In October 2015, Vernalis also acquired the US rights to Moxatag®, a once-a-day amoxicillin for strep throat in adult and pediatric patients 12 years of age or older and re-launched the product in Q4 2016.

Read more: Moxatag®

VERNALIS THERAPEUTICS, INC.’S CORPORATE COMPLIANCE PROGRAM

Vernalis Therapeutics, Inc. (VTI) is committed to ensuring that all business operations and activities that VTI is involved with are conducted in accordance with the highest of ethical standards.  VTI considers its reputation within the medical community a valuable asset and, as such, is committed to promoting the honest and ethical behavior of all individuals employed by VTI.

Compliance with all laws, regulations, company policies and other best practices applicable to the organization by all VTI employees is a critical component of our professional standards and contributes to our corporate success.  VTI’s Compliance Program incorporates the fundamental elements addressed within the Office of the Inspector General’s (OIG) “Compliance Program Guidance for Pharmaceutical Manufacturers,” and includes the following:

 

  • Written Policies and Procedures

VTI has adopted policies, procedures, training programs and mechanisms to promote an atmosphere of open, honest and ethical communication throughout VTI. 

VTI has also developed a Code of Business Conduct and Ethics to guide its business practices in an ethical and compliant manner.  VTI expects all its employees and executives to abide by this Code.

In addition, VTI has implemented written policies and procedures to address risk areas identified in the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers.

 

 

  • Corporate Compliance Officer (CCO) and Compliance Committee

 

VTI has designated a Compliance Officer (CCO) who is primarily responsible for oversight of the Compliance Program, but all employees play an important role in building and supporting the Compliance Program for VTI.  The CCO oversees the Compliance Program and is primarily responsible for ensuring that all employees, directors and officers act in an ethical, compliant and professional manner.

VTI has established a Compliance Committee consisting of representatives from each business function within VTI. The Compliance Committee assists the CCO in overseeing and providing guidance over VTI’s Healthcare Compliance Program with regard to adherence to laws and regulations applicable to its business operations and activities; compliance with VTI’s Code of Business Conduct and Ethics; and compliance with healthcare compliance policies and procedures by all employees and officers of VTI.  The Committee also assists the CCO in ensuring the effectiveness, and communicating the value and importance of, the Corporate Compliance Program and its requirements.

 

 

  • Training and Education

 

Appropriate training and education are essential to reinforcing VTI’s compliance and ethical standards as well as providing personnel with the resources they need to understand and effectively abide by all legal, regulatory and healthcare compliance requirements.  We train our personnel on our Code of Business Conduct and Ethics and appropriate job-related policies, procedures and other guidelines.  Our training program and materials are updated on an as-needed basis.

 

 

  • Effective Lines of Communication

 

VTI encourages an atmosphere of open communication that fosters dialog between management and employees regarding compliance or ethical concerns or reporting suspected misconduct.  Our employees are encouraged to report concerns to management and/or the compliance hotline and we have implemented policies and procedures to ensure any reported concerns will not subject the individual to retaliation or retribution.

 

 

  • Monitoring and Auditing

 

Monitoring and auditing of business activities are essential components of a Corporate Compliance Program. VTI has implemented policies and procedures to ensure that business processes and operations are efficient and effective as well as conducted in compliance with applicable regulations and industry requirements. VTI’s CCO is responsible for ensuring that the elements of the Compliance Program are audited and monitored on an ongoing basis.

 

 

  • Enforcement and Discipline

 

VTI develops and maintains documentation that informs all employees of its dedication to, and enforcement of, ethics and compliance policies governing each employee’s day-to-day responsibilities and the consequences of violations of these policies. Any employee who fails to abide by these ethics and compliance standards may be subject to appropriate disciplinary action following an investigation.  

