PATIENT SITE

PRIVACY POLICY

By using or accessing one of the websites ("Sites") owned by Corcept Therapeutics Incorporated ("we", "us" or "Corcept"), you agree to the terms of this Privacy Policy. Because you may submit your resume, contact information or other personally identifiable information to us through our Sites or via email, we feel you should fully understand the terms and conditions relating to the collection, use and possible disclosure of that information. The term "Personal Information" as used throughout this Privacy Policy, applies to any information that we may collect, and which can be used to identify or to locate an individual.

Your privacy and security are important to us. Because you may submit your resume, contact information or other Personal Information to us through our Sites or via email, we feel you should fully understand the terms and conditions relating to the collection, use and possible disclosure of that information. Our Privacy Policy is clear: we will collect no Personal Information about you when you visit our Sites unless you elect to provide that information to us. This Privacy Policy discloses what Personal Information (as described below) we collect from you when you visit and use our Sites, how we use that Personal Information, and how you can correct or make changes to that information. If you do not consent to the terms of our Privacy Policy you do not have the right to use the Sites in any way, including by reviewing information available on our Sites. We reserve the right to change our Privacy Policy at any time. In the event we decide to make material changes to our Privacy Policy, we will attempt to notify you and other users of the Sites by sending a notice to the primary email address provided to us and/or by placing a notice on our Sites. You should periodically check our Sites for such notices. This Privacy Policy only applies to information we collect at our Sites and via the electronic communications technologies that we use. It does not apply to information collected through other means, including Personal Information you provide in e-mail messages you send to us or Personal Information we may collect from you offline. This Privacy Policy is intended for all visitors to the Corcept Sites including consumers, healthcare professionals and Corcept business partners.

At some of our Sites, we may use Personal Information in a manner not described in this Privacy Policy. In those instances, the different uses of Personal Information will be disclosed to you at the web page where your Personal Information is collected, prior to such collection.

Capitalized terms not defined in this Privacy Policy have the meanings set forth in the Terms of Use.

Your California Privacy Rights

As further discussed in this Privacy Policy, we may from time to time provide you with the opportunity to receive information about our products and services and/or those of our Affiliates (as defined below) or third party partners. You can prevent future disclosures of your Personal Information to our Affiliates and third parties for their direct marketing purposes, at no charge, by exercising your "opt out" rights through any of the means described below in our Privacy Policy.

The Information We Collect

When you visit the Sites you may provide us with two types of information: (i) information regarding your use of the Sites automatically collected by us as you interact with the Sites, even if you do nothing during your visit but browse the Sites, and (ii) information you submit voluntarily via the Sites.

(i) When you enter the Sites, we may collect your browser type, your operating system (e.g., Windows 7), the domain name of your internet service provider (e.g., Comcast), the date and time of your visit, the pages viewed, the time spent at our Sites, and the websites visited just before and just after our Sites (including any third-party website that links to our Sites, if you followed a link to our Sites), and your IP address. Even when you visit areas of the Sites anonymously, we may collect IP addresses automatically. An IP address is a number that is automatically assigned to your computer whenever you begin service with an internet service provider. Each time you access the Sites and each time you request one of our pages, our server logs your IP address. Standing alone, your IP address is not necessarily personally identifiable. We may use your IP address to administer the Sites, to assist in diagnosing problems with our server, to monitor our system performance and/or to make it easier and more convenient for you to navigate and use the Sites. In addition, we store certain information from your browser using "cookies." A cookie is a piece of data stored on the user's computer tied to information about the user. We may use session ID cookies to confirm that users are logged in. Any and all of this information may be associated with your Personal Information. Most web browsers automatically accept cookies, but you can usually configure your browser to prevent this. Not accepting cookies may make certain features of the Sites unavailable to you.

(ii) Through the use of certain functionality of the Sites, including but not limited to emails you send to us directly via hyperlink, you may provide us with your name, company affiliation, email address, telephone number, physical address, and other information that may be required for you to use such functionality. Additionally, if you are an employment applicant, you may provide us with information regarding your prior employment, education, gender, and ethnicity. This includes information provided in resumes, emails, and cover letters we receive electronically. You may always choose not to provide us with your Personal Information, and we will disclose to you at the time we collect your Personal Information whether it is required for you to receive the information or services you have requested. To better understand and address your interests, and to keep the Personal Information we have about you accurate, we may correct or add to the Personal Information you provide to us at our Sites with Personal Information we receive from you offline or from other sources. You have several choices regarding your use of our Sites. You could decide not to submit any Personal Information at all. Although certain Sites may ask for permission to use your Personal Information for certain purposes, you can agree or decline to provide your Personal Information. If you subscribe for particular communications or services such as e-mail updates, you will be able to unsubscribe at any time by: (x) following any opt-out instructions contained in communications you receive from Corcept, (y) un-subscribing at specific areas of the Sites where you registered, if available, or (z) sending a written request to the Corcept contact address, which appears at the end of this Privacy Policy.

