Terms and Conditions
Alexion Pharmaceuticals, Inc., Alexion Pharma GmbH, and their global affiliates (collectively, “Alexion” or “we”) provides this website as a source of general information about Alexion and information related to Alexion’s pharmaceutical products, disease awareness, information, and/or diagnostic information. This page describes the terms and conditions (hereinafter “Terms”) that apply to any user visiting this or other Alexion controlled domains (hereinafter “the Site”). This website may be linked to other websites and applications for mobile devices (“Applications”) provided by Alexion, which together with this website shall be referred to in this statement as the “Site.”
By using the Site, you acknowledge that you have read and understood the terms and that you accept them without limitation. If you do not agree to these Terms, please do not use the Site. As the Terms may be amended at any time without prior notice to you, we advise you to consult them regularly.
Please read this legal statement carefully before using the Site. This statement includes
- Data Privacy Statement
- Cookie and Site Usage Tracking Policy
Scope of the Site
The Site is intended to provide information on Alexion’s pharmaceutical products and/or information relating to treatments, disease awareness, and/or diagnostics.
The information contained on the Site is intended for informational purposes only. It is not a substitute for actual medical care, advice and is in no way intended to replace professional medical care or attention by a healthcare professional. Persons requiring diagnosis or treatment or with questions specific to a single individual are urged to contact their local healthcare provider. You should not use the information contained herein for diagnosing a health and/or fitness problem and/or disease. The information provided on the Site is not intended for minors.
Alexion has made reasonable efforts to ensure that information is complete and accurate when posted. However, Alexion makes no warranties or representations as to the completeness or accuracy of the information presented.
The Site may offer opinions by experts consulted in a particular field in relation to the content of the Site or excerpts from press articles. Experts’ opinions reflect their own personal views and should never be interpreted as being the opinion or responsibility of Alexion and its affiliates.
Information, especially financial (if any), published on the Site shall not be considered as an encouragement to invest. The Site may contain forward-looking statements regarding Alexion’s operations, financial condition, prospects, products, services, and strategies. Such forward-looking statements are based on estimates and projections about our industry, management’s beliefs, and certain assumptions made by our management. Such statements are subject to certain factors which may cause Alexion’s plans or results to differ from those expected, including, without limitation, decisions of regulatory authorities regarding marketing approval or material limitations on marketing of Alexion’s products; delays in arranging satisfactory manufacturing capability and establishing commercial infrastructure; the possibility that results of clinical trials are not predictive of safety and efficacy results of Alexion’s products in broader patient populations in the disease studied or other diseases; the risk that acquisitions will not result in short-term or long-term benefits; the possibility that current results of commercialization are not predictive of future rates of commercialization; the risk that third parties will not agree to license any necessary intellectual property to Alexion on reasonable terms or at all; the risk that third party payers (including governmental agencies) will not reimburse for the use of Alexion’s products at acceptable rates or at all; the risk that estimates regarding the number of patients is inaccurate; our ability to successfully complete preclinical or clinical development of our products; our ability to expand the use of our product in other indications; and other risks set forth from time to time in Alexion’s filings with the US Securities and Exchange Commission. Alexion undertakes no obligation to update any of these forward-looking statements.
You may use the Site for lawful purposes only. Alexion specifically prohibits the use of the Site for, and you agree not to: (i) use any device, software or routine to interfere or attempt to interfere with the proper working of the Site; (ii) take any action that imposes an unreasonably large load on the Site’s infrastructure; and (iii) decipher, decompile, disassemble, or reverse engineer any of the software comprising or in any way making up any part of the Site, or attempt to do the same.
Restrictions on Use of Materials and Intellectual Property
The Site is owned and operated by Alexion. The contents of the Site, such as text, graphics, images, logos, button icons, software and other material (the “Material”) are protected under copyright, trademark, and other laws. You may not copy, reproduce, republish, modify, upload, post, transmit, or distribute Material in any way. For purposes of these Terms, the use of the Material or a modification of the Material on any other Site or networked computer environment is prohibited unless permission is obtained in writing from Alexion. You may not copy or adapt any Material we use to generate the web pages. This is also protected by copyright and other laws.
Links to Third-Party Websites and Social Plugins
Links to other websites not controlled by Alexion (non-Alexion) are provided for convenience only. The Site also may use social plugins from social networking, including but not limited to Facebook, Twitter, LinkedIn, Google+, etc. operated by third-parties.