 

 

  • Response and Corrective Action for Detected Problems

 

Prompt responses and corrective actions for identified and confirmed compliance violations are necessary and appropriate to ensure the effectiveness of the compliance program. All employees are expected to report any suspected compliance issues or concerns they may have through our Compliance Hotline or other lines of reporting.  All reported compliance issues will be reviewed, investigated and remedied as considered appropriate on a case-by-case basis.

 

 

VTI is committed to ensuring compliance with Company policies and applicable laws and regulations to preserve the Company’s reputation, ensuring the safety of its customers, and continuing to be successful.  This is all possible because of the Company’s dedication to compliance with all applicable laws and regulations and Company policies. VTI is committed to establishing and maintaining a culture of compliance to prevent, detect, and resolve any activities or interactions that may not conform to its standards of compliance and business conduct.

To request a copy of VTI’s Comprehensive Compliance Program please email info@vernalis.com.

 

 

VERNALIS THERAPEUTICS, INC. DECLARATION OF COMPLIANCE

 

Vernalis Therapeutics, Inc. (VTI), based upon a good faith belief and understanding of legal requirements, hereby declares that it has adopted a Comprehensive Compliance Program compliant with the requirements of California Health and Safety Code §§119400-119402.  VTI has tailored its Comprehensive Compliance Program to its current size and business operations and continues to develop and implement changes to the Comprehensive Compliance Program as compliance and operational needs evolve.  To the best of its knowledge and based on a good faith belief, VTI is in compliance with its Comprehensive Compliance Program.  June 18, 2018.

 

VTI's compliance hotline number: 1-855-229-9304

 

 

 

 

 

 

VERNALIS THERAPEUTICS, INC. CORPORATE GOVERNANCE

Vernalis Therapeutics, Inc. (VTI) is committed to maintaining the highest ethical standards in its dealings with all parties involved in the Company’s business activities, including employees, vendors, contractors and other third parties with which VTI interacts.  VTI’s Compliance Program and Code of Business Conduct and Ethics are intended to promote honest and ethical conduct among all individuals employed by VTI.  VTI expects every individual, all staff and management and contract workers (full time or temporary) to comply with established compliance governance program requirements and all other applicable laws, regulations and Company policies.

 

  • Workplace Standards

 

VTI recognizes its employees are a valuable asset of the Company.  We expect all employees to be ethical, innovative and hard working.  We work to retain and recruit individuals by providing appropriate compensation, growth opportunities and a diverse workplace free from bias, discrimination, and harassment.

 

Equal Opportunity

 

VTI is committed to providing equal opportunity in employment to all employees and applicants.  This commitment applies to recruitment, hiring, employment and employment-related decisions. We are also committed to complying with all applicable laws regarding nondiscrimination in employment.

 

Discrimination and Harassment

VTI respects diversity and the personal dignity of its employees. Company employees are expected to treat all colleagues with respect and dignity.  As such, VTI strives to ensure that the Company’s work environment is free from discrimination and harassment

 

 

  • Marketplace Standards

 

VTI’s reputation for integrity and excellence requires careful adherence to all applicable laws and regulations as well as a commitment to the highest standards of corporate conduct and personal integrity.  VTI expects all Company employees to conduct Company business in an ethical manner and the Company is committed to educating and training its employees so that everyone understands relevant laws as well as Company policies.

 

Anti-trust and Fair Competition

 

VTI’s reputation for integrity and excellence requires careful adherence to all applicable Anti-trust and Fair Competition laws and regulations.  VTI expects all Company employees to conduct Company business in an ethical manner consistent with anti-trust and fair competition laws. Company employees should not knowingly enter into business contracts or engage in activities that violate, or give the appearance of violating these laws. 

 

Employees are expected and encouraged to seek guidance by speaking with their supervisor or, if appropriate, the CEO or the Compliance Officer.

 

Interactions with Healthcare Professionals, Organizations, and Patients

 

Building strong, appropriate and ethical relationships with HCPs, HCOs and patients is an integral part of VTI’s business operations.  To ensure compliance with state and federal regulations pertaining to interactions with HCPs, HCOs and patients, VTI has drafted and implemented written policies and procedures that provide guidance to employees.

