PRIVACY POLICY
Last updated: June 2024
Pharmacosmos Therapeutics Inc. and its subsidiaries (“Pharmacosmos” “we,” “our,” or “us”) value your privacy and the protection of your personal data. This Privacy Policy explains how we collect, store, use, share, transfer, delete, protect and process information (“Personal Data”) collected from or about you on or through the websites or applications operated and controlled by us from which you are accessing this Privacy Policy (collectively “Pharmacosmos Sites”). Except as specifically provided below in the Additional State Disclosures Section, this Privacy Policy does not apply to any other information collected by Pharmacosmos by or through any other means, such as information collected offline.
Pharmacosmos is a fully owned subsidiary of Pharmacosmos A/S, located at Roervangsvej 30, 4300 Holbaek, Denmark, a global company, and is firmly committed to protecting the privacy of information we may collect from our online visitors. When we refer to ourselves as “we" or "Pharmacosmos," we mean Pharmacosmos Therapeutics, Inc. Our website may contain links to third party websites/content/services that are not owned or controlled by Pharmacosmos. Pharmacosmos is not responsible for how these properties operate or treat your personal data, so we recommend that you read the privacy policies and terms associated with these third-party properties carefully.
Pharmacosmos may have other unique privacy policies that apply to certain specific situations, including informed consent forms for use in clinical studies. To the extent you were provided with a different privacy policy or notice and those policies or notices apply, those policies or notices will govern our interactions with you, not this one.
The following explains the types of Personal Data that Pharmacosmos may collect or process, how we may use and disclose that Personal Data, and how you may exercise any rights you may have regarding our processing of your Personal Data.
I. DATA WE COLLECT AND USE
We collect information about you directly from you, automatically through your use of our Site, and from Third Parties.
You may interact with Pharmacomsos or our partners’ websites and platforms that relate to Pharmacosmos products, job application, patient recruitment, disease awareness, scientific research, engagement with health care providers (“HCPs”) and other medical professionals, alliance websites, or applications used in the context of patient support or management programs.
We enter into arrangements for those collaborations to require appropriate protection of your Personal Data. Some areas of our web sites and platforms may require you to submit information in order for Pharmacosmos to respond to your request, permit you to access specific areas or participate in a particular activity.
When visiting our websites, please also read our Terms and Conditions of Use, and if you are visiting our website for safety reasons our page on medical information.
We have identified examples of the Online Information we may collect when you use our sites where we use your Personal Data online in the table below.
Information We Collect Directly From You. | We collect personal data you choose to provide, e.g., through registrations, applications and surveys, and in connection with your inquiries and purchases. For example, you may choose to provide us the following information:
If you submit any personal data relating to other people to us, you represent that you have the authority to do so and to permit us to use the information in accordance with this Privacy Policy. |
Information We Collect Automatically About Your Use of the Pharmacosmos Sites | When you visit the Pharmacosmos Sites, we and our third-party business partners automatically collect information, such as your browser and device type and operating system, web pages you view, links you click, your IP address, pages visited, time spent on the site, language, date of your visit and the referring URL, or webpage that led you to our Sites. Our third-party business partners may use these technologies to collect information about your online activities. See also, the Section below on Cookies. More specifically,
|
Information We Collect From Other Sources. | From time to time, we may use or augment the personal data we have about you with information obtained from other sources, such as public databases, social media platforms and other third parties. For example, we may use such third-party information to confirm contact or financial information, to verify licensure of healthcare professionals or to better understand your interests by associating demographic information with the information you have provided. |
II. HOW PERSONAL DATA IS USED
We use your personal data to contact you when you give us your consent to do so.