In case you use such a plugin, your browser will contact the third-party server and load the visual presentation of the plugin as well as present it to you. During this exercise, the third-party server receives information concerning your visit of the Site of our internet presence as well as further data like your IP address.
By providing these links and social plugins, we are not endorsing or agreeing with content contained at any of the linked sites. Furthermore, the content of the linked websites is not part of the Site. The use of third-party sites and social plugins is at your own risk and subject to the terms and conditions of the third-party site.
Neither Alexion nor any other party involved in creating, producing, or delivering the Site or any linked non-Alexion site from or to this Site shall be liable in any manner whatsoever for any damages of any nature arising out of your access to this Site or any linked non-Alexion site and/or social plugin from this Site, or any errors or omissions in their content. In addition, you are responsible for taking the precautions necessary to prevent any infection, in particular by one or more computer viruses, Trojan horses or any other “virus.”
We also want you to know that when you link from an Alexion website to another website and/or use the social plugin function, the website and/or the social plugin provider may have the ability to recognize that you have come from the Site. If you do not want any other websites and/or provider to know that you have been on this Site, we recommend that you do not use the links and social plugins provided in our Site.
Alexion appreciates hearing from interested parties and welcomes your comments regarding Alexion’s products or technologies, including Alexion’s on-line services. However, Alexion’s company policy does not allow it to accept or consider confidential creative ideas, suggestions, inventions, note drawings, concepts, materials or other information (collectively “Information”) other than those it has specifically requested in writing. If you nonetheless send us any Information, it shall be deemed, and shall remain, the property of Alexion. None of the Information shall be subject to any obligation of confidence on the part of Alexion and Alexion shall not be liable for any use or disclosure of any Information. Without limitation of the foregoing, Alexion shall exclusively own all now known or hereafter existing rights to the Information and shall be entitled to unrestricted use of the Information for any purpose whatsoever, commercial or otherwise, without compensation to the provider of the Information.
Limitation on Liability
The Site is for informational purposes only. You should not use the information contained herein for diagnosing a health or fitness problem or disease. Alexion makes no warranties or representations as to its accuracy. The materials in this Site are provided “as is” and without warranties of any kind either expressed or implied. To the fullest extent permissible pursuant to applicable law, Alexion disclaims all explicit or implicit warranties, including but not limited to implied warranties of merchantability and suitability for a particular purpose of the Site.
Consequently, except for direct damages resulting from gross negligence or willful misconduct, Alexion assumes no liability or responsibility for any direct, indirect, special, incidental or consequential damages under any legal theory arising out of or in connection with this Site; for any inaccuracy, errors or omissions in the content of Site; for any damage resulting from fraudulent intrusion by a third party resulting in an alteration of information or items made available on the Site or for the ability or inability to use the Site or the information contained herein. Furthermore, Alexion does not warrant that the functions contained in the materials will be uninterrupted or error free; that defects will be corrected or that this Site or the server that makes it available are free of viruses or other harmful components.
Availability of the Site
You acknowledge that (i) it is technically impossible to provide the Site free from any defect and that Alexion cannot undertake to do so; (ii) defects may lead to the Site being temporarily unavailable; and (iii) operation of the Site can be affected by events and/or matters that Alexion does not control. Alexion may, at any time, alter or interrupt, temporarily or permanently, all or part of the Site to undertake maintenance and/or make improvements and/or changes to the Site. Alexion is not responsible for any alteration, suspension or interruption of the Site.
Trademark and Copyright Information
Copyright ©2017 Alexion Pharmaceuticals, Inc. This Alexion website is protected by copyright, including images, layout, and text. All rights reserved.
ALEXION, the ALEXION logo, DEDICATED TO RARE DISEASES, EVERY DAY WITH HPP, KANUMA, the KANUMA logo, PNHSOURCE, PNH REGISTRY, RXPEDITE, SOLIRIS, and STRENSIQ, whether or not appearing in bold typeface or with the trademark symbol ®, are trademarks of Alexion Pharmaceuticals, Inc. Alexion’s trademarks are registered in the United States, the European Union, and in other countries worldwide and may not be used without permission. Use, reproduction, copying, or redistribution of these trademarks is prohibited.
The use or misuse of these trademarks, copyrights, or other materials is expressly prohibited and may be in violation of copyright law, trademark law, communications regulations and statutes, and other laws, statutes, and/or regulations.