 

Gifts

 

VTI does not use gifts, meals, hospitality, entertainment, recreation, and other items or activities of value to influence HCPs, HCOs or patients to prescribe, use, purchase, recommend, or make favorable formulary recommendations concerning its products.

 

Privacy

 

VTI is committed to compliance with applicable legal and regulatory requirements protecting the privacy of Protected Health Information and other confidential information, and safeguarding this information in a manner consistent with federal and state laws.

 

Product Complaints and Adverse Event Reporting

 

VTI has implemented procedures that allow product complaints and adverse event information to be reported to the Company.  The procedures in place allow product complaints and adverse event reports to be documented and handled in accordance with applicable laws and regulations.  Adverse events or product complaints should be reported to the Company by calling 1-855-705-9546 immediately upon awareness of the potential adverse event or product complaint.

 

 

  • Business Standards

 

At VTI, we work together to adhere to applicable laws and regulations.  This includes a personal responsibility for each employee to protect corporate assets and business integrity.

 

Conflicts of Interest

 

Company employees will strive to avoid conflicts of interest whenever possible, keeping the Company’s best interest in mind at all times.  We expect that our business decisions will be compatible with professional and/or ethical obligations to VTI, and will not be made for individual personal gain.

 

Competitive Intelligence

 

VTI respects the privacy and confidentiality of its competitors’ information and will only gather such information in a reasonable and ethical manner.  Any employee who has acquired a competitor’s private and confidential information unlawfully will be subject to disciplinary action by the Company and potentially legal action. 

 

Training

 

To ensure that VTI performs its operations compliantly, it will ensure that it becomes aware of all amendments or implementation of laws, regulations, guidance and standards.  To inform our employees of such changes, we will provide training annually, quarterly and on an ad-hoc basis, as needed.

 

Record Retention and Documentation

All employees are expected to capture accurate and complete records in line with any regulatory, legal and financial requirements.  Employees should also ensure that information is stored in a secure manner and complete records are identified, indexed for retrieval, securely stored, and disposed of in the appropriate manner.

 

 

  • Public Standards

 

VTI is committed to being a good corporate citizen in the communities in which it does business and will provide an accurate and consistent message to the public.

 

Charitable Contributions

 

VTI acknowledges that charitable contributions can make a significant difference in the lives of those in the community and will ensure that contributions are provided in accordance with Company policies and applicable laws and regulations.

 

Political Contributions and Activities

 

While VTI encourages its employees to engage in political activities, such as the right to vote, individual political activities are expected to be completed in personal time without the involvement of any Company resources.

 

Media and Public Inquiries

 

Only designated persons within VTI may speak with the media and respond to public inquiries. All such communications with the public through the media, press releases, promotional materials or other means will be accurate, consistent and authorized by the appropriate person at VTI and conducted in compliance with VTI’s policies and guidelines for such activities.

 

Social Media Use

VTI respects the right of all employees to use social media tools as a form of self- expression during personal time; however, only authorized employees will utilize social media technologies on behalf of VTI.  All Company content released through social media will be accurate, appropriate, and in compliance with industry regulations and guidelines for promotional and non-promotional communications. 

 

 

  • VTI’s Compliance Program

VTI has adopted policies, procedures, training programs and mechanisms to promote an atmosphere of open, honest and ethical communication throughout VTI.  More details about VTI’s Compliance Program, its structure, and requirements are available here.

 

 

Tuzistra® XR
(Codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII

 

The lead programme in Vernalis' cough cold pipeline, Tuzistra® XR, was approved by the US FDA in April 2015 for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

To access the Tuzistra® XR product website please click here.

Description

Tuzistra® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII, is the first product from Vernalis' development and licensing deal with Tris to be approved by FDA.