In addition, as permitted under applicable data protection laws, Pharmacosmos collects, uses, and processes your personal data for complying with legal or regulatory obligations of Pharmacosmos, or for the legitimate interest of Pharmacosmos’ business. We process your Personal Data where we have legitimate interests or a legal obligation for the following purposes, to:
- Operate our business;
- Deliver our products;
- Process, complete and fulfill your requested transactions;
- Provide customer service and respond to requests or inquiries;
- Communicate with you;
- To Validate your identity;
- To comply with our legal requirements;
- Tailor our marketing programs and campaigns;
- To inform you of significant changes to this Privacy Policy;
- Provide you with newsletters, articles, alerts, announcements, invitations, and other information about products, brands, health topics and disease states; and
- To process your application for employment, including requesting any additional information, responding to your questions and informing you of other employment positions that may be of interest to you (through our personnel or third-party recruiters contracted on our behalf).
On occasion, we may also use your Personal Data:
- To Connect You with Third Parties: We may provide functionality on the Site that will allow you to forward and share certain content with a friend or colleague. If you choose to use this sharing functionality to refer someone to our content, products or services, we will use your data and that of the individual you are sharing with to send the content or link you request. In addition, we may offer access to third party sharing functionality, such as third-party social media widgets/tools/buttons. If you use that functionality, your use is subject to the third party’s privacy policy and terms. As with all links to non-Pharmacosmos websites/content/services, we recommend that you read the privacy policies and terms associated with third party properties carefully.
- To Validate Your Ability to Access/Use Certain Products, Services and Information: Some products, services and information we offer may only be suitable for/accessible to individuals meeting certain eligibility or other criteria. In such cases, we may verify that you meet such criteria. For example, certain information relating to our products is only intended for and accessible to licensed healthcare professionals in certain geographic regions and we may use information we collect directly from you and from outside sources to validate your licensure and eligibility to view such information. We may also use your Personal Data to enroll you in and administer our patient assistance programs and for eligibility to participate in our clinical studies.
- To Improve Products and Services and Protect Patients and Consumers: We use the information you provide for data analysis, to better understand how our products and services impact you and those you care for, to track and respond to concerns, for fraud prevention and to further develop and improve our products and services. In addition, we use the information you provide to comply with our regulatory monitoring and reporting obligations including those related to adverse events, product complaints and patient safety.
- In Aggregated or De-identified Form: We may aggregate and/or deidentify Personal Data (thereby making it not Personal Data) and use it for any purpose, including product and service development and improvement activities. To the extent we deidentify any data originally based on Personal Data, we will maintain and use such data only in deidentified form and will not attempt to reidentify the data.
III. WHO WE SHARE YOUR PERSONAL DATA WITH
Pharmacosmos may disclose your personal data for our business purposes to the following:
- Our affiliates, which are bound to the terms of this Privacy Policy
- Our collaborators and partners that provide services that support clinical trials and patient support programs.
- Our service providers that are contractually obligated to provide services to us in a manner consistent with this Privacy Policy. We may retain other companies and individuals to perform services on our behalf and we may collaborate with other companies and individuals with respect to particular products or services. These third parties may be provided with access to personal data needed to perform their functions, but they may not use such data other than on our behalf or subject to contracts that protect the confidentiality of the data. Examples of our service providers include: vendors and suppliers that provide us with technology, services and/or content related to better operation and maintenance of the Pharmacosmos Sites; our attorneys and auditors; vendors that provide analytics and research services, credit card processing companies, customer service and support providers, email and SMS vendors, data analytics firms, web hosting and development companies and fulfillment companies.
- As part of a merger, acquisition or other sale or transfer of Pharmacosmos and/or any of its affiliates to another party. If we sell or transfer a business unit (such as a subsidiary) or an asset (such as a website) to another company (including in connection with any bankruptcy or similar proceedings), we will disclose your personal data to such company and will require such company to use and protect your personal data consistent with this Privacy Policy.
Please note that we may need to disclose your personal data if we are required to do so by law, to exercise and protect the legal rights of Pharmacosmos or its personnel and representatives, and to investigate, prevent or respond to suspected illicit activities, including fraud and threats of harm to individuals.
IV. THIRD-PARTY ADVERTISING AND SOCIAL MEDIA
Pharmacosmos does not use or share your Personal Data for the purposes of “targeted” or cross-context behavioral advertising, but we may place advertisements on third-party—including social media—platforms that direct you to the Pharmacosmos Sites. When you click on such advertisements, we may automatically collect information indicating which platform(s) referred you to us.