Children; Parental Consent Policy

The Children's Online Privacy Protection Act imposes certain requirements on websites directed toward children under 13 that collect information on those children, or on websites that know they are collecting Personal Information from children under the age of 13. The Sites are not intended for children under the age of 13, and it currently is our policy not to collect Personal Information from any person under 13, and we request that children under the age of 13 not submit any Personal Information to us via the Sites. If we learn that we have inadvertently gathered Personal Information from children under 13, we will use reasonable efforts to notify such child's parent or guardian and erase such information from our records, unless the child's parent or guardian consents to our maintaining such information.

Use of Information Obtained by Corcept

Information collected automatically when you access the Sites is used to administer the Sites and to analyze trends and gather statistical information for aggregate use. We may disclose any such information for our legitimate business purposes.

In general, Personal Information you provide to us is used to respond to requests that you make (For example, we may use your Personal Information to process an employment application, should you submit one to us. Any information regarding your gender and ethnicity collected via our employment application, however, is used for statistical purposes only and is not used to process your employment application); and for our internal records, tracking and business purposes. We may use your contact information to send you information regarding new products or services offered by Corcept that we think you may find valuable. This includes information and services you have requested, or as otherwise disclosed to you in this Privacy Policy or on the web page where you submitted your Personal Information to us. Corcept may also send you service-related announcements from time to time through the general operation of the Sites. Generally, you may opt out of such communications, although Corcept reserves the right to send you service-related notices even if you opt out of all voluntary notifications.

Policy on Use of Social Security Numbers

Corcept has a policy which provides for the proper use and protection of Social Security numbers obtained in the course of doing business by Corcept. Such policy protects the confidentiality of Social Security numbers, prohibits unlawful disclosure of Social Security numbers, and limits access to Social Security numbers. This policy applies to all methods of collection of Social Security numbers, including Social Security numbers obtained by oral, written and electronic means. However, we cannot and do not guarantee that breaches of our or your security will never occur, as outlined below. Note to Healthcare Professionals and Business Partners If you have a business or professional relationship with Corcept, we may use your Personal Information, including Personal Information we may collect about you from other sources, to develop our business relationship with you and your organization.

Sharing Your Information with Third Parties

You may choose to provide information about you and your company or organization to other users and to the public by providing such information on public areas of the Sites ("Public Information"). Public information does not include information you submit to us but do not post on areas of the Sites accessible by other users or the public ("Non-Public Information"). Non-Public Information may include Personal Information.

We share your Non-Public Information with third parties only in limited circumstances where we believe such sharing is reasonably necessary to operate the Sites, legally required or, permitted by you. For example:

  • We may share your Non-Public Information with a parent company, any subsidiaries, joint ventures, or other companies under common control with Corcept now or in the future (collectively, "Affiliates"), in which case we will require our Affiliates to honor this Privacy Policy with respect to such shared information.
  • Should you submit an employment application to us, we may disclose your Non-Public Information to third parties in order to verify your employment application and/or discuss the same with your prior employer or provided references.
  • We may provide Non-Public Information to service providers who help us bring you the services we offer, such as hosting the service at a co-location facility, sending email updates about Corcept, removing repetitive information from our user lists, or to provide search results or links. In connection with these offerings and business operations, our service providers may have access to your Non-Public Information for use for a limited time in connection with these business activities. Where we utilize third parties for the processing of any of your Non-Public Information, we implement reasonable contractual protections limiting the use of that Non-Public Information to the provision of services to Corcept.
  • We may offer to provide services jointly with other companies on the Sites, and we may share Non-Public Information with that company in connection with such offer or your use of that service.
  • We may share your Non-Public Information if you request such a disclosure, to enforce an agreement we have with you, or to comply with the terms of an agreement with a product-related co-promotion partner. If the ownership of all or substantially all of the Corcept business, or individual business units or assets owned by Corcept that are related to the Sites, were to change, your Non-Public Information may be transferred to the new owner. In such event, Corcept will notify you by posting such notice on one or more of the Sites before information about you is transferred and becomes subject to a different privacy policy in order to give you a reasonable opportunity to opt out of such different privacy policy, provided however, in the event Corcept fails to notify you, your Personal Information will still be transferred but subject to this Privacy Policy.
  • Notwithstanding anything to the contrary herein, we may disclose account or other Non-Public Information (i) pursuant to lawful requests, such as subpoenas or court orders, or in compliance with applicable laws, or (ii) when we believe it is necessary to comply with law, to protect our interests or property, including, but not limited to, in the context of a legal dispute, to protect the rights, property or safety of our employees or others, to prevent fraud or other illegal activity perpetrated through the Sites or using the Corcept name, or to prevent imminent harm. This may include sharing Non-Public Information with other companies, lawyers, agents or government agencies or where needed, for corporate audits or to investigate or respond to a complaint or security threat.

