Effective Date: November 1, 2021
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.
California residents, please see our CCPA-specific notice at the bottom of this notice.
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:
We also may collect certain information automatically when you visit the Services, including:
We may use first- or third-party cookies, and similar technologies to automatically collect this information. Cookies are small bits of information that are stored by your computer’s web browser. You can decide if and how your computer will accept a cookie by configuring your preferences or options in your browser. You may also click on “Cookie Preferences” on our websites to manage your choices. However, if you choose to reject cookies, you may not be able to use certain online products, services or features available through the Services.
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.
We process your information for a variety of legitimate business interests including, but not limited to, the following examples:
We may also process your information in order to comply with our legal obligations, satisfy any contract between us and you, establish and defend any legal claims, and in specific cases process your information based on your consent.
We are committed to maintaining your trust, and we want you to understand when and with whom we may share the information we collect.
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.
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.
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.
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.
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.
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.
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.
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.
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
The California Consumer Privacy Act of 2018 (CCPA) gives California residents the right to know what Personal Information BioMarin Pharmaceutical Inc. (“BioMarin,” “we,” “us,” or “our”) collects about them, including whether it is being sold or disclosed to third parties.
In this Notice, “Personal Information” (or “PI”) means any information that identifies, relates to, describes, or is capable of being associated with you or your household, whether directly or indirectly.
The CCPA also grants certain rights to California residents, including the right to delete their Personal Information (subject to certain exceptions) and the right to prevent BioMarin from selling their Personal Information. Companies are also prohibited from retaliating or discriminating against consumers for exercising their rights under the CCPA.
The types of Personal Information we collect and disclose depends on your relationship and interaction with BioMarin. Please review the information below to learn about our data collection and disclosure practices generally. The information below describes the categories of personal information we have collected in the preceding 12 months, along with the categories of sources from which the personal information was collected, the purpose for collecting or selling the personal information, the categories of third parties with whom we share the personal information, and if we sell the information, the categories of third parties to whom we sell it.
In addition to the purposes for collecting and sharing Personal Information described in the information below, BioMarin may collect and disclose any and all Personal Information to our service providers and corporate affiliates (but only as necessary or appropriate to perform legitimate business purposes). We also collect and disclose any and all Personal Information as necessary to: comply with laws and regulations; monitor, investigate potential breaches of, and enforce compliance with BioMarin’s policies and procedures and legal and regulatory requirements; comply with civil, criminal, judicial, or regulatory inquiries, investigations, subpoenas, or summons; and exercise or defend the legal rights of BioMarin and its employees, affiliates, customers, contractors, and agents. We will not collect additional categories of Personal Information nor use the Personal Information collected for additional purposes without providing you notice.
If you are a California resident, you have the following rights under the CCPA with respect to your Personal Information, subject to certain exceptions and exemptions:
You can exercise your rights by calling 1-800-983-4587 (toll free) or by completing and submitting the webform found here. In accordance with applicable law, you may only make a personal information request twice in a 12-month period. We will respond to any personal information request within 45 days of receiving it.
VERIFICATION: We value the security and confidentiality of your Personal Information. Therefore, if you exercise your right to notice, right of access, or right to deletion, we must first verify your identify to make sure that you are the person about whom we have collected Personal Information. We will verify every request carefully.
You may also authorize someone else to submit these requests on your behalf. To do so, you may designate another person who may act on your behalf by providing us with a notarized copy of power of attorney, or ask the authorized agent to provide us with a copy of your written permission and a scanned copy of their own government-issued ID.
Call 1-800-983-4587 (toll free) or email us at firstname.lastname@example.org to contact us with questions regarding this Notice. California residents who are unable to review or access this Notice due to a disability may email us at email@example.com to request an accommodation including access to this Notice in an alternative format.
For each of the categories of Personal Information listed below, here are: (1) the definition of each category; (2) the source(s) we collect such PI from; (3) our purpose(s) for collecting or sharing the PI; (4) the third parties to whom we disclose the PI; and (5) the third parties to whom we sell the PI, if any.
Life-threatening anaphylactic reactions have occurred in some patients during VIMIZIM infusions. Anaphylaxis, presenting as cough, erythema, throat tightness, urticaria, flushing, cyanosis, hypotension, rash, dyspnea, chest discomfort, and gastrointestinal symptoms in conjunction with urticaria, have been reported to occur during VIMIZIM infusions, regardless of duration of the course of treatment. Closely observe patients during and after VIMIZIM administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with acute respiratory illness may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions and require additional monitoring.
Due to the potential for anaphylaxis, appropriate medical support should be readily available when VIMIZIM is administered and for an appropriate period of time following administration. In clinical trials, cases of anaphylaxis occurred as early as 30 minutes from the start of infusion and up to 3 hours after infusion, and as late into treatment as the 47th infusion.
In clinical trials, hypersensitivity reactions have been observed as early as 30 minutes from the start of infusion but as late as 6 days after infusion. Frequent symptoms of hypersensitivity reactions (occurring in more than 2 patients) included anaphylactic reactions, urticaria, peripheral edema, cough, dyspnea, and flushing.
Because of the potential for hypersensitivity reactions, administer antihistamines with or without antipyretics prior to infusion. Management of hypersensitivity reactions should be based on the severity of the reaction and includes slowing or temporary interruption of the infusion and/or administration of additional antihistamines, antipyretics, and/or corticosteroids for mild reactions. However, if severe hypersensitivity reactions occur, immediately stop the infusion of VIMIZIM and initiate appropriate treatment.
Consider the risks and benefits of re-administering VIMIZIM following a severe reaction.
Patients with acute febrile or respiratory illness at the time of VIMIZIM infusion may be at higher risk of life-threatening complications from hypersensitivity reactions. Careful consideration should be given to the patient’s clinical status prior to administration of VIMIZIM; consider delaying the VIMIZIM infusion.
Sleep apnea is common in MPS IVA patients. Evaluation of airway patency should be considered prior to initiation of treatment with VIMIZIM. Patients using supplemental oxygen or continuous positive airway pressure (CPAP) during sleep should have these treatments readily available during infusion in the event of an acute reaction, or extreme drowsiness/sleep induced by antihistamine use.
Spinal or cervical cord compression (SCC) is a known and serious complication of MPS IVA and may occur as part of the natural history of the disease. In clinical trials, SCC was observed both in patients receiving VIMIZIM and patients receiving placebo. Patients with MPS IVA should be monitored for signs and symptoms of SCC (including back pain, paralysis of limbs below the level of compression, and urinary and fecal incontinence) and given appropriate clinical care.
All patients treated with VIMIZIM 2 mg/kg once per week in the placebo-controlled trial developed anti-drug antibodies. The relationship between the presence of neutralizing antibodies and long-term therapeutic response or occurrence of anaphylaxis or other hypersensitivity reactions could not be determined.
VIMIZIM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if VIMIZIM is present in human milk. Exercise caution when administering VIMIZIM to a nursing mother. There is a Morquio A Registry that collects data on pregnant women and nursing mothers with MPS IVA who are treated with VIMIZIM. Contact MARS@BMRN.com for information and enrollment.
Safety and effectiveness in pediatric patients below 5 years of age have not been established and are currently being evaluated.
In clinical trials, the most common adverse reactions (≥10%) occurring during infusion included pyrexia, vomiting, headache, nausea, abdominal pain, chills, and fatigue. The acute reactions requiring intervention were managed by either temporarily interrupting or discontinuing infusion, and administering additional antihistamines, antipyretics, or corticosteroids.
To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information, including Boxed Warning.
VIMIZIM® (elosulfase alfa) is indicated for patients with mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).