Some web browsers may transmit “do-not-track” signals to websites with which the browser communicates. As of the effective date of this Privacy Policy, an industry standard has not yet been established on how to respond to these signals. Therefore, Pharmacosmos does not currently respond to these signals. You can opt out from advertisers that use your browsing history to deliver online targeted advertisements by visiting adchoices.
Pharmacosmos is not responsible for the information collection, use, disclosure or security policies or practices of other organizations, such as Facebook, Apple, Google, Microsoft, RIM or any other social media platform provider, operating system provider, wireless service provider or device manufacturer, including with respect to any personal data you disclose to other organizations through or in connection with our Social Media Pages.
Pharmacosmos may provide the option for individuals to participate in polling activities. Additionally, Pharmacosmos may monitor social media channels for mentions of our brand, competitors and products, which gives Pharmacosmos an opportunity to track, analyze and respond to conversations about us on social media.
V. COOKIES AND WEBSITE ANALYTICS
A cookie is a simple text file that is stored on your computer or mobile device by a website's server and only that server will be able to retrieve or read the contents of that cookie. Each cookie is unique to your web browser. It will contain some information such as a unique identifier, the site name, some digits, and numbers. It allows a website to remember things like your preferences - e.g. choice of language.
When you first enter the website, or when you have deleted the cookies used on the website, you can access a detailed cookie overview at the bottom of the website. Pharmacosmos uses the following cookies on this website:
- Strictly necessary cookies; Strictly necessary cookies help make a website navigable by activating basic functions such as page navigation and access to secure website areas. Without these cookies, the website would not be able to work properly.
- Functionality cookies; Functional cookies make it possible to save information that changes the way the website appears or acts. For instance your preferred language or region.
- Statistical cookies; Statistical cookies help the website owner understand how visitors interact with the website by collecting and reporting information.
You can learn more about cookies in general here, including how to deselect cookies. Most browsers automatically accept cookies by default, but you can adjust the preferences in the browser of your computer or device to warn you each time a cookie is being sent, or to block some or all cookies. While you may still use the Pharmacosmos Sites if you reject cookies, your ability to use some areas of the Pharmacosmos Sites may be limited.
We may use Google Analytics, which uses cookies and similar technologies to collect and analyze information about use of the Site and report on activities and trends. The information captured on this website is transferred to Microsoft, because we use the service Azure Online Services for hosting this website and for the purpose, This service may also collect information regarding the use of other websites, apps and online resources. You can learn about Google’s practices by going to www.google.com/policies/privacy/partners/, and opt-out of them by downloading the Google Analytics opt-out browser add-on, available at https://tools.google.com/dlpage/gaoptout.
VI. SECURITY POLICIES
We use technical, administrative and procedural measures designed to safeguard your personal data from unauthorized access or use. No such measure is ever 100% effective though, so we do not guarantee that your personal data will be secure from theft, loss, or unauthorized access or use, and we make no representation as to the reasonableness, efficacy, or appropriateness of the measures we use to safeguard such data.
VII. CROSS BORDER TRANSFERS
Please be aware that Personal Data we collect and process may be transferred and maintained outside your state, province, country, or other jurisdiction where the privacy laws may not be as protective as those in your location, including the United States. Pharmacosmos has put in place lawful transfer mechanisms and adequate safeguards, in accordance with applicable legal requirements, to protect your Personal Data.
VIII. YOUR PRIVACY CHOICES
Your right to make informed decisions about information collection is important to Pharmacosmos. Please note that you may have the right to:
- obtain confirmation that Pharmacosmos has collected your personal data and information about how we use your personal data and/or obtain a copy of your personal data;
- verify the accuracy of your personal data;
- request that we correct, update, amend, delete or transform your personal data into anonymous form;
- request that we stop or restrict our use of your personal data (including opting out of receiving emails or calls from us);
- request the portability of your personal data in a structured, commonly used and machine-readable format and to transfer this personal data to another data controller or, if technically feasible, to have it transferred by us if the legal requirements are met;
- withdraw your consent where you may have provided your consent to the collection, processing and transfer of your personal data for a specific purpose at any time; and
- object to the processing of your personal data which is necessary for the purpose of our legitimate interests, on grounds relating to your particular situation. If your personal data is processed by us for direct marketing purposes, you have the right to object to this processing at any time, without any special reason.
