associated low diastolic blood pressures. Hypoxia resolved after oxygen administration. No treatment was administered for the low diastolic blood pressure, which returned to normal while the patient continued to receive Brineura infusion without change to the infusion rate or dose.
Due to the potential for anaphylaxis, appropriate medical support should be readily available when Brineura is administered. If anaphylaxis occurs, immediately discontinue the infusion and initiate appropriate medical treatment. Observe patients closely during and after the infusion.
Hypersensitivity reactions were reported in 11 patients during or within 24 hours after completion of the Brineura infusion. The signs and symptoms observed concomitantly with hypersensitivity reactions include pyrexia, vomiting, pleocytosis, or irritability. Patients were routinely pre-medicated with antihistamines with or without antipyretics or corticosteroids, prior to infusion of Brineura.
The management of hypersensitivity reactions should be based on the severity of the reaction and may include temporarily interrupting the infusion, and/or treatment with antihistamines, antipyretics, and/or corticosteroids. If a severe hypersensitivity reaction occurs, immediately discontinue the infusion and initiate appropriate medical treatment.
Brineura has not been studied in pregnancy or lactation.
Safety and effectiveness in pediatric patients below 3 years of age have not been established.
In clinical trials, the most frequently reported adverse reactions (≥8%) were pyrexia, ECG abnormalities, decreased CSF protein, vomiting, seizures, hypersensitivity, increased CSF protein, hematoma, headache, irritability, pleocytosis, device-related infection, bradycardia, feeling jittery, and hypotension.
Seizures were reported in 12 patients and included atonic, generalized tonic-clonic, focal, and absence. Seizures were managed with standard anticonvulsive therapies and did not result in discontinuation of Brineura treatment.
In clinical studies with Brineura, device-related adverse reactions were reported in 12 patients and included infection, delivery system–related complications, and pleocytosis. Intraventricular access device-related CNS infections were observed in 2 patients; antibiotics were administered, the intraventricular access device was replaced, and treatment continued. Device-related complications did not result in discontinuation of Brineura treatment. Other device-related adverse reactions included 1 patient with leakage of the intraventricular access device and 1 with pleocytosis.
Hematoma adverse reactions were reported in 5 patients and presented as hematoma, post procedural hematoma, traumatic hematoma, and subdural hematoma. Hematomas did not require treatment and did not interfere with Brineura infusion.
Anti-drug antibodies (ADAs) were detected in serum (79%) and CSF (33.3%) in patients treated with Brineura. No association was found between serum or CSF ADA titers and incidence or severity of hypersensitivity.
Intraventricular access device-related infections, including sub-clinical infections and meningitis, have been observed in patients treated with Brineura. The signs and symptoms of infections may not be readily apparent in patients with CLN2 disease. Healthcare providers should be vigilant for the development of signs and symptoms of infection, including meningitis. In clinical studies, antibiotics were administered, the intraventricular access device was replaced, and the patient continued on Brineura treatment.
Inform caregivers of the signs and symptoms of anaphylaxis, hypotension, bradycardia, and device-related complications and meningitis. Instruct them to seek immediate medical care should any of these signs and symptoms occur.
To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088, or go to www.fda.gov/medwatch.
Please see accompanying full Prescribing Information, or visit www.Brineura.com.
Indication
Brineura® (cerliponase alfa) is a prescription medication used to slow loss of ability to walk or crawl (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Important Safety Information
Brineura is a prescription medicine. Before treatment with Brineura, it is important to discuss your child’s medical history with their doctor. Tell the doctor if they are sick or taking any medication and if they are allergic to any medicines. Your child’s doctor will decide if Brineura is right for them. If you have questions or would like more information about Brineura, contact your child’s doctor.
Brineura is only given by infusion into the fluid of the brain (known as an intraventricular injection) and using sterile technique to reduce the risk of infection. An intraventricular access device or port must be in place at least 5 to 7 days prior to the first infusion. Intraventricular access device-related infections, including meningitis, were observed with Brineura treatment. If any signs of infection or meningitis occur, contact your child’s doctor immediately. The signs and symptoms of infections may not be readily apparent in patients with CLN2 disease. Your doctor should vigilantly be looking for signs and symptoms of infection, including meningitis, during treatment with Brineura.
Your child’s intraventricular access device should be replaced prior to 4 years of single-puncture administration of Brineura, because the device may deteriorate due to repeated use.
Brineura should not be used in patients with active intraventricular access device-related complications (e.g., leakage, device failure, or device-related infection, including meningitis), symptom of acute, unresolved localized infection around the device insertion site (e.g. cellulitis or abscess), or and with shunts used to drain extra fluid around the brain. Your child’s doctor should inspect the scalp and collect samples of your child’s cerebrospinal fluid (CSF) prior to each infusion of Brineura, to check that there is no device failure or infections present.
Low blood pressure and/or slow heart rate may occur during and following the Brineura infusion. Contact your child’s doctor immediately if these reactions occur.
Undesirable or hypersensitivity reactions related to Brineura treatment, including fever, vomiting, and irritability, may occur during treatment and as late as 24 hours after infusion. Your child may receive medication such as antihistamines before Brineura infusions to reduce the risk of reactions. Serious and severe allergic reactions (anaphylaxis) may occur. If a reaction occurs, the infusion will be stopped and your child may be given additional medication. If a severe reaction occurs, the infusion will be stopped and your child will receive appropriate medical treatment. If any signs of anaphylaxis occur, immediately seek medical care.
Safety and effectiveness in pediatric patients below 3 years of age have not been established.
The most common side effects reported during Brineura infusions included fever, problems with the electrical activity of the heart, decreased or increased protein in the fluid of the brain, vomiting, seizures, hypersensitivity, collection of blood outside of blood vessels (hematoma), headache, irritability, and increased white blood cell count in the fluid of the brain, device-related infection, slow heart rate, feeling jittery, and low blood pressure. Intraventricular device-related side effects included infection, delivery system-related complications, and increased white blood cell count in fluid of the brain.
These are not all of the possible side effects with Brineura. Talk to your child’s doctor if they have any symptoms that bother them or that do not go away.
Call your doctor for medical advice about side effects. You may report side effects to BioMarin Pharmaceutical Inc. at 1-866-906-6100, or the FDA at 1-800-FDA-1088 or go to www.fda.gov/medwatch.
Please see accompanying full Prescribing Information, or visit www.Brineura.com.