All photos and videos are used with permission.
The Site and its content are governed by and interpreted in accordance with the laws of the United States of America, any dispute relating thereto are subject to the jurisdiction of the courts of Connecticut. Alexion reserves the right to limit provision of any product or service to any person, geographic region or jurisdiction and to limit the products or services that we provide.
If any of these Terms are held invalid or unenforceable by any court of competent jurisdiction, the other provisions of these Terms shall remain in full force and effect. If any provision of these Terms are held invalid or unenforceable only in part or degree, the remainder will continue in full force and effect to the extent not held invalid or unenforceable.
How to contact Alexion
If you have any questions about the Terms of the Site, you may contact us as follows:
Alexion Pharmaceuticals, Inc.
121 Seaport Blvd | Boston, MA | 02210
United States of America
Last updated on: 8/1/2017
Data Privacy Statement
At Alexion, we understand that various laws and regulations govern data protection and we respect your privacy and personal information. Please review this Data Privacy Statement to learn about how Alexion collects, uses, shares and protects information.
In accordance with the relevant laws, “Personal information” is information relating to an identified or identifiable natural person; an identifiable person is one who can be identified, directly or indirectly, by using a combination of information such as identification number or other information which is submitted to and/or collected by the Site and maintained by or for Alexion in an accessible form. Examples of Personal Information that directly identify you can include your name, address, telephone number, email address and other similar information.
Information Collected – Information You Give Us
The Site is not designed to receive any confidential and/or personal information. The Site, if applicable, collects your personal information only if you choose to give it to us voluntarily by email or forms. We use such information only for those purposes which you have approved. If you do not consent to the collection, use or disclosure of your personal data as outlined herein, please do not submit any personal information to Alexion.
By providing personal information to us, you give your consent to these being processed by Alexion for the purpose of answering your question, granting you access to the Site or some other aspects defined on the Site or requested by you. While we retain the right to share your personal information with our corporate affiliates, and with outside companies or agents working on our behalf to help fulfill our business obligations, we do not share any of your personal information with third parties for their own use unless you explicitly give us permission to do so. If you submit Personal Information we may use that information to contact you by email, phone or mail as you indicated to provide you with information you have requested. Thus, with the exception of the personal information outlined above, all information, whatever form it is in: documents, data, graphics, questions, suggestions, concepts, remarks or other – which you communicate on the Site will in no way be considered as confidential. The simple fact of you transmitting this data to us grants us the right to use, reproduce, diffuse or modify this data, or to transmit it in the aim of processing your request.
In some cases, we remove personal identifiers from data and maintain it in aggregate form. We may combine this data with other information to produce anonymous, aggregated statistical information helpful to us in improving our products and services.
Automatically Collected Information
We may automatically collect certain types of information that is not personal or linked to any personal information whenever you interact with us on the Site. Examples of such information are: IP address, geographical location, browser type, device type, operating system, etc. We may use this information to improve the quality of the Site and it is only used in an aggregated form. This depersonalized, aggregated information collected from our Site help us to understand trends and your needs. For example, we may analyze the gender or age of visitors to the Site about a particular medication or disease state, and we may use that analysis of aggregate data internally or share it with others for the purposes set forth in this Data Privacy Statement.
For further information please see our Cookie and Site Usage Tracking Policy
Data Sharing and Transfer
In case you share personal information with Alexion, Alexion will not disclose to third parties your personal information except (i) to affiliated entities; (ii) to vendors and service providers who assist Alexion in providing service to you (e.g. a fulfillment company for processing and mailing purposes, providing customer service, sending marketing communications about our products, services and offers, and doing technological maintenance) and complies with the applicable data privacy laws and regulations. We may also disclose personal information for these purposes:
- in connection with the sale, assignment or other transfer of the business of the Site to which the data relates;
- to respond to requests of government or law enforcement agencies or where required or permitted by applicable laws, court orders, or government regulations; or
- when needed for corporate audits or to investigate or respond to a complaint or security threat.
Any affiliated entity, vendor or service provider, or other third party who has permitted access to or to whom we transfer personal information is required to keep your personal data confidential.
No Third-Party Direct Marketing Use: Alexion will not sell or otherwise transfer the personal information you provide to us at our Site to any third party for their own direct marketing use unless we provide clear notice to you and obtain your explicit consent for your data to be shared in this manner.
