Camurus is a research based pharmaceutical company with a firm commitment to the development and commercialization of innovative specialty medicines, providing patients suffering from serious and chronic disease, with better treatment outcomes and quality of life.
By combining the FluidCrystal® formulation technologies with already established, effective and safe active substances, new patent protected drugs with improved properties and treatment outcome are created. The exploitation of e.g. the registration pathway 505(b)(2) in the US and hybrid applications in EU means that these products can be developed in a shorter time, to a lower risk and lower cost compared to new chemical entity drugs.
Camurus was founded in 1991 by leading scientists in biophysical chemistry in collaboration with a local entrepeneur. Being pioneers in the research of lipid phase nanostructures and aware of the challenges in pharmaceutical development, they recognized the potential of lyotropic liquid crystal structures for solubilization, stabilization and delivery of active pharmaceutical substances.
The final quarter of 2016 saw us achieve a major milestone for Camurus. Results from our completed Phase 3 study of CAM2038 in opioid dependence demonstrated significantly better treatment effect with our long-acting depots versus standard of care with daily sublingual tablets. With this achievement, we now initiated the work on the market approval applications for both the EMA and FDA.
Our long-acting buprenorphine depots, CAM2038, for treatment of opioid dependence, clearly fulfilled efficacy primary endpoints agreed with the European Medicines Agency (EMA) as well as US Food and Drug Administration (FDA). Additionally, secondary analyses demonstrated superior efficacy versus daily sublingual buprenorphine/naloxone tablets. These clear-cut, positive Phase 3 results are particularly impressive in the light of the randomized, controlled double blind, double dummy design, and with regard to the complex patient population that was included directly from the active opioid misuse. Approximately 70% of the 428 study participants were using heroin and more than half of them were injection opioid users. Most of them also used other illicit drugs, including cocaine, amphetamine and marijuana. This group is representative of patients starting their treatment of opioid dependency both in EU and the US.
Present daily treatment with buprenorphine or methadone has been clearly demonstrated to be effective in decreasing opioid misuse, reducing mortality and the spreading of infectious diseases. Unfortunately, these treatments have some significant limitations. These include poor treatment adherence, costs and stigma in connection to need of frequent clinic visits and supervised dosing, overdosing, as well as diversion and misuse. Using long-acting medications, these limitations can be significantly reduced, or even eliminated, as pointed out by Prof. Edward Nunes MD, PhD, Columbia University Medical School during his presentation at Camurus’ first Capital Markets and R&D Day in Stockholm, December 14, 2016. Combined with the documented treatment efficacy and favorable safety profile, our long-acting depot products have the potential to transform the treatment of opioid dependence and provide improvement to patients, healthcare providers and society. Process of filing market authorization and new drug applications for CAM2038 to the EMA and FDA mid 2017 are on track.
During the period, important advances were also made regarding commercial manufacturing as well as establishment of our commercial organization and operational structure in front of the planned launching of CAM2038 in Europe during 2018. We have been working closely with experts and stakeholders within the various national health systems, as well as performing health economic analyses and modelling. Initial results will be presented at the AMCP Managed Care Specialty Pharmacy Annual Meeting i Denver, Colorado in March 2017.
In our collaboration with Novartis, following the announcement of positive Phase 2 results for our subcutaneous long-acting octreotide depot, CAM2029, for treatment of acromegaly and neuroendocrine tumours (NET), a clinical study report has been completed during the quarter. Results will be presented at several conferences during the spring, including ENETS, Barcelona in March and at ENDO, Orlando in April. After completed preparations for GMP-manufacturing of the product during the quarter, GMP manufacturing is now initiated ahead of planned Phase 3 start later in the year.
In the collaboration with Rhythm regarding weekly setmelanotide FluidCrystal® investigational product for treatment of genetic obesity disease, GMP-manufacturing was successfully completed and preparations of a clinical trial are ongoing ahead of the start during 2017.