To exercise any of these privacy rights, please contact us at dataprotection@pharmacosmos.com. Please know that in order for us to respond to your request we may require that you verify your identity.
If you need further assistance regarding your rights, please contact our Data Protection Officer at DataProtection@Pharmacosmos.com, and we will consider your request in accordance with applicable laws.
IX. CHILDREN’S PRIVACY
This Site is not directed to individuals under the age of eighteen (18). Pharmacosmos does not knowingly collect, maintain, disclose, or otherwise process Personal Data from minors below the age of 18.
X. ADDITIONAL STATE DISCLOSURES
You may have certain rights regarding our processing of your personal data under applicable local state law, including, for example, if you are a consumer in California or Virginia. If our processing of your personal data is governed by such laws, the following provisions apply to our processing of your personal data, whether collected online or offline. These provisions supplement the other sections of the Privacy Policy.
We do not “sell” or “share” for targeted or cross-contextual behavioral advertising (as those terms are defined under applicable local law) the categories of personal data described below. We do not use or disclose sensitive personal data for purposes other than permitted under applicable local law.
As may be required under applicable local law, the chart below provides the categories of personal data that we: (1) collect and have collected in the preceding 12 months; and (2) disclose for a business purpose and have disclosed for a business purpose in the preceding 12 months. For more information about how we disclose your personal data, refer to the other sections of this Privacy Policy.
Pharmacosmos has collected the following categories of personal data about consumers within the last twelve (12) months:
- Name, contact information and identifiers: Identifiers such as a real name, alias, postal address, unique personal identifier, online identifier, Internet Protocol address, email address, account name, user name, social security number, tax ID, driver’s license number, passport number, or other similar identifiers.
- Customer and other records: Paper and electronic customer records containing personal data, such as name, signature, physical characteristics or description, address, telephone number, driver’s license or state identification card number, insurance policy number, education, employment, employment history, bank account number, credit card number, debit card number, or any other financial information, medical information, or health insurance information.
- Protected classifications: Characteristics of protected classifications under applicable state or federal law such as race, color, sex, gender, age, national origin, disability, and citizenship status.
- Online Identifiers: IP address, cookie IDs
- Internet Activity Information: Internet or other electronic network activity information, including, but not limited to, browsing history, search history, and information regarding a resident’s interaction with an internet website, application, or advertisement.
- Audio/visual: Audio, electronic, or visual recordings, or similar information.
- Employment history: Professional or employment related information
- Sensitive information: as defined under applicable local law, such as certain characteristics of protected classifications, precise geolocation, account login credential and passwords, health information, and financial information.
- Profiles and inferences: Inferences drawn from any of the information identified above to create a profile about a resident reflecting the resident’s preferences, characteristics, psychological trends, predispositions, behavior, attitudes, intelligence, abilities, and aptitudes.
Pharmacosmos has collected personal data from the following categories of sources:
As described in this Privacy Policy, we collect this personal data from you and from other categories of sources: public databases; social media platforms; and other third parties, healthcare providers, and/or payors when they share the information with us. For example, we may use such third party information to confirm contact or financial information, to verify licensure of healthcare professionals, or to better understand your interests by associating demographic information with the information you have provided.
Also as described above in the How Personal Data Is Used Section, we may use this personal data to serve you; to connect you with third parties; to validate your ability to access and/or use certain products, services and information; to provide and improve products and services; to protect patients and consumers; in accordance with special program terms; to operate, manage, and maintain our business; to respond to your inquiries and fulfill your requests; to send administrative information to you; to send you certain marketing communications; to personalize certain experiences; and to facilitate social sharing or messages services when available. We may also use your personal data for our business purposes and objectives, including, data analysis; audits; developing new products; improving existing products; identifying usage trends; determining the effectiveness of promotional campaigns; preventing fraud; and expanding our business activities. Additionally, we may use this personal data to comply with applicable law, legal process, respond to requests from public and government authorities, and to protect our rights, operations, and enforce our terms of service.