Proof-of-concept was achieved in March 2013, with the pivotal single dose and multi dose bioavailability studies completed by February 2014. The NDA was submitted to FDA in June 2014 and approval granted on 30 April 2015.

Tris supplies the product to Vernalis and Vernalis is promoting the product in the US prescription cough cold market.

Product Information

Tuzistra® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension is a Schedule III (CIII) DEA controlled drug that has been approved by the FDA:

• for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older;
• Important Limitations of Use: Not indicated for pediatric patients under 18 years of age.

Tuzistra® XR is administered as an oral dose of 10mL every 12 hours and may be taken with or without food.

Like other codeine-containing products, Tuzistra® XR has a Boxed Warning relating to the use of codeine in children.

IMPORTANT SAFETY INFORMATION

WARNING
 
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN
 
Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism.


TUZISTRA XR is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of TUZISTRA XR in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
 
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
 
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

 

IMPORTANT RISK INFORMATION

What is the most important information I should know about TUZISTRA® XR?

  • TUZISTRA XR can cause children to stop breathing (respiratory depression) and cause death.
    • Do not give TUZISTRA XR to children younger than 12 years of age, or to children younger than 18 years of age after tonsillectomy or adenoidectomy surgery.
    • You should not give TUZISTRA XR to children between 12 to 18 years of age who have certain risk factors for breathing problems, including:
      • recent surgery
      • obstructive sleep apnea
      • are obese
      • severe lung problems
      • other medical conditions that can cause difficulty breathing, such as neuromuscular problems
      • taking other medicines that cause breathing problems
  • You should not breastfeed during treatment with TUZISTRA XR because it may cause your child to stop breathing and cause death.
  • Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in adults and children who take TUZISTRA XR with benzodiazepines, or other central nervous system depressants, including alcohol.
    • Avoid taking other medicines that can cause drowsiness or sleepiness, or drinking alcohol during treatment with TUZISTRA XR. Ask your healthcare provider for a list of these medicines if you are not sure.
  • TUZISTRA XR can cause breathing problems (respiratory depression) and drowsiness
    • Take TUZISTRA XR exactly as prescribed by your healthcare provider. If you take the wrong dose of TUZISTRA XR, you could overdose and die. See the Medication Guide section called “How should I take TUZISTRA XR?” for important information about how to take TUZISTRA XR correctly.
    • Avoid driving a car or operating machinery during treatment with TUZISTRA XR.
  • Call your healthcare provider or get emergency medical help right away if anyone taking TUZISTRA XR, or your breastfeeding baby has any of the symptoms listed below:
    • increased sleepiness
    • shallow breathing
    • confusion
    • limpness
    • difficulty breathing
    • your baby has difficulty breastfeeding
  • Keep TUZISTRA XR in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes TUZISTRA XR, get emergency help right away.

What is TUZISTRA XR?

  • TUZISTRA XR (two-zis-tra) is a prescription medicine used to treat cough and respiratory symptoms that you can have with allergies or a common cold. TUZISTRA XR contains 2 medicines, codeine and chlorpheniramine. Codeine is a narcotic cough suppressant. Chlorpheniramine is an antihistamine.
  • TUZISTRA XR is a federal controlled substance (C-III) because it contains codeine that can be abused or lead to dependence. Keep TUZISTRA XR in a safe place to prevent misuse and abuse. Selling or giving away TUZISTRA XR may harm others, and it is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • TUZISTRA XR is not for children under 18 years of age. It is not known if TUZISTRA XR is safe and effective in children under 18 years of age.

Who should not take TUZISTRA XR?

  • Do not give TUZISTRA XR to any children younger than 12 years of age.
  • Do not give TUZISTRA XR to children younger than 18 years of age after tonsillectomy or adenoidectomy surgery.
  • Do not take TUZISTRA XR if you are allergic to any of the ingredients in TUZISTRA XR.

What should I tell my healthcare professional before taking TUZISTRA XR?