In our early development pipeline, we initiated a clinical pharmacokinetic study of new product candidates for treatment of pain as well as nausea and vomiting. Two of the programs are conducted with our US partner Braeburn Pharmaceuticals, after having expanded our license agreement during the period.
A new exciting program in our pipeline is a subcutaneous depot of treprostinil, CAM2043, for treatment of pulmonary arterial hypertension. PAH is a rare progressive lung and heart disease with a poor life expectancy of less than 3 years, if left untreated. Based on our preclinical results, we believe that CAM2043 has potential to significantly improve treatment versus available treatments. Presently treprostinil is administrated using continuous infusion, a complex procedure associated with significant and treatment limiting side-effects such as pain and serious infections. The PAH market exceeded USD 4 billion 2015, with treprostinil representing about 25%.
Our strong results delivered during the past year have resulted in an increased interest in Camurus and contributed to a positive development of the company value.
Behind the success is our team of fantastic coworkers, dedicated partners and clinical investigators, as well as their study teams. Warm thanks to you all!
Adopted at a board meeting on June 25, 2015
Camurus strives to be recognized for the value it brings to patients, health care professionals, society, customers and partners. We strive to always be trusted and respected for the way we conduct our businesses; research, develop and market our products. This Code of Conduct (the “Code”) is a critical document setting out the business conduct and ethics for Camurus.
Scope and Responsibility
Our professional activities and daily decisions should be supported by the objectives and reflect our respect for each other’s skills, viewpoints and decisions. We are energetic, proactive and innovative and always respectful of each other, our business partners, and customers. The Code applies to all directors, officers, employees, contractors and temporary staff of Camurus (below referred to as “Employees”).
We expect our employees to promote our core values by acting appropriately towards colleagues, business partners and society at large; and to take into consideration that when acting outside company, Camurus’ employees are regarded as representatives of the company.
Camurus’ Code of Conduct applies to all employees, including temporary personnel, consultant, agents and others working on the behalf of Camurus. All employees are required to confirm that they have read and understood the Code. Line managers are responsible for making these guidelines known and for promoting them, and monitoring compliance. Violation of this Code of Conduct is not accepted and may result in formal sanctions being applied, according to the nature and severity, and according to all applicable laws and regulations.
Objective of the Code of Conduct
Camurus’ Code of Conduct is intended to assist the organization their daily work and business activities to promote the long-term positive development of the company. The code recognizes that compliance with law and relevant regulation is a fundamental duty and an essential part of the responsibility of each employee.
Corporate social and sustainable entrepreneurship are central to the whole world and also play an increasingly important role in corporate competitiveness, profitability and thereby also to sustainable shareholder value.
In order to respect human rights, promote fair employment, safe working conditions, environmental responsibility and ethical business standards, the Code is to be applicable globally to all Camurus products and services, as detailed below:
Research and Development
Camurus is engaged in developing new and innovative medicines and medical products with the ultimate goal of contribute to lives of patients and a better society as a whole. Clinical research and the conduct of clinical trials in humans to evaluate the safety and efficacy of products for the diagnosis, treatment, and prevention of disease are critical components of medicinal product development. Camurus will always apply high ethical standards in the conduct of its research and development activities, complying with applicable laws and regulations, including the declaration from Helsinki governing research and development performance, and international standards of good practices, such Good Laboratory Practices (”GLP”) and Good Clinical Practices (”GCP”).
Camurus is fully committed to protecting the patients and volunteers who take part in our clinical trials; ensuring we uphold the highest ethical, scientific and clinical standards in all of our research initiatives; and providing study results in a timely, objective, accurate and complete manner and recognizes there are important public health benefits in making study results available to patients, health care providers, and the general public. All data from clinical research is recorded, handled and stored in a way that enables accurate reporting, interpretation and verification. Individuals participating in clinical trials should not be exposed to any unnecessary risks.