Note to Users of Business or Professional Websites: If you have a business or professional relationship with Alexion, we may use information you submit on our Site, including sites intended specifically for business and professional users, to fulfill your requests and develop our business relationship with you and the entities you represent. We may also share such information with third parties acting on our behalf.
Privacy Statement for Minors
Our Site is not intended or designed for persons under the age of 18 (hereinafter “minor”). If you are under the age of 18, you must not provide your personal information. We will not knowingly collect, use or disclose personal information from minors without the prior written consent from his/her parents and/or legal guardian.
The Site will be hosted by Alexion or may be directed to a third-party site administered and hosted by a third-party vendor.
Additional Information on Websites
If parts of the Site have particular provisions relating to privacy that differ from those stated here, those provisions will be disclosed to you on the page on which your personal information is collected.
Right to Withdraw
You have the right to withdraw your consent at any time, to access, to modify, to rectify and where applicable to suppress any personal information concerning you, simply by requesting it through the following ways:
Alexion Pharmaceuticals, Inc.
121 Seaport Blvd | Boston, MA | 02210
United States of America
Last updated on: 8/1/2017
Cookie and Site Usage Tracking Policy
Automatic technologies we use may include, for example, web server logs and IP addresses, cookies and web beacons. We may also use tracking technologies and third-party analysis services to understand aggregate site-usage patterns.
Web Server Logs and IP Addresses: An IP address is a number assigned to your computer whenever you access the Internet that allows computers and servers to recognize and communicate with each other. Alexion may collect IP addresses to conduct system administration and report aggregate information to affiliates, business partners, service providers and/or vendors to conduct website and application analysis and performance reviews.
Web Beacons: A web beacon is an unobtrusive web object (image, code) placed on the website pages to verify whether the visitor has accessed the site and also to collect some basic information such as IP address.
Our site may use Session andor Persistent cookies:
Session cookies: Session Cookies are stored only temporarily during a browsing session and are deleted from the user’s device when the browser is closed.
Persistence cookies: This type of cookie is saved on your computer for a fixed period (usually a year or longer) and is not deleted when the browser is closed. Persistent cookies are used where we need to know who you are for more than one browsing session. For example, we use this type of cookie to store your preferences, so that they are remembered for the next visit.
Cookies and other tracking technologies do not automatically obtain personal information about you. Only if you voluntarily submit personal information, such as by registering or sending e-mails, can these automatic tracking technologies be used to provide further information about your use of the websites to improve their usefulness to you.
If you wish to prevent cookies from being used and tracking technology from tracking you as you navigate our Site, you can reset your browser to refuse all cookies and/or tracking technology or to indicate when a cookie is being sent. To learn more about how to do this, visit the help pages of your browser. You can delete all cookies that are already on your computer and you can set most browsers to prevent them from being placed. If you do this, however, you may have to manually adjust some preferences every time you visit a site and some services and functionalities may not work. To find out more about cookies, including how to see what cookies have been set and how to manage and delete them, visit www.allaboutcookies.org.
Last updated on: 8/1/2017
© 2017 Alexion Pharmaceuticals, Inc.
INDICATION & IMPORTANT SAFETY INFORMATION FOR SOLIRIS® (eculizumab)
Generalized Myasthenia Gravis (gMG)
Soliris is indicated for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris.
Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.
- Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
- Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection)
- Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy
(REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.
Soliris is contraindicated in:
- Patients with unresolved serious Neisseria meningitidis infection
- Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection
Warnings and Precautions
Serious Meningococcal Infections
Risk and Prevention
See Boxed WARNING for additional information on serious meningococcal infections.
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).
Vaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations, considering the duration of Soliris therapy.
Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If urgent Soliris therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.
The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving Soliris have not been established.
Vaccination reduces, but does not eliminate, the risk of meningococcal infections.
Closely monitor patients for early signs and symptoms of meningococcal infection, and evaluate patients immediately if an infection is suspected. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.
Because of the risk of meningococcal infections, Soliris is available only through a restricted program under a REMS. Under the Soliris REMS, prescribers must enroll in the program.
Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).
Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.
Soliris blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Use caution when administering Soliris to patients with any systemic infection.
Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction that required discontinuation of Soliris. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.
The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain.
Please see full prescribing information for Soliris, including boxed WARNING regarding serious meningococcal infections.