Privacy Policy

VERITY PHARMACEUTICALS, INC. PRIVACY POLICY Effective May 2020

California residents please see Verity's Supplemental California Privacy Policy.

Verity Pharmaceuticals, Inc. ("Verity") recognizes the importance of protecting the privacy of information we may collect from you as a result of your visit to our Website, www.veritypharma.com (hereinafter, "Website"). This Privacy Policy describes how Verity, 1255 Drummers Lane, Suite 350, Wayne PA 19087 (hereinafter, "us," "we," or "our") uses and protects the personal information that you provide when using our Website. This Privacy Policy does not apply to our collection of personal information from other sources.

This Privacy Policy, together with the Terms and Conditions posted on our Website, set forth the general rules and policies governing your use of our Website.

What Personal Information Do We Collect?

We may collect the following information:

  • Name
  • Mailing address
  • Contact information, including e-mail address and telephone number
  • Other types of personal information that you voluntarily provide to us.

We use "cookies" to enhance your experience and gather information about your visits to our Website. We may also use your personal information to personalize your Website experience and deliver content and product information that we believe reflects your interests. For more information, please see the "How We Use Cookies" section below.

How Do We Use Your Information?

We may use the personal information we collect from you when you fill in forms or correspond with us by mail, phone, and e-mail, submit questions, purchase products, or consent to receive marketing or promotional communications from Verity. In addition, we may also use your personal information for internal record-keeping purposes, to provide customer service and respond to requests or inquiries, to further develop and improve our products and services, to provide you with newsletters, articles, alerts, announcements, invitations, and other information about products, brands, health topics and disease states or to conduct market research.

We take measures to ensure that the personal information we collect from you is accurate and up-to-date and that you have the ability to access it and make corrections to it consistent with applicable law (see the "Contact Us" section below to request any amendments to your personal information to which you may be legally entitled).

Do We Disclose Your Personal Information to Third Parties?

In general, personal information about you that is collected from this Website will not be transferred outside Verity without your prior consent. However, it may be used by our agents, affiliates and third party service providers and business partners for purposes that include assisting us in operating our website, running our business, or providing services to you, provided that they keep your personal information confidential.

We reserve the right to disclose your personal information as required by law when we believe disclosure is necessary or appropriate to comply with a regulatory requirement, judicial proceeding, court order, government request, or legal process service on us, or to protect the safety, rights, or property of our customers, the public, Verity, or others.

We will not sell or rent your personal information without your express consent.

How do I Opt-Out/Unsubscribe?

When you access any service on the Website that collects your personal information, you will be asked to affirmatively choose to provide the requested personal information. You may always choose not to provide the requested personal information or to opt-out of, or unsubscribe from, any communications as appropriate.

You can ask us or third parties to stop sending you communications at any time by following the opt-out links on any message sent to you. Where you opt-out of receiving these communications, this will not apply to personal data provided to us as a result of a product/service purchase, experience or other transaction, warranty, adverse event or product complaint.

Links to Third Party Websites

Our Website may contain links to third party websites, content, or services that are not owned or controlled by Verity. Verity is not responsible for how third parties operate or treat your personal information. We recommend that you carefully read the privacy policies and terms of use of any third party websites before providing them with your personal information.

How Do We Protect the Security of Your Information?

We are committed to ensuring the security of your personal information. To prevent unauthorized access or disclosure, we have implemented a variety of security measures, including, but not limited to, securing our networks and utilizing industry standard encryption technology to safeguard your information.

How We Use Cookies

A cookie is a small file which requests permission to be placed on your computer's hard drive. If you agree to accept the cookies, our Website can capture and remember certain information (for example, what items were in your shopping cart). We use cookies to help us understand your preferences based on previous or current site activity and to customize and improve users' experiences on our Website.

You can choose to accept or decline cookies. While most internet browsers automatically accept cookies, if you do not wish to have cookies on your system, you can set your browser preferences to reject them or to alert you when cookies are being sent. The "Help" section of your browser may tell you how to prevent your browser from accepting cookies. If your browser is set to reject cookies, websites that are cookie-enabled will not recognize you when you return to the website, and some website functionality may be lost.

"Do Not Track" Signals

Verity does not track its customers to provide targeted advertising and therefore does not respond to "Do Not Track" (DNT) signals. However, some third party sites do keep track of your browsing activities when they provide content, which enables them to tailor what they present to you. Please note that some browsers allow you to set the DNT signal on your browser so that third parties (particularly advertisers) know you do not want to be tracked.

Children's Privacy

The Site is not directed to individuals under the age of thirteen (13), and we do not knowingly collect personal data from children under the age of thirteen.

Privacy Policy Updates

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 information, we will not use the personal information we previously gathered in the manner described in the new policy without providing notice and/or obtaining your consent, as appropriate. We encourage you to periodically review this page for the latest information.

