Thank you for visiting a Roche Web site or interacting with us via e-mail.

At Roche, we understand that protecting the privacy of visitors to our Web sites is very important and that information about your health is particularly sensitive. We only collect personally identifiable information about you if you choose to give it to us. We do not share any of your personally identifiable information with third parties for their own marketing use unless you explicitly give us permission to do so. Please review this Privacy Statement to learn more about how we collect, use, share and protect information online.

Table of Contents

Information Collected

  • Information You Give Us:
  • At our Web sites, we only collect your personally identifiable information (such as name, address, telephone number or e-mail address) when you choose to submit it to us. For example, you may choose to register to receive information about a disease state that interests you.
  • In some cases we also 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 automatically receive certain types of information whenever you interact with us on our sites and in some e-mails we may send each other. Automatic technologies we use may include, for example, Web server logs/IP addresses, cookies and Web beacons.
  • Web Server Logs/IP Addresses. An IP address is a number assigned to your computer whenever you access the Internet. All computer identification on the Internet is conducted with IP addresses, which allow computers and servers to recognize and communicate with each other. Roche collects IP addresses to conduct system administration and report aggregate information to affiliates, business partners and/or vendors to conduct site analysis and Web site performance review.
  • Cookies. A cookie is a piece of information that is placed on your computer when you access certain Web sites. The cookie uniquely identifies your browser to the server. Cookies allow us to store information on the server to help make the Web experience better for you and to conduct site analysis and Web site performance review. Most Web browsers are set up to accept cookies, although you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.
  • Web Beacons. On certain Web pages or e-mails, Roche may utilize a common Internet technology called a “Web beacon” (also known as an “action tag” or “clear GIF technology.”) Web beacons help analyze the effectiveness of Web sites by measuring, for example, the number of visitors to a site or how many visitors clicked on key elements of a site.
  • Web beacons, cookies and other tracking technologies do not automatically obtain personally identifiable information about you. Only if you voluntarily submit personally identifiable 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 Web sites and/or interactive e-mails to improve their usefulness to you.

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Your Choices

You have several choices regarding your use of our Web sites. You could decide not to submit any personally identifiable information at all by not entering it into any forms or data fields on our sites and not using any available personalized services. Certain sites may ask for your permission for certain uses of your information and you can agree to or decline those uses. If you opt-in for particular services or communications, such as an e-newsletter, you will be able to unsubscribe at any time by following the instructions included in each communication. If you decide to unsubscribe from a service or communication, we will work to remove your information promptly, although we may require additional information before we can process your request.

As described above, if you wish to prevent cookies from tracking you anonymously as you navigate our sites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.

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Use of Data

Roche and/or the companies we hire to perform services on our behalf will use any personally identifiable information you choose to give us to comply with your requests or as otherwise disclosed to you in this Statement or on the Web page where you submit your information to us. We may refer to this information to better understand your needs and how we can improve our products and services.

We use aggregated (non-personally identifiable) information to help us understand trends and customer needs. For example, we may analyze the gender or age of visitors to sites about a particular medication or disease state, and we may use that analysis of aggregate data internally or share it with others.

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Data Sharing and Transfer

Roche shares personally identifiable data about you with various outside companies or agents working on our behalf to help fulfill business transactions, such as providing customer services, sending marketing communications about our products, services and offers, and doing technological maintenance. We may also share personally identifiable data with our company's subsidiaries and affiliates.

We may also disclose personally identifiable information for these purposes:

(a) in connection with the sale, assignment or other transfer of the business of the site to which the data relates;
(b) to respond to appropriate requests of legitimate government agencies or where required by applicable laws, court orders, or government regulations; or,
(c) where needed for corporate audits or to investigate or respond to a complaint or security threat.

No Third-Party Direct Marketing Use. We will not sell or otherwise transfer the personally identifiable information you provide to us at our Web sites to any third parties 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.

E-mail a Friend or Colleague. On some Roche sites, you can choose to send a link or a message to a friend or colleague referring them to a Roche Web site. E-mail addresses you may provide for a friend will be used to send your friend information on your behalf and will not be collected or used by Roche or other third parties for additional purposes.

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Links to Other Sites

Our sites contain links to a number of Web sites that may offer useful information to our visitors. This Privacy Statement does not apply to those sites, and we recommend communicating to them directly for information on their privacy policies.

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Privacy Statement for Children

Our Web sites are not intended or designed to attract children under the age of 13. We do not collect any personally identifiable information from anyone we know to be under the age of 18.

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Additional Information on Web Sites

If a Web site has particular provisions relating to privacy that differ from those stated here, those provisions will be disclosed to you on the page on which personally identifiable information is collected.

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Note to Users of Business or Professional Web Sites

If you have a business or professional relationship with Roche, we may use information you submit on our sites, 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.

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Updates to Privacy Statement

From time to time, Roche may revise this online Privacy Statement. Any such changes to this Privacy Statement will be promptly communicated on this page. Continued use of our sites after receiving notice of a change in our Privacy Statement indicates your consent to the use of newly submitted information in accordance with the amended Roche Privacy Statement. The effective date of this Privacy Statement is October 28, 2004.

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How to Contact ROCHE


If you have any questions about ROCHE Privacy Statement or the information practices of our sites, you may contact us as follows:

Roche Subject: Attention: Privacy Office or

Roche
Attention: Privacy Office
340 Kingsland Street
Nutley, NJ 07110-119

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Unless explicitly stated otherwise, this Privacy Statement applies to Roche Laboratories Inc. or Hoffmann-La Roche Inc. Web sites.

Indication

FUZEON (enfuvirtide) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

This indication is based on results from two controlled studies of 48-weeks’ duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral-naive patients.

Important Safety Information

Pneumonia

An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. However, because of this finding, patients with HIV infection should be monitored for signs and symptoms of pneumonia, especially if they have underlying conditions that may predispose them to pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.

Hypersensitivity Reactions

FUZEON is contraindicated in patients with known hypersensitivity to FUZEON or any of its components. Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have occurred in < 1% of patients and have included combinations of rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune-mediated and have been reported in subjects receiving FUZEON include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome. Patients developing signs and symptoms suggestive of a systemic hypersensitivity reaction should discontinue FUZEON treatment and should seek medical evaluation immediately. Therapy with FUZEON should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction. Risk factors that may predict the occurrence or severity of hypersensitivity to FUZEON have not been identified.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including FUZEON.

Administration with Biojector 2000

Nerve pain (neuralgia and/or paresthesia) lasting up to 6 months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with use of the Biojector 2000 needle-free device for administration of FUZEON.
Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.

Other Adverse Events

Excluding ISRs, the events most frequently reported in patients receiving FUZEON plus a background regimen were diarrhea (38 per 100 patient-years, or 32%), nausea (27 per 100 patient-years, or 23%) and fatigue (24 per 100 patient-years, or 20%). These events were seen at a lower incidence than in patients receiving a background regimen without FUZEON: diarrhea (73 per 100 patient-years), nausea (50 per 100 patient-years) and fatigue (38 per 100 patient-years).

Most Common Adverse Events

Injection Site Reactions (ISRs)

ISRs were the most frequently reported adverse event (98%). Few patients (4%) discontinued treatment because of ISRs. Signs/symptoms may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, ecchymosis and infection. Eleven percent of patients had local reactions that required analgesics or limited usual activities.

FUZEON is not a cure for HIV infection or AIDS. FUZEON does not prevent the transmission of HIV.

For more information on FUZEON, please see package insert, go to www.FUZEON.com or call 1.877.4.FUZEON (1.877.438.9366).