Products and Services
Camurus is committed to providing only truthful, non-misleading and accurate information about the approved uses of our products and we never offer or promise anything of value to influence purchasing decisions. Patients and HCPs have a right to decide the best course of care, based on truthful, fair, substantiated and scientifically rigorous claims.
i. Always give an accurate, non-misleading, balanced presentation of our products attributes, including relevant safety information.
ii. Only promote products for uses that have been approved in a manner consistent with the country-specific approved labeling.
iii. Never promise or provide anything of value to reward or encourage the use, purchase or recommendation of our products.
iv. Comply with applicable laws and regulations.
Product Safety and Quality
Patient safety is the highest priority for Camurus. In our research, development, manufacture, storage, distribution and post-marketing activities, we will comply with all applicable laws and regulations, including reporting of safety information designed to ensure the safety and quality of pharmaceutical products. We also will always adhere to our internal policies and standard operating procedures designed to protect patient safety and to ensure quality of our products.
Products on the market will continue to be monitored for adverse events, new and unexpected safety signals and the regulatory agencies will be informed about these in accordance with applicable rules and regulations. Every employee is responsible for reporting any safety or performance issues relating to investigational drugs in clinical trials and our marketed products.
Interactions with Healthcare Professionals
Camurus is committed to, in all interactions with Healthcare Professionals and Organizations, apply the highest standards of integrity and honesty, and follow applicable laws and regulations and codes. There must be legitimate needs for engaging services of HCPs or organizations and any payment for services. Payments may furthermore only be provided if there is a written agreement governing the applicable services, and must not exceed reasonable market rate for such service.
Advertisement and Promotion
Camurus is committed to complying with all applicable laws, regulations and industry codes governing promotional activities and advertising and will conduct these activities in an appropriate and ethical manner.
Applicable company procedures are designed to ensure that our promotional information and advertisements follow applicable regulatory requirements and are accurate, balanced, and supported by scientific evidence, and are not false or misleading.
Interactions with Government Regulatory Agencies
Camurus operates in a highly regulated industry. Governmental regulatory agencies routinely request information during audits, inquiries and investigations. All employees shall deal honestly and professionally with such officials at all times.
Camurus’ suppliers play an important role in our research, development and commercialization of the important medicines to the patients. We will always choose our suppliers based on objective criteria, and with the expectation that our suppliers will act in a manner consistent with our own commitment to lawful, fair and ethical business practices.
Camurus’ employees shall always:
i. Select vendors and suppliers based on objective criteria, such as price, merit, quality, service, reliability, and reputation.
ii. Make sure that vendors and suppliers comply with all legal requirements and local laws, and act in a manner consistent with our commitment to ethics and compliance as outlined in this Code.
iii. Report to the management all allegations of improper business practices, bribery and corruption relating to vendors and suppliers.
iv. Avoid conflicts of interest, inappropriate gifts and entertainment. Never accept any cash, credit, services, payments, loans, personal discounts or other favors from a vendor or supplier.
Anti-Corruption and Anti-Bribery
Employee’s or third party’s acting on Camurus’ behalf should never make a payment or provide a benefit that is intended to improperly influence, or appears to influence, a business decision. This is particularly true in the case of public officials, government employees, health care professionals and organizations, patients and patient groups. Violations of anti-bribery and anti-corruption laws, including local laws, are punishable by substantial fines and penalties, including imprisonment.
No employee shall accept, offer or pay bribes or directly or indirectly accept gifts, hospitality, fringes or compensation in any form from a third party which may be unlawful or which could in any way affect his/her professional judgment in performing any duty or service for Camurus or a third party.
All payments made to a government official or private individual must be reported and appropriately recorded.
Competition and Anti-Trust Laws
Camurus must comply with all applicable competition and anti-trust laws. These laws prohibit agreements with competitors, suppliers and customers to fix prices or to otherwise restrain trade. Antitrust and competition laws are vigorously enforced and can result in enormous financial penalties, as well as possible imprisonment for individuals, and must always be followed.
