- Enters 2016 with most robust clinical pipeline in its 30-year history, focused on rare diseases and specialty conditions
- Over 25 clinical development programs planned for 2016 including over 10 in Phase 3
Lexington, Mass. – December 15, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that Flemming Ornskov, M.D., Chief Executive Officer, Shire, will present at the 34th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Tuesday, January 12, 2016 at 2:30 pm PT (5:30pm ET). Dr. Ornskov will provide an update on the business and the progress of Shire’s pipeline at the conference. A live audio webcast will be available on the Presentations and Webcasts section of Shire's Investor website at http://investors.shire.com/presentations-and-webcasts/year-2015.aspx. Subsequently, a replay of the webcast will be available on this same website for approximately 90 days.
“Shire enters 2016 with its most robust clinical pipeline in the Company’s 30-year history,” said Flemming Ornskov, M.D. “Our significant pipeline progress reflects our continued commitment to developing and delivering innovative, best-in-class programs in core therapeutic areas through our internal research and development efforts as well as our strategic acquisitions and partnerships. Our sharp focus on innovation is the driving force behind Shire’s ability to advance its mission of enabling people with life-altering conditions to lead better lives.”
“Shire’s expertise in developing therapies for rare, life-threatening genetic diseases and other specialty conditions is clearly evident from the advancement of our innovative pipeline, with over 25 programs in clinical development. In 2016, our pipeline will include more than 10 programs in Phase 3 trials and compounds already under regulatory review, such as lifitegrast (SHP-606) for Dry Eye Disease in adults,” said Philip J. Vickers, Ph.D., Head of Research & Development, Shire. “We continue to leverage a number of innovative platforms and technologies to advance our pipeline and are excited by the potential of these therapies for patients with severe unmet needs.”
Shire’s portfolio programs focus on five distinct areas: Complement Biology, Central Nervous System (CNS)/Neuromuscular diseases, Gastroenterology (GI)/Endocrine/Metabolic diseases, Ophthalmic diseases and Renal/Fibrotic diseases.
Shire’s planned Phase 3 programs for 2016 include:
- SHP-465 for ADHD in adults
- SHP-640 for Infectious Conjunctivitis (viral and bacterial)
- SHP-620 (maribavir) for CMV infection in transplant recipients
- SHP-621 for Eosinophilic Esophagitis
- SHP-609 for Hunter Syndrome-intrathecal delivery (Phase 2/3)
- SHP-555 in the United States for chronic constipation
- SHP-616 (CINRYZE) for Antibody-Mediated Rejection (AMR) in kidney transplant recipients
- SHP-616 (CINRYZE) for Acute Neuromyelitis Optica (Phase 2/3)
- SHP-616 (CINRYZE) for subcutaneous delivery for Hereditary Angioedema (HAE) prophylaxis
- SHP-616 (CINRYZE) for HAE prophylaxis in Japan
- INTUNIV for ADHD in Japan
- LDX for ADHD in Japan
- GATTEX for Short Bowel Syndrome in Japan
- FIRAZYR for Hereditary Angioedema (HAE) in Japan
Pending the approval by Dyax shareholders and the close of the proposed acquisition by Shire of Dyax Corp., Shire’s Phase 3 pipeline would also include DX-2930. A long-acting injectable monoclonal antibody for HAE prophylaxis, DX-2930 has the potential to lower rates of HAE attacks and significantly improve patient convenience based on clinical trial data reported to date. DX-2930 received Fast Track, Breakthrough Therapy and Orphan Drug designations by the FDA and Orphan Drug status in the EU. If approved for the prevention of angioedema attacks in patients with HAE, DX-2930 could expand HAE-treated patients and generate estimated annual worldwide sales of up to $2 billion with anticipated regulatory exclusivity beyond 2030.
The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 as amended (HSR Act), which is applicable to the proposed acquisition of Dyax by Shire, was terminated by the United States Federal Trade Commission (FTC) on December 2, 2015. Termination of the HSR Act waiting period is one of the specified conditions required for the transaction to close. A Dyax shareholder meeting to vote on the proposed acquisition is scheduled for January 21, 2016.
Shire updates its pipeline on a quarterly basis. The current pipeline can be found in the Q3 2015 results presentation located at http://investors.shire.com/~/media/Files/S/Shire-IR/quarterly-reports/2015/q3-2015-presentation-23-october-2015.pdf.
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NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts, including without limitation statements concerning our proposed acquisition of Dyax Corp. (Dyax) and the timing and financial and strategic benefits thereof, the anticipated timing of clinical trials and approval, as well as the commercial potential, for DX-2930 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, that:
- Shire’s and Dyax’s products may not be a commercial success;
- product sales from ADDERALL XR and INTUNIV are subject to generic competition;
- the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for Shire's products may affect 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 significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- Shire and Dyax have portfolios of products in various stages of research and development. The successful development of these products, including DX-2930, 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 condition or results of operations;
- 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;
- adverse outcomes in legal matters 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 Shire’s revenues, financial condition or results of operations;
- Shire faces intense competition for highly qualified personnel from other companies and organizations. Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect Shire’s ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
- failure to achieve Shire’s strategic objectives with respect to the acquisition of NPS Pharmaceuticals Inc. and Dyax may adversely affect Shire’s financial condition and results of operations;
- Shire's strategy to acquire Baxalta may not be successful: Baxalta may refuse to cooperate with Shire; if the proposed combination is consummated, the businesses may not be integrated successfully, including that expected synergies and other benefits of the combination may not be realized and unforeseen costs may arise; and disruption caused by the proposed transaction may adversely affect Shire;
- 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’s proposed acquisition of Dyax may not be consummated due to the occurrence of an event, change or other circumstances that gives rise to the termination of the merger agreement;
- Dyax may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other business partners pending the consummation of the proposed acquisition by Shire, or Dyax’s business may be disrupted by the proposed acquisition, including increased costs and diversion of management time and resources;
- difficulties in integrating Dyax into Shire may lead to the combined company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or
- other benefits at the time anticipated or at all; andother risks and uncertainties detailed from time to time in Shire’s and Dyax’s filings with the Securities and Exchange Commission, including those risks outlined in “Item 1A: Risk Factors” in Shire’s Annual Report on Form 10-K for the year ended December 31, 2014.