Contact Us

If you have questions about this Privacy Policy or how we use your personal information, please contact us by emailing verityusa@veritypharma.com or by writing to us at the following address:
Verity Pharmaceuticals, Inc.
1255 Drummers Lane
Suite 350,
Wayne PA 19087

 

 

 

VERITY PHARMACEUTICALS, INC.
SUPPLEMENTAL CALIFORNIA PRIVACY POLICY
Effective May 2020

If you reside in California, please read this section for additional disclosures about how we collect, use, and disclose information about you as well as your rights under the California Consumer Privacy Act (“CCPA”) (California Civil Code Section 1798.100 et seq.).

INFORMATION WE COLLECT

We may collect information that identifies, relates to, describes, references, is capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular person or device (“Personal Information").

Personal Information does not include:

  • Publicly available information from government records
  • De-identified or aggregated consumer information
  • Information excluded from the CCPA's scope, like:
    • Health or medical information collected by entities directly subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA) or clinical trial data;
    • Personal information covered by certain sector-specific privacy laws, including the Fair Credit Reporting Act (FRCA), the Gramm-Leach-Bliley Act (GLBA) or California Financial Information Privacy Act (FIPA), and the Driver's Privacy Protection Act of 1994.

We have not collected any of the following categories of Personal Information within the last twelve (12) months; however in the future, Verity may collect:

  • Identifiers such as first name, maiden name, last name, username or similar identifier, Internet Protocol address, email address, Social Security number, date of birth and gender or other similar identifiers;
  • Personal information categories listed in the California Customer Records statute (Cal. Civ. Code § 1798.80(e) such as address, telephone number, passport number, driver’s license or state identification card number, bank account, and payroll data;
  • Internet or other electronic network activities information such browser type and version, time zone setting and location, browser plug-in types and versions, operating system and platform and other technology on the devices you use to access our website or intranet, as well as information about how you use our website;
  • Education or employment information of the professionals with whom we engage, including current or past job history; level of education, institutions attended, level of study and degrees attained, areas of specialty, and certifications;
  • Characteristics of protected classifications such as age, race, color, ancestry, national origin, citizenship, religion or creed, marital status, medical condition, physical or mental disability, sex, veteran or military status, and genetic information (including familial genetic information);
  • Biometric information such as physical and behavioral characteristics and health information that you choose to provide related to a patient assistance or support program or a clinical trial that contains identifying information; and
  • Commercial information related to services, treatment or care, such as insurance information, and marketing and communications data, including your preferences in receiving marketing and communications from us and our third parties.

SOURCES OF PERSONAL INFORMATION

We may obtain the Personal Information from the following categories of sources:

  • Directly from you, your caregiver or agent
  • Indirectly from you or your caregivers or agents (i.e., in the course of providing services)
  • Directly and indirectly from activity on our websites (for example, from submissions through our websites or from website usage details collected automatically)
  • From third parties in connection with the provision of services

USE OF PERSONAL INFORMATION

We may use or disclose the personal information we collect for one or more of the business purposes described in the "How Do We Use Your Information" Section of Verity's Privacy Policy.

HOW WE SHARE YOUR PERSONAL INFORMATION

Verity will not sell or rent your Personal Information without your express consent. We may, however, share your Personal Information with other parties for business purposes as described in the "Do We Disclose Your Personal Information to Third Parties?" Section of Verity's Privacy Policy.

In the last 12 months, we have not disclosed any categories of your Personal Information identified under "Information We Collect" for a business purpose.

YOUR CALIFORNIA PRIVACY RIGHTS

The California Consumer Privacy Act (“CCPA”) provides consumers (i.e., California residents) with specific rights (listed below and subsequently referred to as "California Privacy Rights"), subject to some limitations and the verification of their identity, regarding their Personal Information:

  1. Consumers have the right to request access to the specific pieces of personal information Verity has collected, disclosed or sold about them in the last 12 months, including the categories of information, sources and business purposes of collection, as well as the categories of third parties to whom Verity has disclosed or shared the personal information.
  2. Consumers have the right to request deletion of their personal information (subject to certain exceptions).
  3. Consumers have the right to opt-out of the sale of their personal information.
  4. Consumers have the right to receive equal service and price and not be discriminated against for exercising their privacy rights under the CCPA.

In order for Verity to process a request for you to exercise your California Privacy Rights, Verity will first verify certain personal information that you provide, depending on the nature of the information you require, which we will attempt to match with information we maintain about you to verify your identity. Information to identify and verify your agent can be submitted through the same mechanism and at the same time that you submit information to verify your identity. Please submit your requests by contacting us at this toll-free number: 877-433-8068 or by using the “Exercise Your California Privacy Rights” interactive web form, available here: Contact Us

You may designate an authorized agent to exercise your California Privacy Rights on your behalf in accordance with the CCPA. Verity may require that you provide the authorized agent with written permission to act on your behalf and that the authorized agent verify his or her identity directly with us. Information to identify and verify your agent can be submitted through the same mechanism and at the same time that you submit information to verify your identity.

We do not charge a fee to process or respond to your verifiable request unless it is excessive, repetitive, or manifestly unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request.

When you submit a request to exercise your California Privacy Rights, Verity will do its best to respond to your request as soon as possible, and, in any event, no later than 45 days after receiving your request. You may only make a request twice within a 12-month calendar year.