Camurus does not engage, directly or indirectly, in activities that may be viewed as anti-competitive or unethical, or in any activity involving bid-rigging or boycott. Employees of Camurus should not engage in discussions or activities that could lead to the appearance of improper behavior, and should never discuss issues relating to pricing, sales, inventory, or marketing plans with competitors.
International Trade Controls
In doing international business, Camurus is also committed to comply with laws, regulations, licensing requirements, boycotts, embargoes and other restrictions approved by recognized national and international authorities, including the United Nations, Sweden, European Union, and United States of America. Camurus will always provide accurate and correct information about our products to Customs authorities and other relevant authorities.
Camurus supports the right to engage in personal political activities, as long as these activities remain private, are lawful and ethical, and are conducted on personal time with personal resources.
Camurus employees shall never act, or appear to act, as a representative of Camurus when engaging in personal political activities; or use Camurus’ assets, including work time, equipment or facilities, for personal political purposes, or solicit contributions or distribute political materials during work hours.
Camurus may in the conduct of its business collect and use personal information. Camurus is committed protecting individuals from unauthorized use and disclosure of their personal information, and providing individuals with transparency and choices regarding how their personal information is used.
Camurus will always comply with Data Privacy laws and related regulations regarding collection, use, retention and disclosure of personal data gathered or entrusted to Camurus. Employees shall always respect the sensitivity regarding collected or entrusted personal data, and make sure such data is secure so that the integrity of such data is not risked and that such data are not wrongfully disclosed.
Conflict of Interest
A conflict of interest can occur when an employee's private interest interferes with the interests of the Camurus. We should always avoid that any private interests influences our ability to act in the interests of Camurus, or makes it difficult to perform our work objectively and effectively.
All Camurus’ employees must disclose any situations that reasonably would be expected to give rise to a conflict of interest.
Company records, disclosures and securities transactions
Company records shall always comply with all applicable laws and regulations and company policies relevant to corporate accounting. We will record all transactions on the company books accurately and properly in accordance with generally accepted accounting principles. We will always maintain internal control systems to ensure that all transactions are accurately and properly recorded, and never make any false or artificial entries.
Disclosures of company information shall always be made timely and accurately disclosure of company information to investors. We will comply with all applicable laws and regulations and company policies regarding financial disclosures. All employees involved in public disclosures will familiarize themselves with these laws and regulations and company policies. All communications and disclosures on behalf of Camurus must be fair, true, correct, timely and not misleading and may be made only by authorized individuals. Any uncertainty about the validity of any entry, data, record or report must be immediately reported to a manager or supervisor.
Insider trading is strictly prohibited and we will comply with all securities laws and regulations restricting insider trading of securities. If we become aware of “material non-public information” concerning Camurus, or any company transacting business with Camurus, we will not buy or sell securities of Camurus or the other company, either on our own account or on behalf of Camurus or any others. Moreover, we will never provide material non-public information to others, until it is publicly disclosed in accordance with applicable laws, regulations and company procedures. “Material non-public information” is any non-public information that could have a material influence on investors’ decisions to sell or buy securities. Examples may include issuance of shares, repurchase of shares, mergers and acquisitions, commercialization of new products, progress or failure of clinical trials, and material changes in financial forecasts.
Information is “non-public” if it has not been made generally available to the public by means of a press release or other means of widespread distribution. Information is “material” if a reasonable investor would consider it important in a decision to buy, hold or sell shares or other securities.
The Camurus Insider Policy and the Camurus Communication Policy further specifies applicable standards and obligations in respect of disclosures and insider trading.
Company Property and Intellectual Property
Camurus physical assets, such as equipment, materials, supplies, money, and its intangible assets, like intellectual property, confidential information, value of our products and brand names, business relationships and employees’ time, skills and talent, may be used solely for the benefit of Camurus and its business, and not for personal or any inappropriate purpose.