Corcept may share your Personal Information with parties described in this section who are (i) located in other countries, and (ii) subject to other applicable laws, rules and regulations relating to your Personal Information, that do not offer the same protections as the country in which your Personal Information was collected. In particular, your Personal Information may be processed in the United States and subject to applicable US laws, rules and regulations. For more information about how Corcept is committed to protecting your Personal Information, see the "Security" section of this Privacy Policy.

Note: We do not share any of your Personal Information with third parties for their own direct marketing purposes unless you explicitly give us permission to do so.

Corcept Sites may contain links to other websites which may collect information directly from you. Each of the websites linked to the Sites may have separate privacy and data collection practices, independent of Corcept. Once you link to another site from ours, you are subject to the Privacy Policy and Terms of Use of the new site, and Corcept has no responsibility or liability for these independent policies or actions and is not responsible for the privacy practices or the content of such websites, nor does Corcept endorse or make any warranties or representations about the contents, products or services offered on such websites or the security of any information you provide to them. If you have any questions about how these other sites use your information, you should contact them directly. This Privacy Policy applies solely to information collected by Corcept via the Sites.

Security

Although we use reasonable efforts to safeguard the security of your Personal Information, transmissions made on or through the Internet are inherently vulnerable to attack and cannot be guaranteed to be secure. Consequently, we cannot and do not guarantee that unauthorized access, hacking, data loss, or other breaches will never occur. In addition, submissions made via email are not protected by encryption and are vulnerable to interception during transmission. You are solely responsible for safeguarding and maintaining the secrecy of your Personal Information. Please be careful and responsible whenever you are online. We urge you to take steps to keep your Personal Information safe. Our hosting provider's computer systems employ software to monitor network traffic in order to identify unauthorized attempts to upload or change information, or otherwise cause damage. Unauthorized attempts to upload information or change information on the Sites are strictly prohibited and may be punishable under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act.

Protecting Yourself; Updating Your Information.

You can learn more about Internet privacy from government websites such as www.ftc.gov/privacy/. In addition, it is important to keep us updated with your most current contact information. You can review and make changes to the information we have on file about you by emailing us your updated information. To the extent we maintain your email address or other information about you, you may ask us via email at compliance@corcept.com to have such information deleted, updated or corrected, and/or to request us to cease collecting Personal Information about you in the future.

Changing Your Preferences; Opt-Out of Receiving Communications

When you provide us with your Personal Information, you will be given some choices about how we use that Personal Information. You may change these preferences later. For example, if you sign up for an e-mail newsletter, you may opt out of receiving future e-mail newsletters at any time. If you opt in to receive communications from Corcept, we will always provide you with one or more of the following ways to opt out: (i) by following any opt-out instructions contained in communications you receive from Corcept, (ii) by un-subscribing at specific areas of the Site(s) where you registered, if available, or (iii) by sending a written request to the Corcept contact address immediately below.

Changes to Our Policy

This Privacy Policy is effective with respect to any information collected on or after the date below. Corcept reserves the right to modify or supplement this Privacy Policy at any time. If we make any changes, we will update the Sites and Privacy Policy to include such change and notice thereof. Please review this Privacy Policy often to review any changes that may affect your use of the Sites. Your continued use of the Sites once the revised Privacy Policy has been posted on any of the Sites with the updated date affirms your agreement to such changes. If you do not agree to abide by this Privacy Policy, do not use or access (or continue to use or access) the Sites.

Contacting Corcept

If you have any questions about this Privacy Policy or Corcept's privacy practices in general, or if you need help accessing your Personal Information or changing your preferences, please contact us at:

Corcept Compliance Officer
Phone: 650–327–3270
Fax: 650–327–3218
Email: compliance@corcept.com

You may also contact us by mail at Corcept Therapeutics, Attn: Compliance Officer, 149 Commonwealth Drive, Menlo Park, CA 94025. Or, you can visit our Contact Us section at www.corcept.com/contact for more information.

Make sure to provide the name of the Site(s) applicable to your request, and your name and contact information. If you do not provide us with this information, we may not be able to respond.

Please also see our Terms of Use at www.corcept.com/terms which apply to your use of our Sites.

Last revised on July 25, 2013

INDICATIONS AND USAGE

Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

Important Limitations of Use

Korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome.

