Lexington, Mass. – November 10, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving people with rare diseases, today announced the broad range of research it will present at the 59th American Society of Hematology (ASH) Annual Meeting, taking place December 9-12, 2017, in Atlanta, Georgia. Shire’s presence at ASH spans its hematology and oncology franchises with 2 oral presentations and 7 poster presentations.
“Shire’s commitment to fighting rare disease, particularly in hematology and oncology, is reflected in the company’s strong presence at ASH, one of the world’s premier medical conferences focused on blood disorders,” said Howard B. Mayer, M.D., SVP and ad-interim Head, Global Research and Development, Shire. “We are committed to continuous and ambitious innovation that helps advance the standards of care and improves outcomes in these therapeutic categories where there remains significant unmet patient need.”
The research presented at ASH will showcase Shire’s broad hematology portfolio, which covers a wide range of rare bleeding indications and highlights real-world safety and efficacy data. In addition to presenting new research, Shire will share updates related to its ongoing innovation and promising pipeline of investigational treatments. Shire has provided a grant to support a satellite symposium at ASH hosted by CMEology that is focused on the latest strategies and innovations to help advance best practices in the management of hemophilia:
- Advancing Standards in the Management of Hemophilia A: Contemporary Strategies and Innovations. Friday, December 8, 2017, 6:00-10:00 p.m. EST. Hyatt Regency Atlanta, International Ballroom North. For more details or to register, visit: http://www.hematology.org/Annual-Meeting/FSS/2941.aspx.
Shire’s expertise in rare and difficult-to-treat cancers includes ongoing research into investigational pegylated asparaginase, as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL). The company’s pipeline in oncology includes assets being developed for the treatment of metastatic pancreatic cancer, ALL, lung cancer, as well as early stage checkpoint inhibitor and allogeneic CAR T targets. At ASH 2017, Shire is co-supporting an Independent Medical Education program organized by prIME-Oncology on:
- Optimizing Management of Acute Lymphoblastic Leukemia: From Adolescence to Adults. Friday, December 8, 2017, 12:30-4:30 p.m. EST. Hyatt Regency Atlanta, International Ballroom North. For more details or to register, visit: http://www.hematology.org/Annual-Meeting/FSS/2911.aspx.
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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, 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 may decrease its business flexibility; 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.