Important Safety Information

Contraindications

Indications and Usage

TRELSTAR® is indicated for the palliative treatment of advanced prostate cancer.

Important Safety Information (cont’d)
Warnings and Precautions

Hypersensitivity Reactions: Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported. In the event of a hypersensitivity reaction, therapy with TRELSTAR® should be discontinued immediately and the appropriate supportive and symptomatic care should be administered.

Transient Increase in Serum Testosterone: Initially, triptorelin, like other GnRH agonists, causes a transient increase in serum testosterone levels. As a result, isolated cases of worsening of signs and symptoms of prostate cancer during the first weeks of treatment have been reported with GnRH agonists. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or urethral or bladder outlet obstruction.

Metastatic Vertebral Lesions and Urinary Tract Obstruction: Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists. If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchiectomy considered.

Patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction should be closely observed during the first few weeks of therapy.

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes.

Cardiovascular Diseases: Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.

Laboratory Tests: Response to TRELSTAR® should be monitored by measuring serum levels of testosterone periodically or as indicated.

Laboratory Test Interactions: Chronic or continuous administration of triptorelin in therapeutic doses results in suppression of pituitary-gonadal axis. Diagnostic tests of the pituitary-gonadal function conducted during treatment and after cessation of therapy may therefore be misleading.

Embryo-Fetal Toxicity: TRELSTAR® can cause fetal harm when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.

Most Common Adverse Reactions

Specific Populations

Pregnancy: Pregnancy Category X. TRELSTAR® is contraindicated in women who are or may become pregnant while receiving the drug. Expected hormonal changes that occur with TRELSTAR® treatment increase the risk for pregnancy loss. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Lactation: The safety and efficacy of TRELSTAR® have not been established in females. There are no data on the presence of triptorelin in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child. Because of the potential for serious adverse reactions in a breastfed child from TRELSTAR®, a decision should be made to either discontinue breastfeeding, or discontinue the drug taking into account the importance of the drug to the mother.

Females and Males of Reproductive Potential: TRELSTAR® may impair fertility in males of reproductive potential.

Renal/Hepatic Impairment: Subjects with renal or hepatic impairment had higher exposure than young healthy males.

Please see full Prescribing Information.

Important Safety Information

Contraindications

  • Hypersensitivity: TRELSTAR® is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.

Indications and Usage

TRELSTAR® is indicated for the palliative treatment of advanced prostate cancer.

Important Safety Information (cont’d)
Warnings and Precautions

Hypersensitivity Reactions: Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported. In the event of a hypersensitivity reaction, therapy with TRELSTAR® should be discontinued immediately and the appropriate supportive and symptomatic care should be administered.

Transient Increase in Serum Testosterone: Initially, triptorelin, like other GnRH agonists, causes a transient increase in serum testosterone levels. As a result, isolated cases of worsening of signs and symptoms of prostate cancer during the first weeks of treatment have been reported with GnRH agonists. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or urethral or bladder outlet obstruction.

Metastatic Vertebral Lesions and Urinary Tract Obstruction: Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists. If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchiectomy considered.

Patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction should be closely observed during the first few weeks of therapy.

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes.

Cardiovascular Diseases: Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.

Laboratory Tests: Response to TRELSTAR® should be monitored by measuring serum levels of testosterone periodically or as indicated.

Laboratory Test Interactions: Chronic or continuous administration of triptorelin in therapeutic doses results in suppression of pituitary-gonadal axis. Diagnostic tests of the pituitary-gonadal function conducted during treatment and after cessation of therapy may therefore be misleading.

Embryo-Fetal Toxicity: TRELSTAR® can cause fetal harm when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.

Most Common Adverse Reactions

  • 3.75 mg: The most common adverse reactions (≥ 5%) during TRELSTAR® 3.75 mg therapy included hot flushes, skeletal pain, impotence, and headache.
  • 11.25 mg: The most common adverse reactions (≥ 5%) during TRELSTAR® 11.25 mg therapy included hot flushes, skeletal pain, headache, edema in the legs, and leg pain.
  • 22.5 mg: The most common adverse reactions (≥ 5%) during TRELSTAR® 22.5 mg therapy included hot flushes, erectile dysfunction, and testicular atrophy.

Specific Populations

Pregnancy: Pregnancy Category X. TRELSTAR® is contraindicated in women who are or may become pregnant while receiving the drug. Expected hormonal changes that occur with TRELSTAR® treatment increase the risk for pregnancy loss. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Lactation: The safety and efficacy of TRELSTAR® have not been established in females. There are no data on the presence of triptorelin in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child. Because of the potential for serious adverse reactions in a breastfed child from TRELSTAR®, a decision should be made to either discontinue breastfeeding, or discontinue the drug taking into account the importance of the drug to the mother.

Females and Males of Reproductive Potential: TRELSTAR® may impair fertility in males of reproductive potential.

Renal/Hepatic Impairment: Subjects with renal or hepatic impairment had higher exposure than young healthy males.

Please see full Prescribing Information.