As described in the Retention Period Section below, we may retain your personal data for as long as needed or permitted in light of the purpose(s) for which it was obtained and as outlined in this Privacy Policy, depending on the length of our relationship with you, whether there is a legal obligation to which we are subject; or whether retention is advisable in light of our legal position.
Subject to certain exceptions and depending on where you live, you may have certain additional rights related to information that we collect about you. We have detailed those rights for you below:
- Right to Notice: Before or at the time we collect personal data from you, you have the right to receive notice of the personal data to be collected and the purposes for which we use it. This Privacy Policy is intended to satisfy this requirement.
- Right to Know: You have the right to request that we provide you with the following:
- The categories of personal data we have collected about you
- The categories of sources from which we have collected personal data about you
- The business or commercial purpose for collecting your personal data
- The categories of third parties with whom we share personal data
- The specific pieces of personal data we have collected about you
- The categories of personal data that we have disclosed about you for a business purpose
- Right Not to Be Subject to Discrimination: You have the right to be free from discrimination or retaliation for exercising any of your data subject rights, including the rights listed above.
- Right to Appeal: You may have a right to appeal a decision we make relating to requests to exercise your rights under applicable local law. You may exercise this right using the same method you used to submit your request.
Please note that Pharmacosmos may not be required to fulfill your requests in certain circumstances. These include instances where we must retain or restrict access to personal data in order to preserve scientific integrity, as your personal data must be managed in specific ways in order for the information to be reliable and accurate and to meet regulatory obligations of Pharmacosmos and its affiliates.
Additionally, Pharmacosmos is not required to provide information in response to a request to know for a particular consumer more than twice in any given 12-month period.
When you submit a request to exercise your right of access, your right to deletion or your right to know, we are required to verify that you are who you say you are. We may request that you provide additional personal data for the verification process.
To exercise the rights described above, to file a concern or complaint, or to opt out of particular programs, please contact our Privacy Office by emailing DataProtection@pharmacosmos.com .
XI. RETENTION PERIOD
We retain your personal data for as long as needed or permitted to fulfill the legitimate business purposes or uses outlined in this Privacy Policy, unless a longer retention period is required or allowed by applicable data protection law or to otherwise fulfill a legal obligation. The criteria used to determine our retention periods include: (i) the length of time we have an ongoing relationship with you and provide the Pharmacosmos Sites to you; (ii) whether there is a legal obligation to which we are subject; or (iii) whether retention is advisable in light of our legal position (such as in regard to the enforcement of the Legal Notice, applicable statutes of limitations, litigation or regulatory investigations).
XII. CONTACT US
If you have questions about this Privacy Policy or about how your Personal Data is processed, please contact us at dataprotection@pharmacosmos.com or write to us at:
Pharmacosmos Therapeutics, Inc.
East Tower, 120 Headquarters Plaza 6th Floor
Morristown, NJ 07960
Attn: Legal Department
We will make reasonable efforts to respond promptly to your requests in accordance with applicable laws. We may, after receiving your request, require additional information from you to honor your request and verify your identity. Please be aware that we may be unable to afford these rights to you under certain circumstances, such as if we are legally prevented from doing so.
XIII. UPDATES TO OUR PRIVACY POLICY
From time to time, we may update this Privacy Policy. Any changes will be effective when we post the revised Privacy Policy. This Privacy Policy was last updated as of the effective date listed above. If the Privacy Policy changes in a way that significantly affects how we handle personal data, we will not use the personal data we previously gathered in the manner described in the new policy without providing notice and/or obtaining your consent, as appropriate. Minor changes to the policy may occur that will not significantly affect our use of personal data without notice or consent. We encourage you to periodically review this page for the latest information on our privacy practices.
INDICATIONS
Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:
- who have intolerance to oral iron or have had unsatisfactory response to oral iron
- who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.
Iron Overload
Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.
ADVERSE REACTIONS
Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.
To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.