Before you take TUZISTRA XR, tell your healthcare professional about all your medical conditions, including if you:

  • have a drug dependence
  • have problems with your urinary tract (urethral stricture)
  • have lung or breathing problems
  • plan to have surgery
  • have had a head injury, drink alcohol, have pain in your stomach-area (abdomen), kidney or liver problems, a history of severe or persistent cough, diabetes, prostate or thyroid problems, such as hypothyroidism
  • are pregnant or plan to become pregnant. It is not known if TUZISTRA XR will harm your unborn baby. You and your healthcare provider should decide if you should take TUZISTRA XR while you are pregnant.
  • are breastfeeding or plan to breastfeed. Codeine and chlorpheniramine pass into your breast milk and may harm your baby. You should not breastfeed during treatment with TUZISTRA XR.

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TUZISTRA XR with certain other medicines can cause side effects or affect how well TUZISTRA XR or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare professional if you:

  • take pain medicines such as narcotics
  • take cold or allergy medicines that contain antihistamines or cough suppressants
  • take medicines for mental illness (anti-psychotics, anti-anxiety)
  • drink alcohol
  • take medicines for depression, including monoamine oxidase inhibitors (MAOIs)
  • take medicines for stomach or intestine problemsAsk your healthcare provider if you are not sure if you take one of these medicines.

How should I take TUZISTRA XR?

  • Take TUZISTRA XR exactly as your healthcare provider tells you.
  • Your healthcare provider will tell you how much TUZISTRA XR to take and when to take it. Do not change your dose without talking to your healthcare provider.
  • TUZISTRA XR is usually taken every 12 hours.
  • Do not take more than 20 mL of TUZISTRA XR in 24 hours.
  • Take TUZISTRA XR by mouth only.
  • Shake the TUZISTRA XR bottle well before you use it.
  • TUZISTRA XR can be taken with or without food.
  • Do not mix TUZISTRA XR with other fluids or medicines.
  • TUZISTRA XR should be taken using an accurate milliliter measuring device.
  • Ask your pharmacist to give you a measuring device to help you measure the correct amount of TUZISTRA XR. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
  • If you take too much TUZISTRA XR, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid doing while taking TUZISTRA XR?

  • TUZISTRA XR can cause you to be drowsy. Avoid driving a car or using machinery during treatment with TUZISTRA XR.
  • Avoid drinking alcohol during treatment with TUZISTRA XR. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of TUZISTRA XR?

TUZISTRA XR may cause serious side effects, including:

  • See “What is the most important information I should know about TUZISTRA XR?”
  • Breathing problems (respiratory depression), which can lead to death. Call your healthcare provider or get emergency treatment right away if you have excessive sleepiness, shallow or slow breathing, or confusion.
  • Physical dependence or abuse. Take TUZISTRA XR exactly as your healthcare provider tells you to take it. Stopping TUZISTRA XR suddenly could cause withdrawal symptoms.
  • Increased intracranial pressure.
  • Bowel problems including constipation or stomach pain.

The most common side effects of TUZISTRA XR are: nausea and vomiting, dizziness, general feeling of discomfort or illness, constipation, swelling or bloating of your stomach-area, depression, inability to control muscle movements, drowsiness, excitability, nervousness, stomach-area pain, headache, agitation, restlessness, irritability, vision problems, including blurred vision and double-vision, feeling high (euphoria), sleepiness, feeling faint, difficulty sleeping (insomnia), confusion, lightheadedness, and tremor.

These are not all the possible side effects of TUZISTRA XR.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the TUZISTRA XR Medication Guide before you start taking TUZISTRA XR and each time you get a refill, as there may be changes. This information does not take the place of talking to your healthcare professional about your medical condition or treatment.

Need to talk to someone?

For financial and corporate information about Vernalis please contact:

FTI Consulting
t: +44 (0)20 3727 1000

Corporate Communications at Vernalis
t: +44 (0)118 938 0015
e: corpcomm@vernalis.com.