Employees of Camurus shall not engage in business activities outside Camurus which would negatively impact the attention and time required to fulfil their responsibilities at Camurus or may require that such activities have to be performed during regular working hours at Camurus.
Camurus’ employees shall protect the Camurus’ properties and ensure their efficient use for its different business purposes. The use of Camurus’ funds or assets for personal gains and other improper purposes is strictly prohibited. Camurus’ equipment is intended for business purposes and not for personal use, other than incidental use that is reasonable and permitted by Camurus’ policies.
Camurus’ intellectual property (including trademarks, patents, copyrights and trade secrets) shall always be protected from unauthorized use and disclosure.
Media and communications
Shareholders, investors, partners, customers and the public rely on Camurus’ to provide accurate and reliable information about our operations, performance and future outlook. As information can be spread widely and instantaneously via the Internet and other media, it is important that our communications with external audiences are consistent and aligned with the policies and needs of the company. For this purpose, it is critical that communication is coordinated and only goes via defined functions:
i. Press and media inquiries should be referred to the CEO. Camurus’ business should never be discussed on or off the record.
ii. Investor inquiries should be directed to the CEO or the Head of IR. All meetings with investment professionals should be done after information to, and approval by the CEO.
iii. Speaking engagements always require approval from management, following appropriate internal review and approval processes.
iv. Submission of abstracts and articles for publication always require written approval and following appropriate internal review and approval processes.
The Camurus Communication Policy further specifies applicable standards and obligations in relation to media and communication.
Employees have access to a variety of confidential information while employed at Camurus. Confidential information includes all information that is internally generated by Camurus concerning the business of Camurus. It may also include information obtained from sources outside Camurus, including information about other companies or their securities. Confidential information includes all non-public information that might be of use to competitors, or, if disclosed, harmful to Camurus or its customers. Employees have a duty to safeguard all confidential information of Camurus or third parties with which Camurus conducts business, except when disclosure is authorized or legally mandated. An employee’s obligation to protect confidential information continues after he or she leaves Camurus. Unauthorized disclosure of confidential information could cause competitive harm to Camurus or its customers and could result in legal liability to the employee and Camurus.
Camurus is committed to being a positive workplace, free from discrimination or harassment of any kind. We value the contributions of each individual and group and treat one another with respect, regardless of position, statue or relationship. Camurus does not tolerate any form of harassment and bases all employment-related decisions, such as recruitment, hiring, remuneration, promotion and development opportunities on the job qualifications, merit and/or performance of the individual, without regard to gender, sexual orientation, age, race, or identity expression, or other characteristics protected by applicable laws. Employees should never harass, degrade or discriminate against others and never behave in a violent or threatening manner.
Camurus is also committed to complying with all applicable employment laws and regulations as well as the principles laid out in the United Nations Declaration of Human Rights. Camurus is also respectful of its employees' right to join and form independent trade unions and freedom of association.
Safety, Health and Environment
Camurus always strives to provide a safe and secure work environment where no one is subject to unnecessary risk. Safety and health considerations should be integrated into everything we do. Camurus has adopted policies and procedures to facilitate workplace safety. Employees are expected to identify and understand the risks associated with their work, manage risks responsibly, and only perform work for which adequate training has been provided.
Employees should promptly report all environmental, health and safety issues, including unsafe conditions, accidents, near misses and work-related injuries; and promptly report all security issues, including threatening or violent behavior to their manager.
Camurus is further committed to conducting business in an environmentally responsible way, enhance and reduce the environmental impact of our work and our products and support waste reduction and energy-saving initiatives.
In addition to minimizing the risks for exposure to chemical, biological and other hazards and proactively reduce the risk for accidents in the work place, Camurus supports programs aimed at improving the health and wellbeing of the employees.
This Code, including all matters contained herein, does not constitute any individual third party rights and may be subject to revisions from time to time. Camurus reserves the right to amend or replace this Code, including its content, without prior notice, at any time.