Shire's CINRYZE® (C1 esterase inhibitor [human]) Receives FDA Fast Track Designation for Investigation in the Treatment of Antibody Mediated Rejection (AMR) in Patients Receiving Kidney Transplants

LEXINGTON, Massachusetts, October 13, 2015 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CINRYZE^® (C1 esterase inhibitor [human]) for intravenous administration in subjects with Antibody Mediated Rejection (AMR) in renal transplant recipients. CINRYZE is being studied as an adjunct treatment to Donor Specific Antibodies (DSA) reduction therapy in kidney transplant patients with acute AMR.

"There are currently no approved therapies for Antibody Mediated Rejection, a life-threatening and debilitating condition which can manifest in patients receiving kidney transplants," said Philip J. Vickers, Ph.D., Head of Research and Development at Shire. "The Fast Track designation represents an understanding of the significant unmet medical need for this condition. Shire looks forward to working closely with the FDA as we continue to study CINRYZE as a potential treatment option for these patients."

Shire is planning a Phase 3 multi-center, multi-national, randomized, double-blind, placebo-controlled study (SHP616-302) to evaluate the efficacy of CINRYZE (intravenous administration) as an adjunct to DSA reduction therapy (plasmapheresis, plasma exchange, and/or immune adsorption treatments and IVIG) for the treatment of acute AMR in kidney transplant recipients. The trial will be conducted in the United States, Europe and Canada and the study will open for enrollment by the end of October 2015.

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation may provide increased opportunities to interact and meet with FDA, and potentially increases the likelihood of being eligible for priority review if relevant criteria are met.

CINRYZE is currently only approved for, and should only be used to treat, routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

About Antibody Mediated Rejection (AMR) 

AMR is a condition that sometimes occurs in patients following solid organ transplantation and is initiated by the presence of DSA in the transplant recipient. DSA identified prior to transplant (pre-formed) may be a contraindication to transplantation due to the risk of AMR, however DSA can also form after a transplant takes place. AMR can be life threating and debilitating to the transplant recipient, often times resulting in declining organ function and reduced graft survival.

About CINRYZE  

CINRYZE is currently approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. HAE is a rare genetic disease characterized by recurrent sudden attacks of swelling of the skin or the mucous membranes which can be disfiguring, painful and potentially life-threatening in the case of laryngeal attacks.

Indication 

CINRYZE® (C1 esterase inhibitor [human]) is an injectable prescription medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE).

Important Safety Information 

You should not use CINRYZE if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.

Tell your healthcare provider about all of your medical conditions, including if you:

• have an indwelling catheter/access device in one of your veins.
• have a history of blood clots, heart disease, or stroke.
• are taking birth control pills or androgens.
• are pregnant or planning to become pregnant. It is not known if CINRYZE can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if CINRYZE passes into your milk and if it can harm your baby.

Allergic reactions may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms: 

• wheezing 
• difficulty breathing 
• chest tightness 
• turning blue (look at lips and gums) 
• fast heartbeat 
• swelling of the face 
• faintness 
• rash 
• hives 

Serious blood clots may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:

• pain and/or swelling of an arm or leg with warmth over the affected area
• discoloration of an arm or leg
• unexplained shortness of breath
• chest pain or discomfort that worsens on deep breathing
• unexplained rapid heart rate
• numbness or weakness on one side of the body

Because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common side effects seen with CINRYZE were headache, nausea, rash, and vomiting. These are not all the possible side effects of CINRYZE. Tell your healthcare provider about any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also report side effects to Shire Medical Information at 1-866-888-0660, press #2.

Please see Full Prescribing Information. http://pi.shirecontent.com/PI/PDFs/Cinryze_USA_ENG.pdf

About Shire 

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 are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.

http://www.shire.com

THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 

Statements included herein that are not historical facts 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 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 the Shire's products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of the 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 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;
• 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. may adversely affect Shire's financial condition and results of operations; and other risks and uncertainties detailed from time to time in Shire's filings with the US Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.

FOR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations        
Matt Osborne [email protected] +1-781-482-9502

Media        
Liz Kalina [email protected]  +1-781-482-2713

SOURCE Shire plc

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