IMPORTANT SAFETY INFORMATION

WARNING: TERMINATION OF PREGNANCY

Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential.

Contraindications

Korlym is contraindicated in women who are pregnant. Pregnancy must be excluded before the initiation of treatment with Korlym or if treatment is interrupted for more than 14 days in females of reproductive potential. Nonhormonal contraceptives should be used during and one month after stopping treatment in all women of reproductive potential.

Korlym is contraindicated in patients taking simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events.

Korlym is contraindicated in patients who require concomitant treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g., immunosuppression after organ transplantation) because Korlym antagonizes the effect of glucocorticoids.

Korlym is contraindicated in women with a history of unexplained vaginal bleeding and women with endometrial hyperplasia with atypia or endometrial carcinoma.

Korlym is contraindicated in patients with prior hypersensitivity reactions to mifepristone or to any of the product components.

Warnings and Precautions

Patients receiving mifepristone may experience adrenal insufficiency. Because serum cortisol levels remain elevated and may even increase during treatment with Korlym, serum cortisol levels do not provide an accurate assessment of hypoadrenalism in patients receiving Korlym. Patients should be closely monitored for signs and symptoms of adrenal insufficiency, including weakness, nausea, increased fatigue, hypotension, and hypoglycemia. If adrenal insufficiency is suspected, discontinue treatment with Korlym immediately and administer glucocorticoids without delay. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor blockade produced by mifepristone. Factors considered in deciding on the duration of glucocorticoid treatment should include the long half-life of mifepristone (85 hours). Treatment with Korlym at a lower dose can be resumed after resolution of adrenal insufficiency. Patients should also be evaluated for precipitating causes of hypoadrenalism (infection, trauma, etc.).

In a study of patients with Cushing's syndrome, hypokalemia was observed in 44% of subjects during treatment with Korlym. Hypokalemia should be corrected prior to initiating Korlym. During Korlym administration, serum potassium should be measured 1 to 2 weeks after starting or increasing the dose of Korlym and periodically thereafter. Hypokalemia can occur at any time during Korlym treatment. Mifepristone-induced hypokalemia should be treated with intravenous or oral potassium supplementation based on event severity. If hypokalemia persists in spite of potassium supplementation, consider adding mineralocorticoid antagonists.

Being an antagonist of the progesterone receptor, mifepristone promotes unopposed endometrial proliferation that may result in endometrium thickening, cystic dilatation of endometrial glands, and vaginal bleeding. Korlym should be used with caution in women who have hemorrhagic disorders or are receiving concurrent anticoagulant therapy. Women who experience vaginal bleeding during Korlym treatment should be referred to a gynecologist for further evaluation.

Mifepristone and its metabolites block IKr. Korlym prolongs the QTc interval in a dose-related manner. There is little or no experience with high exposure, concomitant dosing with other QT-prolonging drugs, or potassium channel variants resulting in a long QT interval. To minimize risk, the lowest effective dose should always be used.

Use of Korlym in patients who receive corticosteroids for other conditions (e.g., autoimmune disorders) may lead to exacerbation or deterioration of such conditions, as Korlym antagonizes the desired effects of glucocorticoid in these clinical settings. For medical conditions in which chronic corticosteroid therapy is life-saving (e.g., immunosuppression in organ transplantation), Korlym is contraindicated.

Korlym should be used with extreme caution in patients taking ketoconazole and other strong inhibitors of CYP3A, such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir, fosamprenavir, boceprevir, clarithromycin, conivaptan, lopinavir, posaconazole, saquinavir, telaprevir, telithromycin, or voriconazole, as these could substantially increase the concentration of mifepristone in the blood. The benefit of concomitant use of these agents should be carefully weighed against the potential risks. Mifepristone should be used in combination with strong CYP3A inhibitors only when necessary, and in such cases the dose should be limited to 300 mg per day.

Patients with endogenous Cushing's syndrome are at risk for opportunistic infections such as Pneumocystis jiroveci pneumonia during Korlym treatment. Patients may present with respiratory distress shortly after initiation of Korlym. Appropriate diagnostic tests should be undertaken and treatment for Pneumocystis jiroveci should be considered.

Korlym does not reduce serum cortisol levels. Elevated cortisol levels may activate mineralocorticoid receptors which are also expressed in cardiac tissues. Caution should be used in patients with underlying heart conditions including heart failure and coronary vascular disease.

Adverse Reactions

The most frequently reported adverse reactions (reported in ≥20% of patients, regardless of relationship to Korlym) were nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, and endometrial hypertrophy. Drug-related adverse events resulted in dose interruption or reduction in study drug in 40% of patients.

Please see full Prescribing Information and Medication Guide.