Shire Continues to Uphold High Standards of Ethics and Transparency With Adoption of Open Access Policy for Publication of Shire-Supported Research
Cambridge, MA - January 23, 2018 - Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, has implemented a new publication policy requiring the submission of all Shire-supported research manuscripts to journals that offer public availability via open access, allowing the public to obtain free, unrestricted online access to Shire's research promptly following publication. Shire's open access policy, which went into effect on January 2, 2018, was announced today at the 2018 European Meeting of International Society for Medical Publication Professionals (ISMPP) taking place in London, UK, January 23-24.
"Shire's new open access policy builds on our commitment to transparency and reflects our dedication to helping patients by allowing everyone to freely access and learn from our research findings," said Christopher Rains, Head, Global Medical Affairs - Medical Shared Services at Shire. "We believe it's imperative to pioneer a new standard of access to publications that can encourage collaboration and drive medical innovation, with a goal of helping to bring innovative treatments to patients more rapidly. This may be particularly important when it comes to advancing new therapies for treating rare diseases."
Approximately 7,000 rare diseases have been identified yet the vast majority of these often severe and complex conditions have no specific treatment.
"I believe Shire is the first biotechnology company to mandate that its research be published under an open access model. This approach helps to ensure that research findings can be can be built on by the widest possible audience in a manner that maximises health and public benefit, said Robert Kiley, Head of Open Research at the Wellcome Trust, a charitable foundation that supports scientific research.
In a presentation and panel discussion at the 2018 European Meeting of ISMPP entitled "Time to embrace change in medical publishing," Mr. Kiley and Mr. Rains discussed the importance of increasing the accessibility of publications through open access. Although pharmaceutical companies fund around 60 percent of all medical research, the industry as a whole has been slow to adopt open access policies. With its commitment to an open access policy, Shire hopes to help usher in a new age of collaboration in global medical research.
Shire's open access policy further underscores the extension of the company's commitment to clinical research beyond developing innovative medicine. Shire believes that sharing clinical trial data with patients, healthcare providers, researchers and the public has the potential to improve public confidence in medicine and help all stakeholders make better healthcare decisions. Shire is thought to be the only company to report the results from all of its clinical studies posted on ClinicalTrials.gov.
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NOTES TO EDITORS
Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.
We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people's lives with medicines that have a meaningful impact on patients and all who support them on their journey.
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
- Shire's products may not be a commercial success;
- increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire's future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire's products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire's products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
- the manufacture of Shire's products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- certain of Shire's therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
- Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
- the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire's revenues, financial conditions or results of operations;
- Shire's products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
- adverse outcomes in legal matters, tax audits and other disputes, including Shire's ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the Company's revenues, financial condition or results of operations;
- inability to successfully compete for highly qualified personnel from other companies and organizations;
- failure to achieve the strategic objectives, including expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all with respect to Shire's acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta Incorporated may adversely affect Shire's financial condition and results of operations;
- Shire's growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
- a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
- failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to Shire's reputation, the withdrawal of the product and legal action against Shire;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire's activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
- Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire's revenues, financial condition or results of operations;
- Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs and may decrease its business flexibility;
- Our ongoing strategic review of our Neuroscience franchise may distract management and employees and may not lead to improved operating performance or financial results; there can be no guarantee that, once completed, our strategic review will result in any additional strategic changes beyond those that have already been announced; and
a further list and description of risks, uncertainties and other matters can be found in Shire's most recent Annual Report on Form 10-K and in Shire's subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in "ITEM 1A: Risk Factors", and in Shire's subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire's website.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.